DISIENTa: enero 2022

miércoles, 12 de enero de 2022

¡EA, EA, EA, EL CENSOR SE CABREA!

Pizarra #44 del canal de télegram Donde las dan las toman.

¿Deseas una sociedad tutelada, un sistema en el que el parecer de unos se juzgue mejor que el de otros, un enjuague paternalista por el cual ciertos valores contingentes representen más que otros absolutos como el de la Libertad? ¿Mantienes que los oyentes o los lectores deben ser protegidos porque su criterio es débil y que necesitan ser auspiciados por los que se arrogan la posesión de principios morales sólidos y consistentes? ¿Crées que la individualidad no vale nada?

Modificar las reglas del juego a mitad del partido se ha vuelto muy habitual y no por eso menos inadmisible. Las decisiones se improvisan y las normas se crean sobre la marcha. Ponte una mordaza, que no sabes protegerte; distánciate de todos, que te juntas demasiado; tómate tu medicina o no te curarás.

A los que hemos pasado una infancia llena de preceptos y órdenes, en un país oprimido, que a estas alturas nos traten de tontos nos toca directamente los cojones. A lo largo de los arrestos domiciliarios masivos que sufrimos en Bozalia (1) advertí que el número de policías era insuficiente, es decir, no había agentes para perseguir el normal ejercicio de los derechos constitucionales, y es que por más que se limite la Libertad y se inventen disposiciones despóticas que traten de terminar con ella, el número de personas a vigilar siempre será muy superior al de vigilantes que traten de llevar a la práctica los estúpidos e ilegales mandatos. El número de censores igualmente, siempre será escaso a pesar de que la inteligencia artificial haya llegado como infausta asistencia ¿A cuántos de ellos se habrá de recurrir para controlar cada medio, artículo, persona o pensamiento? Solo la falta general de resolución y ánimo podrá hacer una función supletoria para lo que de otro modo sería inalcanzable (2).

Alfonso Longo afirma que las democracias son ya regímenes políticos que pertenecen al pasado y puede que en la práctica sea así pero nominalmente no lo es. En teoría los regímenes absolutos vivieron su canto del cisne a partir de 1789 y en las constituciones y declaraciones internacionales se consagraron los principios que ahora son vulnerados groseramente.

La censura, como todo, tiene sin embargo su parte positiva. Si durante los grises y fríos años de la dictadura franquista los creadores tuvieron que proveerse de ingenio para contrarrestar la burda e inculta zarpa de los censores de bigotillo, en estos tiempos en los que las agresiones a la libertad son tan abundantes, los nefastos Google, Instagram, Facebook, Twitter, Pinterest, Linkedin, Ivoox y tántos otros brindan la oportunidad de desenvainar el florete y exhibir con destreza lo que la necedad y el servilismo tratan de ocultar con torpeza.
Recuerdo que en las fiestas locales de hace años existían los llamados juegos florales en los que los poetas libraban con su sagacidad batallas incruentas a base de versos. En estas circunstancias los creadores han de porfiar en combates semejantes de brillantez y astucia. En cierto medio de difusión cuya labor debería ser la de proteger y flanquear el libre discurrir de las ideas y favorecer la mayor libertad posible se me ha venido censurando ya en dos o tres ocasiones.
Los abyectos censores cercenaron parte de mis emisiones radiadas en función de criterios espurios e ignotos, imposibles de hallar en sus propias normas públicas de funcionamiento. Reprochada y recurrida la artimaña esperé durante semanas una explicación, si no plausible, al menos con un mínimo de fundamento o lógica que avalase tan mezquina actitud, para al cabo recibir la respuesta de que se había procedido a un ajuste de orden técnico (3).

¿Es la censura inocente?¿Se trata de procedimientos arbitrarios pero sin consecuencias? ¿Atañe solo a detalles o a cuestiones insignificantes? ¡De ninguna de las maneras! La censura es responsable de crímenes atroces y causa el sufrimiento y la muerte de las personas. Limitar la información en determinados ámbitos es una conducta tan irresponsable que puede llevar a la toma de graves decisiones con consecuencias fatales. No hay más que ver los razonamientos del Colegio de Abogados de la India respecto a la criminal ocultación de información por parte de la OMS y sus consecuencias en víctimas humanas (4). Cuando Google, por ejemplo, censura los resultados que pueden conducir a tratamientos o a averiguaciones concernientes a la salud, se está dirigiendo a millones de personas en una dirección absolutamente contraria a sus intereses y al bien común.

El sonsonete de «se han violado las normas de la comunidad» no engaña a nadie. Con ese pretexto en realidad se manifiesta que se ha expresado libremente una opinión legítima pero contraria a los mezquinos intereses del propietario globalista del medio. En ciertos países africanos algunas de estas impresentables redes sociales se han prohibido, al estimarse incompatible su actuación con los principios de los países democráticos (5), mientras que en los Estados Unidos el discurso de Trump llamando a la paz social el 6 de enero de 2021 fue bloqueado en la mayoría de las redes cómplices con el objetivo de incriminarlo y sin consecuencia alguna.

Esto se hace estatalmente pero ¿qué puede hacer un ciudadano común en la lucha contra estos gigantes de la esclavitud y de la cobardía? Se puede responder de varios modos. Si la censura es generalizada y escandalosa, hay que denunciarla en toda su dimensión, sobre todo en otras redes sociales y si es posible judicialmente, y alejarse en consecuencia de la red en cuestión. Si se trata de episodios puntuales o subsanables, deberán recurrirse en la propia red y tratar por todos los medios de que no sucedan, advirtiendo en cualquier caso de la enorme repercusión de su aplicación.

A quien no ha antepuesto con brío y determinación sus valores morales y se ha dejado envenenar, la defensa de la libertad de expresión le parecerá un asunto menor, puesto que ni siquiera se ha levantado previamente en defensa de su propia salud o de los derechos inalienables que se creían mas asentados. A los naturales de algunos países que aún viven bajo el yugo autocrático tal vez les parezca admisible que existan estos continuos ataques a la libertad de expresión, pero a los que hemos vivido bajo una dictadura no nos hace ni pizca de gracia este reiterado ultraje. En resumidas cuentas, señor censor: respétese, encuentre una profesión más digna, deje de ejercer su labor infame de mancillar los derechos y libertades de las personas y pásese al bando de los que luchan con fe y valor por la Libertad y por la vida.

No se me dio respuesta acerca de por qué fue censurado el símbolo de la bandera de Gadsden y por qué se volvió a autorizar su uso cuando aflojé la mosca. Tampoco es necesario: a poco que se discurra, la razón se vuelve evidente para cualquiera (6).

Si se reflexiona un poco, la defensa encarnizada y a ultranza del pase vacunazi que constate o apremie una inoculación tóxica colectiva tiene el mismo carácter que la censura en los medios, ya que lo que pretende establecer es un pensamiento único del que nadie ose desplazarse. Las razones de «salud pública» son patrañas inverosímiles toda vez que ha quedado perfectamente constatado en Israel, Gran Bretaña, Irlanda o en la sumisa Gibraltar del ¡118 % de tasa inoculatoria! que cuanto mayor es el porcentaje de la inoculación tóxica, mayor lo es también el de discapacitados permanentes y fallecidos (7). Así pues, que no se presenten la seguridad, la salud o el ascendiente de la ciencia como motivos inspiradores pues el propósito último es el castigo inmediato de la disidencia, al igual que pretende la censura.

Cuando en la mencionada plataforma eliminaban los vínculos en la descripción del podcast, pensaba: «Bueno, ahí al menos tienen la excusa de proteger la fuga de lectores u oyentes hacia medios de la competencia. No es algo ideológico sino puramente mercantil». Cuando acto seguido y tras enorme mosqueo del censor fueron suprimidas ante mis ojos en tiempo real, a zarpazo limpio, todas las referencias a fuentes en la descripción del programa, no pude por menos que titular esa parte: ¡Ea, ea, ea, el censor se cabrea! Me pareció una conducta tan pueril y fuera de lugar como para no poder ser descrita de otra manera que con esa tonada de patio de colegio (8).

___________________
Referencias.

1. Bozalia, covidicio y un sinfín de otros términos ocurrentes han sido ideados y usados por el chispeante Colin Rivas <https://t.me/colinrivas>

2. «Hasta ahora habéis creído que existen tiranos. Y bien, os habéis engañado, no hay sino esclavos: allí donde nadie obedece, nadie manda»
Anselme Bellegarrigue. Manifiesto. Leído en el canal de télegram Inmune al rebaño <https://t.me/inmunealachusma>

3. La cuestión aún se halla en revisión por mi parte.

4. La censura y la desinformación puede tener graves consecuencias. En el caso contra Soumya Swaminathan emprendido en la India las agencias de verificación (también conocidas como intoxicadores informativos a sueldo del globalismo) se han apresurado a asegurar que el Colegio de Abogados de la India es una asociación privada de escasa relevancia. Su nuevo intento de control de daños ha sido inútil. En la página del Colegio de Abogados de la India podemos leer:

«La agenda patrocinada para impedir el uso de la ivermectina y poner en peligro la vida de los ciudadanos fue detenida en seco, debido a la firme posición adoptada por el Gobierno de Goa y el Tribunal Superior de Bombay.

»El Colegio de Abogados de la India ha puesto de manifiesto la mala fe de la doctora Soumya Swaminathan al suprimir los datos auténticos de la Front Line Covid-19 Critical Care Alliance (FLCCC) y del British Ivermectin Recommendation Development Panel (BIRD)».

»El Colegio de Abogados de la India ha instado a que se emprendan acciones en virtud de la sección 302 y otras relativas del Código Penal de la India contra la doctora Soumya Swaminathan y otros, por el asesinato de cada persona que muera debido a la obstrucción en el tratamiento de pacientes de COVID-19 de forma efectiva por la ivermectina. El castigo bajo la sección 302 del Código Penal Indio es la pena de muerte o la cadena perpetua.

»La acción del CAI de cursar una notificación oficial a la doctora Soumya Swaminathan, ha cosechado un inmenso aprecio y un amplio apoyo de numerosos internautas, incluyendo médicos, activistas, periodistas, líderes políticos y grupos de medios de comunicación».

<https://indianbarassociation.in/indian-bar-associationiba-vs-dr-soumyaswaminathan/>

5. Twitter es prohibido en Nigeria por censurar un tuit del presidente del país.
<https://www.bbc.com/news/world-africa-57368535>

6. Solución: descensura censitaria. Pues muy bien entonces. Cojonudo <https://www.ivoox.com/podcast-templanza_sq_f11382348_1.html>

7. Convengamos que, cuando un remedio no funciona, es absurdo aumentar la dosis y lo que hay que hacer es buscar otro o, en este caso, suspender su uso y dejar de lucrar a las farmacéuticas, pues la enfermedad había remitido ya antes del inicio de la campaña genocida. La circunstancia de Gibraltar, con más inoculados que habitantes es paradigmática. Antes de la campaña de administración de venenos la enfermedad en cuestión no existía. Esta circunstancia se ha repetido en gran cantidad de países cuyos problemas empezaron con las dosis. No se ha llegado a tal cantidad de enfermos, discapacitados y fallecidos a pesar de las inoculaciones sino a causa de ellas. Esta es una verdad de perogrullo que cualquiera con un poco de sentido común puede admitir.

Si hay fallecidos los tests no son necesarios, cuando no los hay, los globalistas recurren a las pruebas diagnósticas masivas cuyo simple porcentaje admitido de fallos fabricará las olas que hagan falta. A partir de ahora, con un número cada vez mayor de decesos las autoridades simulan una hipócrita sorpresa y de ninguna manera reconocerán que no se trata de cáncer, ictus, ataques cardíacos, obesidad, hipertensión o suicidios sino el efecto combinado de las inoculaciones, la detracción de oxígeno de las mordazas, el aislamiento, el deterioro del sistema inmunitario y la consecuencia en suma de todas las medidas que se han tomado en contra de la población.

<https://www.riotimesonline.com/brazil-news/modern-day-censorship/in-gibraltar-100-of-adults-are-fully-vaccinated-against-covid-19-and-yet-new-cases-are-exploding/>

<http://opinionatedbastard2021.com/2021/11/30/the-world-gibraltar-and-vaccine-failure/>

8. Compruébese en las referencias finales de la descripción en <https://www.ivoox.com/sofrosine-audios-mp3_rf_77966945_1.html>

9. “El moho nunca duerme”. Me acaban de llegar noticias de un nuevo tipo de aviesa censura diseñada a medida para cada usuario de internet, llamada DRM (Digital Rights Management) que prohibe el acceso a ciertos contenidos. Habrá que vigilar su uso y consecuencias sobre la limitación de derechos y libertades puesto que lo que en teoría se presenta como una herramienta de protección de la propiedad intelectual puede ser torticeramente empleada como shadow banning o censura no declarada para restringir la libertad de expresión y la distribución de la obra de los creadores. Me aseguran que la audición de mis podcasts está siendo coartada también por esta vía.

lunes, 10 de enero de 2022

PALIMPSESTO

https://www.ivoox.com/palimpsesto-audios-mp3_rf_80561249_1.html

“Es inadmisible pedir que yo reniegue de mí mismo en provecho de todos, porque si todos deben renegar de sí como yo, nadie ganará en este estúpido juego más de lo que ya habrá perdido y, en consecuencia, quedará igual, es decir, sin provecho. Evidentemente, esto haría absurda la renuncia inicial. Y si la abnegación de todos no puede beneficiar a todos, necesariamente beneficiará a algunos en particular. Entonces, estos últimos serán los dueños de todo y también, probablemente, los que se dolerán de mi egoísmo. Pues bien, que se fastidien.”

Anselme Bellegarrigue.
Manifiesto.

Cuando en mi camino hacia el instituto Padre Suárez, pasaba por la calle Gracia, a unos metros de distancia de la casa de la emperatriz Eugenia de Montijo, me asomaba fascinado a las ventanas de la Escuela de Artes Aplicadas y Oficios Artísticos. Allí, en una habitación llena de polvo y objetos extraños, estaban los dioses del Olimpo. Provistos de un gran martillo cuadrangular, alzaban y descargaban sus brazos, dando forma a las rocas, los alumnos de talla; lo que para mí era sin duda la actividad humana más esforzada, compleja y sublime.

El 14 de octubre de 2021 envié el texto de mi primer podcast y fue emitido. Cuando tuve que rellenar la hoja de inscripción en el sistema titulé a esta serie de programas “Templanza”, que fue lo primero que se me pasó por la cabeza. La sofrosine clásica es más un propósito que un rasgo afianzado en mi carácter. Los arrebatos y la impulsividad son actitudes que genéticamente han sido transmitidas por mis ancestros y que pretendo mantener en parámetros aceptables.

Al cabo del tiempo he conseguido muchos de mis sueños. Tallar la piedra y radiar emisiones con mis propios textos no han sido dos de los menores entre ellos. Quiero agradecer al Universo y a usted la bondad que tienen al hacerme caso, al concederme mis caprichos y al contribuir a que se materialicen mis deseos. Sin ambos en torno a mí y al otro lado, nada de esto sería posible.

Lo que nace de la sinceridad, de la bondad y de la entrega tiene por fuerza que prosperar y ser atendido. Por eso el engaño, la maldad y el trabajo desde las tinieblas de los inicuos globalistas obtendrá un estrepitoso fracaso y ayudará a la transformación planetaria hacia la luz y la fraternidad humana. Tengamos fe y templanza; exhibamos comprensión y justicia; y dejémonos guiar ante todo por nuestro corazón y por nuestros mejores y más humanos sentimientos.

Dicho esto he de renocer que tengo una deuda que es preciso saldar, para lo cual debo rendir tributo a mi gran amigo David, que ha corregido todos mis escritos y les ha sacado brillo, elaborando algunas de las frases más destacadas y lapidarias que me atribuyo. Si tengo el atrevimiento de no mencionar su extraordinaria colaboración se debe solo a su irracional y desmesurada modestia. Sirvan estas líneas no obstante para dejar constancia de mi aprecio y de la parte de la autoría que le corresponde.

En este último espacio de la primera temporada de Templanza, voy explicar algunas de las afirmaciones vertidas y a rectificar algunos errores que, sin querer, he cometido.

UN LIGERO MATIZ
https://www.ivoox.com/un-ligero-matiz-audios-mp3_rf_76818899_1.html

Entonces creía que los artículos que había publicado en Euskalnews me darían para mucho tiempo porque ya llevaba bastantes. Me propuse publicar cada seis días pero creo que he roto esta pauta al final en dos o tres ocasiones. En este episodio desarrollé una interpretación bastante histriónica, cercana a la de los actores de la Comedia del Arte. Estaba explorando las posibilidades de la entonación en los podcasts y el resultado me hizo bastante gracia, Además, no tenía los conocimientos suficientes sobre edición de audio y lo dejé sin banda sonora.
Cito un libro de Dale Carnegie (1) que recomiendo a todo el mundo para desarrollar la empatía de la que nunca se anda sobrado. Su capítulo quinto de la cuarta parte se titula: "Permita que la otra persona salve su prestigio".
Al principio de este libro se puede leer: "Tengo bajo la ropa un corazón fatigado, un corazón bueno: un corazón que a nadie haría daño". Quien así se expresaba era "Dos Pistolas Crowley" un asesino frío y sanguinario que no se lo pensaba dos veces a la hora de descerrajar un disparo a alguien.
Todo el mundo suele tener un buen concepto de sí mismo, pese a cometer las mas injustificables fechorías y es seguro que esto también se aplica a los infames globalistas y sus palafreneros. Es inevitable que se piense que mis predicciones son sumamente optimistas, de hecho Alfonso Longo piensa que ya vivimos en regímenes totalitarios. No le falta razón, pero la realidad la creamos nosotros mismos y que lleven a término todos sus siniestros planes aún está por ver.

NEGACIONISTA... ¡TU PASTELERA MADRE!
https://www.ivoox.com/negacionista-tu-pastelera-madre-audios-mp3_rf_77161309_1.html

En este episodio uso por primera vez mi composición "Snow flakes" pero sin montaje de audio, me limitaba a subir y bajar el volumen del ordenador conforme iba hablando. Tampoco corto reiteradas reiteraciones, balbuce-e-e-e-os ni chasquidos -tsk- y puede apreciarse la diferencia respecto a posteriores emisiones.
No, no, no. No quise emplear el título como eufemismo de... "tu puta madre" --- Hubo un comentario de alguien a quien le pareció mal el título. En realidad es un homenaje a la película de Forges: "El vengador gusticiero y su pastelera madre.”
Si fuera un eufemismo lo sería en cualquier caso de "puñetera". -

CON CALIFICAR A ALGUIEN COMO NEGACIONISTA O CONSPIRANÓICO YA ESTÁ RESUELTO EL TEMA, HALA.

No hay que consentir los insultos y menos las palabras comodín sumamente peiorativas.
Es como si te dijeran “apestado” o “hereje”. Son eufemismos para no llamarte a la cara nombres peores, improperios que agravian y ofenden y que definen la intención del que los utiliza de asumir sin razonar los cuentos chinos que inventan gobiernos y grandes compañías farmacéuticas.

LOS AFIRMACIONISTAS

El calificativo irónico “afirmacionista” es usado para señalar que los globalistas son los que niegan, censuran, prohiben y castigan ante su carencia de pruebas científicas y su descalificación de cualquier razonamiento lógico.

INOCULACIÓN DE PATÓGENOS

La batalla semántica es importante. No se puede llamar vacuna a un cóctel químico en cuya documentación se puede leer “no contiene el virus atenuado”. En realidad, una vacuna es por definición una inoculación de patógenos, el virus atenuado lo es, pero me he querido referir aquí a todos los patógenos reconocidos que cualquiera que no deje por sistema su salud en manos de terceros podrá reconocer, previa lectura del prospecto (2) o de la ficha técnica. Es muy fácil hacerlo y quien no se tome la molestia, podrá reclamar con posterioridad pero su desinterés e ingenuidad hablan por sí mismos. Puede contemplarse esta abdicación en la protección de la propia vida, como uno de los mas claros casos de “acto fallido” o “desliz freudiano” , es decir, una acción contraria a la intención consciente del sujeto, mediante este olvido, u omisión inexplicable.

NOTAS Y REFERENCIAS DE FUENTES

He necesitado ocho podcasts para darme cuenta que este tipo de emisiones no son trabajos monográficos de carácter científico. Desde el principio he querido mostrar que mis afirmaciones no son opiniones de taberna y que vienen respaldadas por datos de fuentes primarias y por artículos científicos que todo el mundo puede contrastar y rebatir llegado el caso. Esto está muy bien pero en emisiones radiadas no funciona. He de reconocer que puede hacerse muy pesado y tremendamente aburrido. Los artículos que he publicado en otros medios tenían al principio este aluvión de notas y referencias pero al final he optado por incluirlos exclusivamente en mi blog político disienta.blogspot.com, sobre todo a partir del episodio nueve, que dediqué a las mascarillas (3). Esto tiene un gran inconveniente pues blogger pertenece a google por lo que se deduce que, si se observa cierta afluencia o si el artículo deja en evidencia las vergüenzas del globalismo, será censurado o el blog clausurado como google ha hecho sistemáticamente en otros casos

AUTORES, COAUTORES Y COOPERADORES NECESARIOS

Sí, tengo una cierta formación jurídica. La mínima como para no dejar que una circular o una norma autonómica de ínfimo rango se me imponga por encima de la Constitución o de Leyes orgánicas o para que cuando el gobierno aprueba un Decreto-ley advierta su nulidad si entra en contradicción directa con preceptos constitucionales. Me ha sorprendido que funcionarios que juran la Constitución en la toma de posesión de sus cargos y que han estudiado largas horas su articulado para conseguir su plaza la hayan olvidado o hayan exhibido su deslealtad y perjurio de forma tan obscena.

PERO QUE HAY FUNCIONARIOS QUE…
Hay mucha gente que está y se está prostituyendo, es decir, que está abusando con bajeza (4), y que muchos proxenetas se están enriqueciendo a base de estos abusos es evidente. La cuestión es que es cómodo “subir al carro del vencedor” en cierto momento pero se subestima con ligereza la posibilidad que el golpe de Estado planetario que respaldan fracase, en cuyo caso serán plenamente conscientes de las consecuencias de su precipitación.
Resulta que la rebelión ha llegado doce años antes de lo que los globalistas en su ensayo Escenarios para el futuro de la tecnología y el desarrollo internacional -y eso sí que es un buen eufemismo- preveían en el escenario “Confinamientos”, que es el que finalmente han elegido.

PROFUNDAMENTE HUMANO
<https://www.ivoox.com/profundamente-humano-audios-mp3_rf_77280254_1.html>

Fue este el primero con edición de sonido y por mi inexperiencia cometí algunos errores como confundir la graduación del volumen con la de los canales izquierdo y derecho, pero la verdad es que no se notó mucho.
Siempre he ido en exteriores sin mascarilla porque el terrible objeto de la sumisión sirve para extender epidemias, empeorar drásticamente el estado de salud de la población y bajar la autoestima.
Mientras trabajé me tuve que aguantar, pero, aun sin haber ejercido en absoluto tareas de policía, me ha pesado hondamente el maltrato de menores ejercido y mi salud se ha deteriorado de forma evidente desde el primer día, lo cual he debido suplir con la ingesta de vitaminas, con la aplicación de tintura de propoleo sobre su interior, con el doblado de la mascarilla hacia fuera, no hacia dentro, para evitar el caldo de cultivo que la humedad ofrece a las bacterias, con su lavado diario y con el uso de mascarillas con pequeños motores de ventilación o la colocación de otras semirígidas con amplias aberturas por donde circula el aire. Remito a la audición del episodio nueve, titulado “Suicidio colectivo” (3) de donde podrá inferirse un balance de los numerosos fallecidos y enfermos que esta práctica inhumana ha producido.

NO HAY COSA MAS RIDÍCULA

Ignoro quién fue el inventor del toque de codos pero el infantilismo y la estupidez del saludo pasarán a la historia para irrisión de las generaciones venideras. Efectivamente, los propios globalistas han abandonado esa práctica y la han sustituido por el choque de puños estilo Shazam y últimamente por el cruce de muñecas. Lo cierto es que la corrección política de los globalistas suele llamar la atención por su ñoñez, he ahí otro de sus puntos flacos.

CUÍDATE
<https://www.ivoox.com/cuidate-audios-mp3_rf_77690891_1.html>

Esta especie de “diez mandamientos” que me inventé sobre la marcha tienen el sentido y el alcance que cada cual les quiera dar. El tema me lo sugirió la expresión de un familiar: “Sé que vosotros os cuidáis” y acertó de lleno. Me temo que alguno de los preceptos puedan ser malinterpretados. A ver.

DESHAZTE DE LA TELEVISIÓN

Salir de la televisión, como de cualquier otro tipo de droga, es posible. Nací en una época en la que no había televisores pero cuando llegó el primero, en blanco y negro, con un solo canal y baja calidad de imagen, su fascinación se apoderó de todos. — He sido telespectador compulsivo pero las circunstancias me han ayudado a abandonar la adicción. — Es más fácil, desde luego con la ayuda de alguien — En las circunstancias actuales, el aparato que ocupa el sitio central de una casa, el que antes era reservado para el hogar de la chimenea, se ha vuelto una máquina diabólica de vulgarización y mentira. —- Cierto es que pueden encontrarse películas, documentales, conciertos y programas muy interesantes pero el precio a pagar por tener a un golpe de pulgar una cascada de mentiras,— la velocidad a la que las personas con la apariencia más seria vierten sartas de embustes, —— la continua intoxicación que crea una realidad ficticia, —— la manera de tergiversar las noticias verdaderas, manipularlas y construir castillos enormes de falsedad y engaño, — hacen que este electrodoméstico en apariencia inocente y amable suponga un peligro extraordinario. Tal vez en el futuro la televisión recupere su capacidad de veracidad y de sano entretenimiento, ahora, su uso masivo es sinónimo de esclavitud, enfermedad y muerte.

SEPÁRATE DE LOS NECIOS

Esta es una de las frases de las que mas me he arrepentido, sobre todo, porque puede interpretarse en forma muy negativa. Cuando la escribí pensaba en aconsejar una actitud que condujese a la paz cuando una situación de convivencia se hubiera hecho insoportable. Pensaba en el caso que me refirieron de una pareja en la que las dudosas medidas de prevención de contagios se habían vuelto obsesivas y patológicas hasta el punto de hacer imposible la convivencia. En tales casos, la ayuda psiquiátrica es necesaria y la separación puede verse como una decisión aconsejable para que uno de los convivientes no arrastre al otro hacia la enfermedad mental. Tengo por cierto que los que se provéen de bozales en la conducción o en solitario pasean amordazados por parajes recónditos son personas que necesitan urgente atención médica y no precisamente por cuenta de las enfermedades físicas que padezcan. El bozal que enferma y mata se ha vuelto para muchos una especie de chupete adulto y nadie logrará separlos de él sin provocarles ataques de ansiedad, ni siquiera cuando ingresen en un frenopático.
Por otra parte, considerar que todos los inoculados sean necios constituye una generalización exagerada. Que han tomado una decisión equivocada… ¡por supuesto! pero muchas personas inteligentes lo han hecho movidas por los motivos más diversos.

SOFROSINE
<https://www.ivoox.com/sofrosine-audios-mp3_rf_77966945_1.html>

Aunque a los aficionados al cine pueda haberles parecido un sacrilegio haber usado el impresionante parlamento de Taxi Driver (5). En el momento actual, somos, muchos los que podemos caer en la tentación del desprecio, y ser invadidos por similares sensaciones de asco. Si lo hacemos, los que han montado todo este lío se habrán salido con la suya. No somos mejores que los que se inyectan tres, cuatro o cinco dosis de venenos sino la misma humanidad despreciada, la misma carne de cañón utilizada. Sigamos adelante mostrando una dignidad estóica y una unidad sin fisuras.

MILES DE PROCESOS JUDICIALES

Sí, miles de procesos están teniendo lugar pero aún se veta el acceso a la información de los que han arrojado resultados favorables. La censura criminal es ferrea y se pretende ocultar las buenas noticias para el flanco de la luz, mientras que se divulga cualquier escaramuza desfavorable y somos tan ingenuos de hacernos eco de sus noticias propagandísticas. ¿Qué se tiende a pensar cuando se difunden las terribles medidas tomadas en algunos países? Pues que estamos perdidos, que el horizonte es sombrío, adónde huir o cómo hacer frente con heroicidad a lo que se nos viene encima. Bien se cuidan ellos de suprimir informaciones de las batallas ganadas a diario, aunque a veces, como en el caso de los deportistas que caen fulminados en el terreno de juego o de personas célebres que fallecen, les sea imposible ocultarlo y desplieguen una cortina de falsedades, conociendo que disponen de un público fiel que, de momento, se lo traga todo. Pero hay muchos indicios de que el despertar de los que han sesteado tan largo tiempo se está produciendo ya (6) y además tiene lugar como una reacción en cadena difícil de contener. En cualquier caso, la duda crece entre los sometidos y no se puede estar pinchando continuamente a la gente sin que reaccione.

…LO SEGUIRÁN EJERCIENDO SIEMPRE

Con la esperanza de que su comportamiento servil les granjeará una fastuosa salida del cargo, he visto pasar a numerosos gobernantes que, una vez fuera del poder, han caído en desgracia. La coyuntura política ha cambiado y los jueces que antes se hallaban bajo sus órdenes, han instruído y juzgado con posterioridad los delitos cometidos. Esto es así, pero los presidentes de gobierno tienden a olvidarlo.
Bien es cierto que no suelen ingresar en prisión pero no lo es menos que cuánto mayor ha sido el desprecio ejercido más probabilidad existe de que algunos de los agraviados que quedaron en el camino tengan éxito en su reclamación última de justicia.
Es cierto que el “Señor X”, por ejemplo, no pagó el precio que sus transgresiones hubieran merecido, mientras que algunos de sus subordinados inmediatos ingresaron en prisión, pero entonces se cometieron 27 asesinatos (7) mientras que la cuenta actual, solo con el genocidio de ancianos en residencias, ya alcanzó los miles, y millones son los discapacitados o arruinados.

LAS VÍCTIMAS PRODUCIDAS POR LAS INOCULACIONES DE PATÓGENOS

Estas eran cifras de principios de septiembre de 2021. Ahora los datos oficiales hablan de 60000 fallecidos y de 9.000.000 de lesionados, las reales son entre diez y cien veces mayores. España ha entrado ya en descenso poblacional (8).

DIGNIDAD Y AMOR PROPIO
<https://www.ivoox.com/dignidad-amor-propio-audios-mp3_rf_78213665_1.html>

Una vez dominado el mecanismo de control del estéreo, en este episodio quise explorar sus posibilidades, e hice que algunas palabras, como los números de las citas, o el propio título del episodio, solo se oyesen por el canal izquierdo.

PÁRATE A PENSAR UNA COSA…

Mi acento granadino relajado hace los plurales con vocales abiertas pero en esta serie de podcasts he optado por un castellano más neutro. Por eso se me ocurrió en este episodio recortar por software la sibilancia de las esess finaless. Probablemente habrá pasado inadvertido y el resultado es bastante curioso. Lo hice en todos los plurales.
No contaba con que el propio sistema de emisión realizara una nueva compresión del archivo de audio, produciendo una pérdida de calidad de sonido adicional, y el producto final difiere mucho del original que yo elaboro.
A partir de este episodio la edición de audio fue meticulosa, teniendo ya un conocimiento más en profundidad del flujo de trabajo y sus peculiaridades. Si la grabación del primer episodio me llevó tres días, la de cualquiera de los otros menos extensos me tomó unas seis horas, incluyendo la edición. La redacción, eso sí, que es la tarea más laboriosa, puede dilatarse aún varios días.

ERRE QUE ERRE… ¡HASTA EL LLANTO Y LA DESESPERACIÓN!

Es muy difícil que los que se han puesto dos o tres inyecciones de venenos admitan su desacierto y no es aconsejable reprocharles su decisión. El doctor Luis Benito usa para estos casos una metáfora esclarecedora: A nadie le gusta que se metan con su coche una vez se lo ha pensado mucho , ha optado por él y ha hecho el desembolso. De manera semejante, hay que respetar las razones que hayan llevado a cada cual a cometer este acto suicida. Es curioso, no obstante, que muchos médicos disidentes aún hablen de porcentajes de eficacia como si se tratara de un medicamento y no de un combinado de tóxicos destinados a producir la catástrofe colectiva que estamos viviendo.

QUIERO HACER UN INCISO

Dejo el comentario de las consecuencias de la censura para un episodio posterior. Ivoox me asegura que la censura no se ha producido sino que se trata de cuestiones técnicas. Démosle un voto de confianza. Haré una prueba y, de ser así, no tendré inconveniente en rectificar lo afirmado aquí. Lo cierto es que efectivamente en el podcast número 7, “Una realidad aparte” (9), colé las referencias intercalándolas en el texto de la descripción con la idea de que, si el censor volvía a las andadas, no lo tuviera tan fácil como la primera vez. Tuve la ocurrencia de escribir en mayusculas en la descripción de este podcasd titulado SOFROSINE: ¡EA, EA, EA, EL CENSOR SE CABREA! y sustituí las referencias eliminadas por él con la frase “Enlace censurado”. Quedando tal que así: “ENLACE CENSURADO CON LO QUE SE PROMUEVE QUE SIGAN PRODUCIÉNDOSE MAS ABORTOS ESPONTÁNEOS … Y CUYO ENLACE HA SIDO CENSURADO, LO CUAL NO IMPIDE QUE TALES POLÍTICOS SIGAN EN LA CÁRCEL O HAYAN SIDO EJECUTADOS Y ENLACE CENSURADO”

EN EL VALOR DEL DÍMERO D

Quise convencer a un familiar y mencioné el testimonio de este doctor de la “Uni” de Maguncia. La cosa es muy simple, la prueba del dímero D detecta si se han formado ya coágulos. Según este doctor los valores del dímero d en un grupo de pacientes estudiado en Alemania se mostraron muy altos en todos ellos una vez inyectados de donde se infiere que la inoculación produce una coagulación anormal de la sangre en todos los casos. Mi familiar debió pensar que me lo inventaba, no se lo expliqué bien o quizás tenía otras razones, pues haciendo caso omiso a mis ruegos, fue y se inoculó la pócima coagulante al día siguiente. Está muy bien de salud, por cierto, y deseo de corazón que siga así. (10)

_______________________________________

(1) Carnegie, D. 1991. “Cómo ganar amigos e influir sobre las personas”. Edhasa. ”Fair use". Uso educativo
(2) Prospectos de las cuatro “vacunas” autorizadas en España. 10 de enero de 2022 <https://disienta.blogspot.com/2022/01/prospectos-de-las-cuatro-vacunas.html>
(3) El artículo dedicado a las mascarillas es este <https://disienta.blogspot.com/2021/12/#2456306639029529016>
y aquí está el podcast <https://www.ivoox.com/suicidio-colectivo-audios-mp3_rf_79483186_1.html>
(4) Definición de prostituir. DRAE <https://dle.rae.es/prostituir?m=form>
(5) El durísimo monólogo en off original de la película Taxi Driver es el siguiente: “All the animals come out at night - whores, skunk pussies, buggers, queens, fairies, dopers, junkies, sick, venal. Someday a real rain will come and wash all this scum off the streets”.
(6) Para asistir al espectáculo de “La venganza de los zombies” no hay mas que leer los comentarios a las noticias de la prensa. Muchas de las diatribas proceden de inoculados que, hartos de ser manipulados, se revuelven contra sus captores.
(7) Los GAL en la, a menudo sesgada y censuradora, wikipedia <https://es.wikipedia.org/wiki/Grupos_Antiterroristas_de_Liberaci%C3%B3n>
(8) Esto sucede en el año 2021, el de la “solución vacunal”, no en el 2020. Véase el gráfico del Instituto Nacional de Estadística. <https://ine.es/dyngs/INEbase/es/operacion.htm?c=Estadistica_C&cid=1254736176951&menu=ultiDatos&idp=1254735572981>
(9) Una realidad aparte. Podcast <https://www.ivoox.com/una-realidad-aparte-audios-mp3_rf_78747066_1.html>
(10) Aunque me refiero al doctor Sucharit Bhakdi, he aquí un vínculo a un pedagógico video del doctor Charles Joffe sobre la coagulación producida por las inoculaciones y la prueba referida <https://odysee.com/@Escuelafeliz:5/Dr.-Charles-Hoffe.-Co%C3%A1gulos-Vacunas:8>
No encontrará nada así en youtube.

PROSPECTOS DE LAS CUATRO "VACUNAS"

PROSPECTOS DE LAS CUATRO "VACUNAS" AUTORIZADAS EN ESPAÑA

Información obtenida el 10 de enero de 2022 de la Agencia Española de Medicamentos y Productos Sanitarios

JANSSEN

COMIRNATY

ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1

This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions.
1. NAME OF THE MEDICINAL PRODUCT
Comirnaty 30 micrograms/dose concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
This is a multidose vial and must be diluted before use.
One vial (0.45 mL) contains 6 doses of 0.3 mL after dilution, see sections 4.2 and 6.6.
One dose (0.3 mL) contains 30 micrograms of tozinameran, a COVID-19 mRNA Vaccine (embedded in lipid nanoparticles).
Tozinameran is a single-stranded, 5’-capped messenger RNA (mRNA) produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Concentrate for dispersion for injection (sterile concentrate).
The vaccine is a white to off-white frozen dispersion (pH: 6.9 - 7.9).
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
Comirnaty 30 micrograms/dose concentrate for dispersion for injection is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 virus, in individuals 12 years of age and older.
The use of this vaccine should be in accordance with official recommendations.
4.2 Posology and method of administration
Posology
Individuals 12 years of age and older
Comirnaty is administered intramuscularly after dilution as a primary course of 2 doses (0.3 mL each). It is recommended to administer the second dose 3 weeks after the first dose (see sections 4.4 and 5.1).
A booster dose (third dose) of Comirnaty may be administered intramuscularly at least 6 months after
the second dose in individuals 18 years of age and older.
The decision when and for whom to
implement a third dose of Comirnaty should be made based on available vaccine effectiveness data,
taking into account limited safety data (see sections 4.4 and 5.1).
2

The interchangeability of Comirnaty with COVID-19 vaccines from other manufacturers to complete the primary vaccination course or the booster dose (third dose) has not been established. Individuals who have received 1 dose of Comirnaty should receive a second dose of Comirnaty to complete the primary vaccination course and for any additional doses. Doses of Comirnaty 30 micrograms/dose concentrate for dispersion for injection after dilution and Comirnaty 30 micrograms/dose dispersion for injection are considered interchangeable.
Paediatric population
There is a paediatric formulation available for children 5 to 11 years of age (i.e. 5 to less than 12 years of age). For details, please refer to the Summary of Product Characteristics for Comirnaty
10 micrograms/dose concentrate for dispersion for injection.
Elderly population
No dosage adjustment is required in elderly individuals ≥ 65 years of age. The safety and immunogenicity of a booster dose (third dose) of Comirnaty in individuals 65 years of age and older is based on safety and immunogenicity data in adults 18 to 55 years of age.
Method of administration
Comirnaty 30 micrograms/dose concentrate for dispersion for injection should be administered intramuscularly after dilution (see section 6.6).
After dilution, vials of Comirnaty contain 6 doses of 0.3 mL of vaccine. In order to extract 6 doses from a single vial, low dead-volume syringes and/or needles should be used. The low dead-volume syringe and needle combination should have a dead volume of no more than 35 microlitres. If standard syringes and needles are used, there may not be sufficient volume to extract a sixth dose from a single vial. Irrespective of the type of syringe and needle:
 Each dose must contain 0.3 mL of vaccine.
 If the amount of vaccine remaining in the vial cannot provide a full dose of 0.3 mL, discard the
vial and any excess volume.
 Do not pool excess vaccine from multiple vials.
The preferred site is the deltoid muscle of the upper arm.
Do not inject the vaccine intravascularly, subcutaneously or intradermally.
The vaccine should not be mixed in the same syringe with any other vaccines or medicinal products.
For precautions to be taken before administering the vaccine, see section 4.4.
For instructions regarding thawing, handling and disposal of the vaccine, see section 6.6.
4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
4.4 Special warnings and precautions for use
Traceability
In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Severely immunocompromised aged 12 years and older
A third dose may be given at least 28 days after the second dose to individuals who are severely
immunocompromised (see section 4.4).
   3

General recommendations
Hypersensitivity and anaphylaxis
Events of anaphylaxis have been reported. Appropriate medical treatment and supervision should always be readily available in case of an anaphylactic reaction following the administration of the vaccine.
Close observation for at least 15 minutes is recommended following vaccination. A second dose of the vaccine should not be given to those who have experienced anaphylaxis to the first dose of Comirnaty.
Myocarditis and pericarditis
There is an increased risk of myocarditis and pericarditis following vaccination with Comirnaty. These conditions can develop within just a few days after vaccination, and have primarily occurred within
14 days. They have been observed more often after the second vaccination, and more often in younger males (see section 4.8). Available data suggest that the course of myocarditis and pericarditis following vaccination is not different from myocarditis or pericarditis in general.
Healthcare professionals should be alert to the signs and symptoms of myocarditis and pericarditis. Vaccinees (including parents or caregivers) should be instructed to seek immediate medical attention if they develop symptoms indicative of myocarditis or pericarditis such as (acute and persisting) chest pain, shortness of breath, or palpitations following vaccination.
Healthcare professionals should consult guidance and/or specialists to diagnose and treat this condition.
The risk of myocarditis after a third dose of Comirnaty has not yet been characterised.
Anxiety-related reactions
Anxiety-related reactions, including vasovagal reactions (syncope), hyperventilation or stress‐related reactions (e.g. dizziness, palpitations, increases in heart rate, alterations in blood pressure, tingling sensations and sweating) may occur in association with the vaccination process itself. Stress-related reactions are temporary and resolve on their own. Individuals should be advised to bring symptoms to the attention of the vaccination provider for evaluation. It is important that precautions are in place to avoid injury from fainting.
Concurrent illness
Vaccination should be postponed in individuals suffering from acute severe febrile illness or acute infection. The presence of a minor infection and/or low-grade fever should not delay vaccination.
Thrombocytopenia and coagulation disorders
As with other intramuscular injections, the vaccine should be given with caution in individuals receiving anticoagulant therapy or those with thrombocytopenia or any coagulation disorder (such as haemophilia) because bleeding or bruising may occur following an intramuscular administration in these individuals.
Immunocompromised individuals
The efficacy and safety of the vaccine has not been assessed in immunocompromised individuals, including those receiving immunosuppressant therapy. The efficacy of Comirnaty may be lower in immunocompromised individuals.
The recommendation to consider a third dose in severely immunocompromised individuals is based on limited serological evidence from a case-series in the literature from the clinical management of patients with iatrogenic immunocompromisation after solid organ transplantation (see section 4.2).
4

Duration of protection
The duration of protection afforded by the vaccine is unknown as it is still being determined by ongoing clinical trials.
Limitations of vaccine effectiveness
As with any vaccine, vaccination with Comirnaty may not protect all vaccine recipients. Individuals may not be fully protected until 7 days after their second dose of vaccine.
Excipients
This vaccine contains less than 1 mmol potassium (39 mg) per dose, that is to say essentially ‘potassium-free’.
This vaccine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’.
4.5 Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed.
Concomitant administration of Comirnaty with other vaccines has not been studied. 4.6 Fertility, pregnancy and lactation
Pregnancy
There is limited experience with use of Comirnaty in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryo/foetal development, parturition or post-natal development (see section 5.3). Administration of Comirnaty in pregnancy should only be considered when the potential benefits outweigh any potential risks for the mother and foetus.
Breast-feeding
It is unknown whether Comirnaty is excreted in human milk.
Fertility
Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).
4.7 Effects on ability to drive and use machines
Comirnaty has no or negligible influence on the ability to drive and use machines. However, some of the effects mentioned under section 4.8 may temporarily affect the ability to drive or use machines.
4.8 Undesirable effects
Summary of safety profile
Comirnaty   12
       The safety of
was evaluated in participants
5
years of age and older in 2 clinical studies
that included 23,205 participants (comprised of 22,074 participants 16 years of age and older and
1,131 adolescents 12 to 15 years of age) that have received at least one dose of Comirnaty.
The overall safety profile of Comirnaty in adolescents 12 to 15 years of age was similar to that seen in
participants 16 years of age and older.

Additionally, 306 existing Phase 3 participants 18 to 55 years of age received a booster dose (third
dose) of Comirnaty approximately 6 months after the second dose. The overall safety profile for the
booster dose (third dose) was similar to that seen after 2 doses.
Participants 16 years of age and older – after 2 doses
In Study 2, a total of 22,026 participants 16 years of age or older received at least 1 dose of
and a total of 22,021 participants 16 years of age or older received placebo (including 138 and
145 adolescents 16 and 17 years of age in the vaccine and placebo groups, respectively). A total of
20,519 participants 16 years of age or older received 2 doses of Comirnaty.
Comirnaty
At the time of the analysis of Study 2 with a data cut-off of 13 March 2021 for the placebo-controlled blinded follow-up period up to the participants’ unblinding dates, a total of 25,651 (58.2%) participants (13,031 Comirnaty and 12,620 placebo) 16 years of age and older were followed up for
≥ 4 months after the second dose. This included a total of 15,111 (7,704 Comirnaty and 7,407 placebo) participants 16 to 55 years of age and a total of 10,540 (5,327 Comirnaty and 5,213 placebo) participants 56 years of age and older.
most frequent
The safety profile in 545 participants 16 years of age and older receiving Comirnaty, that were seropositive for SARS-CoV-2 at baseline, was similar to that seen in the general population.
Adolescents 12 to 15 years of age – after 2 doses
In an analysis of Study 2, based on data up to the cut-off date of 13 March 2021, 2,260 adolescents (1,131 Comirnaty and 1,129 placebo) were 12 to 15 years of age. Of these, 1,308 adolescents
(660 Comirnaty and 648 placebo) have been followed for at least 2 months after the second dose of Comirnaty. The safety evaluation in Study 2 is ongoing.
The most frequent adverse reactions in adolescents 12 to 15 years of age that received 2 doses were injection site pain (> 90%), fatigue and headache (> 70%), myalgia and chills (> 40%), arthralgia and pyrexia (> 20%).
Participants 18 years of age and older – after booster dose (third dose)
A subset from Study 2 Phase 2/3 participants of 306 adults 18 to 55 years of age who completed the original Comirnaty 2-dose course, received a booster dose (third dose) of Comirnaty approximately 6 months (range of 4.8 to 8.0 months) after receiving Dose 2.
The most frequent adverse reactions in participants 18 to 55 years of age were injection site pain (> 80%), fatigue (> 60%), headache (> 40%), myalgia (> 30%), chills and arthralgia (> 20%).
The
adverse reactions in participants 16 years of age and older that received 2 doses
     were injection site pain (>
80%), fatigue (>
60%), headache (>
50%), myalgia
(> 40%),
chills
     (>
30%), arthralgia (>
20%),
pyrexia
and injection site swelling (> 10%)
and were usually mild or
moderate in intensity and resolved within a few days after vaccination. A slightly lower frequency of
reactogenicity events was associated with greater age.
6

Tabulated list of adverse reactions from clinical studies and post-authorisation experience in individuals 12 years of age and older
Adverse reactions observed during clinical studies are listed below according to the following frequency categories:
Very common (≥ 1/10),
Common (≥ 1/100 to < 1/10),
Uncommon (≥ 1/1,000 to < 1/100),
Rare (≥ 1/10,000 to < 1/1,000),
Very rare (< 1/10,000),
Not known (cannot be estimated from the available data).
Table 1: Adverse reactions from Comirnaty clinical trials and post-authorisation experience in individuals 12 years of age and older
    System Organ Class
     Very common (≥ 1/10)
   Common (≥ 1/100 to < 1/10)
Uncommon (≥ 1/1,000 to < 1/100)
Rare
(≥ 1/10,000 to < 1/1,000)
     Very rare (< 1/10,000)
Not known (cannot be estimated from the available data)
Blood and lymphatic system disorders
               Lymphadenopathya
                Immune system disorders
   Hypersensitivity reactions (e.g. rash, pruritus, urticaria,b angioedemab)
    Anaphylaxis
Metabolism and nutrition disorders
         Decreased appetite
           Psychiatric disorders
               Insomnia
                Nervous system disorders
Headache
Lethargy
Acute peripheral facial paralysisc
     Cardiac disorders
                Myocarditisd; Pericarditisd
    Gastrointestinal disorders
      Diarrhoead
      Nausea; Vomitingd
                   Skin and subcutaneous tissue disorder
   Hyperhidrosis; Night sweats
    Erythema multiformed
Musculoskeletal and connective tissue disorders
      Arthralgia; Myalgia
         Pain in extremitye
                7

System Organ Class
      Very common (≥ 1/10)
      Common (≥ 1/100 to < 1/10)
   Uncommon (≥ 1/1,000 to < 1/100)
   Rare
(≥ 1/10,000 to < 1/1,000)
      Very rare (< 1/10,000)
     Not known (cannot be estimated from the available data)
General disorders and administration site conditions
      Injection site pain; Fatigue; Chills; Pyrexia;f Injection site swelling
    Injection site redness
Asthenia; Malaise; Injection site pruritus
         Extensive swelling of vaccinated limb;d Facial swellingg
     a. A higher frequency of lymphadenopathy (5.2% vs 0.4%) was observed in participants receiving a booster dose (third dose) compared to participants receiving 2 doses.
b. The frequency category for urticaria and angioedema was Rare.
c. Through the clinical trial safety follow-up period to 14 November 2020, acute peripheral facial paralysis (or palsy) was
reported by four participants in the COVID-19 mRNA Vaccine group. Onset was Day 37 after Dose 1 (participant did not receive Dose 2) and Days 3, 9, and 48 after Dose 2. No cases of acute peripheral facial paralysis (or palsy) were reported in the placebo group.
d. Adverse reaction determined post-authorisation.
e. Refers to vaccinated arm.
f. A higher frequency of pyrexia was observed after the second dose compare to the first dose.
g. Facial swelling in vaccine recipients with a history of injection of dermatological fillers has been reported in the post-
marketing phase.
Description of selected adverse reactions
Myocarditis
The increased risk of myocarditis after vaccination with Comirnaty is highest in younger males (see section 4.4).
Two large European pharmacoepidemiological studies have estimated the excess risk in younger males following the second dose of Comirnaty. One study showed that in a period of 7 days after the second dose there were about 0.265 (95% CI 0.255 - 0.275) extra cases of myocarditis in 12-29 year old males per 10,000 compared to unexposed persons. In another study, in a period of 28 days after the second dose there were 0.57 [95% CI 0.39 – 0.75] extra cases of myocarditis in 16-24 year old males per 10,000 compared to unexposed persons.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V and include batch/Lot number if available.
4.9 Overdose
Overdose data is available from 52 study participants included in the clinical trial that due to an error in dilution received 58 micrograms of Comirnaty. The vaccine recipients did not report an increase in reactogenicity or adverse reactions.
In the event of overdose, monitoring of vital functions and possible symptomatic treatment is recommended.
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5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: vaccines, other viral vaccines, ATC code: J07BX03 Mechanism of action
The nucleoside-modified messenger RNA in Comirnaty (tozinameran) is formulated in lipid nanoparticles, which enable delivery of the non replicating RNA into host cells to direct transient expression of the SARS-CoV-2 S antigen. The mRNA codes for membrane-anchored, full-length S with two point mutations within the central helix. Mutation of these two amino acids to proline locks S in an antigenically preferred prefusion conformation. The vaccine elicits both neutralizing antibody and cellular immune responses to the spike (S) antigen, which may contribute to protection against COVID-19.
Efficacy
Study 2 is a multicentre, multinational, Phase 1/2/3 randomised, placebo-controlled, observer-blind dose-finding, vaccine candidate selection and efficacy study in participants 12 years of age and older. Randomisation was stratified by age: 12 to 15 years of age, 16 to 55 years of age, or 56 years of age and older, with a minimum of 40% of participants in the ≥ 56-year stratum. The study excluded participants who were immunocompromised and those who had previous clinical or microbiological diagnosis of COVID-19. Participants with pre-existing stable disease, defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 6 weeks before enrolment, were included as were participants with known stable infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV) or hepatitis B virus (HBV).
Efficacy in participants 16 years of age and older – after 2 doses
In the Phase 2/3 portion of Study 2, based on data accrued through 14 November 2020, approximately 44,000 participants were randomised equally and were to receive 2 doses of COVID-19 mRNA Vaccine or placebo. The efficacy analyses included participants that received their second vaccination within 19 to 42 days after their first vaccination. The majority (93.1%) of vaccine recipients received the second dose 19 days to 23 days after Dose 1. Participants are planned to be followed for up to
24 months after Dose 2, for assessments of safety and efficacy against COVID-19. In the clinical study, participants were required to observe a minimum interval of 14 days before and after administration of an influenza vaccine in order to receive either placebo or COVID-19 mRNA Vaccine. In the clinical study, participants were required to observe a minimum interval of 60 days before or after receipt of blood/plasma products or immunoglobulins within through conclusion of the study in order to receive either placebo or COVID-19 mRNA Vaccine.
The population for the analysis of the primary efficacy endpoint included, 36,621 participants 12 years of age and older (18,242 in the COVID-19 mRNA Vaccine group and 18,379 in the placebo group) who did not have evidence of prior infection with SARS-CoV-2 through 7 days after the second dose. In addition, 134 participants were between the ages of 16 to 17 years of age (66 in the COVID-19 mRNA Vaccine group and 68 in the placebo group) and 1,616 participants 75 years of age and older (804 in the COVID-19 mRNA Vaccine group and 812 in the placebo group).
At the time of the primary efficacy analysis, participants had been followed for symptomatic COVID-19 for in total 2,214 person-years for the COVID-19 mRNA Vaccine and in total 2,222 person-years in the placebo group.
There were no meaningful clinical differences in overall vaccine efficacy in participants who were at risk of severe COVID-19 including those with 1 or more comorbidities that increase the risk of severe COVID-19 (e.g. asthma, body mass index (BMI) ≥ 30 kg/m2, chronic pulmonary disease, diabetes mellitus, hypertension).
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The vaccine efficacy information is presented in Table 2.
Table 2: Vaccine efficacy – First COVID-19 occurrence from 7 days after Dose 2, by age subgroup – participants without evidence of infection prior to 7 days after Dose 2 – evaluable efficacy (7 days) population
     First COVID-19 occurrence from 7 days after Dose 2 in participants without evidence of prior SARS-CoV-2 infection*
     Subgroup
COVID-19 mRNA Vaccine
Na = 18,198 Cases
n1b Surveillancetimec (n2d)
   Placebo
Na = 18,325 Cases
n1b Surveillancetimec (n2d)
     Vaccine efficacy % (95% CI)e
     All participants
8
2.214 (17,411)
   162 2.222 (17,511)
     95.0 (90.0, 97.9)
     16 to 64 years
7
1.706 (13,549)
   143 1.710 (13,618)
     95.1 (89.6, 98.1)
     65 years and older
1 0.508 (3848)
   19 0.511 (3880)
     94.7 (66.7, 99.9)
     65 to 74 years
1 0.406 (3074)
   14 0.406 (3095)
     92.9 (53.1, 99.8)
     75 years and older
    0 0.102 (774)
    5 0.106 (785)
       100.0 (-13.1, 100.0)
   Note: Confirmed cases were determined by Reverse Transcription-Polymerase Chain Reaction (RT-PCR) and at least 1 symptom consistent with COVID-19 [*Case definition: (at least 1 of) fever, new or increased cough, new or increased shortness of breath, chills, new or increased muscle pain, new loss of taste or smell, sore throat, diarrhoea or vomiting.]
* Participants who had no serological or virological evidence (prior to 7 days after receipt of the last dose) of past SARS-CoV-2 infection (i.e., N-binding antibody [serum] negative at Visit 1 and SARS-CoV-2 not detected by nucleic acid amplification tests (NAAT) [nasal swab] at Visits 1 and 2), and had negative NAAT (nasal swab) at any unscheduled visit prior to 7 days after Dose 2 were included in the analysis.
a. N = Number of participants in the specified group.
b. n1 = Number of participants meeting the endpoint definition.
c. Total surveillance time in 1,000 person-years for the given endpoint across all participants within each
group at risk for the endpoint. Time period for COVID-19 case accrual is from 7 days after Dose 2 to the
end of the surveillance period.
d. n2 = Number of participants at risk for the endpoint.
e. Two-sided confidence interval (CI) for vaccine efficacy is derived based on the Clopper and Pearson
method adjusted to the surveillance time. CI not adjusted for multiplicity.
Efficacy of COVID-19 mRNA Vaccine in preventing first COVID-19 occurrence from 7 days after Dose 2 compared to placebo was 94.6% (95% confidence interval of 89.6% to 97.6%) in participants 16 years of age and older with or without evidence of prior infection with SARS-CoV-2.
Additionally, subgroup analyses of the primary efficacy endpoint showed similar efficacy point estimates across genders, ethnic groups, and participants with medical comorbidities associated with high risk of severe COVID-19.
Updated efficacy analyses were performed with additional confirmed COVID-19 cases accrued during blinded placebo-controlled follow-up, representing up to 6 months after Dose 2 in the efficacy population.
The updated vaccine efficacy information is presented in Table 3.
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Table 3: Vaccine efficacy – First COVID-19 occurrence from 7 days after Dose 2, by age subgroup – participants without evidence of prior SARS-CoV-2 infection* prior to 7 days after Dose 2 – evaluable efficacy (7 days) population during the placebo-controlled follow-up period
    Subgroup
COVID-19 mRNA Vaccine Na=20,998 Cases
n1b
Surveillance timec (n2d)
   Placebo Na=21,096 Cases n1b
Surveillance timec (n2d)
     Vaccine efficacy % (95% CIe)
   All participantsf
77 6.247 (20,712)
   850 6.003 (20,713)
     91.3 (89.0, 93.2)
   16 to 64 years
70 4.859 (15,519)
   710 4.654 (15,515)
     90.6 (87.9, 92.7)
   65 years and older
7 1.233 (4192)
   124 1.202 (4226)
     94.5 (88.3, 97.8)
   65 to 74 years
6 0.994 (3350)
   98 0.966 (3379)
     94.1 (86.6, 97.9)
   75 years and older
   1 0.239 (842)
    26 0.237 (847)
       96.2 (76.9, 99.9)
   Note: Confirmed cases were determined by Reverse Transcription-Polymerase Chain Reaction (RT-PCR) and at least 1 symptom consistent with COVID-19 (symptoms included: fever; new or increased cough; new or increased shortness of breath; chills; new or increased muscle pain; new loss of taste or smell; sore throat; diarrhoea; vomiting).
* Participants who had no evidence of past SARS-CoV-2 infection (i.e., N-binding antibody [serum] negative at Visit 1 and SARS-CoV-2 not detected by NAAT [nasal swab] at Visits 1 and 2), and had negative NAAT (nasal swab) at any unscheduled visit prior to 7 days after Dose 2 were included in the analysis.
a. N = Number of participants in the specified group.
b. n1 = Number of participants meeting the endpoint definition.
c. Total surveillance time in 1,000 person-years for the given endpoint across all participants within each
group at risk for the endpoint. Time period for COVID-19 case accrual is from 7 days after Dose 2 to the
end of the surveillance period.
d. n2 = Number of participants at risk for the endpoint.
e. Two-sided 95% confidence interval (CI) for vaccine efficacy is derived based on the Clopper and Pearson
method adjusted to the surveillance time.
f. Included confirmed cases in participants 12 to 15 years of age: 0 in the COVID-19 mRNA Vaccine group;
16 in the placebo group.
In the updated efficacy analysis, efficacy of COVID-19 mRNA Vaccine in preventing first COVID-19 occurrence from 7 days after Dose 2 compared to placebo was 91.1% (95% CI of 88.8% to 93.0%) in participants in the evaluable efficacy population with or without evidence of prior infection with SARS-CoV-2.
Additionally, the updated efficacy analyses by subgroup showed similar efficacy point estimates across sexes, ethnic groups, geography and participants with medical comorbidities and obesity associated with high risk of severe COVID-19.
Efficacy against severe COVID-19
Updated efficacy analyses of secondary efficacy endpoints supported benefit of the COVID-19 mRNA Vaccine in preventing severe COVID‐19.
As of 13 March 2021, vaccine efficacy against severe COVID-19 is presented only for participants with or without prior SARS-CoV-2 infection (Table 4) as the COVID-19 case counts in participants without prior SARS-CoV-2 infection were the same as those in participants with or without prior SARS-CoV-2 infection in both the COVID-19 mRNA Vaccine and placebo groups.
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Table 4: Vaccine efficacy – First severe COVID-19 occurrence in participants with or without prior SARS-CoV-2 infection based on the Food and Drug Administration (FDA)* after Dose 1 or from 7 days after Dose 2 in the placebo-controlled follow-up
        COVID-19 mRNA Vaccine Cases
n1a
Surveillance time (n2b)
Placebo Cases
n1a
Surveillance time (n2b)
     Vaccine efficacy % (95% CIc)
    After Dose 1d
   1
8.439e (22,505)
30 8.288e (22,435)
     96.7 (80.3, 99.9)
    7 days after Dose 2f
      1
6.522g (21,649)
   21 6.404g (21,730)
      95.3 (70.9, 99.9)
   Note: Confirmed cases were determined by Reverse Transcription-Polymerase Chain Reaction (RT-PCR) and at least 1 symptom consistent with COVID-19 (symptoms included: fever; new or increased cough; new or increased shortness of breath; chills; new or increased muscle pain; new loss of taste or smell; sore throat; diarrhoea; vomiting).
* Severe illness from COVID-19 as defined by FDA is confirmed COVID-19 and presence of at least 1 of the following:
 Clinical signs at rest indicative of severe systemic illness (respiratory rate ≥ 30 breaths per minute, heart rate ≥ 125 beats per minute, saturation of oxygen ≤ 93% on room air at sea level, or ratio of arterial oxygen partial pressure to fractional inspired oxygen < 300 mm Hg);
 Respiratory failure [defined as needing high-flow oxygen, noninvasive ventilation, mechanical ventilation or extracorporeal membrane oxygenation (ECMO)];
 Evidence of shock (systolic blood pressure < 90 mm Hg, diastolic blood pressure < 60 mm Hg, or requiring vasopressors);
 Significant acute renal, hepatic, or neurologic dysfunction;
 Admission to an Intensive Care Unit;
 Death.
a. n1 = Number of participants meeting the endpoint definition.
b. n2 = Number of participants at risk for the endpoint.
c. Two-side confidence interval (CI) for vaccine efficacy is derived based on the Clopper and Pearson method
adjusted to the surveillance time.
d. Efficacy assessed based on the Dose 1 all available efficacy (modified intention-to-treat) population that
included all randomised participants who received at least 1 dose of study intervention.
e. Total surveillance time in 1,000 person-years for the given endpoint across all participants within each
group at risk for the endpoint. Time period for COVID-19 case accrual is from Dose 1 to the end of the
surveillance period.
f. Efficacy assessed based on the evaluable efficacy (7 Days) population that included all eligible randomised
participants who receive all dose(s) of study intervention as randomised within the predefined window,
have no other important protocol deviations as determined by the clinician.
g. Total surveillance time in 1,000 person-years for the given endpoint across all participants within each
group at risk for the endpoint. Time period for COVID-19 case accrual is from 7 days after Dose 2 to the end of the surveillance period.
Efficacy and immunogenicity in adolescents 12 to 15 years of age – after 2 doses
In an analysis of Study 2 in adolescents 12 to 15 years of age without evidence of prior infection, there were no cases in 1,005 participants who received the vaccine and 16 cases out of 978 who received placebo. The point estimate for efficacy is 100% (95% confidence interval 75.3, 100.0). In participants with or without evidence of prior infection there were 0 cases in the 1,119 who received vaccine and 18 cases in 1,110 participants who received placebo. This also indicates the point estimate for efficacy is 100% (95% confidence interval 78.1, 100.0).
In Study 2, an analysis of SARS-CoV-2 neutralising titres 1 month after Dose 2 was conducted in a randomly selected subset of participants who had no serological or virological evidence of past SARS-CoV-2 infection up to 1 month after Dose 2, comparing the response in adolescents 12 to 15 years of age (n = 190) to participants 16 to 25 years of age (n = 170).
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The ratio of the geometric mean titres (GMT) in the 12 to 15 years of age group to the 16 to 25 years of age group was 1.76, with a 2-sided 95% CI of 1.47 to 2.10. Therefore, the 1.5-fold noninferiority criterion was met as the lower bound of the 2-sided 95% CI for the geometric mean ratio [GMR] was > 0.67.
Immunogenicity in participants 18 years of age and older – after booster dose (third dose)
Effectiveness of a booster dose of Comirnaty was based on an assessment of 50% neutralizing antibody titers (NT50) against SARS-CoV-2 (USA_WA1/2020). In Study 2, analyses of NT50
1 month after the booster dose compared to 1 month after the primary series in individuals 18 through 55 years of age who had no serological or virological evidence of past SARS-CoV-2 infection up to
1 month after the booster vaccination demonstrated noninferiority for both geometric mean ratio (GMR) and difference in seroresponse rates. Seroresponse for a participant was defined as achieving a ≥ 4-fold rise in NT50 from baseline (before primary series). These analyses are summarized in
Table 5.
Table 5:
SARS-CoV-2 neutralization assay - NT50 (titer)† (SARS-CoV-2 USA_WA1/2020) – GMT and seroresponse rate comparison of 1 month after booster dose to 1 month after primary series – participants 18 through 55 years of age without evidence of infection up to 1 month after booster dose* – booster dose evaluable immunogenicity population±
        N
1 month after booster dose (95% CI)
   1 month after primary series (95% CI)
   1 month after booster dose/- 1 month after primary series
(97.5% CI)
    Met noninferiority objective (Y/N)
   Geometric mean 50% neutralizing titer (GMTb)
       212a
    2466.0b (2202.6, 2760.8)
    750.6b (656.2, 858.6)
     3.29c (2.77, 3.90)
      Yd
   Seroresponse rate (%) for 50% neutralizing titer†
    200e
   199f 99.5% (97.2%, 100.0%)
196f 98.0% (95.0%, 99.5%)
   1.5%g (-0.7%, 3.7%h)
    Yi
Abbreviations: CI = confidence interval; GMR = geometric mean ratio; GMT = geometric mean titer;
LLOQ = lower limit of quantitation; N-binding = SARS-CoV-2 nucleoprotein-binding; NAAT = nucleic acid amplification test; NT50 = 50% neutralizing titer; SARS-CoV-2 = severe acute respiratory syndrome coronavirus 2; Y/N = yes/no.
† SARS-CoV-2 NT50 were determined using the SARS-CoV-2 mNeonGreen Virus Microneutralization
Assay. The assay uses a fluorescent reporter virus derived from the USA_WA1/2020 strain and virus neutralization is read on Vero cell monolayers. The sample NT50 is defined as the reciprocal serum dilution at which 50% of the virus is neutralized.
* Participants who had no serological or virological evidence (up to 1 month after receipt of a booster dose of Comirnaty) of past SARS-CoV-2 infection (i.e., N-binding antibody [serum] negative and SARS-CoV-2 not detected by NAAT [nasal swab]) and had a negative NAAT (nasal swab) at any unscheduled visit up to 1 month after the booster dose were included in the analysis.
± All eligible participants who had received 2 doses of Comirnaty as initially randomized, with Dose 2 received within the predefined window (within 19 to 42 days after Dose 1), received a booster dose of Comirnaty, had at least 1 valid and determinate immunogenicity result after booster dose from a blood collection within an appropriate window (within 28 to 42 days after the booster dose), and had no other important protocol deviations as determined by the clinician.
a. n = Number of participants with valid and determinate assay results at both sampling time points within specified window.
b. GMTs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to
0.5 × LLOQ.
c. GMRs and 2-sided 97.5% CIs were calculated by exponentiating the mean differences in the logarithms of the assay and the corresponding CIs (based on the Student t distribution).
d. Noninferiority is declared if the lower bound of the 2-sided 97.5% CI for the GMR is > 0.67 and the point estimate of the GMR is ≥ 0.80.
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e. n = Number of participants with valid and determinate assay results for the specified assay at baseline, 1 month after Dose 2 and 1 month after the booster dose within specified window. These values are the denominators for the percentage calculations.
f. Number of participants with seroresponse for the given assay at the given dose/sampling time point. Exact 2-sided CI based on the Clopper and Pearson method.
g. Difference in proportions, expressed as a percentage (1 month after booster dose – 1 month after Dose 2).
h. Adjusted Wald 2-sided CI for the difference in proportions, expressed as a percentage.
i. Noninferiority is declared if the lower bound of the 2-sided 97.5% CI for the percentage difference is
> -10%.
Paediatric population
The European Medicines Agency has deferred the obligation to submit the results of studies with Comirnaty in the paediatric population in prevention of COVID-19 (see section 4.2 for information on paediatric use).
This medicinal product has been authorised under a so-called ‘conditional approval’ scheme. This means that further evidence on this medicinal product is awaited. The European Medicines Agency will review new information on this medicinal product at least every year and this SmPC will be updated as necessary.
5.2 Pharmacokinetic properties
Not applicable.
5.3 Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of repeat dose toxicity and reproductive and developmental toxicity.
General toxicity
Rats intramuscularly administered Comirnaty (receiving 3 full human doses once weekly, generating relatively higher levels in rats due to body weight differences) demonstrated some injection site oedema and erythema and increases in white blood cells (including basophils and eosinophils) consistent with an inflammatory response as well as vacuolation of portal hepatocytes without evidence of liver injury. All effects were reversible.
Genotoxicity/Carcinogenicity
Neither genotoxicity nor carcinogenicity studies were performed. The components of the vaccine (lipids and mRNA) are not expected to have genotoxic potential.
Reproductive toxicity
Reproductive and developmental toxicity were investigated in rats in a combined fertility and developmental toxicity study where female rats were intramuscularly administered Comirnaty prior to mating and during gestation (receiving 4 full human doses that generate relatively higher levels in rat due to body weight differences, spanning between pre-mating day 21 and gestational day 20). SARS-CoV-2 neutralizing antibody responses were present in maternal animals from prior to mating to the end of the study on postnatal day 21 as well as in foetuses and offspring. There were no vaccine-related effects on female fertility, pregnancy, or embryo-foetal or offspring development. No Comirnaty data are available on vaccine placental transfer or excretion in milk.
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6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate) (ALC-0315) 2-[(polyethylene glycol)-2000]-N,N-ditetradecylacetamide (ALC-0159) 1,2-Distearoyl-sn-glycero-3-phosphocholine (DSPC)
Cholesterol
Potassium chloride
Potassium dihydrogen phosphate Sodium chloride
Disodium phosphate dihydrate Sucrose
Water for injections
Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment)
6.2 Incompatibilities
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
6.3 Shelf life
Unopened vial
Frozen vial
9 months when stored at -90 °C to -60 °C.
Within the 9-month shelf life unopened vials may be stored and transported at -25 °C to -15 °C for a single period of up to 2 weeks and can be returned to -90 °C to -60 °C.
When stored frozen at -90 °C to -60 °C, 195-vial packs of the vaccine can be thawed at 2 °C to 8 °C for 3 hours or individual vials can be thawed at room temperature (up to 30 °C) for 30 minutes.
Thawed vial
1 month at 2 °C to 8 °C within the 9-month shelf life.
Within the 1-month shelf life at 2 °C to 8 °C, up to 12 hours may be used for transportation. Prior to use, the unopened vial can be stored for up to 2 hours at temperatures up to 30 °C. Thawed vials can be handled in room light conditions.
Once thawed, the vaccine should not be re-frozen.
Handling of temperature excursions once removed from the freezer
Stability data indicate that the unopened vial is stable for up to:
 24 hours when stored at temperatures from -3 °C to 2 °C
 a total of 4 hours when stored at temperatures from 8 °C to 30 °C; this includes the 2 hours at up
to 30 °C detailed above
This information is intended to guide healthcare professionals only in case of temporary temperature excursion.
Transfers of frozen vials stored at ultra-low temperature (< -60 °C)
 Closed-lid vial trays containing 195 vials removed from ultra-low temperature frozen storage (< -60 °C) may be at temperatures up to 25 °C for up to 5 minutes.
 Open-lid vial trays, or vial trays containing less than 195 vials, removed from ultra-low temperature frozen storage (< -60 °C) may be at temperatures up to 25 °C for up to 3 minutes.
 After vial trays are returned to frozen storage following temperature exposure up to 25 °C, they must remain in frozen storage for at least 2 hours before they can be removed again.
     15

Transfers of frozen vials stored at -25 °C to -15 °C
 Closed-lid vial trays containing 195 vials removed from frozen storage (-25 °C to -15 °C) may be at temperatures up to 25 °C for up to 3 minutes.
 Open-lid vial trays, or vial trays containing less than 195 vials, removed from frozen storage (-25 °C to -15 °C) may be at temperatures up to 25 °C for up to 1 minute.
Once a vial is removed from the vial tray, it should be thawed for use. Diluted medicinal product
Chemical and physical in-use stability, including during transportation, has been demonstrated for
6 hours at 2 oC to 30 oC after dilution in sodium chloride 9 mg/mL (0.9%) solution for injection. From a microbiological point of view, unless the method of dilution precludes the risk of microbial contamination, the product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user.
6.4 Special precautions for storage
Store in a freezer at -90 °C to -60 °C.
Store in the original package in order to protect from light.
During storage, minimise exposure to room light, and avoid exposure to direct sunlight and ultraviolet light.
For storage conditions after thawing and dilution of the medicinal product, see section 6.3.
6.5 Nature and contents of container
0.45 mL concentrate in a 2 mL clear multidose vial (type I glass) with a stopper (synthetic bromobutyl rubber) and a purple flip-off plastic cap with aluminium seal. Each vial contains 6 doses, see
section 6.6.
Pack size: 195 vials
6.6 Special precautions for disposal and other handling
Handling instructions
Comirnaty should be prepared by a healthcare professional using aseptic technique to ensure the sterility of the prepared dispersion.
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     DOSE VERIFICATION OF COMIRNATY 30 MICROGRAMS/DOSE CONCENTRATE FOR DISPERSION FOR INJECTION (12 YEARS AND OLDER)
         Purple cap
 Verify that the vial has a purple plastic cap.
 If the vial has a grey plastic cap, please make reference to the Summary of Product Characteristics for Comirnaty 30 micrograms/dose dispersion for injection.
 If the vial has an orange plastic cap, please make reference to the Summary of Product Characteristics for Comirnaty 10 micrograms/dose concentrate for dispersion for injection.
       THAWING PRIOR TO DILUTION OF COMIRNATY 30 MICROGRAMS/DOSE CONCENTRATE FOR DISPERSION FOR INJECTION (12 YEARS AND OLDER)
       No more than 2 hours at room temperature (up to 30 °C)
 The multidose vial is stored frozen and must be thawed prior to dilution. Frozen vials should be transferred to an environment of 2 °C to 8 °C to thaw; a 195 vial pack may take 3 hours to thaw. Alternatively, frozen vials may also be thawed for 30 minutes at temperatures up to 30 °C for immediate use.
 The unopened vial can be stored for up to 1 month at 2 °C to 8 °C within the 9-month shelf life. Within the 1-month shelf life at 2 °C to 8 °C, up to 12 hours may be used for transportation.
 Allow the thawed vial to come to room temperature. Prior to use, the unopened vial can be stored for up to 2 hours at temperatures up to 30 °C. Thawed vials can be handled in room light conditions.
 Gently invert the vial 10 times prior to dilution. Do not shake.
 Prior to dilution, the thawed dispersion may contain white to off-white opaque amorphous particles.
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     DILUTION OF COMIRNATY 30 MICROGRAMS/DOSE CONCENTRATE FOR DISPERSION FOR INJECTION (12 YEARS AND OLDER)
       1.8 mL of 0.9% sodium chloride injection
    The thawed vaccine must be diluted in its original vial with 1.8 mL sodium chloride 9 mg/mL (0.9%) solution for injection, using a 21 gauge or narrower needle and aseptic techniques.
     Pull back plunger to 1.8 mL to remove air from vial.
        Equalise vial pressure before removing the needle from the vial stopper by withdrawing 1.8 mL air into the empty diluent syringe.
   18

    Gently × 10
       Gently invert the diluted dispersion 10 times. Do not shake.
 The diluted vaccine should present as an off-white dispersion with no particulates visible. Do not use the diluted vaccine if particulates or discolouration are present.
     Record appropriate date and time. Use within 6 hours after dilution.
        The diluted vials should be marked with the appropriate date and time.
 After dilution, store at 2 oC to 30 oC and use within 6 hours, including any transportation time.
 Do not freeze or shake the diluted dispersion. If refrigerated, allow the diluted dispersion to come to room temperature prior to use.
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     PREPARATION OF INDIVIDUAL 0.3 mL DOSES OF COMIRNATY
30 MICROGRAMS/DOSE CONCENTRATE FOR DISPERSION FOR INJECTION (12 YEARS AND OLDER)
       0.3 mL diluted vaccine
 After dilution, the vial contains
2.25 mL from which 6 doses of 0.3 mL can be extracted.
 Using aseptic technique, cleanse the vial stopper with a single-use antiseptic swab.
 Withdraw 0.3 mL of Comirnaty.
Low dead-volume syringes and/or needles should be used in order to extract 6 doses from a single vial. The low dead-volume syringe and needle combination should have a dead volume of no more than 35 microlitres.
If standard syringes and needles are used, there may not be sufficient volume to extract a sixth dose from a single vial.
 Each dose must contain 0.3 mL of vaccine.
 If the amount of vaccine remaining in the vial cannot provide a full dose of 0.3 mL, discard the vial and any excess volume.
 Discard any unused vaccine within 6 hours after dilution.
   Disposal
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
7. MARKETING AUTHORISATION HOLDER
BioNTech Manufacturing GmbH An der Goldgrube 12
55131 Mainz
Germany
Phone: +49 6131 9084-0 Fax: +49 6131 9084-2121 service@biontech.de
8. MARKETING AUTHORISATION NUMBER(S)
EU/1/20/1528/001
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 21 December 2020
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Date of latest renewal: 03 November 2021
10. DATE OF REVISION OF THE TEXT
Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
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This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions.
1. NAME OF THE MEDICINAL PRODUCT
Comirnaty 30 micrograms/dose dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
This is a multidose vial. Do not dilute prior to use.
One vial (2.25 mL) contains 6 doses of 0.3 mL, see sections 4.2 and 6.6.
One dose (0.3 mL) contains 30 micrograms of tozinameran, a COVID-19 mRNA Vaccine (embedded in lipid nanoparticles).
Tozinameran is a single-stranded, 5’-capped messenger RNA (mRNA) produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Dispersion for injection.
The vaccine is a white to off-white frozen dispersion (pH: 6.9 - 7.9).
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
Comirnaty 30 micrograms/dose dispersion for injection is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 virus, in individuals 12 years of age and older.
The use of this vaccine should be in accordance with official recommendations.
4.2 Posology and method of administration
Posology
Individuals 12 years of age and older
Comirnaty is administered intramuscularly as a primary course of 2 doses (0.3 mL each). It is recommended to administer the second dose 3 weeks after the first dose (see sections 4.4 and 5.1).
The interchangeability of Comirnaty with COVID-19 vaccines from other manufacturers to complete the primary vaccination course or the booster dose (third dose) has not been established. Individuals
A booster dose (third dose) of Comirnaty may be administered intramuscularly at least 6 months after
the second dose in individuals 18 years of age and older.
The decision when and for whom to
implement a third dose of Comirnaty should be made based on available vaccine effectiveness data,
taking into account limited safety data (see sections 4.4 and 5.1).
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who have received 1 dose of Comirnaty should receive a second dose of Comirnaty to complete the primary vaccination course and for any additional doses. Doses of Comirnaty 30 micrograms/dose concentrate for dispersion for injection after dilution and Comirnaty 30 micrograms/dose dispersion for injection are considered interchangeable.
Paediatric population
There is a paediatric formulation available for children 5 to 11 years of age (i.e. 5 to less than 12 years of age). For details, please refer to the Summary of Product Characteristics for Comirnaty
10 micrograms/dose concentrate for dispersion for injection.
Elderly population
No dosage adjustment is required in elderly individuals ≥ 65 years of age. The safety and immunogenicity of a booster dose (third dose) of Comirnaty in individuals 65 years of age and older is based on safety and immunogenicity data in adults 18 to 55 years of age.
Method of administration
Comirnaty 30 micrograms/dose dispersion for injection should be administered intramuscularly (see section 6.6). Do not dilute prior to use.
Vials of Comirnaty contain 6 doses of 0.3 mL of vaccine. In order to extract 6 doses from a single vial, low dead-volume syringes and/or needles should be used. The low dead-volume syringe and needle combination should have a dead volume of no more than 35 microlitres. If standard syringes and needles are used, there may not be sufficient volume to extract a sixth dose from a single vial. Irrespective of the type of syringe and needle:
 Each dose must contain 0.3 mL of vaccine.
 If the amount of vaccine remaining in the vial cannot provide a full dose of 0.3 mL, discard the
vial and any excess volume.
 Do not pool excess vaccine from multiple vials.
The preferred site is the deltoid muscle of the upper arm.
Do not inject the vaccine intravascularly, subcutaneously or intradermally.
The vaccine should not be mixed in the same syringe with any other vaccines or medicinal products.
For precautions to be taken before administering the vaccine, see section 4.4.
For instructions regarding thawing, handling and disposal of the vaccine, see section 6.6.
4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
4.4 Special warnings and precautions for use
Traceability
In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Severely immunocompromised aged 12 years and older
A third dose may be given at least 28 days after the second dose to individuals who are severely
immunocompromised (see section 4.4).
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General recommendations
Hypersensitivity and anaphylaxis
Events of anaphylaxis have been reported. Appropriate medical treatment and supervision should always be readily available in case of an anaphylactic reaction following the administration of the vaccine.
Close observation for at least 15 minutes is recommended following vaccination. A second dose of the vaccine should not be given to those who have experienced anaphylaxis to the first dose of Comirnaty.
Myocarditis and pericarditis
There is an increased risk of myocarditis and pericarditis following vaccination with Comirnaty. These conditions can develop within just a few days after vaccination, and have primarily occurred within
14 days. They have been observed more often after the second vaccination, and more often in younger males (see section 4.8). Available data suggest that the course of myocarditis and pericarditis following vaccination is not different from myocarditis or pericarditis in general.
Healthcare professionals should be alert to the signs and symptoms of myocarditis and pericarditis. Vaccinees (including parents or caregivers) should be instructed to seek immediate medical attention if they develop symptoms indicative of myocarditis or pericarditis such as (acute and persisting) chest pain, shortness of breath, or palpitations following vaccination.
Healthcare professionals should consult guidance and/or specialists to diagnose and treat this condition.
The risk of myocarditis after a third dose of Comirnaty has not yet been characterised.
Anxiety-related reactions
Anxiety-related reactions, including vasovagal reactions (syncope), hyperventilation or stress‐related reactions (e.g. dizziness, palpitations, increases in heart rate, alterations in blood pressure, tingling sensations and sweating) may occur in association with the vaccination process itself. Stress-related reactions are temporary and resolve on their own. Individuals should be advised to bring symptoms to the attention of the vaccination provider for evaluation. It is important that precautions are in place to avoid injury from fainting.
Concurrent illness
Vaccination should be postponed in individuals suffering from acute severe febrile illness or acute infection. The presence of a minor infection and/or low-grade fever should not delay vaccination.
Thrombocytopenia and coagulation disorders
As with other intramuscular injections, the vaccine should be given with caution in individuals receiving anticoagulant therapy or those with thrombocytopenia or any coagulation disorder (such as haemophilia) because bleeding or bruising may occur following an intramuscular administration in these individuals.
Immunocompromised individuals
The efficacy and safety of the vaccine has not been assessed in immunocompromised individuals, including those receiving immunosuppressant therapy. The efficacy of Comirnaty may be lower in immunocompromised individuals.
The recommendation to consider a third dose in severely immunocompromised individuals is based on limited serological evidence from a case-series in the literature from the clinical management of patients with iatrogenic immunocompromisation after solid organ transplantation (see section 4.2).
Duration of protection
The duration of protection afforded by the vaccine is unknown as it is still being determined by ongoing clinical trials.
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Limitations of vaccine effectiveness
As with any vaccine, vaccination with Comirnaty may not protect all vaccine recipients. Individuals may not be fully protected until 7 days after their second dose of vaccine.
4.5 Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed.
Concomitant administration of Comirnaty with other vaccines has not been studied. 4.6 Fertility, pregnancy and lactation
Pregnancy
There is limited experience with use of Comirnaty in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryo/foetal development, parturition or post-natal development (see section 5.3). Administration of Comirnaty in pregnancy should only be considered when the potential benefits outweigh any potential risks for the mother and foetus.
Breast-feeding
It is unknown whether Comirnaty is excreted in human milk.
Fertility
Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).
4.7 Effects on ability to drive and use machines
Comirnaty has no or negligible influence on the ability to drive and use machines. However, some of the effects mentioned under section 4.8 may temporarily affect the ability to drive or use machines.
   4.8 Undesirable effects
Summary of safety profile
Comirnaty   12
   The safety of
was evaluated in participants
years of age and older in 2 clinical studies
that included 23,205 participants (comprised of 22,074 participants 16 years of age and older and
1,131 adolescents 12 to 15 years of age) that have received at least one dose of Comirnaty.
The overall safety profile of Comirnaty in adolescents 12 to 15 years of age was similar to that seen in
participants 16 years of age and older.
Additionally, 306 existing Phase 3 participants 18 to 55 years of age received a booster dose (third
dose) of Comirnaty approximately 6 months after the second dose. The overall safety profile for the
booster dose (third dose) was similar to that seen after 2 doses.
Participants 16 years of age and older – after 2 doses
In Study 2, a total of 22,026 participants 16 years of age or older received at least 1 dose of
and a total of 22,021 participants 16 years of age or older received placebo (including 138 and
145 adolescents 16 and 17 years of age in the vaccine and placebo groups, respectively). A total of
20,519 participants 16 years of age or older received 2 doses of Comirnaty.
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Comirnaty

At the time of the analysis of Study 2 with a data cut-off of 13 March 2021 for the placebo-controlled blinded follow-up period up to the participants’ unblinding dates, a total of 25,651 (58.2%) participants (13,031 Comirnaty and 12,620 placebo) 16 years of age and older were followed up for
≥ 4 months after the second dose. This included a total of 15,111 (7,704 Comirnaty and 7,407 placebo) participants 16 to 55 years of age and a total of 10,540 (5,327 Comirnaty and 5,213 placebo) participants 56 years of age and older.
most frequent
The safety profile in 545 participants 16 years of age and older receiving Comirnaty, that were seropositive for SARS-CoV-2 at baseline, was similar to that seen in the general population.
Adolescents 12 to 15 years of age – after 2 doses
In an analysis of Study 2, based on data up to the cut-off date of 13 March 2021, 2,260 adolescents (1,131 Comirnaty and 1,129 placebo) were 12 to 15 years of age. Of these, 1,308 adolescents
(660 Comirnaty and 648 placebo) have been followed for at least 2 months after the second dose of Comirnaty. The safety evaluation in Study 2 is ongoing.
The most frequent adverse reactions in adolescents 12 to 15 years of age that received 2 doses were injection site pain (> 90%), fatigue and headache (> 70%), myalgia and chills (> 40%), arthralgia and pyrexia (> 20%).
Participants 18 years of age and older – after booster dose (third dose)
A subset from Study 2 Phase 2/3 participants of 306 adults 18 to 55 years of age who completed the original Comirnaty 2-dose course, received a booster dose (third dose) of Comirnaty approximately 6 months (range of 4.8 to 8.0 months) after receiving Dose 2.
The most frequent adverse reactions in participants 18 to 55 years of age were injection site pain (> 80%), fatigue (> 60%), headache (> 40%), myalgia (> 30%), chills and arthralgia (> 20%).
Tabulated list of adverse reactions from clinical studies and post-authorisation experience in individuals 12 years of age and older
Adverse reactions observed during clinical studies are listed below according to the following frequency categories:
Very common (≥ 1/10),
Common (≥ 1/100 to < 1/10),
Uncommon (≥ 1/1,000 to < 1/100),
Rare (≥ 1/10,000 to < 1/1,000),
Very rare (< 1/10,000),
Not known (cannot be estimated from the available data).
The
adverse reactions in participants 16 years of age and older that received 2 doses
     were injection site pain (>
80%), fatigue (>
60%), headache (>
50%), myalgia
(> 40%),
chills
     (>
30%), arthralgia (>
20%),
pyrexia
and injection site swelling (> 10%)
and were usually mild or
moderate in intensity and resolved within a few days after vaccination. A slightly lower frequency of
reactogenicity events was associated with greater age.
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Table 1: Adverse reactions from Comirnaty clinical trials and post-authorisation experience in individuals 12 years of age and older
                     System Organ Class
Very common (≥ 1/10)
Common (≥ 1/100 to < 1/10)
Uncommon (≥ 1/1,000 to < 1/100)
                  Lymphadenopathya
Rare
(≥ 1/10,000 to < 1/1,000)
Very rare (< 1/10,000)
Not known (cannot be estimated from the available data)
   Blood and lymphatic system disorders
                     Immune system disorders
Hypersensitivity reactions (e.g. rash, pruritus, urticaria,b angioedemab)
Anaphylaxis
                     Metabolism and nutrition disorders
Decreased appetite
                     Psychiatric disorders
Insomnia
                     Nervous system disorders
Headache
Lethargy
Acute peripheral facial paralysisc
                     Cardiac disorders
Myocarditisd; Pericarditisd
                     Gastrointestinal disorders
Diarrhoead
Nausea; Vomitingd
                     Skin and subcutaneous tissue disorder
Hyperhidrosis; Night sweats
Erythema multiformed
                     Musculoskeletal and connective tissue disorders
Arthralgia; Myalgia
Pain in extremitye
                     General disorders and administration site conditions
Injection site pain; Fatigue; Chills; Pyrexia;f Injection site swelling
Injection site redness
Asthenia; Malaise; Injection site pruritus
Extensive swelling of vaccinated limb;d Facial swellingg
                    a. A higher frequency of lymphadenopathy (5.2% vs 0.4%) was observed in participants receiving a booster dose (third dose) compared to participants receiving 2 doses.
b. The frequency category for urticaria and angioedema was Rare.
c. Through the clinical trial safety follow-up period to 14 November 2020, acute peripheral facial paralysis (or palsy) was
reported by four participants in the COVID-19 mRNA Vaccine group. Onset was Day 37 after Dose 1 (participant did not receive Dose 2) and Days 3, 9, and 48 after Dose 2. No cases of acute peripheral facial paralysis (or palsy) were reported in the placebo group.
d. Adverse reaction determined post-authorisation.
e. Refers to vaccinated arm.
f. A higher frequency of pyrexia was observed after the second dose compare to the first dose.
g. Facial swelling in vaccine recipients with a history of injection of dermatological fillers has been reported in the post-
marketing phase.
Description of selected adverse reactions
Myocarditis
The increased risk of myocarditis after vaccination with Comirnaty is highest in younger males (see section 4.4).
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Two large European pharmacoepidemiological studies have estimated the excess risk in younger males following the second dose of Comirnaty. One study showed that in a period of 7 days after the second dose there were about 0.265 (95% CI 0.255 - 0.275) extra cases of myocarditis in 12-29 year old males per 10,000 compared to unexposed persons. In another study, in a period of 28 days after the second dose there were 0.57 [95% CI 0.39 – 0.75] extra cases of myocarditis in 16-24 year old males per 10,000 compared to unexposed persons.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V and include batch/Lot number if available.
4.9 Overdose
Overdose data is available from 52 study participants included in the clinical trial that due to an error in dilution received 58 micrograms of Comirnaty. The vaccine recipients did not report an increase in reactogenicity or adverse reactions.
In the event of overdose, monitoring of vital functions and possible symptomatic treatment is recommended.
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: vaccines, other viral vaccines, ATC code: J07BX03 Mechanism of action
The nucleoside-modified messenger RNA in Comirnaty (tozinameran) is formulated in lipid nanoparticles, which enable delivery of the non replicating RNA into host cells to direct transient expression of the SARS-CoV-2 S antigen. The mRNA codes for membrane-anchored, full-length S with two point mutations within the central helix. Mutation of these two amino acids to proline locks S in an antigenically preferred prefusion conformation. The vaccine elicits both neutralizing antibody and cellular immune responses to the spike (S) antigen, which may contribute to protection against COVID-19.
Efficacy
Study 2 is a multicentre, multinational, Phase 1/2/3 randomised, placebo-controlled, observer-blind dose-finding, vaccine candidate selection and efficacy study in participants 12 years of age and older. Randomisation was stratified by age: 12 to 15 years of age, 16 to 55 years of age, or 56 years of age and older, with a minimum of 40% of participants in the ≥ 56-year stratum. The study excluded participants who were immunocompromised and those who had previous clinical or microbiological diagnosis of COVID-19. Participants with pre-existing stable disease, defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 6 weeks before enrolment, were included as were participants with known stable infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV) or hepatitis B virus (HBV).
Efficacy in participants 16 years of age and older – after 2 doses
In the Phase 2/3 portion of Study 2, based on data accrued through 14 November 2020, approximately 44,000 participants were randomised equally and were to receive 2 doses of COVID-19 mRNA Vaccine or placebo. The efficacy analyses included participants that received their second vaccination
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within 19 to 42 days after their first vaccination. The majority (93.1%) of vaccine recipients received the second dose 19 days to 23 days after Dose 1. Participants are planned to be followed for up to
24 months after Dose 2, for assessments of safety and efficacy against COVID-19. In the clinical study, participants were required to observe a minimum interval of 14 days before and after administration of an influenza vaccine in order to receive either placebo or COVID-19 mRNA Vaccine. In the clinical study, participants were required to observe a minimum interval of 60 days before or after receipt of blood/plasma products or immunoglobulins within through conclusion of the study in order to receive either placebo or COVID-19 mRNA Vaccine.
The population for the analysis of the primary efficacy endpoint included, 36,621 participants 12 years of age and older (18,242 in the COVID-19 mRNA Vaccine group and 18,379 in the placebo group) who did not have evidence of prior infection with SARS-CoV-2 through 7 days after the second dose. In addition, 134 participants were between the ages of 16 to 17 years of age (66 in the COVID-19 mRNA Vaccine group and 68 in the placebo group) and 1,616 participants 75 years of age and older (804 in the COVID-19 mRNA Vaccine group and 812 in the placebo group).
At the time of the primary efficacy analysis, participants had been followed for symptomatic COVID-19 for in total 2,214 person-years for the COVID-19 mRNA Vaccine and in total 2,222 person-years in the placebo group.
There were no meaningful clinical differences in overall vaccine efficacy in participants who were at risk of severe COVID-19 including those with 1 or more comorbidities that increase the risk of severe COVID-19 (e.g. asthma, body mass index (BMI) ≥ 30 kg/m2, chronic pulmonary disease, diabetes mellitus, hypertension).
The vaccine efficacy information is presented in Table 2.
Table 2: Vaccine efficacy – First COVID-19 occurrence from 7 days after Dose 2, by age subgroup – participants without evidence of infection prior to 7 days after Dose 2 – evaluable efficacy (7 days) population
      First COVID-19 occurrence from 7 days after Dose 2 in participants without evidence of prior SARS-CoV-2 infection*
     Subgroup
COVID-19 mRNA Vaccine
Na = 18,198 Cases
n1b Surveillancetimec (n2d)
   Placebo
Na = 18,325 Cases
n1b Surveillancetimec (n2d)
     Vaccine efficacy % (95% CI)e
     All participants
8
2.214 (17,411)
   162 2.222 (17,511)
     95.0 (90.0, 97.9)
     16 to 64 years
7
1.706 (13,549)
   143 1.710 (13,618)
     95.1 (89.6, 98.1)
     65 years and older
1 0.508 (3848)
   19 0.511 (3880)
     94.7 (66.7, 99.9)
     65 to 74 years
1 0.406 (3074)
   14 0.406 (3095)
     92.9 (53.1, 99.8)
     75 years and older
    0 0.102 (774)
    5 0.106 (785)
       100.0 (-13.1, 100.0)
   Note: Confirmed cases were determined by Reverse Transcription-Polymerase Chain Reaction (RT-PCR) and at least 1 symptom consistent with COVID-19 [*Case definition: (at least 1 of) fever, new or increased cough, new or increased shortness of breath, chills, new or increased muscle pain, new loss of taste or smell, sore throat, diarrhoea or vomiting.]
* Participants who had no serological or virological evidence (prior to 7 days after receipt of the last dose) of past SARS-CoV-2 infection (i.e., N-binding antibody [serum] negative at Visit 1 and SARS-CoV-2 not detected by nucleic acid amplification tests (NAAT) [nasal swab] at Visits 1 and 2), and had negative NAAT (nasal swab) at any unscheduled visit prior to 7 days after Dose 2 were included in the analysis.
a. N = Number of participants in the specified group.
b. n1 = Number of participants meeting the endpoint definition.
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     First COVID-19 occurrence from 7 days after Dose 2 in participants without evidence of prior SARS-CoV-2 infection*
     Subgroup
    COVID-19 mRNA Vaccine
Na = 18,198 Cases
n1b Surveillancetimec (n2d)
    Placebo
Na = 18,325 Cases
n1b Surveillancetimec (n2d)
       Vaccine efficacy % (95% CI)e
   c. Total surveillance time in 1,000 person-years for the given endpoint across all participants within each group at risk for the endpoint. Time period for COVID-19 case accrual is from 7 days after Dose 2 to the end of the surveillance period.
d. n2 = Number of participants at risk for the endpoint.
e. Two-sided confidence interval (CI) for vaccine efficacy is derived based on the Clopper and Pearson
method adjusted to the surveillance time. CI not adjusted for multiplicity.
Efficacy of COVID-19 mRNA Vaccine in preventing first COVID-19 occurrence from 7 days after Dose 2 compared to placebo was 94.6% (95% confidence interval of 89.6% to 97.6%) in participants 16 years of age and older with or without evidence of prior infection with SARS-CoV-2.
Additionally, subgroup analyses of the primary efficacy endpoint showed similar efficacy point estimates across genders, ethnic groups, and participants with medical comorbidities associated with high risk of severe COVID-19.
Updated efficacy analyses were performed with additional confirmed COVID-19 cases accrued during blinded placebo-controlled follow-up, representing up to 6 months after Dose 2 in the efficacy population.
The updated vaccine efficacy information is presented in Table 3.
Table 3: Vaccine efficacy – First COVID-19 occurrence from 7 days after Dose 2, by age subgroup – participants without evidence of prior SARS-CoV-2 infection* prior to 7 days after Dose 2 – evaluable efficacy (7 days) population during the placebo-controlled follow-up period
    Subgroup
COVID-19 mRNA Vaccine Na=20,998 Cases
n1b
Surveillance timec (n2d)
   Placebo Na=21,096 Cases n1b
Surveillance timec (n2d)
     Vaccine efficacy % (95% CIe)
   All participantsf
77 6.247 (20,712)
   850 6.003 (20,713)
     91.3 (89.0, 93.2)
   16 to 64 years
70 4.859 (15,519)
   710 4.654 (15,515)
     90.6 (87.9, 92.7)
   65 years and older
7 1.233 (4192)
   124 1.202 (4226)
     94.5 (88.3, 97.8)
   65 to 74 years
6 0.994 (3350)
   98 0.966 (3379)
     94.1 (86.6, 97.9)
   75 years and older
   1 0.239 (842)
    26 0.237 (847)
       96.2 (76.9, 99.9)
   Note: Confirmed cases were determined by Reverse Transcription-Polymerase Chain Reaction (RT-PCR) and at least 1 symptom consistent with COVID-19 (symptoms included: fever; new or increased cough; new or increased shortness of breath; chills; new or increased muscle pain; new loss of taste or smell; sore throat; diarrhoea; vomiting).
* Participants who had no evidence of past SARS-CoV-2 infection (i.e., N-binding antibody [serum] negative at Visit 1 and SARS-CoV-2 not detected by NAAT [nasal swab] at Visits 1 and 2), and had negative NAAT (nasal swab) at any unscheduled visit prior to 7 days after Dose 2 were included in the analysis.
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Table 3: Vaccine efficacy – First COVID-19 occurrence from 7 days after Dose 2, by age subgroup – participants without evidence of prior SARS-CoV-2 infection* prior to 7 days after Dose 2 – evaluable efficacy (7 days) population during the placebo-controlled follow-up period
a. N = Number of participants in the specified group.
b. n1 = Number of participants meeting the endpoint definition.
c. Total surveillance time in 1,000 person-years for the given endpoint across all participants within each
group at risk for the endpoint. Time period for COVID-19 case accrual is from 7 days after Dose 2 to the
end of the surveillance period.
d. n2 = Number of participants at risk for the endpoint.
e. Two-sided 95% confidence interval (CI) for vaccine efficacy is derived based on the Clopper and Pearson
method adjusted to the surveillance time.
f. Included confirmed cases in participants 12 to 15 years of age: 0 in the COVID-19 mRNA Vaccine group;
16 in the placebo group.
In the updated efficacy analysis, efficacy of COVID-19 mRNA Vaccine in preventing first COVID-19 occurrence from 7 days after Dose 2 compared to placebo was 91.1% (95% CI of 88.8% to 93.0%) in participants in the evaluable efficacy population with or without evidence of prior infection with SARS-CoV-2.
Additionally, the updated efficacy analyses by subgroup showed similar efficacy point estimates across sexes, ethnic groups, geography and participants with medical comorbidities and obesity associated with high risk of severe COVID-19.
Efficacy against severe COVID-19
Updated efficacy analyses of secondary efficacy endpoints supported benefit of the COVID-19 mRNA Vaccine in preventing severe COVID‐19.
As of 13 March 2021, vaccine efficacy against severe COVID-19 is presented only for participants with or without prior SARS-CoV-2 infection (Table 4) as the COVID-19 case counts in participants without prior SARS-CoV-2 infection were the same as those in participants with or without prior SARS-CoV-2 infection in both the COVID-19 mRNA Vaccine and placebo groups.
Table 4: Vaccine efficacy – First severe COVID-19 occurrence in participants with or without prior SARS-CoV-2 infection based on the Food and Drug Administration (FDA)* after Dose 1 or from 7 days after Dose 2 in the placebo-controlled follow-up
         COVID-19 mRNA Vaccine Cases
n1a
Surveillance time (n2b)
Placebo Cases
n1a
Surveillance time (n2b)
     Vaccine efficacy % (95% CIc)
    After Dose 1d
   1
8.439e (22,505)
30 8.288e (22,435)
     96.7 (80.3, 99.9)
    7 days after Dose 2f
      1
6.522g (21,649)
   21 6.404g (21,730)
      95.3 (70.9, 99.9)
   Note: Confirmed cases were determined by Reverse Transcription-Polymerase Chain Reaction (RT-PCR) and at least 1 symptom consistent with COVID-19 (symptoms included: fever; new or increased cough; new or increased shortness of breath; chills; new or increased muscle pain; new loss of taste or smell; sore throat; diarrhoea; vomiting).
* Severe illness from COVID-19 as defined by FDA is confirmed COVID-19 and presence of at least 1 of the following:
 Clinical signs at rest indicative of severe systemic illness (respiratory rate ≥ 30 breaths per minute, heart rate ≥ 125 beats per minute, saturation of oxygen ≤ 93% on room air at sea level, or ratio of arterial oxygen partial pressure to fractional inspired oxygen < 300 mm Hg);
 Respiratory failure [defined as needing high-flow oxygen, noninvasive ventilation, mechanical ventilation or extracorporeal membrane oxygenation (ECMO)];
 Evidence of shock (systolic blood pressure < 90 mm Hg, diastolic blood pressure < 60 mm Hg, or requiring vasopressors);
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Table 4: Vaccine efficacy – First severe COVID-19 occurrence in participants with or without prior SARS-CoV-2 infection based on the Food and Drug Administration (FDA)* after Dose 1 or from 7 days after Dose 2 in the placebo-controlled follow-up
 Significant acute renal, hepatic, or neurologic dysfunction;
 Admission to an Intensive Care Unit;
 Death.
a. n1 = Number of participants meeting the endpoint definition.
b. n2 = Number of participants at risk for the endpoint.
c. Two-side confidence interval (CI) for vaccine efficacy is derived based on the Clopper and Pearson method
adjusted to the surveillance time.
d. Efficacy assessed based on the Dose 1 all available efficacy (modified intention-to-treat) population that
included all randomised participants who received at least 1 dose of study intervention.
e. Total surveillance time in 1,000 person-years for the given endpoint across all participants within each
group at risk for the endpoint. Time period for COVID-19 case accrual is from Dose 1 to the end of the
surveillance period.
f. Efficacy assessed based on the evaluable efficacy (7 Days) population that included all eligible randomised
participants who receive all dose(s) of study intervention as randomised within the predefined window,
have no other important protocol deviations as determined by the clinician.
g. Total surveillance time in 1,000 person-years for the given endpoint across all participants within each
group at risk for the endpoint. Time period for COVID-19 case accrual is from 7 days after Dose 2 to the end of the surveillance period.
Efficacy and immunogenicity in adolescents 12 to 15 years of age – after 2 doses
In an analysis of Study 2 in adolescents 12 to 15 years of age without evidence of prior infection, there were no cases in 1,005 participants who received the vaccine and 16 cases out of 978 who received placebo. The point estimate for efficacy is 100% (95% confidence interval 75.3, 100.0). In participants with or without evidence of prior infection there were 0 cases in the 1,119 who received vaccine and 18 cases in 1,110 participants who received placebo. This also indicates the point estimate for efficacy is 100% (95% confidence interval 78.1, 100.0).
In Study 2, an analysis of SARS-CoV-2 neutralising titres 1 month after Dose 2 was conducted in a randomly selected subset of participants who had no serological or virological evidence of past SARS-CoV-2 infection up to 1 month after Dose 2, comparing the response in adolescents 12 to 15 years of age (n = 190) to participants 16 to 25 years of age (n = 170).
The ratio of the geometric mean titres (GMT) in the 12 to 15 years of age group to the 16 to 25 years of age group was 1.76, with a 2-sided 95% CI of 1.47 to 2.10. Therefore, the 1.5-fold noninferiority criterion was met as the lower bound of the 2-sided 95% CI for the geometric mean ratio [GMR] was > 0.67.
Immunogenicity in participants 18 years of age and older – after booster dose (third dose)
Effectiveness of a booster dose of Comirnaty was based on an assessment of 50% neutralizing antibody titers (NT50) against SARS-CoV-2 (USA_WA1/2020). In Study 2, analyses of NT50
1 month after the booster dose compared to 1 month after the primary series in individuals 18 through 55 years of age who had no serological or virological evidence of past SARS-CoV-2 infection up to
1 month after the booster vaccination demonstrated noninferiority for both geometric mean ratio (GMR) and difference in seroresponse rates. Seroresponse for a participant was defined as achieving a ≥ 4-fold rise in NT50 from baseline (before primary series). These analyses are summarized in
Table 5.
32

Table 5: SARS-CoV-2 neutralization assay - NT50 (titer)† (SARS-CoV-2 USA_WA1/2020) – GMT and seroresponse rate comparison of 1 month after booster dose to 1 month after primary series – participants 18 through 55 years of age without evidence of infection up to 1 month after booster dose* – booster dose evaluable immunogenicity population±
        n
1 month after booster dose (95% CI)
   1 month after primary series (95% CI)
   1 month after booster dose/- 1 month after primary series
(97.5% CI)
    Met noninferiority objective (Y/N)
   Geometric mean 50% neutralizing titer (GMTb)
       212a
    2466.0b (2202.6, 2760.8)
    750.6b (656.2, 858.6)
     3.29c (2.77, 3.90)
      Yd
   Seroresponse rate (%) for 50% neutralizing titer†
    200e
   199f 99.5% (97.2%, 100.0%)
196f 98.0% (95.0%, 99.5%)
   1.5%g (-0.7%, 3.7%h)
    Yi
Abbreviations: CI = confidence interval; GMR = geometric mean ratio; GMT = geometric mean titer;
LLOQ = lower limit of quantitation; N-binding = SARS-CoV-2 nucleoprotein-binding; NAAT = nucleic acid amplification test; NT50 = 50% neutralizing titer; SARS-CoV-2 = severe acute respiratory syndrome coronavirus 2; Y/N = yes/no.
† SARS-CoV-2 NT50 were determined using the SARS-CoV-2 mNeonGreen Virus Microneutralization
Assay. The assay uses a fluorescent reporter virus derived from the USA_WA1/2020 strain and virus neutralization is read on Vero cell monolayers. The sample NT50 is defined as the reciprocal serum dilution at which 50% of the virus is neutralized.
* Participants who had no serological or virological evidence (up to 1 month after receipt of a booster dose of Comirnaty) of past SARS-CoV-2 infection (i.e., N-binding antibody [serum] negative and SARS-CoV-2 not detected by NAAT [nasal swab]) and had a negative NAAT (nasal swab) at any unscheduled visit up to 1 month after the booster dose were included in the analysis.
± All eligible participants who had received 2 doses of Comirnaty as initially randomized, with Dose 2 received within the predefined window (within 19 to 42 days after Dose 1), received a booster dose of Comirnaty, had at least 1 valid and determinate immunogenicity result after booster dose from a blood collection within an appropriate window (within 28 to 42 days after the booster dose), and had no other important protocol deviations as determined by the clinician.
a. n = Number of participants with valid and determinate assay results at both sampling time points within specified window.
b. GMTs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to
0.5 × LLOQ.
c. GMRs and 2-sided 97.5% CIs were calculated by exponentiating the mean differences in the logarithms of the assay and the corresponding CIs (based on the Student t distribution).
d. Noninferiority is declared if the lower bound of the 2-sided 97.5% CI for the GMR is > 0.67 and the point estimate of the GMR is ≥ 0.80.
e. n = Number of participants with valid and determinate assay results for the specified assay at baseline, 1 month after Dose 2 and 1 month after the booster dose within specified window. These values are the denominators for the percentage calculations.
f. Number of participants with seroresponse for the given assay at the given dose/sampling time point. Exact 2-sided CI based on the Clopper and Pearson method.
g. Difference in proportions, expressed as a percentage (1 month after booster dose – 1 month after Dose 2).
h. Adjusted Wald 2-sided CI for the difference in proportions, expressed as a percentage.
i. Noninferiority is declared if the lower bound of the 2-sided 97.5% CI for the percentage difference is
> -10%.
Paediatric population
The European Medicines Agency has deferred the obligation to submit the results of studies with Comirnaty in the paediatric population in prevention of COVID-19 (see section 4.2 for information on paediatric use).
33

This medicinal product has been authorised under a so-called ‘conditional approval’ scheme. This means that further evidence on this medicinal product is awaited. The European Medicines Agency will review new information on this medicinal product at least every year and this SmPC will be updated as necessary.
5.2 Pharmacokinetic properties
Not applicable.
5.3 Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of repeat dose toxicity and reproductive and developmental toxicity.
General toxicity
Rats intramuscularly administered Comirnaty (receiving 3 full human doses once weekly, generating relatively higher levels in rats due to body weight differences) demonstrated some injection site oedema and erythema and increases in white blood cells (including basophils and eosinophils) consistent with an inflammatory response as well as vacuolation of portal hepatocytes without evidence of liver injury. All effects were reversible.
Genotoxicity/Carcinogenicity
Neither genotoxicity nor carcinogenicity studies were performed. The components of the vaccine (lipids and mRNA) are not expected to have genotoxic potential.
Reproductive toxicity
Reproductive and developmental toxicity were investigated in rats in a combined fertility and developmental toxicity study where female rats were intramuscularly administered Comirnaty prior to mating and during gestation (receiving 4 full human doses that generate relatively higher levels in rat due to body weight differences, spanning between pre-mating day 21 and gestational day 20). SARS-CoV-2 neutralizing antibody responses were present in maternal animals from prior to mating to the end of the study on postnatal day 21 as well as in foetuses and offspring. There were no vaccine-related effects on female fertility, pregnancy, or embryo-foetal or offspring development. No Comirnaty data are available on vaccine placental transfer or excretion in milk.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate) (ALC-0315) 2-[(polyethylene glycol)-2000]-N,N-ditetradecylacetamide (ALC-0159) 1,2-Distearoyl-sn-glycero-3-phosphocholine (DSPC)
Cholesterol
Trometamol
Trometamol hydrochloride Sucrose
Water for injections
6.2 Incompatibilities
This medicinal product must not be mixed with other medicinal products.
    34

6.3 Shelf life
Unopened vial
Frozen vial
9 months when stored at -90 °C to -60 °C.
The vaccine may be received frozen at -90 °C to -60 °C or at -25 °C to -15 °C. Frozen vaccine can be stored either at -90 °C to -60 °C or 2 °C to 8 °C upon receipt.
When stored frozen at -90 °C to -60 °C, 10-vial packs of the vaccine can be thawed at 2 °C to 8 °C for 6 hours or individual vials can be stored at room temperature (up to 30 °C) for 30 minutes.
Thawed vial
10 weeks storage and transportation at 2 °C to 8 °C within the 9-month shelf life.
 Upon moving the product to 2 °C to 8 °C storage, the updated expiry date must be written on the outer carton and the vaccine should be used or discarded by the updated expiry date. The original expiry date should be crossed out.
 If the vaccine is received at 2 °C to 8 °C it should be stored at 2 °C to 8 °C. Check that the expiry date on the outer carton has been updated to reflect the refrigerated expiry date and that the original expiry date has been crossed out.
Prior to use, the unopened vials can be stored for up to 12 hours at temperatures between 8 °C and 30 °C.
Thawed vials can be handled in room light conditions.
Once thawed, the vaccine should not be re-frozen.
Handling of temperature excursions during refrigerated storage
 Stability data indicate that the unopened vial is stable for up to 10 weeks when stored at temperatures from -2 °C to 2 °C, within the 10-week storage period between 2 °C and 8 °C.
 Stability data indicate the vial can be stored for up to 24 hours at temperatures of 8 °C to 30 °C, including up to 12 hours following first puncture.
This information is intended to guide healthcare professionals only in case of temporary temperature excursion.
Opened vial
Chemical and physical in-use stability has been demonstrated for12 hours at 2 oC to 30 oC. From a microbiological point of view, unless the method of opening precludes the risks of microbial contamination, the product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user.
6.4 Special precautions for storage
Store in a freezer at -90 °C to -60 °C.
Store in the original package in order to protect from light.
During storage, minimise exposure to room light, and avoid exposure to direct sunlight and ultraviolet light.
For storage conditions after thawing and first opening, see section 6.3.
35

6.5 Nature and contents of container
2.25 mL solution in a 2 mL clear multidose vial (type I glass) with a stopper (synthetic bromobutyl rubber) and a grey flip-off plastic cap with aluminium seal. Each vial contains 6 doses, see section 6.6.
Pack sizes: 195 vials or 10 vials
Not all pack sizes may be marketed.
6.6 Special precautions for disposal and other handling Handling instructions
Comirnaty should be prepared by a healthcare professional using aseptic technique to ensure the sterility of the prepared dispersion.
      DOSE VERIFICATION OF COMIRNATY 30 MICROGRAMS/DOSE DISPERSION FOR INJECTION (12 YEARS AND OLDER)
         Grey cap
 Verify that the vial has a grey plastic cap.
 If the vial has a purple plastic cap, please make reference to the Summary of Product Characteristics for Comirnaty 30 micrograms/dose concentrate for dispersion for injection.
 If the vial has an orange plastic cap, please make reference to the Summary of Product Characteristics for Comirnaty 10 micrograms/dose concentrate for dispersion for injection.
         HANDLING PRIOR TO USE OF COMIRNATY 30 MICROGRAMS/DOSE DISPERSION FOR INJECTION (12 YEARS AND OLDER))
       Store for up to 10 weeks at 2 °C to 8 °C, update expiry on carton
     If the multidose vial is stored frozen it must be thawed prior to use. Frozen vials should be transferred to an environment of 2 °C to 8 °C to thaw; a 10 vial pack may take 6 hours to thaw. Ensure vials are completely thawed prior to use.
 Uponmovingvialsto2°Cto8°C storage, update the expiry date on the carton.
 Unopened vials can be stored for up to 10 weeks at 2 °C to 8 °C within the 9-month shelf life.
 Alternatively, individual frozen vials may be thawed for 30 minutes at temperatures up to 30 °C.
 Prior to use, the unopened vial can be stored for up to 12 hours at temperatures up to 30 °C. Thawed vials can be handled in room light conditions.
   36

    Gently × 10
     Gently mix by inverting vials 10 times prior to use. Do not shake.
 Prior to mixing, the thawed dispersion may contain white to off-white opaque amorphous particles.
 After mixing, the vaccine should present as a white to off-white dispersion with no particulates visible. Do not use the vaccine if particulates or discolouration are present.
        PREPARATION OF INDIVIDUAL 0.3 mL DOSES OF COMIRNATY
30 MICROGRAMS/DOSE DISPERSION FOR INJECTION (12 YEARS AND OLDER)
       0.3 mL vaccine
     Using aseptic technique, cleanse the vial stopper with a single-use antiseptic swab.
 Withdraw 0.3 mL of Comirnaty.
Low dead-volume syringes and/or needles should be used in order to extract 6 doses from a single vial. The low dead-volume syringe and needle combination should have a dead volume of no more than 35 microlitres.
If standard syringes and needles are used, there may not be sufficient volume to extract a sixth dose from a single vial.
 Each dose must contain 0.3 mL of vaccine.
 If the amount of vaccine remaining in the vial cannot provide a full dose of 0.3 mL, discard the vial and any excess volume.
 Discard any unused vaccine 12 hours after first puncture. Record the appropriate date/time on the vial.
     Disposal
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
37

7. MARKETING AUTHORISATION HOLDER
BioNTech Manufacturing GmbH An der Goldgrube 12
55131 Mainz
Germany
Phone: +49 6131 9084-0 Fax: +49 6131 9084-2121 service@biontech.de
8. MARKETING AUTHORISATION NUMBER(S)
EU/1/20/1528/003 EU/1/20/1528/002
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 21 December 2020 Date of latest renewal: 03 November 2021
10. DATE OF REVISION OF THE TEXT
Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
38

This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions.
1. NAME OF THE MEDICINAL PRODUCT
Comirnaty 10 micrograms/dose concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
This is a multidose vial and must be diluted before use.
One vial (1.3 mL) contains 10 doses of 0.2 mL after dilution, see sections 4.2 and 6.6.
One dose (0.2 mL) contains 10 micrograms of tozinameran, a COVID-19 mRNA Vaccine (embedded in lipid nanoparticles).
Tozinameran is a single-stranded, 5’-capped messenger RNA (mRNA) produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Concentrate for dispersion for injection (sterile concentrate).
The vaccine is a white to off-white frozen dispersion (pH: 6.9 - 7.9).
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
Comirnaty 10 micrograms/dose concentrate for dispersion for injection is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 virus, in children aged 5 to 11 years.
The use of this vaccine should be in accordance with official recommendations.
4.2 Posology and method of administration
Posology
Children 5 to 11 years of age (i.e. 5 to less than 12 years of age)
Comirnaty 10 micrograms/dose is administered intramuscularly after dilution as a course of 2 doses (0.2 mL each). It is recommended to administer the second dose 3 weeks after the first dose (see sections 4.4 and 5.1).
The interchangeability of Comirnaty with COVID-19 vaccines from other manufacturers to complete the vaccination course has not been established. Individuals who have received 1 dose of Comirnaty should receive a second dose of Comirnaty to complete the vaccination course.
Comirnaty 10 micrograms/dose should be used only for children 5 to 11 years of age.
39

Severely immunocompromised aged 5 years and older
A third dose may be given at least 28 days after the second dose to individuals who are severely
immunocompromised (see section 4.4).
Paediatric population
The safety and efficacy of Comirnaty in paediatric children aged less than 5 years have not yet been established.
Method of administration
Comirnaty 10 micrograms/dose concentrate for dispersion for injection should be administered intramuscularly after dilution (see section 6.6).
After dilution, vials of Comirnaty contain 10 doses of 0.2 mL of vaccine. In order to extract 10 doses from a single vial, low dead-volume syringes and/or needles should be used. The low dead-volume syringe and needle combination should have a dead volume of no more than 35 microlitres. If standard syringes and needles are used, there may not be sufficient volume to extract 10 doses from a single vial. Irrespective of the type of syringe and needle:
 Each dose must contain 0.2 mL of vaccine.
 If the amount of vaccine remaining in the vial cannot provide a full dose of 0.2 mL, discard the
vial and any excess volume.
 Do not pool excess vaccine from multiple vials.
The preferred site is the deltoid muscle of the upper arm.
Do not inject the vaccine intravascularly, subcutaneously or intradermally.
The vaccine should not be mixed in the same syringe with any other vaccines or medicinal products.
For precautions to be taken before administering the vaccine, see section 4.4.
For instructions regarding thawing, handling and disposal of the vaccine, see section 6.6.
4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
4.4 Special warnings and precautions for use
Traceability
In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
General recommendations
Hypersensitivity and anaphylaxis
Events of anaphylaxis have been reported. Appropriate medical treatment and supervision should always be readily available in case of an anaphylactic reaction following the administration of the vaccine.
Close observation for at least 15 minutes is recommended following vaccination. A second dose of the vaccine should not be given to those who have experienced anaphylaxis to the first dose of Comirnaty.
    40

Myocarditis and pericarditis
There is an increased risk of myocarditis and pericarditis following vaccination with Comirnaty. These conditions can develop within just a few days after vaccination, and have primarily occurred within
14 days. They have been observed more often after the second vaccination, and more often in younger males (see section 4.8). Available data suggest that the course of myocarditis and pericarditis following vaccination is not different from myocarditis or pericarditis in general.
Healthcare professionals should be alert to the signs and symptoms of myocarditis and pericarditis. Vaccinees (including parents or caregivers) should be instructed to seek immediate medical attention if they develop symptoms indicative of myocarditis or pericarditis such as (acute and persisting) chest pain, shortness of breath, or palpitations following vaccination.
Healthcare professionals should consult guidance and/or specialists to diagnose and treat this condition.
The risk of myocarditis after a third dose of Comirnaty has not yet been characterised.
Anxiety-related reactions
Anxiety-related reactions, including vasovagal reactions (syncope), hyperventilation or stress‐related reactions (e.g. dizziness, palpitations, increases in heart rate, alterations in blood pressure, tingling sensations and sweating) may occur in association with the vaccination process itself. Stress-related reactions are temporary and resolve on their own. Individuals should be advised to bring symptoms to the attention of the vaccination provider for evaluation. It is important that precautions are in place to avoid injury from fainting.
Concurrent illness
Vaccination should be postponed in individuals suffering from acute severe febrile illness or acute infection. The presence of a minor infection and/or low-grade fever should not delay vaccination.
Thrombocytopenia and coagulation disorders
As with other intramuscular injections, the vaccine should be given with caution in individuals receiving anticoagulant therapy or those with thrombocytopenia or any coagulation disorder (such as haemophilia) because bleeding or bruising may occur following an intramuscular administration in these individuals.
Immunocompromised individuals
The efficacy and safety of the vaccine has not been assessed in immunocompromised individuals, including those receiving immunosuppressant therapy. The efficacy of Comirnaty may be lower in immunocompromised individuals.
The recommendation to consider a third dose in severely immunocompromised individuals is based on limited serological evidence from a case-series in the literature from the clinical management of adult patients with iatrogenic immunocompromisation after solid organ transplantation (see section 4.2).
Duration of protection
The duration of protection afforded by the vaccine is unknown as it is still being determined by ongoing clinical trials.
Limitations of vaccine effectiveness
As with any vaccine, vaccination with Comirnaty may not protect all vaccine recipients. Individuals may not be fully protected until 7 days after their second dose of vaccine.
4.5 Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed.
Concomitant administration of Comirnaty with other vaccines has not been studied.
41

4.6 Fertility, pregnancy and lactation
Pregnancy
There is limited experience with use of Comirnaty in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryo/foetal development, parturition or post-natal development (see section 5.3). Administration of Comirnaty in pregnancy should only be considered when the potential benefits outweigh any potential risks for the mother and foetus.
Breast-feeding
It is unknown whether Comirnaty is excreted in human milk.
Fertility
Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).
4.7 Effects on ability to drive and use machines
Comirnaty has no or negligible influence on the ability to drive and use machines. However, some of the effects mentioned under section 4.8 may temporarily affect the ability to drive or use machines.
   4.8 Undesirable effects
Summary of safety profile
Comirnaty
    The safety of
was evaluated in participants 5
years of age and older in 3 clinical studies that
included 24,675 participants (comprised of 22,026 participants 16 years of age and older,
1,131 adolescents 12 to 15 years of age, and 3,109 children 5 to 11 years of age) that have received at
least 1 dose of Comirnaty.
The overall safety profile of Comirnaty in participants 5 to 15 years of age was similar to that seen in
participants 16 years of age and older.
Additionally, 306 existing Phase 3 participants 18 to 55 years of age received a booster dose (third
dose) of Comirnaty approximately 6 months after the second dose. The overall safety profile for the
booster dose (third dose) was similar to that seen after 2 doses.
– after 2 doses
of age received at least 1 dose of
of age received placebo.
Children 5 to 11 years of age (i.e. 5 to less than 12 years of age)
In Study 3,   1,518 5 to 11 years 5 to 11 years
Comirnaty 10 mcg At the time of the analysis of Study 3
a total of
children
and a total of 750 children
Phase 2/3 with data up to the cut-off date of 6 September 2021, 2,158 (95.1%) (1,444 Comirnaty
10 mcg and 714 placebo) children have been followed for at least 2 months after the second dose of Comirnaty 10 mcg. An analysis of Study 3 Phase 2/3 adverse event data also included another
2,379 participants [1,591 Comirnaty 10 mcg and 788 placebo], of whom 71.2% had a follow-up period for at least 2 weeks after Dose 2 up to the cut-off date of 8 October 2021. The safety evaluation in Study 3 is ongoing.
The most frequent adverse reactions in children 5 to 11 years of age were injection site pain (>80%), fatigue (>50%), headache (>30%), injection site redness and swelling (>20%), myalgia and chills (>10%).
Comirnaty
Participants 16 years of age and older – after 2 doses
In Study 2, a total of 22,026 participants 16 years of age or older received at least 1 dose of
30 mcg and a total of 22,021 participants 16 years of age or older received placebo (including 138 and
42

145 adolescents 16 and 17 years of age in the vaccine and placebo groups, respectively). A total of
20,519 participants 16 years of age or older received 2 doses of Comirnaty.
At the time of the analysis of Study 2 with a data cut-off of 13 March 2021 for the placebo-controlled blinded follow-up period up to the participants’ unblinding dates, a total of 25,651 (58.2%) participants (13,031 Comirnaty and 12,620 placebo) 16 years of age and older were followed up for
≥ 4 months after the second dose. This included a total of 15,111 (7,704 Comirnaty and 7,407 placebo) participants 16 to 55 years of age and a total of 10,540 (5,327 Comirnaty and 5,213 placebo) participants 56 years of age and older.
most frequent
The safety profile in 545 participants 16 years of age and older receiving Comirnaty, that were seropositive for SARS-CoV-2 at baseline, was similar to that seen in the general population.
Adolescents 12 to 15 years of age – after 2 doses
In an analysis of Study 2, based on data up to the cutoff date of 13 March 2021, 2,260 adolescents (1,131 Comirnaty 30 mcg and 1,129 placebo) were 12 to 15 years of age. Of these, 1,308 adolescents (660 Comirnaty and 648 placebo) have been followed for at least 2 months after the second dose of Comirnaty. The safety evaluation in Study 2 is ongoing.
The most frequent adverse reactions in adolescents 12 to 15 years of age that received 2 doses were injection site pain (> 90%), fatigue and headache (> 70%), myalgia and chills (> 40%), arthralgia and pyrexia (> 20%).
Participants 18 years of age and older – after booster dose (third dose)
A subset from Study 2 Phase 2/3 participants of 306 adults 18 to 55 years of age who completed the original Comirnaty 2-dose course, received a booster dose (third dose) of Comirnaty approximately 6 months (range of 4.8 to 8.0 months) after receiving Dose 2.
The most frequent adverse reactions in participants 18 to 55 years of age were injection site pain (> 80%), fatigue (> 60%), headache (> 40%), myalgia (> 30%), chills and arthralgia (> 20%).
Tabulated list of adverse reactions from clinical studies and post-authorisation experience in individuals 5 years of age and older
Adverse reactions observed during clinical studies are listed below according to the following frequency categories:
Very common (≥ 1/10),
Common (≥ 1/100 to < 1/10),
Uncommon (≥ 1/1,000 to < 1/100),
Rare (≥ 1/10,000 to < 1/1,000),
Very rare (< 1/10,000),
Not known (cannot be estimated from the available data).
The
adverse reactions in participants 16 years of age and older that received 2 doses
     were injection site pain (>
80%), fatigue (>
60%), headache (>
50%), myalgia
(> 40%),
chills
     (>
30%), arthralgia (>
20%),
pyrexia
and injection site swelling (> 10%)
and were usually mild or
moderate in intensity and resolved within a few days after vaccination. A slightly lower frequency of
reactogenicity events was associated with greater age.
   43

Table 1: Adverse reactions from Comirnaty clinical trials and post-authorisation experience in individuals 5 years of age and older
                     System Organ Class
Very common (≥ 1/10)
Common (≥ 1/100 to < 1/10)
Uncommon (≥ 1/1,000 to < 1/100)
Rare
(≥ 1/10,000 to < 1/1,000)
Very rare (< 1/10,000)
Not known (cannot be estimated from the available data)
                     Blood and lymphatic system disorders
Lymphadenopathya
                     Immune system disorders
Hypersensitivity reactions (e.g. rash, pruritus, urticaria,b angioedemab)
Anaphylaxis
                     Metabolism and nutrition disorders
Decreased appetite
                     Psychiatric disorders
Insomnia
                     Nervous system disorders
Headache
Lethargy
Acute peripheral facial paralysisc
                     Cardiac disorders
Myocarditisd; Pericarditisd
                     Gastrointestinal disorders
Diarrhoead
Nausea; Vomitingd
                     Skin and subcutaneous tissue disorder
Hyperhidrosis; Night sweats
Erythema multiformed
                     Musculoskeletal and connective tissue disorders
Arthralgia; Myalgia
Pain in extremitye
                     General disorders and administration site conditions
Injection site pain; Fatigue; Chills; Pyrexia;f Injection site swelling
Injection site rednessh
Asthenia; Malaise; Injection site pruritus
Extensive swelling of vaccinated limb;d Facial swellingg
                    a. A higher frequency of lymphadenopathy (5.2% vs 0.4%) was observed in participants receiving a booster dose (third dose) compared to participants receiving 2 doses.
b. The frequency category for urticaria and angioedema was Rare.
c. Through the clinical trial safety follow-up period to 14 November 2020, acute peripheral facial paralysis (or palsy) was
reported by four participants in the COVID-19 mRNA Vaccine group. Onset was Day 37 after Dose 1 (participant did not receive Dose 2) and Days 3, 9, and 48 after Dose 2. No cases of acute peripheral facial paralysis (or palsy) were reported in the placebo group.
d. Adverse reaction determined post-authorisation.
e. Refers to vaccinated arm.
f. A higher frequency of pyrexia was observed after the second dose compare to the first dose.
g. Facial swelling in vaccine recipients with a history of injection of dermatological fillers has been reported in the post-
marketing phase.
h. Injection site redness occurred at a higher frequency (very common) in children 5 to 11 years of age.
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Description of selected adverse reactions
Myocarditis
The increased risk of myocarditis after vaccination with Comirnaty is highest in younger males (see section 4.4).
Two large European pharmacoepidemiological studies have estimated the excess risk in younger males following the second dose of Comirnaty. One study showed that in a period of 7 days after the second dose there were about 0.265 (95% CI 0.255 - 0.275) extra cases of myocarditis in 12-29 year old males per 10,000 compared to unexposed persons. In another study, in a period of 28 days after the second dose there were 0.57 [95% CI 0.39 – 0.75] extra cases of myocarditis in 16-24 year old males per 10,000 compared to unexposed persons.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V and include batch/Lot number if available.
4.9 Overdose
Overdose data is available from 52 study participants included in the clinical trial that due to an error in dilution received 58 micrograms of Comirnaty. The vaccine recipients did not report an increase in reactogenicity or adverse reactions.
In the event of overdose, monitoring of vital functions and possible symptomatic treatment is recommended.
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: vaccines, other viral vaccines, ATC code: J07BX03 Mechanism of action
The nucleoside-modified messenger RNA in Comirnaty is formulated in lipid nanoparticles, which enable delivery of the non replicating RNA into host cells to direct transient expression of the SARS-CoV-2 S antigen. The mRNA codes for membrane-anchored, full-length S with two point mutations within the central helix. Mutation of these two amino acids to proline locks S in an antigenically preferred prefusion conformation. The vaccine elicits both neutralizing antibody and cellular immune responses to the spike (S) antigen, which may contribute to protection against COVID-19.
Efficacy
Study 2 is a multicentre, multinational, Phase 1/2/3 randomised, placebo-controlled, observer-blind dose-finding, vaccine candidate selection and efficacy study in participants 12 years of age and older. Randomisation was stratified by age: 12 to 15 years of age, 16 to 55 years of age, or 56 years of age and older, with a minimum of 40% of participants in the ≥ 56-year stratum. The study excluded participants who were immunocompromised and those who had previous clinical or microbiological diagnosis of COVID-19. Participants with pre-existing stable disease, defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 6 weeks before enrolment, were included as were participants with known stable infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV) or hepatitis B virus (HBV).
      45

Efficacy in participants 16 years of age and older – after 2 doses
In the Phase 2/3 portion of Study 2, based on data accrued through 14 November 2020, approximately 44,000 participants were randomised equally and were to receive 2 doses of COVID-19 mRNA Vaccine or placebo. The efficacy analyses included participants that received their second vaccination within 19 to 42 days after their first vaccination. The majority (93.1%) of vaccine recipients received the second dose 19 days to 23 days after Dose 1. Participants are planned to be followed for up to
24 months after Dose 2, for assessments of safety and efficacy against COVID-19. In the clinical study, participants were required to observe a minimum interval of 14 days before and after administration of an influenza vaccine in order to receive either placebo or COVID-19 mRNA Vaccine. In the clinical study, participants were required to observe a minimum interval of 60 days before or after receipt of blood/plasma products or immunoglobulins within through conclusion of the study in order to receive either placebo or COVID-19 mRNA Vaccine.
The population for the analysis of the primary efficacy endpoint included 36,621 participants 12 years of age and older (18,242 in the COVID-19 mRNA Vaccine group and 18,379 in the placebo group) who did not have evidence of prior infection with SARS-CoV-2 through 7 days after the second dose. In addition, 134 participants were between the ages of 16 to 17 years of age (66 in the COVID-19 mRNA Vaccine group and 68 in the placebo group) and 1,616 participants 75 years of age and older (804 in the COVID-19 mRNA Vaccine group and 812 in the placebo group).
At the time of the primary efficacy analysis, participants had been followed for symptomatic COVID-19 for in total 2,214 person-years for the COVID-19 mRNA Vaccine and in total 2,222 person-years in the placebo group.
There were no meaningful clinical differences in overall vaccine efficacy in participants who were at risk of severe COVID-19 including those with 1 or more comorbidities that increase the risk of severe COVID-19 (e.g. asthma, body mass index (BMI) ≥ 30 kg/m2, chronic pulmonary disease, diabetes mellitus, hypertension).
The vaccine efficacy information is presented in Table 2.
Table 2: Vaccine efficacy – First COVID-19 occurrence from 7 days after Dose 2, by age subgroup – participants without evidence of infection prior to 7 days after Dose 2 – evaluable efficacy (7 days) population
      First COVID-19 occurrence from 7 days after Dose 2 in participants without evidence of prior SARS-CoV-2 infection*
     Subgroup
COVID-19 mRNA Vaccine
Na = 18,198 Cases
n1b Surveillancetimec (n2d)
   Placebo
Na = 18,325 Cases
n1b Surveillancetimec (n2d)
     Vaccine efficacy % (95% CI)e
     All participants
8
2.214 (17,411)
   162 2.222 (17,511)
     95.0 (90.0, 97.9)
     16 to 64 years
7
1.706 (13,549)
   143 1.710 (13,618)
     95.1 (89.6, 98.1)
     65 years and older
1 0.508 (3848)
   19 0.511 (3880)
     94.7 (66.7, 99.9)
     65 to 74 years
1 0.406 (3074)
   14 0.406 (3095)
     92.9 (53.1, 99.8)
     75 years and older
    0 0.102 (774)
    5 0.106 (785)
       100.0 (-13.1, 100.0)
   Note: Confirmed cases were determined by Reverse Transcription-Polymerase Chain Reaction (RT-PCR) and at least 1 symptom consistent with COVID-19 [*Case definition: (at least 1 of) fever, new or increased cough, new or increased shortness of breath, chills, new or increased muscle pain, new loss of taste or smell, sore throat, diarrhoea or vomiting.]
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     First COVID-19 occurrence from 7 days after Dose 2 in participants without evidence of prior SARS-CoV-2 infection*
     Subgroup
    COVID-19 mRNA Vaccine
Na = 18,198 Cases
n1b Surveillancetimec (n2d)
    Placebo
Na = 18,325 Cases
n1b Surveillancetimec (n2d)
       Vaccine efficacy % (95% CI)e
   * Participants who had no serological or virological evidence (prior to 7 days after receipt of the last dose) of past SARS-CoV-2 infection (i.e., N-binding antibody [serum] negative at Visit 1 and SARS-CoV-2 not detected by nucleic acid amplification tests (NAAT) [nasal swab] at Visits 1 and 2), and had negative NAAT (nasal swab) at any unscheduled visit prior to 7 days after Dose 2 were included in the analysis.
a. N = Number of participants in the specified group.
b. n1 = Number of participants meeting the endpoint definition.
c. Total surveillance time in 1,000 person-years for the given endpoint across all participants within each
group at risk for the endpoint. Time period for COVID-19 case accrual is from 7 days after Dose 2 to the
end of the surveillance period.
d. n2 = Number of participants at risk for the endpoint.
e. Two-sided confidence interval (CI) for vaccine efficacy is derived based on the Clopper and Pearson
method adjusted to the surveillance time. CI not adjusted for multiplicity.
Efficacy of COVID-19 mRNA Vaccine in preventing first COVID-19 occurrence from 7 days after Dose 2 compared to placebo was 94.6% (95% confidence interval of 89.6% to 97.6%) in participants 16 years of age and older with or without evidence of prior infection with SARS-CoV-2.
Additionally, subgroup analyses of the primary efficacy endpoint showed similar efficacy point estimates across genders, ethnic groups, and participants with medical comorbidities associated with high risk of severe COVID-19.
Updated efficacy analyses were performed with additional confirmed COVID-19 cases accrued during blinded placebo-controlled follow-up, representing up to 6 months after Dose 2 in the efficacy population.
The updated vaccine efficacy information is presented in Table 3.
Table 3: Vaccine efficacy – First COVID-19 occurrence from 7 days after Dose 2, by age subgroup – participants without evidence of prior SARS-CoV-2 infection* prior to 7 days after Dose 2 – evaluable efficacy (7 days) population during the placebo-controlled follow-up period
    Subgroup
COVID-19 mRNA Vaccine Na=20,998 Cases
n1b
Surveillancetimec (n2d)
Placebo Na=21,096
Cases
n1b Surveillancetimec (n2d)
     Vaccine efficacy % (95% CIe)
   All participantsf
77 6.247 (20,712)
850 6.003 (20,713)
     91.3 (89.0, 93.2)
   16 to 64 years
   70 4.859 (15,519)
710 4.654 (15,515)
      90.6 (87.9, 92.7)
     65 years and older
7 1.233 (4192)
124 1.202 (4226)
94.5 (88.3, 97.8)
   65 to 74 years
6 0.994 (3350)
98 0.966 (3379)
     94.1 (86.6, 97.9)
   75 years and older
    1 0.239 (842)
26 0.237 (847)
      96.2 (76.9, 99.9)
   Note: Confirmed cases were determined by Reverse Transcription-Polymerase Chain Reaction (RT-PCR) and at least 1 symptom consistent with COVID-19 (symptoms included: fever; new or increased cough; new or
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Table 3: Vaccine efficacy – First COVID-19 occurrence from 7 days after Dose 2, by age subgroup – participants without evidence of prior SARS-CoV-2 infection* prior to 7 days after Dose 2 – evaluable efficacy (7 days) population during the placebo-controlled follow-up period
increased shortness of breath; chills; new or increased muscle pain; new loss of taste or smell; sore throat; diarrhoea; vomiting).
* Participants who had no evidence of past SARS-CoV-2 infection (i.e., N-binding antibody [serum] negative at
Visit 1 and SARS-CoV-2 not detected by NAAT [nasal swab] at Visits 1 and 2), and had negative NAAT
(nasal swab) at any unscheduled visit prior to 7 days after Dose 2 were included in the analysis.
a. N = Number of participants in the specified group.
b. n1 = Number of participants meeting the endpoint definition.
c. Total surveillance time in 1,000 person-years for the given endpoint across all participants within each group
at risk for the endpoint. Time period for COVID-19 case accrual is from 7 days after Dose 2 to the end of the
surveillance period.
d. n2 = Number of participants at risk for the endpoint.
e. Two-sided 95% confidence interval (CI) for vaccine efficacy is derived based on the Clopper and Pearson
method adjusted to the surveillance time.
f. Included confirmed cases in participants 12 to 15 years of age: 0 in the COVID-19 mRNA Vaccine group; 16
in the placebo group.
In the updated efficacy analysis, efficacy of COVID-19 mRNA Vaccine in preventing first COVID-19 occurrence from 7 days after Dose 2 compared to placebo was 91.1% (95% CI of 88.8% to 93.0%) in participants in the evaluable efficacy population with or without evidence of prior infection with SARS-CoV-2.
Additionally, the updated efficacy analyses by subgroup showed similar efficacy point estimates across sexes, ethnic groups, geography and participants with medical comorbidities and obesity associated with high risk of severe COVID-19.
Efficacy against severe COVID-19
Updated efficacy analyses of secondary efficacy endpoints supported benefit of the COVID-19 mRNA Vaccine in preventing severe COVID‐19.
As of 13 March 2021, vaccine efficacy against severe COVID-19 is presented only for participants with or without prior SARS-CoV-2 infection (Table 4) as the COVID-19 case counts in participants without prior SARS-CoV-2 infection were the same as those in participants with or without prior SARS-CoV-2 infection in both the COVID-19 mRNA Vaccine and placebo groups.
Table 4: Vaccine efficacy – First severe COVID-19 occurrence in participants with or without prior SARS-CoV-2 infection based on the Food and Drug Administration (FDA)* after Dose 1 or from 7 days after Dose 2 in the placebo-controlled follow-up
Note: Confirmed cases were determined by Reverse Transcription-Polymerase Chain Reaction (RT-PCR) and at least 1 symptom consistent with COVID-19 (symptoms included: fever; new or increased cough; new or increased shortness of breath; chills; new or increased muscle pain; new loss of taste or smell; sore throat; diarrhoea; vomiting).
* Severe illness from COVID-19 as defined by FDA is confirmed COVID-19 and presence of at least 1 of the following:
 Clinical signs at rest indicative of severe systemic illness (respiratory rate ≥ 30 breaths per minute, heart rate ≥ 125 beats per minute, saturation of oxygen ≤ 93% on room air at sea level, or ratio of arterial oxygen partial pressure to fractional inspired oxygen < 300 mm Hg);
       COVID-19 mRNA Vaccine Cases
n1a
Surveillance time (n2b)
   Placebo Cases
n1a Surveillance time (n2b)
     Vaccine efficacy % (95% CIc)
    After Dose 1d
1
8.439e (22,505)
   30 8.288e (22,435)
     96.7 (80.3, 99.9)
    7 days after Dose 2f
    1
6.522g (21,649)
    21 6.404g (21,730)
       95.3 (70.9, 99.9)
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Table 4: Vaccine efficacy – First severe COVID-19 occurrence in participants with or without prior SARS-CoV-2 infection based on the Food and Drug Administration (FDA)* after Dose 1 or from 7 days after Dose 2 in the placebo-controlled follow-up
 Respiratory failure [defined as needing highflow oxygen, noninvasive ventilation, mechanical ventilation or extracorporeal membrane oxygenation (ECMO)];
 Evidence of shock (systolic blood pressure < 90 mm Hg, diastolic blood pressure < 60 mm Hg, or requiring vasopressors);
 Significant acute renal, hepatic, or neurologic dysfunction;
 Admission to an Intensive Care Unit;
 Death.
a. n1 = Number of participants meeting the endpoint definition.
b. n2 = Number of participants at risk for the endpoint.
c. Two-side confidence interval (CI) for vaccine efficacy is derived based on the Clopper and Pearson method
adjusted to the surveillance time.
d. Efficacy assessed based on the Dose 1 all available efficacy (modified intention-to-treat) population that
included all randomised participants who received at least 1 dose of study intervention.
e. Total surveillance time in 1,000 person-years for the given endpoint across all participants within each group
at risk for the endpoint. Time period for COVID-19 case accrual is from Dose 1 to the end of the surveillance
period.
f. Efficacy assessed based on the evaluable efficacy (7 Days) population that included all eligible randomised
participants who receive all dose(s) of study intervention as randomised within the predefined window, have
no other important protocol deviations as determined by the clinician.
g. Total surveillance time in 1,000 person-years for the given endpoint across all participants within each group
at risk for the endpoint. Time period for COVID-19 case accrual is from 7 days after Dose 2 to the end of the surveillance period.
Efficacy and immunogenicity in adolescents 12 to 15 years of age – after 2 doses
In an analysis of Study 2 in adolescents 12 to 15 years of age without evidence of prior infection, there were no cases in 1005 participants who received the vaccine and 16 cases out of 978 who received placebo. The point estimate for efficacy is 100% (95% confidence interval 75.3, 100.0). In participants with or without evidence of prior infection there were 0 cases in the 1119 who received vaccine and 18 cases in 1110 participants who received placebo. This also indicates the point estimate for efficacy is 100% (95% confidence interval 78.1, 100.0).
In Study 2, an analysis of SARS-CoV-2 neutralising titres 1 month after Dose 2 was conducted in a randomly selected subset of participants who had no serological or virological evidence of past SARS-CoV-2 infection up to 1 month after Dose 2, comparing the response in adolescents 12 to 15 years of age (n = 190) to participants 16 to 25 years of age (n = 170).
The ratio of the geometric mean titres (GMT) in the 12 to 15 years of age group to the 16 to 25 years of age group was 1.76, with a 2-sided 95% CI of 1.47 to 2.10. Therefore, the 1.5-fold noninferiority criterion was met as the lower bound of the 2-sided 95% CI for the geometric mean ratio [GMR] was > 0.67.
Efficacy and immunogenicity in children 5 to 11 years of age (i.e. 5 to less than 12 years of age) – after 2 doses
Study 3 is a Phase 1/2/3 study comprised of an open-label vaccine dose-finding portion (Phase 1) and a multicentre, multinational, randomised, saline placebo-controlled, observer-blind efficacy portion (Phase 2/3) that has enrolled participants 5 to 11 years of age. The majority (94.4%) of randomised vaccine recipients received the second dose 19 days to 23 days after Dose 1.
The descriptive vaccine efficacy results in children 5 to 11 years of age without evidence of prior SARS-CoV-2 infection are presented in Table 5. No cases of COVID-19 were observed in either the vaccine group or the placebo group in participants with evidence of prior SARS-CoV-2 infection.
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Table 5: Vaccine efficacy – First COVID-19 occurrence from 7 days after Dose 2: Without evidence of infection prior to 7 days after Dose 2 – Phase 2/3 – Children 5 to 11 years of age evaluable efficacy population
     First COVID-19 occurrence from 7 days after Dose 2 in children 5 to 11 years of age without evidence of prior SARS-CoV-2 infection*
         COVID-19 mRNA Vaccine
10 mcg/dose Na=1305 Cases
n1b
Surveillance timec (n2d)
Placebo Na=663 Cases n1b
Surveillance timec (n2d)
     Vaccine efficacy %
(95% CI)
   Children 5 to 11 years of age
       3 0.322 (1273)
    16 0.159 (637)
      90.7 (67.7, 98.3)
   Note: Confirmed cases were determined by Reverse Transcription-Polymerase Chain Reaction (RT-PCR) and at least 1 symptom consistent with COVID-19 (symptoms included: fever; new or increased cough; new or increased shortness of breath; chills; new or increased muscle pain; new loss of taste or smell; sore throat; diarrhea; vomiting).
* Participants who had no evidence of past SARS-CoV-2 infection (i.e., N-binding antibody [serum] negative at Visit 1 and SARS-CoV-2 not detected by NAAT [nasal swab] at Visits 1 and 2), and had negative NAAT (nasal swab) at any unscheduled visit prior to 7 days after Dose 2 were included in the analysis.
a. N = Number of participants in the specified group.
b. n1 = Number of participants meeting the endpoint definition.
c. Total surveillance time in 1000 person-years for the given endpoint across all participants within each
group at risk for the endpoint. Time period for COVID-19 case accrual is from 7 days after Dose 2 to the
end of the surveillance period.
d. n2 = Number of participants at risk for the endpoint.
In Study 3, an analysis of SARS-CoV-2 50% neutralising titres (NT50) 1 month after Dose 2 in a randomly selected subset of participants demonstrated effectiveness by immunobridging of immune responses comparing children 5 to 11 years of age (i.e. 5 to less than 12 years of age) in the Phase 2/3 part of Study 3 to participants 16 to 25 years of age in the Phase 2/3 part of Study 2 who had no serological or virological evidence of past SARS-CoV-2 infection up to 1 month after Dose 2, meeting the prespecified immunobridging criteria for both the geometric mean ratio (GMR) and the seroresponse difference with seroresponse defined as achieving at least 4-fold rise in SARS-CoV-2 NT50 from baseline (before Dose 1).
The GMR of the SARS-CoV-2 NT50 1 month after Dose 2 in children 5 to 11 years of age (i.e. 5 to less than 12 years of age) to that of young adults 16 to 25 years of age was 1.04 (2-sided 95% CI: 0.93, 1.18). Among participants without prior evidence of SARS-CoV-2 infection up to 1 month after
Dose 2, 99.2% of children 5 to 11 years of age and 99.2% of participants 16 to 25 years of age had a seroresponse at 1 month after Dose 2. The difference in proportions of participants who had seroresponse between the 2 age groups (children – young adult) was 0.0% (2-sided 95% CI: -2.0%, 2.2%). This information is presented in Table 6.
50

Table 6: Summary of geometric mean ratio for 50% neutralising titre and difference in percentages of participants with seroresponse – comparison of children 5 to 11 years of age (Study 3) to participants 16 to 25 years of age (Study 2) – participants without evidence of infection up to 1 month after Dose 2 – immunobridging subset –
Phase 2/3 – evaluable immunogenicity population
          COVID-19 mRNA Vaccine
         5 to 11 years/ 16 to 25 years
10 mcg/dose 5 to 11 years Na=264
   30 mcg/dose 16 to 25 years Na=253
           Time pointb
   GMTc (95% CIc)
GMTc (95% CIc)
      GMRd (95% CId)
      Met immunobridging objectivee (Y/N)
   Geometric mean 50% neutralizing titerf (GMTc)
1 month after Dose 2
1197.6 (1106.1, 1296.6)
1146.5 (1045.5, 1257.2)
1.04 (0.93, 1.18)
Y
          Time pointb
    ng (%) (95% CIh)
   ng (%) (95% CIh)
      Difference %i
(95% CIj)
      Met immunobridging objectivek (Y/N)
   Seroresponse rate (%) for 50% neutralizing titerf
    1 month after Dose 2
   262 (99.2) (97.3, 99.9)
251 (99.2) (97.2, 99.9)
   0.0 (-2.0, 2.2)
    Y
Abbreviations: CI = confidence interval; GMR = geometric mean ratio; GMT = geometric mean titre;
LLOQ = lower limit of quantitation; NAAT = nucleic acid amplification test; NT50 = 50% neutralising titre; SARS-CoV-2 = severe acute respiratory syndrome coronavirus 2.
Note: Participants who had no serological or virological evidence (up to 1 month post-Dose 2 blood sample collection) of past SARS-CoV-2 infection (i.e., N-binding antibody [serum] negative at Dose 1 visit and
1 month after Dose 2, SARS-CoV-2 not detected by NAAT [nasal swab] at Dose 1 and Dose 2 visits, and negative NAAT (nasal swab) at any unscheduled visit up to 1 month after Dose 2 blood collection) and had no medical history of COVID-19 were included in the analysis.
Note: Seroresponse is defined as achieving a ≥4-fold rise from baseline (before Dose 1). If the baseline measurement is below the LLOQ, a postvaccination assay result ≥4 × LLOQ is considered a seroresponse.
a. N = Number of participants with valid and determinate assay results before vaccination and at 1 month after
Dose 2. These values are also the denominators used in the percentage calculations for seroresponse rates.
b. Protocol-specified timing for blood sample collection.
c. GMTs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titres and the
corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to
0.5 × LLOQ.
d. GMRs and 2-sided 95% CIs were calculated by exponentiating the mean difference of the logarithms of the
titres (5 to 11 years of age minus 16 to 25 years of age) and the corresponding CI (based on the Student t
distribution).
e. Immunobridging based on GMT is declared if the lower bound of the 2-sided 95% CI for the GMR is
greater than 0.67 and the point estimate of the GMR is ≥0.8.
f. SARS-CoV-2 NT50 were determined using the SARS-CoV-2 mNeonGreen Virus Microneutralization
Assay. The assay uses a fluorescent reporter virus derived from the USA_WA1/2020 strain and virus neutralisation is read on Vero cell monolayers. The sample NT50 is defined as the reciprocal serum dilution at which 50% of the virus is neutralised.
g. n = Number of participants with seroresponse based on NT50 1 month after Dose 2.
h. Exact 2-sided CI based on the Clopper and Pearson method.
i. Difference in proportions, expressed as a percentage (5 to 11 years of age minus16 to 25 years of age).
j. 2-Sided CI, based on the Miettinen and Nurminen method for the difference in proportions, expressed as a
percentage.
k. Immunobridging based on seroresponse rate is declared if the lower bound of the 2-sided 95% CI for the
seroresponse difference is greater than -10.0%.
51

Paediatric population
The European Medicines Agency has deferred the obligation to submit the results of studies with Comirnaty in the paediatric population in prevention of COVID-19 (see section 4.2 for information on paediatric use).
This medicinal product has been authorised under a so-called ‘conditional approval’ scheme. This means that further evidence on this medicinal product is awaited. The European Medicines Agency will review new information on this medicinal product at least every year and this SmPC will be updated as necessary.
5.2 Pharmacokinetic properties
Not applicable.
5.3 Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of repeat dose toxicity and reproductive and developmental toxicity.
General toxicity
Rats intramuscularly administered Comirnaty (receiving 3 full human doses once weekly, generating relatively higher levels in rats due to body weight differences) demonstrated some injection site oedema and erythema and increases in white blood cells (including basophils and eosinophils) consistent with an inflammatory response as well as vacuolation of portal hepatocytes without evidence of liver injury. All effects were reversible.
Genotoxicity/Carcinogenicity
Neither genotoxicity nor carcinogenicity studies were performed. The components of the vaccine (lipids and mRNA) are not expected to have genotoxic potential.
Reproductive toxicity
Reproductive and developmental toxicity were investigated in rats in a combined fertility and developmental toxicity study where female rats were intramuscularly administered Comirnaty prior to mating and during gestation (receiving 4 full human doses that generate relatively higher levels in rat due to body weight differences, spanning between pre-mating day 21 and gestational day 20). SARS-CoV-2 neutralizing antibody responses were present in maternal animals from prior to mating to the end of the study on postnatal day 21 as well as in foetuses and offspring. There were no vaccine-related effects on female fertility, pregnancy, or embryo-foetal or offspring development. No Comirnaty data are available on vaccine placental transfer or excretion in milk.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate) (ALC-0315) 2-[(polyethylene glycol)-2000]-N,N-ditetradecylacetamide (ALC-0159) 1,2-Distearoyl-sn-glycero-3-phosphocholine (DSPC)
Cholesterol
Trometamol
Trometamol hydrochloride Sucrose
Water for injections
    52

6.2 Incompatibilities
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
6.3 Shelf life
Unopened vial
Frozen vial
9 months when stored at -90 °C to -60 °C.
The vaccine may be received frozen at -90 °C to -60 °C or at -25 °C to -15 °C. Frozen vaccine can be stored either at -90 °C to -60 °C or 2 °C to 8 °C upon receipt.
When stored frozen at -90 °C to -60 °C, 10-vial packs of the vaccine can be thawed at 2 °C to 8 °C for 4 hours or individual vials can be thawed at room temperature (up to 30 °C) for 30 minutes.
Thawed vial
10 weeks storage and transportation at 2 °C to 8 °C within the 9-month shelf life.
 Upon moving the vaccine to 2 °C to 8 °C storage, the updated expiry date must be written on the outer carton and the vaccine should be used or discarded by the updated expiry date. The original expiry date should be crossed out.
 Ifthevaccineisreceivedat2°Cto8°Citshouldbestoredat2°Cto8°C.Theexpirydateon the outer carton should have been updated to reflect the refrigerated expiry date and the original expiry date should have been crossed out.
Prior to use, the unopened vials can be stored for up to 12 hours at temperatures between 8 °C and 30 °C.
Thawed vials can be handled in room light conditions.
Once thawed, the vaccine should not be re-frozen.
Handling of temperature excursions during refrigerated storage
 Stability data indicate that the unopened vial is stable for up to 10 weeks when stored at temperatures from -2 °C to 2 °C, and within the 10 weeks storage period between 2 °C and 8 °C.
 Stability data indicate the vial can be stored for up to 24 hours at temperatures of 8 °C to 30 °C, including up to 12 hours following first puncture.
This information is intended to guide healthcare professionals only in case of temporary temperature excursion.
Diluted medicinal product
Chemical and physical in-use stability has been demonstrated for 12 hours at 2 oC to 30 oC, after dilution with sodium chloride 9 mg/mL (0.9%) solution for injection. From a microbiological point of view, unless the method of dilution precludes the risk of microbial contamination, the product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user.
6.4 Special precautions for storage
Store in a freezer at -90 °C to -60 °C.
53

Store in the original package in order to protect from light.
During storage, minimise exposure to room light, and avoid exposure to direct sunlight and ultraviolet light.
For storage conditions after thawing and dilution of the medicinal product, see section 6.3.
6.5 Nature and contents of container
1.3 mL concentrate for dispersion in a 2 mL clear multidose vial (type I glass) with a stopper (synthetic bromobutyl rubber) and an orange flip-off plastic cap with aluminium seal. Each vial contains 10 doses, see section 6.6.
Pack sizes: 10 vials or 195 vials
Not all pack sizes may be marketed.
6.6 Special precautions for disposal and other handling
Handling instructions
Comirnaty 10 micrograms/dose should be prepared by a healthcare professional using aseptic technique to ensure the sterility of the prepared dispersion.
54

     DOSE VERIFICATION OF COMIRNATY 10 MICROGRAMS/DOSE CONCENTRATE FOR DISPERSION FOR INJECTION (CHILDREN 5 TO 11 YEARS)
        Orange cap
10 mcg
 Verify that the vial has an orange plastic cap.
 If the vial has a purple plastic cap, please make reference to the Summary of Product Characteristics for Comirnaty 30 micrograms/dose concentrate for dispersion for injection.
 If the vial has a grey plastic cap, please make reference to the Summary of Product Characteristics for Comirnaty 30 micrograms/dose dispersion for injection.
        HANDLING PRIOR TO USE OF COMIRNATY 10 MICROGRAMS/DOSE CONCENTRATE FOR DISPERSION FOR INJECTION (CHILDREN 5 TO 11 YEARS)
      Store for up to 10 weeks at 2 °C to 8 °C
 If the multidose vial is stored frozen it must be thawed prior to use. Frozen vials should be transferred to an environment of 2 °C to 8 °C to thaw; a 10 vial pack may take 4 hours to thaw. Ensure vials are completely thawed prior to use.
 Uponmovingvialsto2°Cto8°C storage, update the expiry date on the carton.
 Unopened vials can be stored for up to 10 weeks at 2 °C to 8 °C within the 9-month shelf life.
 Alternatively, individual frozen vials may be thawed for 30 minutes at temperatures up to 30 °C.
 Prior to use, the unopened vial can be stored for up to 12 hours at temperatures up to 30 °C. Thawed vials can be handled in room light conditions.
        MIXING PRIOR TO DILUTION OF COMIRNATY 10 MICROGRAMS/DOSE CONCENTRATE FOR DISPERSION FOR INJECTION (CHILDREN 5 TO 11 YEARS)
      Gently × 10
 Allow the thawed vial to come to room temperature and gently invert it 10 times prior to dilution. Do not shake.
 Prior to dilution, the thawed dispersion may contain white to off-white opaque amorphous particles.
   55

     DILUTION OF COMIRNATY 10 MICROGRAMS/DOSE CONCENTRATE FOR DISPERSION FOR INJECTION (CHILDREN 5 TO 11 YEARS)
       1.3 mL of 0.9% sodium chloride injection
     The thawed vaccine must be diluted in its original vial with 1.3 mL sodium chloride 9 mg/mL (0.9%) solution for injection, using a 21 gauge or narrower needle and aseptic techniques.
     Pull back plunger to 1.3 mL to remove air from vial.
    Equalise vial pressure before removing the needle from the vial stopper by withdrawing 1.3 mL air into the empty diluent syringe.
56

     Gently × 10
      Gently invert the diluted dispersion 10 times. Do not shake.
 The diluted vaccine should present as a white to off-white dispersion with no particulates visible. Do not use the diluted vaccine if particulates or discolouration are present.
     Record appropriate date and time. Use within 12 hours after dilution.
    The diluted vials should be marked with the appropriate date and time.
 After dilution, store at 2 oC to 30 oC and use within 12 hours.
 Do not freeze or shake the diluted dispersion. If refrigerated, allow the diluted dispersion to come to room temperature prior to use.
   57

     PREPARATION OF INDIVIDUAL 0.2 mL DOSES OF COMIRNATY
10 MICROGRAMS/DOSE CONCENTRATE FOR DISPERSION FOR INJECTION (CHILDREN 5 TO 11 YEARS)
       0.2 mL diluted vaccine
 After dilution, the vial contains 2.6 mL from which 10 doses of 0.2 mL can be extracted.
 Using aseptic technique, cleanse the vial stopper with a single use antiseptic swab.
 Withdraw 0.2 mL of Comirnaty for children age 5 to 11 years.
Low dead-volume syringes and/or needles should be used in order to extract 10 doses from a single vial. The low dead-volume syringe and needle combination should have a dead volume of no more than 35 microlitres.
If standard syringes and needles are used, there may not be sufficient volume to extract ten doses from a single vial.
 Each dose must contain 0.2 mL of vaccine.
 If the amount of vaccine remaining in the vial cannot provide a full dose of 0.2 mL, discard the vial and any excess volume.
 Discard any unused vaccine within 12 hours after dilution.
Disposal
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
7. MARKETING AUTHORISATION HOLDER
BioNTech Manufacturing GmbH An der Goldgrube 12
55131 Mainz
Germany
Phone: +49 6131 9084-0 Fax: +49 6131 9084-2121 service@biontech.de
8. MARKETING AUTHORISATION NUMBER(S)
EU/1/20/1528/004 EU/1/20/1528/005
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 21 December 2020 Date of latest renewal: 03 November 2021
58

10. DATE OF REVISION OF THE TEXT
Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
59

ANNEX II
A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
E. SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES FOR THE CONDITIONAL MARKETING AUTHORISATION
60

A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
Name and address of the manufacturers of the biological active substance(s)
BioNTech Manufacturing GmbH An der Goldgrube 12
55131 Mainz
Germany
BioNTech Manufacturing Marburg GmbH Emil-von-Behring-Strasse 76
35401 Marburg
Germany
Rentschler Biopharma SE Erwin-Rentschler-Strasse 21 88471 Laupheim
Germany
Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC 1 Burtt Road
Andover, MA 01810
USA
Name and address of the manufacturers responsible for batch release
BioNTech Manufacturing GmbH Kupferbergterrasse 17 - 19 55116 Mainz
Germany
Pfizer Manufacturing Belgium NV Rijksweg 12
2870 Puurs
Belgium
The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.
In view of the declared Public Health Emergency of International Concern and in order to ensure early supply this medicinal product is subject to a time-limited exemption allowing reliance on batch control testing conducted in the registered site(s) that are located in a third country. This exemption ceases to be valid on 31 August 2021. Implementation of EU based batch control arrangements, including the necessary variations to the terms of the marketing authorisation, has to be completed by
31 August 2021 at the latest, in line with the agreed plan for this transfer of testing. Progress reports have to be submitted on 31 March 2021 and included in the annual renewal application.
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
Medicinal product subject to medical prescription.
 Official batch release
In accordance with Article 114 of Directive 2001/83/EC, the official batch release will be undertaken
by a state laboratory or a laboratory designated for that purpose.
61

C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
 Periodic safety update reports (PSURs)
The requirements for submission of PSURs for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
The marketing authorisation holder (MAH) shall submit the first PSUR for this product within 6 months following authorisation.
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
 Risk management plan (RMP)
The marketing authorisation holder (MAH) shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreed subsequent updates of the RMP.
An updated RMP should be submitted:
 At the request of the European Medicines Agency;
 Whenever the risk management system is modified, especially as the result of new information
being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
E. SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES FOR THE CONDITIONAL MARKETING AUTHORISATION
This being a conditional marketing authorisation and pursuant to Article 14-a of Regulation (EC) No 726/2004, the MAH shall complete, within the stated timeframe, the following measures:
        Description
Due date
       In order to complete the characterisation of the active substance and finished product, the MAH should provide additional data.
July 2021. Interim reports: 31 March 2021
       In order to ensure consistent product quality, the MAH should provide additional information to enhance the control strategy, including the active substance and finished product specifications.
July 2021. Interim reports: March 2021
       In order to confirm the efficacy and safety of Comirnaty, the MAH should submit the final Clinical Study Report for the randomized, placebo-controlled, observer-blind study C4591001.
December 2023
        In order to confirm the efficacy and safety of Comirnaty, the MAH should
July 2024
submit the final Clinical Study Report for the randomized, placebo-controlled,
observer-blind study C4591007.
    62

ANNEX III
LABELLING AND PACKAGE LEAFLET
63

A. LABELLING
64

     PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON BOX LABEL
            1. NAME OF THE MEDICINAL PRODUCT
   COMIRNATY 30 micrograms/dose concentrate for dispersion for injection Adults and adolescents from 12 years
COVID-19 mRNA Vaccine (nucleoside modified)
tozinameran
After dilution, each vial contains 6 doses of 0.3 mL.
Excipients: ALC-0315, ALC-0159, DSPC, cholesterol, potassium chloride, potassium dihydrogen phosphate, sodium chloride, disodium phosphate dihydrate, sucrose, water for injections, sodium hydroxide, hydrochloric acid
Concentrate for dispersion for injection 195 multidose vials
Intramuscular use after dilution. Read the package leaflet before use.
Scan QR code for more information.
Dilute before use: Dilute each vial with 1.8 mL sodium chloride 9 mg/mL (0.9%) solution for injection.
Keep out of the sight and reach of children.
EXP (at -90 °C to -60 °C)
Expiry date at 2 °C to 8 °C: ................
     2. STATEMENT OF ACTIVE SUBSTANCE(S)
        3. LIST OF EXCIPIENTS
        4. PHARMACEUTICAL FORM AND CONTENTS
        5. METHOD AND ROUTE(S) OF ADMINISTRATION
        6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN
           7. OTHER SPECIAL WARNING(S), IF NECESSARY
        8. EXPIRY DATE
   65

(Maximum 1 month. Cross out former expiry date.)
     9. SPECIAL STORAGE CONDITIONS
   Storage:
Prior to dilution, store at -90 °C to -60 °C in the original package in order to protect from light. After dilution, store the vaccine at 2 °C to 30 °C and use within 6 hours.
BioNTech Manufacturing GmbH An der Goldgrube 12
55131 Mainz, Germany
EU/1/20/1528/001
LOT
     10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
            11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
        12. MARKETING AUTHORISATION NUMBER(S)
        13. BATCH NUMBER
        14. GENERAL CLASSIFICATION FOR SUPPLY
        15. INSTRUCTIONS ON USE
        16. INFORMATION IN BRAILLE
    Justification for not including Braille accepted.
2D barcode carrying the unique identifier included.
PC SN NN
     17. UNIQUE IDENTIFIER – 2D BARCODE
         18. UNIQUE IDENTIFIER - HUMAN READABLE DATA
    66

     MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL
            1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION
   COMIRNATY 30 mcg sterile concentrate COVID-19 mRNA Vaccine
tozinameran
IM
EXP
LOT
6 doses of 30 mcg after dilution
Discard time:
      2. METHOD OF ADMINISTRATION
        3. EXPIRY DATE
        4. BATCH NUMBER
        5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
        6. OTHER
   67

      PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON
            1. NAME OF THE MEDICINAL PRODUCT
   COMIRNATY 30 micrograms/dose dispersion for injection Adults and adolescents from 12 years
COVID-19 mRNA Vaccine (nucleoside modified) tozinameran
Each vial contains 6 doses of 0.3 mL.
Excipients: ALC-0315, ALC-0159, DSPC, cholesterol, trometamol, trometamol hydrochloride, sucrose, water for injections
Dispersion for injection 195 multidose vials
10 multidose vials
Intramuscular use.
Do not dilute prior to use
Scan QR code for more information.
Keep out of the sight and reach of children.
EXP (at -90 °C to -60 °C)
Expiry date at 2 °C to 8 °C: ................
(Maximum 10 weeks. Cross out the former expiry date.)
     2. STATEMENT OF ACTIVE SUBSTANCE(S)
        3. LIST OF EXCIPIENTS
        4. PHARMACEUTICAL FORM AND CONTENTS
         5. METHOD AND ROUTE(S) OF ADMINISTRATION
        6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN
           7. OTHER SPECIAL WARNING(S), IF NECESSARY
        8. EXPIRY DATE
   68

     9. SPECIAL STORAGE CONDITIONS
   Storage:
Store at 2 °C to 8 °C after receipt. Do not refreeze once thawed.
Store in the original package in order to protect from light.
Read the package leaflet before use and for additional storage information. After first puncture, store at 2 °C to 30 °C and use within 12 hours.
BioNTech Manufacturing GmbH An der Goldgrube 12
55131 Mainz, Germany
EU/1/20/1528/003
LOT
     10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
            11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
        12. MARKETING AUTHORISATION NUMBER(S)
    195 multidose vials
EU/1/20/1528/002 10 multidose vials
     13. BATCH NUMBER
        14. GENERAL CLASSIFICATION FOR SUPPLY
        15. INSTRUCTIONS ON USE
        16. INFORMATION IN BRAILLE
    Justification for not including Braille accepted.
2D barcode carrying the unique identifier included.
PC SN NN
     17. UNIQUE IDENTIFIER – 2D BARCODE
         18. UNIQUE IDENTIFIER - HUMAN READABLE DATA
    69

     MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL
            1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION
   COMIRNATY 30 mcg injection COVID-19 mRNA Vaccine tozinameran
IM
Do not dilute
EXP
LOT
6 doses of 30 mcg
Discard time:
      2. METHOD OF ADMINISTRATION
        3. EXPIRY DATE
        4. BATCH NUMBER
        5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
        6. OTHER
   70

     PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON
            1. NAME OF THE MEDICINAL PRODUCT
   COMIRNATY 10 micrograms/dose concentrate for dispersion for injection Children 5 to 11 years
COVID-19 mRNA Vaccine (nucleoside modified)
tozinameran
After dilution, each vial contains 10 doses of 0.2 mL.
Excipients: ALC-0315, ALC-0159, DSPC, cholesterol, trometamol, trometamol hydrochloride sucrose, water for injections
Concentrate for dispersion for injection 10 multidose vials
195 multidose vials
Intramuscular use after dilution.
Read the package leaflet before use and additional storage information.
Scan QR code for more information.
Dilute before use: Dilute each vial with 1.3 mL sodium chloride 9 mg/mL (0.9%) solution for injection.
Keep out of the sight and reach of children.
      2. STATEMENT OF ACTIVE SUBSTANCE(S)
        3. LIST OF EXCIPIENTS
        4. PHARMACEUTICAL FORM AND CONTENTS
         5. METHOD AND ROUTE(S) OF ADMINISTRATION
        6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN
           7. OTHER SPECIAL WARNING(S), IF NECESSARY
   71

     8. EXPIRY DATE
   EXP (at -90 °C to -60 °C)
Expiry date at 2 °C to 8 °C: ................ (Maximum 10 weeks. Cross out former expiry date.)
Storage:
Store at 2 °C to 8 °C after receipt. Do not refreeze once thawed.
Keep in the original package in order to protect from light.
After dilution, store the vaccine at 2 °C to 30 °C and use within 12 hours.
BioNTech Manufacturing GmbH An der Goldgrube 12
55131 Mainz, Germany
EU/1/20/1528/004 EU/1/20/1528/005
LOT
     9. SPECIAL STORAGE CONDITIONS
        10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
            11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
        12. MARKETING AUTHORISATION NUMBER(S)
    10 multidose vials
195 multidose vials
     13. BATCH NUMBER
        14. GENERAL CLASSIFICATION FOR SUPPLY
        15. INSTRUCTIONS ON USE
        16. INFORMATION IN BRAILLE
    Justification for not including Braille accepted.
2D barcode carrying the unique identifier included.
     17. UNIQUE IDENTIFIER – 2D BARCODE
    72

     18. UNIQUE IDENTIFIER - HUMAN READABLE DATA
   PC SN NN
73

     MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL
            1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION
   COMIRNATY 10 mcg sterile concentrate COVID-19 mRNA Vaccine
tozinameran
IM
EXP
LOT
10 doses of 10 mcg after dilution
Discard date/time:
      2. METHOD OF ADMINISTRATION
        3. EXPIRY DATE
        4. BATCH NUMBER
        5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
        6. OTHER
   74

B. PACKAGE LEAFLET
75

Package leaflet: Information for the user
Comirnaty 30 micrograms/dose concentrate for dispersion for injection Adults and adolescents from 12 years
COVID-19 mRNA Vaccine (nucleoside modified) tozinameran
This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.
Read all of this leaflet carefully before you receive this vaccine because it contains important information for you.
 Keep this leaflet. You may need to read it again.
 If you have any further questions, ask your doctor, pharmacist or nurse.
 If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Comirnaty is and what it is used for
2. What you need to know before you receive Comirnaty
3. How Comirnaty is given
4. Possible side effects
5. How to store Comirnaty
6. Contents of the pack and other information
1. What Comirnaty is and what it is used for
Comirnaty is a vaccine used for preventing COVID-19 caused by SARS-CoV-2 virus.
Comirnaty 30 micrograms/dose concentrate for dispersion for injection is given to adults and adolescents from 12 years of age and older.
The vaccine causes the immune system (the body’s natural defences) to produce antibodies and blood cells that work against the virus, so giving protection against COVID-19.
As Comirnaty does not contain the virus to produce immunity, it cannot give you COVID-19.
2. What you need to know before you receive Comirnaty
Comirnaty should not be given
 if you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6)
Warnings and precautions
Talk to your doctor, pharmacist or nurse before you are given the vaccine if:
 you have ever had a severe allergic reaction or breathing problems after any other vaccine
injection or after you were given Comirnaty in the past.
 you are feeling nervous about the vaccination process or have ever fainted following any needle
injection.
 you have a severe illness or infection with high fever. However, you can have your vaccination
if you have a mild fever or upper airway infection like a cold.
 you have a bleeding problem, you bruise easily or you use a medicine to prevent blood-clots.
76

 you have a weakened immune system, because of a disease such as HIV infection or a medicine such as corticosteroid that affects your immune system.
There is an increased risk of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside the heart) after vaccination with Comirnaty (see section 4). These conditions can develop within just a few days after vaccination and have primarily occurred within
14 days. They have been observed more often after the second vaccination, and more often in younger males. Following vaccination, you should be alert to signs of myocarditis and pericarditis, such as breathlessness, palpitations and chest pain, and seek immediate medical attention should these occur.
As with any vaccine, Comirnaty may not fully protect all those who receive it and it is not known how long you will be protected.
You may receive a third dose of Comirnaty. The efficacy of Comirnaty, even after a third dose, may be lower in people who are immunocompromised. In these cases, you should continue to maintain physical precautions to help prevent COVID-19. In addition, your close contacts should be vaccinated as appropriate. Discuss appropriate individual recommendations with your doctor.
Children
Comirnaty is not recommended for children aged under 12 years.
Other medicines and Comirnaty
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines or have recently received any other vaccine.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before you receive this vaccine.
Driving and using machines
Some of the effects of vaccination mentioned in section 4 (Possible side effects) may temporarily affect your ability to drive or use machines. Wait until these effects have worn off before you drive or use machines.
Comirnaty contains potassium and sodium
This vaccine contains less than 1 mmol potassium (39 mg) per dose, that is to say essentially ‘potassium-free’.
This vaccine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’.
3. How Comirnaty is given
Comirnaty is given after dilution as an injection of 0.3 mL into a muscle of your upper arm. You will receive 2 injections.
It is recommended to receive the second dose of the same vaccine 3 weeks after the first dose to complete the vaccination course.
A booster dose (third dose) of Comirnaty may be given at least 6 months after the second dose in individuals 18 years of age and older.
If you are immunocompromised, you may receive a third dose of Comirnaty at least 28 days after the second dose.
77

If you have any further questions on the use of Comirnaty, ask your doctor, pharmacist or nurse.
4. Possible side effects
Like all vaccines, Comirnaty can cause side effects, although not everybody gets them.
Very common side effects: may affect more than 1 in 10 people
 injection site: pain, swelling
 tiredness
 headache
 muscle pain
 chills
 joint pain
 diarrhoea
 fever
Some of these side effects were slightly more frequent in adolescents 12 to 15 years than in adults.
Common side effects: may affect up to 1 in 10 people
 injection site redness
 nausea
 vomiting
Uncommon side effects: may affect up to 1 in 100 people
 enlarged lymph nodes (more frequently observed after the booster dose)
 feeling unwell
 arm pain
 insomnia
 injection site itching
 allergic reactions such as rash or itching
 feeling weak or lack of energy/sleepy
 decreased appetite
 excessive sweating
 night sweats
Rare side effects: may affect up to 1 in 1,000 people
 temporary one sided facial drooping
 allergic reactions such as hives or swelling of the face
Very rare side effects: may affect up to 1 in 10,000 people
 inflammation of the heart muscle (myocarditis) or inflammation of the lining outside the heart
(pericarditis) which can result in breathlessness, palpitations or chest pain
Not known (cannot be estimated from the available data)
 severe allergic reaction
 extensive swelling of the vaccinated limb
 swelling of the face (swelling of the face may occur in patients who have had facial
dermatological fillers)
 a skin reaction that causes red spots or patches on the skin, that may look like a target or
“bulls-eye” with a dark red centre surrounded by paler red rings (erythema multiforme)
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. You can also report side effects directly via the national reporting 78

system listed in Appendix V and include batch/Lot number if available. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Comirnaty
Keep this medicine out of the sight and reach of children.
The following information about storage, expiry and use and handling is intended for healthcare professionals.
Do not use this medicine after the expiry date which is stated on the carton and label after EXP. The expiry date refers to the last day of that month.
Store in freezer at -90 °C to -60 °C. Within the 9-month shelf life unopened vials may be stored and transported at -25 °C to -15 °C for a single period of up to 2 weeks and can be returned to -90 °C
to -60 °C.
Store in the original package in order to protect from light.
When stored frozen at -90 °C to -60 °C, 195-vial packs of the vaccine can be thawed at 2 °C to 8 °C for 3 hours or individual vials can be thawed at room temperature (up to 30 °C) for 30 minutes.
Transfers of frozen vials stored at ultra-low temperature (< -60 °C)
 Closed-lid vial trays containing 195 vials removed from ultra-low temperature frozen storage
(< -60 °C) may be at temperatures up to 25 °C for up to 5 minutes.
 Open-lid vial trays, or vial trays containing less than 195 vials, removed from ultra-low
temperature frozen storage (< -60 °C) may be at temperatures up to 25 °C for up to 3 minutes.
 After vial trays are returned to frozen storage following temperature exposure up to 25 °C, they
must remain in frozen storage for at least 2 hours before they can be removed again.
Transfers of frozen vials stored at -25 °C to -15 °C
 Closed-lid vial trays containing 195 vials removed from frozen storage (-25 °C to -15 °C) may be at temperatures up to 25 °C for up to 3 minutes.
 Open-lid vial trays, or vial trays containing less than 195 vials, removed from frozen storage (-25 °C to -15 °C) may be at temperatures up to 25 °C for up to 1 minute.
Once a vial is removed from the vial tray, it should be thawed for use.
After thawing, the vaccine should be diluted and used immediately. However, in-use stability data have demonstrated that once removed from freezer, the undiluted vaccine can be stored for up to
1 month at 2 °C to 8 °C within the 9-month shelf life. Within the 1-month shelf life at 2 °C to 8 °C, up to 12 hours may be used for transportation. Prior to use, the unopened vaccine can be stored for up to 2 hours at temperatures up to 30 °C.
Thawed vials can be handled in room light conditions.
After dilution, store and transport the vaccine at 2 °C to 30 °C and use within 6 hours. Discard any unused vaccine.
Once removed from the freezer and diluted, the vials should be marked with the new discard date and time. Once thawed, the vaccine cannot be re-frozen.
Do not use this vaccine if you notice particulates in the dilution or discolouration.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
         79

6. Contents of the pack and other information
What Comirnaty contains
 The active substance is COVID-19 mRNA Vaccine called tozinameran. After dilution, the vial contains 6 doses of 0.3 mL with 30 micrograms tozinameran each.
 The other ingredients are:
 ((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate) (ALC-0315)
 2-[(polyethylene glycol)-2000]-N,N-ditetradecylacetamide (ALC-0159)
 1,2-Distearoyl-sn-glycero-3-phosphocholine (DSPC)
 cholesterol
 potassium chloride
 potassium dihydrogen phosphate
 sodium chloride
 disodium phosphate dihydrate
 sucrose
 water for injections
 sodium hydroxide (for pH adjustment)
 hydrochloric acid (for pH adjustment)
What Comirnaty looks like and contents of the pack
The vaccine is a white to off-white dispersion (pH: 6.9 - 7.9) provided in a multidose vial of 6 doses in a 2 mL clear vial (type I glass), with a rubber stopper and a purple flip-off plastic cap with aluminium seal.
Pack size: 195 vials
Marketing Authorisation Holder
BioNTech Manufacturing GmbH An der Goldgrube 12
55131 Mainz
Germany
Phone: +49 6131 9084-0 Fax: +49 6131 9084-2121 service@biontech.de
Manufacturers
BioNTech Manufacturing GmbH Kupferbergterrasse 17 - 19 55116 Mainz
Germany
Pfizer Manufacturing Belgium NV Rijksweg 12
2870 Puurs
Belgium
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
België/Belgique/Belgien Luxembourg/Luxemburg Pfizer S.A./N.V.
Tél/Tel: +32 (0)2 554 62 11
Lietuva
Pfizer Luxembourg SARL filialas Lietuvoje Tel. +370 52 51 4000
80

България
Пфайзер Люксембург САРЛ, Клон България
Teл: +359 2 970 4333
Česká republika
Pfizer, spol. s r.o.
Tel: +420 283 004 111
Danmark
Pfizer ApS
Tlf: +45 44 201 100
Deutschland
BioNTech Manufacturing GmbH Tel: +49 6131 90840
Eesti
Pfizer Luxembourg SARL Eesti filiaal Tel: +372 666 7500
Ελλάδα
Pfizer Ελλάς A.E.
Τηλ.: +30 210 6785 800
España
Pfizer, S.L. Tel:+34914909900
France
Pfizer
Tél +33 1 58 07 34 40
Hrvatska
Pfizer Croatia d.o.o. Tel: +385 1 3908 777
Ireland
Pfizer Healthcare Ireland Tel: 1800 633 363 (toll free) +44 (0)1304 616161
Ísland
Icepharma hf
Simi: +354 540 8000
Italia
Pfizer S.r.l.
Tel: +39 06 33 18 21
Κύπρος
Pfizer Ελλάς Α.Ε. (Cyprus Branch) Tηλ: +357 22 817690
Magyarország
Pfizer Kft
Tel: +36 1 488 3700
Malta
Vivian Corporation Ltd. Tel: +35621 344610
Norge
Pfizer AS
Tlf: +47 67 526 100
Nederland
Pfizer BV
Tel: +31 (0)10 406 43 01
Österreich
Pfizer Corporation Austria Ges.m.b.H Tel: +43 (0)1 521 15-0
Polska
Pfizer Polska Sp. z o.o. Tel.: +48 22 335 61 00
Portugal
Laboratórios Pfizer, Lda. Tel: +351 21 423 5500
România
Pfizer Romania S.R.L Tel: +40 (0) 21 207 28 00
Slovenija
Pfizer Luxembourg SARL
Pfizer, podružnica za svetovanje s področja farmacevtske dejavnosti, Ljubljana
Tel.: +386 (0) 1 52 11 400
Slovenská republika
Pfizer Luxembourg SARL, organizačná zložka
Tel: +421 2 3355 5500
Suomi/Finland
Pfizer Oy
Puh/Tel: +358 (0)9 430 040
Sverige
Pfizer AB
Tel: +46 (0)8 550 520 00
United Kingdom (Northern Ireland)
Pfizer Limited
Tel: +44 (0) 1304 616161
81

Latvija
Pfizer Luxembourg SARL filiāle Latvijā Tel.: +371 670 35 775
This leaflet was last revised in {MM/YYYY}
This medicine has been given ‘conditional approval’. This means that there is more evidence to come about this medicine. The European Medicines Agency will review new information on this medicine at least every year and this leaflet will be updated as necessary.
Scan the code with a mobile device to get the package leaflet in different languages.
URL: www.comirnatyglobal.com
Detailed information on this medicine is available on the European Medicines Agency web site:
http://www.ema.europa.eu.
This package leaflet is available in all EU/EEA languages on the European Medicines Agency website.
------------------------------------------------------------------------------------------------------------------------
The following information is intended for healthcare professionals only:
Administer Comirnaty intramuscularly after dilution as a primary course of 2 doses (0.3 mL each) 3 weeks apart.
A booster dose (third dose) of Comirnaty may be given at least 6 months after the second dose in individuals 18 years of age and older.
A third dose may be given at least 28 days after the second dose to individuals who are severely immunocompromised.
Traceability
In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Handling instructions
Comirnaty should be prepared by a healthcare professional using aseptic technique to ensure the sterility of the prepared dispersion.
     82

     DOSE VERIFICATION OF COMIRNATY 30 MICROGRAMS/DOSE CONCENTRATE FOR DISPERSION FOR INJECTION (12 YEARS AND OLDER)
         Purple cap
 Verify that the vial has a purple plastic cap.
 If the vial has a grey plastic cap, please make reference to the Summary of Product Characteristics for Comirnaty 30 micrograms/dose dispersion for injection.
 If the vial has an orange plastic cap, please make reference to the Summary of Product Characteristics for Comirnaty 10 micrograms/dose concentrate for dispersion for injection.
       THAWING PRIOR TO DILUTION OF COMIRNATY 30 MICROGRAMS/DOSE CONCENTRATE FOR DISPERSION FOR INJECTION (12 YEARS AND OLDER)
       No more than 2 hours at room temperature (up to 30 °C)
 The multidose vial is stored frozen and must be thawed prior to dilution. Frozen vials should be transferred to an environment of 2 °C to 8 °C to thaw; a 195 vial pack may take 3 hours to thaw. Alternatively, frozen vials may also be thawed for 30 minutes at temperatures up to 30 °C for immediate use.
 The unopened vial can be stored for up to 1 month at 2 °C to 8 °C within the 9-month shelf life. Within the 1-month shelf life at 2 °C to 8 °C, up to 12 hours may be used for transportation.
 Allow the thawed vial to come to room temperature. Prior to use, the unopened vial can be stored for up to 2 hours at temperatures up to 30 °C. Thawed vials can be handled in room light conditions.
 Gently invert the vial 10 times prior to dilution. Do not shake.
 Prior to dilution, the thawed dispersion may contain white to off-white opaque amorphous particles.
     83

     DILUTION OF COMIRNATY 30 MICROGRAMS/DOSE CONCENTRATE FOR DISPERSION FOR INJECTION (12 YEARS AND OLDER)
       1.8 mL of 0.9% sodium chloride injection
    The thawed vaccine must be diluted in its original vial with 1.8 mL sodium chloride 9 mg/mL (0.9%) solution for injection, using a 21 gauge or narrower needle and aseptic techniques.
     Pull back plunger to 1.8 mL to remove air from vial.
       Equalise vial pressure before removing the needle from the vial stopper by withdrawing 1.8 mL air into the empty diluent syringe.
84

    Gently × 10
       Gently invert the diluted dispersion 10 times. Do not shake.
 The diluted vaccine should present as an off-white dispersion with no particulates visible. Do not use the diluted vaccine if particulates or discolouration are present.
     Record appropriate date and time. Use within 6 hours after dilution.
     The diluted vials should be marked with the appropriate date and time.
 After dilution, store at 2 oC to 30 oC and use within 6 hours, including any transportation time.
 Do not freeze or shake the diluted dispersion. If refrigerated, allow the diluted dispersion to come to room temperature prior to use.
   85

     PREPARATION OF INDIVIDUAL 0.3 mL DOSES OF COMIRNATY
30 MICROGRAMS/DOSE CONCENTRATE FOR DISPERSION FOR INJECTION (12 YEARS AND OLDER)
       0.3 mL diluted vaccine
 After dilution, the vial contains
2.25 mL from which 6 doses of 0.3 mL can be extracted.
 Using aseptic technique, cleanse the vial stopper with a single-use antiseptic swab.
 Withdraw 0.3 mL of Comirnaty.
Low dead-volume syringes and/or needles should be used in order to extract 6 doses from a single vial. The low dead-volume syringe and needle combination should have a dead volume of no more than 35 microlitres.
If standard syringes and needles are used, there may not be sufficient volume to extract a sixth dose from a single vial.
 Each dose must contain 0.3 mL of vaccine.
 If the amount of vaccine remaining in the vial cannot provide a full dose of 0.3 mL, discard the vial and any excess volume.
 Discard any unused vaccine within 6 hours after dilution.
   Disposal
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
86

Package leaflet: Information for the user
Comirnaty 30 micrograms/dose dispersion for injection Adults and adolescents from 12 years COVID-19 mRNA Vaccine (nucleoside modified) tozinameran
This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.
Read all of this leaflet carefully before you receive this vaccine because it contains important information for you.
 Keep this leaflet. You may need to read it again.
 If you have any further questions, ask your doctor, pharmacist or nurse.
 If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Comirnaty is and what it is used for
2. What you need to know before you receive Comirnaty
3. How Comirnaty is given
4. Possible side effects
5. How to store Comirnaty
6. Contents of the pack and other information
1. What Comirnaty is and what it is used for
Comirnaty is a vaccine used for preventing COVID-19 caused by SARS-CoV-2 virus.
Comirnaty 30 micrograms/dose dispersion for injection is given to adults and adolescents from 12 years of age and older.
The vaccine causes the immune system (the body’s natural defences) to produce antibodies and blood cells that work against the virus, so giving protection against COVID-19.
As Comirnaty does not contain the virus to produce immunity, it cannot give you COVID-19.
2. What you need to know before you receive Comirnaty
Comirnaty should not be given
 if you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6)
Warnings and precautions
Talk to your doctor, pharmacist or nurse before you are given the vaccine if:
 you have ever had a severe allergic reaction or breathing problems after any other vaccine
injection or after you were given Comirnaty in the past.
 you are feeling nervous about the vaccination process or have ever fainted following any needle
injection.
 you have a severe illness or infection with high fever. However, you can have your vaccination
if you have a mild fever or upper airway infection like a cold.
 you have a bleeding problem, you bruise easily or you use a medicine to prevent blood-clots.
87

 you have a weakened immune system, because of a disease such as HIV infection or a medicine such as corticosteroid that affects your immune system.
There is an increased risk of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside the heart) after vaccination with Comirnaty (see section 4). These conditions can develop within just a few days after vaccination and have primarily occurred within
14 days. They have been observed more often after the second vaccination, and more often in younger males. Following vaccination, you should be alert to signs of myocarditis and pericarditis, such as breathlessness, palpitations and chest pain, and seek immediate medical attention should these occur.
As with any vaccine, Comirnaty may not fully protect all those who receive it and it is not known how long you will be protected.
You may receive a third dose of Comirnaty. The efficacy of Comirnaty, even after a third dose, may be lower in people who are immunocompromised. In these cases, you should continue to maintain physical precautions to help prevent COVID-19. In addition, your close contacts should be vaccinated as appropriate. Discuss appropriate individual recommendations with your doctor.
Children
Comirnaty is not recommended for children aged under 12 years.
Other medicines and Comirnaty
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines or have recently received any other vaccine.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before you receive this vaccine.
Driving and using machines
Some of the effects of vaccination mentioned in section 4 (Possible side effects) may temporarily affect your ability to drive or use machines. Wait until these effects have worn off before you drive or use machines.
3. How Comirnaty is given
Comirnaty is given as an injection of 0.3 mL into a muscle of your upper arm. You will receive 2 injections.
It is recommended to receive the second dose of the same vaccine 3 weeks after the first dose to complete the vaccination course.
A booster dose (third dose) of Comirnaty may be given at least 6 months after the second dose in individuals 18 years of age and older.
If you are immunocompromised, you may receive a third dose of Comirnaty at least 28 days after the second dose.
If you have any further questions on the use of Comirnaty, ask your doctor, pharmacist or nurse.
88

4. Possible side effects
Like all vaccines, Comirnaty can cause side effects, although not everybody gets them.
Very common side effects: may affect more than 1 in 10 people
 injection site: pain, swelling
 tiredness
 headache
 muscle pain
 chills
 joint pain
 diarrhoea
 fever
Some of these side effects were slightly more frequent in adolescents 12 to 15 years than in adults.
Common side effects: may affect up to 1 in 10 people
 injection site redness
 nausea
 vomiting
Uncommon side effects: may affect up to 1 in 100 people
 enlarged lymph nodes (more frequently observed after the booster dose)
 feeling unwell
 arm pain
 insomnia
 injection site itching
 allergic reactions such as rash or itching
 feeling weak or lack of energy/sleepy
 decreased appetite
 excessive sweating
 night sweats
Rare side effects: may affect up to 1 in 1,000 people
 temporary one sided facial drooping
 allergic reactions such as hives or swelling of the face
Very rare side effects: may affect up to 1 in 10,000 people
 inflammation of the heart muscle (myocarditis) or inflammation of the lining outside the heart
(pericarditis) which can result in breathlessness, palpitations or chest pain
Not known (cannot be estimated from the available data)
 severe allergic reaction
 extensive swelling of the vaccinated limb
 swelling of the face (swelling of the face may occur in patients who have had facial
dermatological fillers)
 a skin reaction that causes red spots or patches on the skin, that may look like a target or
“bulls-eye” with a dark red centre surrounded by paler red rings (erythema multiforme)
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V and include batch/Lot number if available. By reporting side effects you can help provide more information on the safety of this medicine.
   89

5. How to store Comirnaty
Keep this medicine out of the sight and reach of children.
The following information about storage, expiry and use and handling is intended for healthcare professionals.
Do not use this medicine after the expiry date which is stated on the carton and label after EXP. The expiry date refers to the last day of that month.
Store in freezer at -90 °C to -60 °C for 9 months.
Store in the original package in order to protect from light.
The vaccine may be received frozen at -90 °C to -60 °C or at -25 °C to -15 °C. Frozen vaccine can be stored either at -90 °C to -60 °C or 2 °C to 8 °C upon receipt.
When stored frozen at -90 °C to -60 °C, 10-vial packs of the vaccine can be thawed at 2 °C to 8 °C for 6 hours or individual vials can be stored at room temperature (up to 30 °C) for 30 minutes.
Once removed from the freezer, the unopened vial may be stored refrigerated at 2 °C to 8 °C for a single period of up to 10 weeks within the 9-month shelf life. The outer carton should be marked with the new discard date at 2 °C to 8 °C. Once thawed, the vaccine cannot be re-frozen.
Prior to use, the unopened vials can be stored for up to 12 hours at temperatures between 8 °C and 30 °C.
Thawed vials can be handled in room light conditions.
After first puncture, store and transport the vaccine at 2 °C to 30 °C and use within 12 hours. Discard any unused vaccine.
Do not use this vaccine if you notice particulates or discolouration.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Comirnaty contains
 The active substance is COVID-19 mRNA Vaccine called tozinameran. The vial contains 6 doses of 0.3 mL with 30 micrograms tozinameran each.
 The other ingredients are:
 ((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate) (ALC-0315)
 2-[(polyethylene glycol)-2000]-N,N-ditetradecylacetamide (ALC-0159)
 1,2-Distearoyl-sn-glycero-3-phosphocholine (DSPC)
 cholesterol
 trometamol
 trometamol hydrochloride
 sucrose
 water for injections
90

What Comirnaty looks like and contents of the pack
The vaccine is a white to off-white dispersion (pH: 6.9 - 7.9) provided in a multidose vial of 6 doses in a 2 mL clear vial (type I glass), with a rubber stopper and a grey flip-off plastic cap with aluminium seal.
Pack sizes: 195 vials or 10 vials
Not all pack sizes may be marketed.
Marketing Authorisation Holder
BioNTech Manufacturing GmbH An der Goldgrube 12
55131 Mainz
Germany
Phone: +49 6131 9084-0 Fax: +49 6131 9084-2121 service@biontech.de
Manufacturers
BioNTech Manufacturing GmbH Kupferbergterrasse 17 - 19 55116 Mainz
Germany
Pfizer Manufacturing Belgium NV Rijksweg 12
2870 Puurs
Belgium
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
België/Belgique/Belgien Luxembourg/Luxemburg Pfizer S.A./N.V.
Tél/Tel: +32 (0)2 554 62 11
България
Пфайзер Люксембург САРЛ, Клон България
Teл: +359 2 970 4333
Česká republika
Pfizer, spol. s r.o.
Tel: +420 283 004 111
Danmark
Pfizer ApS
Tlf: +45 44 201 100
Deutschland
BioNTech Manufacturing GmbH Tel: +49 6131 90840
Lietuva
Pfizer Luxembourg SARL filialas Lietuvoje Tel. +370 52 51 4000
Magyarország
Pfizer Kft
Tel: +36 1 488 3700
Malta
Vivian Corporation Ltd. Tel: +35621 344610
Norge
Pfizer AS
Tlf: +47 67 526 100
Nederland
Pfizer BV
Tel: +31 (0)10 406 43 01
91

Eesti
Pfizer Luxembourg SARL Eesti filiaal Tel: +372 666 7500
Ελλάδα
Pfizer Ελλάς A.E.
Τηλ.: +30 210 6785 800
España
Pfizer, S.L. Tel:+34914909900
France
Pfizer
Tél +33 1 58 07 34 40
Hrvatska
Pfizer Croatia d.o.o. Tel: +385 1 3908 777
Ireland
Pfizer Healthcare Ireland Tel: 1800 633 363 (toll free) +44 (0)1304 616161
Ísland
Icepharma hf
Simi: +354 540 8000
Italia
Pfizer S.r.l.
Tel: +39 06 33 18 21
Κύπρος
Pfizer Ελλάς Α.Ε. (Cyprus Branch) Tηλ: +357 22 817690
Latvija
Pfizer Luxembourg SARL filiāle Latvijā Tel.: +371 670 35 775
This leaflet was last revised in {MM/YYYY}
Österreich
Pfizer Corporation Austria Ges.m.b.H Tel: +43 (0)1 521 15-0
Polska
Pfizer Polska Sp. z o.o. Tel.: +48 22 335 61 00
Portugal
Laboratórios Pfizer, Lda. Tel: +351 21 423 5500
România
Pfizer Romania S.R.L Tel: +40 (0) 21 207 28 00
Slovenija
Pfizer Luxembourg SARL
Pfizer, podružnica za svetovanje s področja farmacevtske dejavnosti, Ljubljana
Tel.: +386 (0) 1 52 11 400
Slovenská republika
Pfizer Luxembourg SARL, organizačná zložka
Tel: +421 2 3355 5500
Suomi/Finland
Pfizer Oy
Puh/Tel: +358 (0)9 430 040
Sverige
Pfizer AB
Tel: +46 (0)8 550 520 00
United Kingdom (Northern Ireland)
Pfizer Limited
Tel: +44 (0) 1304 616161
This medicine has been given ‘conditional approval’. This means that there is more evidence to come about this medicine. The European Medicines Agency will review new information on this medicine at least every year and this leaflet will be updated as necessary.
Scan the code with a mobile device to get the package leaflet in different languages.
92

URL: www.comirnatyglobal.com
Detailed information on this medicine is available on the European Medicines Agency web site:
http://www.ema.europa.eu.
This package leaflet is available in all EU/EEA languages on the European Medicines Agency website.
------------------------------------------------------------------------------------------------------------------------
The following information is intended for healthcare professionals only:
Administer Comirnaty intramuscularly as a primary course of 2 doses (0.3 mL each) 3 weeks apart.
A booster dose (third dose) of Comirnaty may be given at least 6 months after the second dose in individuals 18 years of age and older.
A third dose may be given at least 28 days after the second dose to individuals who are severely immunocompromised.
Traceability
In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Handling instructions
Comirnaty should be prepared by a healthcare professional using aseptic technique to ensure the sterility of the prepared dispersion.
    93

     DOSE VERIFICATION OF COMIRNATY 30 MICROGRAMS/DOSE DISPERSION FOR INJECTION (12 YEARS AND OLDER)
         Grey cap
 Verify that the vial has a grey plastic cap.
 If the vial has a purple plastic cap, please make reference to the Summary of Product Characteristics for Comirnaty
30 micrograms/dose concentrate
for dispersion for injection.
 If the vial has an orange plastic
cap, please make reference to the Summary of Product Characteristics for Comirnaty
10 micrograms/dose concentrate for dispersion for injection.
         HANDLING PRIOR TO USE OF COMIRNATY 30 MICROGRAMS/DOSE DISPERSION FOR INJECTION (12 YEARS AND OLDER)
       Store for up to 10 weeks at 2 °C to 8 °C, update the expiry on the carton
 If the multidose vial is stored frozen it must be thawed prior to use. Frozen vials should be transferred to an environment of
2 °C to 8 °C to thaw; a 10 vial pack may take 6 hours to thaw. Ensure vials are completely thawed prior to use.
 Uponmovingvialsto2°Cto8°C storage, update the expiry date on the carton.
 Unopened vials can be stored for up to 10 weeks at 2 °C to 8 °C within the 9-month shelf life.
 Alternatively, individual frozen vials may be thawed for
30 minutes at temperatures up to 30 °C. Prior to use, the unopened vial can be stored for up to
12 hours at temperatures up to 30 °C. Thawed vials can be handled in room light conditions.
     94

     Gently x 10
     Gently mix by inverting vials 10 times prior to use. Do not shake.
 Prior to mixing, the thawed dispersion may contain white to off-white opaque amorphous particles.
 After mixing, the vaccine should present as an off-white dispersion with no particulates visible. Do not use the vaccine if particulates or discolouration are present.
        PREPARATION OF INDIVIDUAL 0.3 mL DOSES OF COMIRNATY
30 MICROGRAMS/DOSE DISPERSION FOR INJECTION (12 YEARS AND OLDER)
        0.3 mL vaccine
 Using aseptic technique, cleanse the vial stopper with a single-use antiseptic swab.
 Withdraw 0.3 mL of Comirnaty.
Low dead-volume syringes and/or needles should be used in order to extract 6 doses from a single vial. The low dead-volume syringe and needle combination should have a dead volume of no more than
35 microlitres.
If standard syringes and needles are used, there may not be sufficient volume to extract a sixth dose from a single vial.
 Each dose must contain 0.3 mL of vaccine.
 If the amount of vaccine remaining in the vial cannot provide a full dose of 0.3 mL, discard the vial and any excess volume.
 Discard any unused vaccine
12 hours after first puncture. Record the appropriate date/time on the vial.
      Disposal
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
95

Package leaflet: Information for the user
Comirnaty 10 micrograms/dose concentrate for dispersion for injection Children 5 to 11 years
COVID-19 mRNA Vaccine (nucleoside modified) tozinameran
This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects your child may get. See the end of section 4 for how to report side effects.
Read all of this leaflet carefully before you receive this vaccine because it contains important information for you.
 Keep this leaflet. You may need to read it again.
 If you have any further questions, ask your doctor, pharmacist or nurse.
 If your child gets any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Comirnaty is and what it is used for
2. What you need to know before your child receives Comirnaty
3. How Comirnaty is given
4. Possible side effects
5. How to store Comirnaty
6. Contents of the pack and other information
1. What Comirnaty is and what it is used for
Comirnaty is a vaccine used for preventing COVID-19 caused by SARS-CoV-2 virus.
Comirnaty 10 micrograms/dose concentrate for dispersion for injection is given to children from 5 to 11 years of age.
The vaccine causes the immune system (the body’s natural defences) to produce antibodies and blood cells that work against the virus, so giving protection against COVID-19.
As Comirnaty does not contain the virus to produce immunity, it cannot give your child COVID-19.
2. What you need to know before your child receives Comirnaty
Comirnaty should not be given
 if your child is allergic to the active substance or any of the other ingredients of this medicine (listed in section 6)
Warnings and precautions
Talk to your doctor, pharmacist or nurse before your child is given the vaccine if your child:
 has ever had a severe allergic reaction or breathing problems after any other vaccine injection or
after having been given Comirnaty in the past.
 is feeling nervous about the vaccination process or has ever fainted following any needle
injection.
 has a severe illness or infection with high fever. However, your child can have the vaccination if
he/she have a mild fever or upper airway infection like a cold.
 has a bleeding problem, bruises easily or uses a medicine to prevent blood-clots.
96

 has a weakened immune system, because of a disease such as HIV infection or a medicine such as corticosteroid that affects the immune system.
There is an increased risk of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside the heart) after vaccination with Comirnaty (see section 4). These conditions can develop within just a few days after vaccination and have primarily occurred within
14 days. They have been observed more often after the second vaccination, and more often in younger males. Following vaccination, you should be alert to signs of myocarditis and pericarditis, such as breathlessness, palpitations and chest pain, and seek immediate medical attention should these occur.
As with any vaccine, Comirnaty may not fully protect all those who receive it and it is not known how long you will be protected.
Your child may receive a third dose of Comirnaty. The third dose may still not provide full immunity to COVID-19 in people who are immunocompromised. In these cases, you should continue to maintain physical precautions to help prevent COVID-19. In addition, your close contacts should be vaccinated as appropriate. Discuss appropriate individual recommendations with your doctor.
Children
Comirnaty is not recommended for children aged under 5 years.
Other medicines and Comirnaty
Tell your doctor or pharmacist if your child is using, has recently used or might use any other medicines or has recently received any other vaccine.
Pregnancy and breast-feeding
If your child is pregnant or breast-feeding, ask your doctor or pharmacist for advice before your child receives this vaccine.
Driving and using machines
Some of the effects of vaccination mentioned in section 4 (Possible side effects) may temporarily affect your ability to use machines or undertake activities such as cycling. Wait until these effects have worn off before resuming activities that require your full attention.
3. How Comirnaty is given
Comirnaty is given after dilution as an injection of 0.2 mL into a muscle of the upper arm. Your child will receive 2 injections.
It is recommended to receive the second dose of the same vaccine 3 weeks after the first dose to complete the vaccination course.
If your child is immunocompromised, he or she may receive a third dose of Comirnaty at least 28 days after the second dose.
If you have any further questions on the use of Comirnaty, ask your doctor, pharmacist or nurse.
4. Possible side effects
Like all vaccines, Comirnaty can cause side effects, although not everybody gets them.
Very common side effects: may affect more than 1 in 10 people
 injection site: pain, swelling, redness
 tiredness
97

 headache
 muscle pain
 chills
 joint pain
 diarrhoea
 fever
Some of these side effects were slightly more frequent in adolescents 12 to 15 years than in adults.
Common side effects: may affect up to 1 in 10 people
 nausea
 vomiting
Uncommon side effects: may affect up to 1 in 100 people
 enlarged lymph nodes (more frequently observed after the booster dose)
 feeling unwell
 arm pain
 insomnia
 injection site itching
 allergic reactions such as rash or itching
 feeling weak or lack of energy/sleepy
 decreased appetite
 excessive sweating
 night sweats
Rare side effects: may affect up to 1 in 1,000 people
 temporary one sided facial drooping
 allergic reactions such as hives or swelling of the face
Very rare side effects: may affect up to 1 in 10,000 people
 inflammation of the heart muscle (myocarditis) or inflammation of the lining outside the heart
(pericarditis) which can result in breathlessness, palpitations or chest pain
Not known (cannot be estimated from the available data)
 severe allergic reaction
 extensive swelling of the vaccinated limb
 swelling of the face (swelling of the face may occur in patients who have had facial
dermatological fillers)
 a skin reaction that causes red spots or patches on the skin, that may look like a target or
“bulls-eye” with a dark red centre surrounded by paler red rings (erythema multiforme)
Reporting of side effects
If your child gets any side effects, talk to your doctor, pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V and include batch/Lot number if available. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Comirnaty
Keep this medicine out of the sight and reach of children.
The following information about storage, expiry and use and handling is intended for healthcare professionals.
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Do not use this medicine after the expiry date which is stated on the carton and label after EXP. The expiry date refers to the last day of that month.
Store in freezer at -90 °C to -60 °C for 9 months.
Store in the original package in order to protect from light.
The vaccine may be received frozen at -90 °C to -60 °C or at -25 °C to -15 °C. Frozen vaccine can be stored either at -90 °C to -60 °C or 2 °C to 8 °C upon receipt.
When stored frozen at -90 °C to -60 °C, 10-vial packs of the vaccine can be thawed at 2 °C to 8 °C for 4 hours or individual vials can be thawed at room temperature (up to 30 °C) for 30 minutes.
Once removed from the freezer, the unopened vial may be stored refrigerated at 2 °C to 8 °C for a single period of up to 10 weeks within the 9-month shelf life. The outer carton should be marked with the new discard date at 2 °C to 8 °C. Once thawed, the vaccine cannot be re-frozen.
Thawed vials can be handled in room light conditions.
After dilution, store and transport the vaccine at 2 °C to 30 °C and use within 12 hours. Discard any unused vaccine.
Do not use this vaccine if you notice particulates in the dilution or discolouration.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Comirnaty contains
 The active substance is COVID-19 mRNA Vaccine called tozinameran. After dilution, the vial contains 10 doses of 0.2 mL with 10 micrograms tozinameran each.
 The other ingredients are:
 ((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate) (ALC-0315)
 2-[(polyethylene glycol)-2000]-N,N-ditetradecylacetamide (ALC-0159)
 1,2-Distearoyl-sn-glycero-3-phosphocholine (DSPC)
 cholesterol
 trometamol
 trometamol hydrochloride
 sucrose
 water for injections
What Comirnaty looks like and contents of the pack
The vaccine is a white to off-white dispersion (pH: 6.9 - 7.9) provided in a multidose vial of 10 doses in a 2 mL clear vial (type I glass), with a rubber stopper and an orange flip-off plastic cap with aluminium seal.
Pack sizes: 195 vials or 10 vials Not all pack sizes may be marketed.
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Marketing Authorisation Holder
BioNTech Manufacturing GmbH An der Goldgrube 12
55131 Mainz
Germany
Phone: +49 6131 9084-0 Fax: +49 6131 9084-2121 service@biontech.de
Manufacturers
BioNTech Manufacturing GmbH Kupferbergterrasse 17 - 19 55116 Mainz
Germany
Pfizer Manufacturing Belgium NV Rijksweg 12
2870 Puurs
Belgium
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
België/Belgique/Belgien Luxembourg/Luxemburg Pfizer S.A./N.V.
Tél/Tel: +32 (0)2 554 62 11
България
Пфайзер Люксембург САРЛ, Клон България
Teл: +359 2 970 4333
Česká republika
Pfizer, spol. s r.o.
Tel: +420 283 004 111
Danmark
Pfizer ApS
Tlf: +45 44 201 100
Deutschland
BioNTech Manufacturing GmbH Tel: +49 6131 90840
Eesti
Pfizer Luxembourg SARL Eesti filiaal Tel: +372 666 7500
Ελλάδα
Pfizer Ελλάς A.E.
Τηλ.: +30 210 6785 800
España
Pfizer, S.L. Tel:+34914909900
Lietuva
Pfizer Luxembourg SARL filialas Lietuvoje Tel. +370 52 51 4000
Magyarország
Pfizer Kft
Tel: +36 1 488 3700
Malta
Vivian Corporation Ltd. Tel: +35621 344610
Norge
Pfizer AS
Tlf: +47 67 526 100
Nederland
Pfizer BV
Tel: +31 (0)10 406 43 01
Österreich
Pfizer Corporation Austria Ges.m.b.H Tel: +43 (0)1 521 15-0
Polska
Pfizer Polska Sp. z o.o. Tel.: +48 22 335 61 00
Portugal
Laboratórios Pfizer, Lda. Tel: +351 21 423 5500
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France
Pfizer
Tél +33 1 58 07 34 40
Hrvatska
Pfizer Croatia d.o.o. Tel: +385 1 3908 777
Ireland
Pfizer Healthcare Ireland Tel: 1800 633 363 (toll free) +44 (0)1304 616161
Ísland
Icepharma hf
Simi: +354 540 8000
Italia
Pfizer S.r.l.
Tel: +39 06 33 18 21
Κύπρος
Pfizer Ελλάς Α.Ε. (Cyprus Branch) Tηλ: +357 22 817690
Latvija
Pfizer Luxembourg SARL filiāle Latvijā Tel.: +371 670 35 775
This leaflet was last revised in {MM/YYYY}
România
Pfizer Romania S.R.L Tel: +40 (0) 21 207 28 00
Slovenija
Pfizer Luxembourg SARL
Pfizer, podružnica za svetovanje s področja farmacevtske dejavnosti, Ljubljana
Tel.: +386 (0) 1 52 11 400
Slovenská republika
Pfizer Luxembourg SARL, organizačná zložka
Tel: +421 2 3355 5500
Suomi/Finland
Pfizer Oy
Puh/Tel: +358 (0)9 430 040
Sverige
Pfizer AB
Tel: +46 (0)8 550 520 00
United Kingdom (Northern Ireland)
Pfizer Limited
Tel: +44 (0) 1304 616161
This medicine has been given ‘conditional approval’. This means that there is more evidence to come about this medicine. The European Medicines Agency will review new information on this medicine at least every year and this leaflet will be updated as necessary.
Scan the code with a mobile device to get the package leaflet in different languages.
URL: www.comirnatyglobal.com
Detailed information on this medicine is available on the European Medicines Agency web site:
http://www.ema.europa.eu.
This package leaflet is available in all EU/EEA languages on the European Medicines Agency website.
------------------------------------------------------------------------------------------------------------------------
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The following information is intended for healthcare professionals only:
Administer Comirnaty intramuscularly after dilution as a course of 2 doses (0.2 mL each) 3 weeks apart.
A third dose may be given at least 28 days after the second dose to individuals who are severely immunocompromised.
Traceability
In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Handling instructions
Comirnaty 10 micrograms/dose should be prepared by a healthcare professional using aseptic technique to ensure the sterility of the prepared dispersion.
      DOSE VERIFICATION OF COMIRNATY 10 MICROGRAMS/DOSE CONCENTRATE FOR DISPERSION FOR INJECTION (CHILDREN 5 TO 11 YEARS)
        Orange cap
10 mcg
 Verify that the vial has an orange plastic cap.
 If the vial has a purple plastic cap, please make reference to the Summary of Product Characteristics for Comirnaty 30 micrograms/dose concentrate for dispersion for injection.
 If the vial has a grey plastic cap, please make reference to the Summary of Product Characteristics for Comirnaty 30 micrograms/dose dispersion for injection.
        HANDLING PRIOR TO USE OF COMIRNATY 10 MICROGRAMS/DOSE CONCENTRATE FOR DISPERSION FOR INJECTION (CHILDREN 5 TO 11 YEARS)
      Store for up to 10 weeks at 2 °C to 8 °C
 If the multidose vial is stored frozen it must be thawed prior to use. Frozen vials should be transferred to an environment of 2 °C to 8 °C to thaw; a 10 vial pack may take 4 hours to thaw. Ensure vials are completely thawed prior to use.
 Uponmovingvialsto2°Cto8°C storage, update the expiry date on the carton.
 Unopened vials can be stored for up to 10 weeks at 2 °C to 8 °C within the 9-month shelf life.
 Alternatively, individual frozen vials may be thawed for 30 minutes at temperatures up to 30 °C.
 Prior to use, the unopened vial can be stored for up to 12 hours at temperatures up to 30 °C. Thawed vials can be handled in room light conditions.
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     MIXING PRIOR TO DILUTION OF COMIRNATY 10 MICROGRAMS/DOSE CONCENTRATE FOR DISPERSION FOR INJECTION (CHILDREN 5 TO 11 YEARS)
      Gently × 10
 Allow the thawed vial to come to room temperature and gently invert it 10 times prior to dilution. Do not shake.
 Prior to dilution, the thawed dispersion may contain white to off-white opaque amorphous particles.
       DILUTION OF COMIRNATY10 MICROGRAMS/DOSE CONCENTRATE FOR DISPERSION FOR INJECTION (CHILDREN 5 TO 11 YEARS)
       1.3 mL of 0.9% sodium chloride injection
 The thawed vaccine must be diluted in its original vial with 1.3 mL sodium chloride 9 mg/mL (0.9%) solution for injection, using a 21 gauge or narrower needle and aseptic techniques.
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     Pull back plunger to 1.3 mL to remove air from vial.
       Equalise vial pressure before removing the needle from the vial stopper by withdrawing 1.3 mL air into the empty diluent syringe.
     Gently × 10
 Gently invert the diluted dispersion 10 times. Do not shake.
 The diluted vaccine should present as a white to off-white dispersion with no particulates visible. Do not use the diluted vaccine if particulates or discolouration are present.
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     Record appropriate date and time. Use within 12 hours after dilution.
    The diluted vials should be marked with the appropriate date and time.
 After dilution, store at 2 oC to 30 oC and use within 12 hours.
 Do not freeze or shake the diluted dispersion. If refrigerated, allow the diluted dispersion to come to room temperature prior to use.
       PREPARATION OF INDIVIDUAL 0.2 mL DOSES OF COMIRNATY
10 MICROGRAMS/DOSE CONCENTRATE FOR DISPERSION FOR INJECTION (CHILDREN 5 TO 11 YEARS)
       0.2 mL diluted vaccine
 After dilution, the vial contains 2.6 mL from which 10 doses of 0.2 mL can be extracted.
 Using aseptic technique, cleanse the vial stopper with a single use antiseptic swab.
 Withdraw 0.2 mL of Comirnaty for children age 5 to 11 years.
Low dead-volume syringes and/or needles should be used in order to extract 10 doses from a single vial. The low dead-volume syringe and needle combination should have a dead volume of no more than 35 microlitres.
If standard syringes and needles are used, there may not be sufficient volume to extract ten doses from a single vial.
 Each dose must contain 0.2 mL of vaccine.
 If the amount of vaccine remaining in the vial cannot provide a full dose of 0.2 mL, discard the vial and any excess volume.
 Discard any unused vaccine within 12 hours after dilution.
   Disposal
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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