Decision: Regulatory approval of Pfizer/BioNTech bivalent Original/Omicron booster vaccine

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Medicines Healthcare Products Regulatory Agency

September 3

10:32 2022

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Summary of Product Characteristics - Pfizer/BioNTech bivalent vaccine - Comirnaty Original / Omicron BA.1

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Patient Information Leaflet - Pfizer/BioNTech bivalent vaccine - Comirnaty Original / Omicron BA.1

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Details

The product information for the Comirnaty original COVID-19 vaccine (formerly COVID-19 Vaccine Pfizer/BioNTech) can be found on a separate page.

Comirnaty Original/Omicron BA.1 is a vaccine used for preventing COVID-19 caused by SARS?CoV-2.

It is given to adults and adolescents from 12years of age and older.

Comirnaty Original/Omicron BA.1 is only for individuals who have previously received at least a primary vaccination course against COVID-19.

The vaccine causes the immune system (the bodys natural defences) to produce antibodies and blood cells that work against the virus, so giving protection against COVID-19.

As Comirnaty Original/Omicron BA.1 does not contain the virus to produce immunity, it cannot give you COVID-19.

Published 3 September 2022

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