Regulatory approval of Pfizer/BioNTech bivalent Original/Omicron booster vaccines
Information for healthcare professionals and the public about the Pfizer/BioNTech's bivalent vaccines
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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 and Comirnaty Original/Omicron BA.4/5 are vaccines used for preventing COVID-19 caused by SARS‑CoV-2.
- Comirnaty Original/Omicron BA.1 (15/15 micrograms)/dose is for use in adults and adolescents from 12 years of age and older.
- Comirnaty Original/Omicron BA.4-5 (15/15 micrograms)/dose is for use in adults and adolescents from 12 years of age and older.
- Comirnaty Original/Omicron BA.4-5 (5/5 micrograms)/dose is for use in children aged 5 to 11 years.
They are only for individuals who have previously received at least a primary vaccination course against COVID-19.
The vaccines cause 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 these vaccines do not contain the virus to produce immunity, they cannot give you COVID-19.
Last updated 21 March 2024 + show all updates
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The product information (SmPC and PIL) of each Comirnaty product has been updated following recent approval on PI updates (Sections 1, 2, and 4.8, and labelling) and shelf-life extension.
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Update to section 4.8 of the SmPC to update the safety information available in 12-15 year olds.
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Updated 'Summary of Product Characteristics - Pfizer/BioNTech bivalent vaccine - BA.4-5 (1.5/1.5 micrograms)/dose for age 6 months to 4 years' to reflect an update to the product shelf-life (Section 6.3 of the SmPC), from 18 months to 2 years.
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Updated the PIL and SmPC for the Comirnaty bivalent vaccine Original/Omicron BA.4-5 (1.5/1.5 microgram)/dose for use in infants and children aged 6m to 4 years following approval of the Comirnaty Omicron XBB.1.5 vaccines and to update information on myocarditis.
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Summary of Product Characteristics and Patient Information Leaflet added for 'Comirnaty Original/Omicron BA.4-5 for use in infants and children aged 6 months to 4 years' - Date of first authorisation - 31 Aug 23.
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Summary of Product Characteristics (SmPC) and Patient Information Leaflets (PIL) updated to reflect: A variation to reflect new posology for primary immunisation and a variation to extend the shelf-life. The updates affect all Comirnaty Original/Omicron BA.4-5 products. Updates applicable from 24 August 2023.
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Updated safety and immunogenicity information has been added to the product information based on six months post-booster dose follow-up data in recipients aged 16 years and older.
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Updated SPCs and PILs for all Comirnaty products, to include: the uncommon side effect ‘dizziness’ & longer-term clinical trial follow-up data in 5-11 year olds.
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Product information has been added for a new, age-appropriate presentation of the bivalent version of the vaccine Comirnaty Original/Omicron BA.4-5 (5/5 micrograms)/dose, which is for use in children aged 5 to 11 years. Minor, consequential updates were made to the product information for the Comirnaty Original/Omicron BA.1 (15/15 micrograms)/dose for use in adults and adolescents from 12 years of age and older, and Comirnaty Original/Omicron BA.4-5 (15/15 micrograms)/dose, also for use in adults and adolescents from 12 years of age and older.
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Added 'Public Assessment Report - Pfizer/BioNTech bivalent vaccine - Comirnaty Original/Omicron BA.4-5'
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Updated the Pfizer Omicron BA.1 and BA.4-5 SmPC and PIL documents
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Added Public Assessment Report
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This page was updated to include information about the Comirnaty Original/Omicron BA.4-5 vaccine.
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First published.