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Decision

Regulatory approval of Pfizer/BioNTech bivalent Original/Omicron booster vaccines

Information for healthcare professionals and the public about the Pfizer/BioNTech's bivalent vaccines

Updates to this page

From:
Medicines and Healthcare products Regulatory Agency
Published:
3 September 2022
Last updated:
8 August 2024
Show all updates

  1. Removed 'Summary of Product Characteristics - Pfizer/BioNTech bivalent vaccine - Comirnaty Original/Omicron BA.4-5 (15/15 micrograms)/dose for age 12+' and 'Patient Information Leaflet - Pfizer/BioNTech bivalent vaccine - Comirnaty Original /Omicron BA.4-5 (15/15 micrograms)/dose for age 12+' Following the recent withdrawal of the licences for this Comirnaty (COVID-19 vaccines) vaccine.

  2. 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.

  3. Update to section 4.8 of the SmPC to update the safety information available in 12-15 year olds.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. Added 'Public Assessment Report - Pfizer/BioNTech bivalent vaccine - Comirnaty Original/Omicron BA.4-5'

  12. Updated the Pfizer Omicron BA.1 and BA.4-5 SmPC and PIL documents

  13. Added Public Assessment Report

  14. This page was updated to include information about the Comirnaty Original/Omicron BA.4-5 vaccine.

  15. First published.

Documents

Last updated 21/03/24 - Summary of Product Characteristics - Pfizer/BioNTech bivalent vaccine - BA.4-5 (1.5/1.5 micrograms)/dose for age 6 months to 4 years

PDF, 167 KB, 33 pages

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Last updated 21/03/24 - Patient Information Leaflet - Pfizer/BioNTech bivalent vaccine - BA.4-5 (1.5/1.5 micrograms)/dose for age 6 months to 4 years

PDF, 108 KB, 7 pages

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Last updated 03/2024 - Patient Information Leaflet - Pfizer/BioNTech bivalent vaccine - Comirnaty Original/Omicron BA.4-5 (5/5 micrograms)/dose for ages 5-11 years

PDF, 107 KB, 7 pages

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Last updated 21/03/24 - Summary of Product Characteristics - Pfizer/BioNTech bivalent vaccine - Comirnaty Original/Omicron BA.4-5 (5/5 micrograms)/dose for ages 5-11 years

PDF, 138 KB, 28 pages

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Last updated 03/2024 - Patient Information Leaflet - Pfizer/BioNTech bivalent vaccine - Comirnaty Original /Omicron BA.4-5 (15/15 micrograms)/dose for age 12+

PDF, 109 KB, 7 pages

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Last updated 21/03/24 - Summary of Product Characteristics - Pfizer/BioNTech bivalent vaccine - Comirnaty Original/Omicron BA.4-5 (15/15 micrograms)/dose for age 12+

PDF, 126 KB, 25 pages

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Public Assessment Report - Pfizer BioNTech bivalent vaccine - Comirnaty Original Omicron BA.4-5

PDF, 791 KB, 13 pages

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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.4/5 are vaccines used for preventing COVID-19 caused by SARS‑CoV-2.

  • 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.
  • Comirnaty Original/Omicron BA.4-5 (1.5/1.5 micrograms)/dose is for use in children aged 6 months to 4 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.

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