Decision

Regulatory approval of Pfizer/BioNTech vaccine for COVID-19

Information for healthcare professionals and the public about the Pfizer/BioNTech vaccine.

Applies to England, Scotland and Wales

Documents

Summary of Product Characteristics for COVID-19 Vaccine Pfizer/BioNTech

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Patient Information Leaflet for COVID-19 Vaccine Pfizer/BioNTech

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Conditions of Authorisation for COVID-19 Vaccine Pfizer/BioNTech

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Details

To date, the COVID-19 Vaccine Pfizer/BioNTech has been supplied in the UK on a temporary basis under Regulation 174 of the Human Medicine Regulations 2012, but as this was always intended to be a temporary arrangement, supply of this vaccine will change to be in accordance with the conditional Marketing Authorisation (CMA).

The product information for the CMA that was granted for Great Britain can be found on this page. This CMA was issued by the European Medicines Agency (EMA) on 21 December 2020 and was automatically converted to a GB CMA on 1 January 2021. The CMA issued by the EMA has continued to have effect in Northern Ireland since 21 December 2020.

Manufacture of the vaccine remains unchanged, as do the clinical, pharmacological and pharmaceutical properties of the vaccine.

The information for healthcare professionals and UK recipients on using the vaccine safely has been periodically updated as new data have become available and this will continue under the CMA. Please regularly check this information as it is often updated.

The product information for the COVID-19 Vaccine Pfizer/BioNTech authorised under Regulation 174 can also be found on this page while the R174 product remains in use.

The MHRA regularly publishes reports of the safety of the COVID-19 vaccines.

For further information on prioritising the first COVID-19 vaccine dose see the statement from the Joint Committee on Vaccination and Immunisation (JCVI).

Published 2 December 2020
Last updated 15 November 2021 + show all updates
  1. Updated sections of the Summary of Product Characteristics and Patient Information Leaflet for COVID-19 Vaccine Pfizer/BioNTech (Conditional Marketing Authorisation documents) to include information about receiving a 3rd/booster dose. Also to include two new reagents, Sodium Hydroxide and Hydrochloric Acid, which are used in small quantities during the preparation of one of the solutions used in the manufacturing process. The official International non-proprietary name ‘tozinameran’ has also been added.

  2. Updated figures in HCP information Table 5: Vaccine efficacy – First COVID-19 occurrence from 7 days after Dose 2 – participants without evidence of infection and with or without evidence of infection prior to 7 days after Dose 2 – adolescents 12 to 15 years of age evaluable efficacy (7 days) population

  3. Update to the summary of product characteristics and patient information leaflet for the Pfizer/BioNTech vaccine condition marketing authorisation documents

  4. Updated for both HCPs and public

  5. Extended vaccine shelf life from 6 months to now 9 months.

  6. Updated sections of Information for Healthcare Professionals on COVID-19 Pfizer/BioNTech (Regulation 174) and Information for UK recipients on COVID-19 Vaccine Pfizer/BioNTech (Regulation 174) to include information about receiving a third dose. Also updated the Regulation 174 Conditions document with an additional pharmacovigilance condition.

  7. Updates to the Conditional Marketing Authorisation SmPC and PIL and updates to the Regulation 174 Information for Healthcare Professionals and Information for recipients

  8. Updated conditions of authorisation for Pfizer BioNTech vaccine

  9. We have published the Summary of Product Information, Patient Information Leaflet and Conditions document for the GB Conditional Marketing Authorisation of the Pfizer/BioNTech vaccine.

  10. Updated the Public Assessment report, to reflect the extension to the current UK approval of the Pfizer/BioNTech COVID-19 vaccine that allows its use in 12- to 15-year-olds, as announced on 4 June 2021.

  11. Added a warning on myocarditis to the Information for UK recipients and the Information for Healthcare Professionals

  12. Updated Conditions of Authorisation, Information for Healthcare Professionals and Information for UK Recipients documents in line with an extension to the current UK approval of the Pfizer/BioNTech COVID-19 vaccine that allows its use in 12- to 15-year-olds.

  13. Updated the Information for Healthcare Professionals, Information for UK recipients and Conditions of Authorisation documents. This is to reflect a change that once removed from the freezer, the undiluted vaccine has a maximum shelf life of up to 1 month (31 days). This was previously 5 days.

  14. Published new versions of the Conditions of Authorisation documents, with an additional clause in the Deployment section relating to transfers of frozen vials stored at ultra-low temperature and handling of temperature excursions

  15. Added information on fevers to Section 4 of Information for UK Recipients and section 4.8 of Information for Healthcare Professionals.

  16. Published new versions of the Conditions of Authorisation documents, with an additional clause relating to off-label prescribing

  17. We have updated the Product Information to state that the vaccine is manufactured with enough volume for six doses, if our latest guidance for Healthcare Professionals is followed.

  18. Updated HTML and PDF attachments for 'Conditions of authorisation for Pfizer BioNTech'

  19. Updated the Information for UK recipients and the Information for healthcare professionals documents, to reflect changes to the dosage interval, advice for women who are pregnant or breastfeeding and to those with allergies.

  20. Updated guidance for Healthcare Professionals on obtaining a sixth dose from a vial.

  21. Added an accessible HTML document: Summary of the Public Assessment Report

  22. Added the Public Assessment Report for the Pfizer/BioNTech COVID-19 vaccine

  23. Changes to section 4.2 and 6 of the Information for UK Healthcare Professionals to provide clarification following further feedback and update to section 4.4 to strengthen information on special warnings and precautions for use. Changes to warnings and precautions and clarification in section 6 of the Information for UK Recipients.

  24. Accessible HTML versions of both the 'Information for Healthcare Professionals on Pfizer/BioNTech COVID-19 vaccine' and the 'Information for UK recipients on Pfizer/BioNTech COVID-19 vaccine' are now available.

  25. A note regarding the ingredients has been added as well as an accessible HTML version of 'Conditions of Authorisation for Pfizer/BioNTech COVID-19 vaccine'. A reference to the Medicines Act 1968 has been corrected.

  26. Added new document: Conditions of Authorisation for Pfizer BioNTech COVID-19 vaccine.

  27. First published.