Decision

Regulatory approval of Pfizer/BioNTech vaccine for COVID-19

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

Documents

Details

Information about the COVID-19 vaccine, approved by MHRA on 2 December 2020.

The Information for healthcare professionals document is a description of a medicinal product’s properties and the conditions attached to its use. It explains how to use and prescribe a medicine. It is used by healthcare professionals, such as doctors, nurses and pharmacists.

The Information for UK recipients document provides information for patients on using the medicine safely. This is based on the Information for healthcare professionals of the product.

The public assessment report is a scientific report, written by the MHRA. It explains how this product was assessed and its authorisation recommended, as well as its conditions of use. It is not intended to provide practical advice on how to use this product.

Find out more about the approval from our press release.

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

Ingredients

The Medicines and Healthcare products Agency can confirm that the Pfizer/BioNTech COVID-19 vaccine does not contain any components of animal origin.

A full list of ingredients for the qualitative and quantitative composition of the vaccine can be found at point 2 in the Information for Healthcare Professionals on Pfizer/BioNtech Vaccine.

A full list of ingredients for the excipient composition of the vaccine can be found at point 6 in the Information for Healthcare Professionals on Pfizer/BioNtech Vaccine.

A full list of ingredients for the qualitative and quantitative composition of the vaccine and a full list of the excipient composition of the vaccine can be found at point 6 in the Information for Recipients of the Pfizer/BioNtech Vaccine.

Published 2 December 2020
Last updated 31 March 2021 + show all updates
  1. 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

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

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

  4. 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.

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

  6. 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.

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

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

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

  10. 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.

  11. 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.

  12. 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.

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

  14. First published.