Pfizer : MHRA - Regulatory approval of Pfizer/BioNTech vaccine for COVID-19

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

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).

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