UK Regulator First to Approve Pfizer-BioNTech COVID Vaccine

December 2, 2020

Companies previously signed an agreement to supply a total of 40 million doses to the UK with delivery in 2020 and 2021.

The UK’s Medicines & Healthcare Products Regulatory Agency (MHRA) has granted a temporary authorization for emergency use for Pfizer and BioNTech‘s COVID-19 mRNA vaccine (BNT162b2) against COVID-19. This constitutes the first Emergency Use Authorization following a worldwide Phase III trial of a vaccine to help fight the pandemic.

The distribution of the vaccine in the UK will be prioritized according to the populations identified in guidance from the Joint Committee on Vaccination and Immunisation (JCVI). “The Emergency Use Authorization in the UK will mark the first time citizens outside of the trials will have the opportunity to be immunized against COVID-19,” said Ugur Sahin, M.D., CEO and Co-founder of BioNTech. “We believe that the roll-out of the vaccination program in the UK will reduce the number of people in the high-risk population being hospitalized.”

In July 2020, Pfizer and BioNTech announced an agreement with the UK to supply 30 million doses of the vaccine, once authorized for emergency use. That agreement was increased to 40 million doses in early October. Now that the vaccine is authorized in the UK, the companies will take action to begin the delivery of vaccine doses. The first doses are expected to arrive in the UK in the coming days, with complete delivery fulfilment expected in 2021.

The companies have filed a request for Emergency Use Authorization with US FDA and have submitted the final Conditional Marketing Authorization Application (CA) following rolling submissions with the European Medicines Agency (EMA) and several other regulatory agencies around the world. These decisions are expected in December.

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