Pfizer, BioNTech COVID-19 vaccine gets emergency approval in the U.K.

By The Science Advisory Board staff writers

December 2, 2020 -- The Medicines and Healthcare Products Regulatory Agency (MHRA) in the U.K. has granted a temporary authorization for emergency use for BNT162b2, Pfizer and BioNTech's COVID-19 messenger RNA (mRNA) vaccine.

The MHRA's decision was based on a rolling submission from the companies which included data from the phase III clinical study, demonstrating a vaccine efficacy rate of 95% in participants without prior exposure to SARS-CoV-2 infection. In the trial, BNT162b2 was generally well-tolerated with no serious safety concerns reported by the data monitoring committee to date. The decision was also based on review of the companies' Chemistry, Manufacturing and Control (CMC) data for BNT162b2.

In July, Pfizer and BioNTech announced an agreement with the U.K. to supply 30 million doses of the vaccine, once authorized. The agreement was increased to 40 million in October. Delivery of these doses will occur throughout 2020 and 2021, in stages to ensure equitable allocation. The first doses of the vaccine are expected to arrive in the U.K. in the coming days. Distribution of the vaccine in the U.K. will be prioritized according to guidance issued from the Joint Committee on Vaccination and Immunization (JCVI).

The companies have also filed a request for emergency use authorization (EUA) with the U.S. Food and Drug Administration (FDA) and have submitted the final conditional marketing authorization (CMA) application following rolling submissions with the European Medicines Agency (EMA) and several other regulatory agencies around the world.

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