Pfizer and BioNTech achieve first authorisation in the world from MHRA in the UK for BNT 162b2 mRNA vaccine against COVID-19

Pfizer Inc.and BioNTech SE announced that the Medicines & Healthcare Products Regulatory Agency (MHRA) in the U.K. has granted a temporary authorization for emergency use for their 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. Pfizer and BioNTech are anticipating further regulatory decisions across the globe in the coming days and weeks and are ready to deliver vaccine doses following potential regulatory authorizations or approvals. The distribution of the vaccine in the U.K. will be prioritized according to the populations identified in guidance from the Joint Committee on Vaccination and Immunisation (JCVI). “Today’s Emergency Use Authorization in the U.K. marks a historic moment in the fight against COVID-19. This authorization is a goal we have been working toward since we first declared that science will win, and we applaud the MHRA for their ability to conduct a careful assessment and take timely action to help protect the people of the U.K.,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “As we anticipate further authorizations and approvals, we are focused on moving with the same level of urgency to safely supply a high-quality vaccine around the world. With thousands of people becoming infected, every day matters in the collective race to end this devastating pandemic.” The first supplies of the vaccine will be transported from Pfizer’s manufacturing site in Belgium. The UK has secured 10 million doses for 2020/21, with the first 800,000 doses available next week, with the majority of the vaccines available in early 2021. Pfizer’s vaccine needs to be stored and transported at -70°C, requiring special arrangements for administration..