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MHRA has granted a temporary authorization for emergency use to Pfizer and BioNTech for the mRNA vaccine against COVID-19.
The United Kingdom’s regulatory body, the Medicines and Healthcare Products Regulatory Agency (MHRA), has granted a temporary authorization for emergency use to Pfizer and BioNTech for the mRNA vaccine (BNT162b2) against COVID-19.
With this decision, the UK becomes the first in the world to grant an emergency use authorization for a vaccine to help fight the coronavirus pandemic. Distribution of the vaccine will be prioritized following guidance from the Joint Committee on Vaccination and Immunization (JCVI).
MHRA’s decision was based on a rolling review of data, including the Phase III clinical study data that demonstrated BNT162b2’s efficacy rate of 95%. Decisions on authorization from the US Food and Drug Administration and the European Medicines Agency are expected to be announced in December 2020.
“Today’s Emergency Use Authorization in the UK 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 UK,” said Albert Bourla, chairman and CEO, Pfizer, in a Dec. 2, 2020 press release. “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 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,” added Ugur Sahin, CEO and co-founder of BioNTech, in the press release. “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. Our aim is to bring a safe and effective vaccine upon approval to the people who need it. The data submitted to regulatory agencies around the world are the result of a scientifically rigorous and highly ethical research and development program.”