Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced today that the Medicines & Healthcare Products regulatory authority (MHRA) within the U.K. has granted a short lived authorization for emergency use for his or her COVID-19 mRNA vaccine (BNT162b2), against COVID-19. This constitutes the primary Emergency Use Authorization following a worldwide Phase 3 trial of a vaccine to assist fight the pandemic. Pfizer and BioNTech are anticipating further regulatory decisions across the world within the coming days and weeks and are able to deliver vaccine doses following potential regulatory authorizations or approvals. The distribution of the vaccine within the U.K. are going to be prioritized consistent with the populations identified in guidance from the Joint Committee on Vaccination and Immunisation (JCVI).
“Today’s Emergency Use Authorization within the U.K. marks a historic moment within the fight against COVID-19. This authorization may be a goal we’ve been working toward since we first declared that science will win, and that we applaud the MHRA for his or her ability to conduct a careful assessment and take timely action to assist protect the people of the U.K.,” said Albert Bourla, Chairman and Chief military officer , Pfizer. “As we anticipate further authorizations and approvals, we are focused on moving with an equivalent level of urgency to securely supply a high-quality vaccine round the world. With thousands of individuals becoming infected, a day matters within the collective race to finish this devastating pandemic.”
“The Emergency Use Authorization within the U.K. will mark the primary time citizens outside of the trials will have the chance 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 within the U.K. will reduce the amount of individuals within the high-risk population being hospitalized. Our aim is to bring a secure and effective vaccine upon approval to the people that need it. the info submitted to regulatory agencies round the world are the results of a scientifically rigorous and highly ethical research and development program.”