Pfizer and BioNTech Achieve First Authorization in the World for a Vaccine to Combat COVID-19

Nachrichtenquelle: globenewswire
02.12.2020, 08:05  |  204   |   |   

  • U.K. regulator, MHRA, authorizes supply of COVID-19 mRNA vaccine for emergency supply under Regulation 174; Companies are ready to deliver the first doses to the U.K. immediately
  • First authorization for a COVID-19 vaccine represents a breakthrough scientific achievement to help combat this devastating pandemic
  • The companies previously signed an agreement to supply a total of 40 million doses to the U.K. with delivery in 2020 and 2021
  • U.S. FDA and EU EMA decisions on authorization are expected in December

NEW YORK and MAINZ, GERMANY, December 2, 2020Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced today 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 3 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 Emergency Use Authorization in the U.K. 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 U.K. 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.”

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Pfizer and BioNTech Achieve First Authorization in the World for a Vaccine to Combat COVID-19 U.K. regulator, MHRA, authorizes supply of COVID-19 mRNA vaccine for emergency supply under Regulation 174; Companies are ready to deliver the first doses to the U.K. immediatelyFirst authorization for a COVID-19 vaccine represents a breakthrough …

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