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Friday, May 07, 2021

UK approves Pfizer/BioNTech vaccine for mass roll out

UK approves Pfizer/BioNTech vaccine for mass roll out

The UK has become the first western country to license a vaccine against COVID-19, allowing for mass immunisation with the Pfizer/BioNTech COVID-19 mRNA vaccine (BNT162b2) to begin for those who are most at risk.
The Medicines & Healthcare Products Regulatory Agency (MHRA) in the UK has granted a temporary authorization for emergency use of the vaccine.

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 UK 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 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 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 UK will mark the first time citizens outside of the trials will have the opportunity to be immunized against COVID-19,” said Ugur Sahin, MD, CEO and Co-founder of BioNTech. “

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.”

The MHRA’s decision is based on a rolling submission, including data from the Phase 3 clinical study, which demonstrated a vaccine efficacy rate of 95% (p
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