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Pfizer and BioNTech Vaccine Authorized for Use in UK

Today, December 2, 2020 (Wednesday), the United Kindom (UK) is the first Western country to have a clinically approved coronavirus vaccine for supply. Wherein, the first vaccine doses are expected to arrive in the UK in the coming days.

On a press release posted by Pfizer today, it stated that Pfizer and BioNTech have announced that UK’s regulatory which is the Medicines & Healthcare Products Regulatory Agency (MHRA) has approved the temporary authorization for emergency use for their COVID mRNA vaccine (BNT162b2) against the virus.

“Pfizer 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.”

-Stetement on Pfizer Press Release

In a Twitter post, today UK Minister Matt Hancock who is in charge of the healthcare system has announced the successful authorization of the vaccine.

Furthermore, last July, Pfizer and BioNTech made an announcement regarding their agreement with the UK that once authorized for emergency use they will supply 30 million vaccine doses which increased to 40 million in early October, with delivery in 2020 and 2021.

In the press release, it was stated that MHRA’s decision was based on a rolling submission which includes data from Phase 3 clinical study demonstrating a vaccine efficacy rate of 95% in participants without prior SARS-CoV-2 infection and also in participants with and without prior SARS-CoV-2 infection in each case measured from 7 days after the second dose.

Also, the decision was also based on a review of Pfizer’s and BioNTech’s Chemistry, Manufacturing and Control (CMC) data for BNT162b2.

Pfizer Statement on the Authorization in the UK

According to Albert Bourla the Chairman and Chief Executive Officer, Pfizer, he stated the approval of the emergency use authorization in the UK is a historical moment in the battle against coronavirus.

“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.,” -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.” Bourla added.

BioNTech Statement on the Authorization in the UK

The CEO and Co-founder of BioNTech Ugur Sahin, M.D. has stated that the emergency use authorization in the UK will mark the first time citizens outside the trials will have the opportunity to be immunized against coronavirus.

“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,” Sahin added.

Furthermore, according to the press release, further regulatory decisions across the globe in the coming days are anticipated by Pfizer and BioNTech. And the companies are ready to deliver vaccine doses following potential regulatory authorizations or approvals.

In addition, according to the populations identified in guidance from the Joint Committee on Vaccination and Immunisation (JCVI), the distribution of the vaccine in the UK will be prioritized.

Source: Pfizer

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