COVID-19: Immunisation to start in UK as Pfizer-BioNTech vaccine gets approval

Pfizer and BioNTech announced on December 2 that the Medicines & Healthcare Products Regulatory Agency (MHRA) in the United Kingdom has granted a temporary authorization for emergency use for their COVID-19 mRNA vaccine, BNT162b2, against COVID-19.

This approval has been granted after a worldwide Phase 3 trial was conducted to ensure the safety and efficacy of BNT162b2.

"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, a press statement from Pfizer said.

It added, "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)."

Albert Bourla, Chairman and Chief Executive Officer, Pfizer said that the 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.,” Bourla said.

He added, “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.”

According to Ugur Sahin, M.D., CEO, and Co-founder of BioNTech, “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.”

He further said “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.”