Medicines and Healthcare Products Regulatory Agency (MHRA) in the United Kingdom has granted a temporary authorization for emergency use for their COVID-19 vaccine (BNT162b2) against COVID-19.
The UK will start distribution of the vaccine manufactured jointly by German company BioNtech and Pfizer from the US, next week. Each doze will cost £20.
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.
BNT162b2 vaccine’s primary efficacy analysis demonstrates it to be 95% effective against COVID-19 beginning 28 days after the first dose. Efficacy was also consistent across age, gender, race and ethnicity demographics. Observed efficacy in adults over 65 years of age was over 94%.
“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, 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.”
Albert Bourla, Chairman and Chief Executive Officer, Pfizer, hailed his team for the breakthrough.
“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.,” he said.
In July 2020, Pfizer and BioNTech announced an agreement with the U.K. to supply 30 million doses of the BNT162b2 mRNA-based vaccine, once authorized for emergency use. That agreement was increased to 40 million doses in early October.
The delivery of the 40 million doses will occur throughout 2020 and 2021, in stages, to ensure an equitable allocation of vaccines across the geographies with executed contracts.