The United Kingdom (UK) regulator, the Medicines & Healthcare Products Regulatory Agency (MHRA) has granted a temporary authorization for emergency use for the COVID-19 mRNA vaccine produced by Pfizer Inc. and BioNTech.
This constitutes the first Emergency Use Authorization following a worldwide Phase 3 trial of the 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.
“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,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer.
“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.”
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<0.0001) in participants without prior SARS-CoV-2 infection (first primary objective) and also in participants with and without prior SARS-CoV-2 infection (second primary objective), in each case measured from 7 days after the second dose.
The first primary objective analysis is based on 170 cases of COVID-19, as specified in the study protocol. Efficacy was consistent across age, gender, race and ethnicity demographics, with an observed efficacy in adults age 65 and over of more than 94%.
In the trial, BNT162b2 was generally well tolerated with no serious safety concerns reported by the Data Monitoring Committee to date. Today’s decision also is based on a review of Pfizer’s and BioNTech’s Chemistry, Manufacturing and Control (CMC) data for BNT162b2.
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. Now that the vaccine is authorized in the U.K., the companies will take immediate action to begin the delivery of vaccine doses. The first doses are expected to arrive in the U.K. in the coming days, with complete delivery fulfilment expected in 2021.
The companies have filed a request for Emergency Use Authorization with the U.S. Food and Drug Administration (FDA) and have submitted the final Conditional Marketing Authorization Application (CA) following rolling submissions with the European Medicines Agency (EMA) and several other regulatory agencies around the world.