UK authorizes Pfizer/BioNTech vaccine, rollout to begin next week
A COVID-19 vaccine developed by U.S. pharmaceutical giant Pfizer and its German partner BioNTech has been approved for use in the United Kingdom.
The U.K. Department of Health and Social Care announced Wednesday that it has accepted the recommendation from the country's drug regulator to grant a temporary authorization for emergency use of the Pfizer/BioNTech vaccine, called BNT162b2. The Medicines and Healthcare products Regulatory Agency (MHRA) concluded that the vaccine met its standards of safety, quality and effectiveness.
"The vaccine will be made available across the U.K. from next week," a Department of Health and Social Care spokesperson said in a statement, adding that the National Health Service, the publicly-funded healthcare system, "will begin putting their extensive preparations into action to provide care and support to all those eligible for vaccination."
The United Kingdom is the first country in the world to approve the Pfizer/BioNTech vaccine. The companies said in a joint press release Wednesday that they are anticipating further regulatory decisions across the globe in the coming days and weeks and are ready to deliver vaccine doses pending authorizations or approvals.
"Today’s Emergency Use Authorization in the U.K. marks a historic moment in the fight against COVID-19," Pfizer chairman and CEO Albert Bourla said in a statement. "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 MHRA made its recommendation based on a rolling submission, including data from the Phase 3 trial which demonstrated a vaccine efficacy rate of 95%. The Pfizer/BioNTech vaccine was generally well tolerated, with no serious safety concerns reported to date.
Pfizer and BioNTech had already agreed to supply the United Kingdom with 40 million doses of BNT162b2 once authorized for emergency use. Now that the vaccine is authorized, the companies will immediately begin delivering doses, the first of which are expected to arrive on U.K. soil in the coming days. The rest of the doses will arrive in stages, with complete delivery fulfillment expected in 2021, according to the press release.
Pfizer and BioNTech said the distribution of their vaccine in the United Kingdom will be prioritized according to the populations identified in guidance from the Joint Committee on Vaccination and Immunisation, an independent expert group that advises the U.K. government on immunization.
"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," BioNTech CEO and co-founder Ugur Sahin said in a statement. "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."
The companies have also filed a request for emergency use authorization with the U.S. Food and Drug Administration and have submitted an application for conditional marketing authorization with the European Medicines Agency.