Pfizer Inc. and German biotech firm BioNTech SE’s mRNA -based COVID-19 vaccine has received a temporary authorization for emergency use in the U.K., marking the first authorization in the world for a Covid vaccine.
The companies, which have applied for regulatory approvals in the U.S., Europe and several other regulatory agencies around the world, expect their decisions in the coming days and weeks.
The Medicines & Healthcare Products Regulatory Agency or MHRA in the U.K. granted the authorization for BNT162b2, based on a rolling submission, including data from the Phase 3 clinical study, which demonstrated a vaccine efficacy rate of 95%.
With the vaccine authorization, the companies plan to 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 fulfillment expected in 2021.
In the U.K., the distribution of the vaccine will be prioritized according to the populations identified in guidance from the Joint Committee on Vaccination and Immunisation.
Ugur Sahin, CEO and Co-founder of BioNTech, 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.”
In July 2020, the companies announced an agreement with the U.K. to supply 30 million doses of the BNT162b2 vaccine. That agreement was increased to 40 million doses in early October.
The companies have filed a request for Emergency Use Authorization with the U.S. Food and Drug Administration, as well as Conditional Marketing Authorization Application with the European Medicines Agency.
The U.S. FDA and EU EMA decisions on authorization are expected in December.
Pfizer and BioNTech, which continue to work with various governments around the world, expect to distribute the vaccine, subject to country authorization or approval.
Based on current projections, the companies’ combined manufacturing network has the potential to supply globally up to 50 million vaccine doses in 2020 and up to 1.3 billion doses by the end of 2021, subject to manufacturing capacity and regulatory approval or authorization.
Source: Read Full Article