FDA Signals It Will Expedite Full-Approval Process for COVID Vaccines
District of Columbia | August 1, 2021
With vaccination rates plateauing in certain regions of the country as a new COVID wave triggered by the highly infectious Delta variant spreads, the Food and Drug Administration (FDA) has signaled it will expedite the process to fully approve the COVID vaccine. A top agency official said Friday that the Pfizer-BioNTech shot will be under accelerated review to earn the designation.
FDA spokesperson Abby Capobianco said the agency is working on “identifying additional resources such as personnel and technological resources from across the agency and opportunities to reprioritize other activities, in order to complete our review to help combat this pandemic surge.”
The agency has deployed an “all hands on deck” strategy for this endeavor, Peter Marks, director of the Center for Biologics Evaluation and Research, said in an interview. The Pfizer vaccine has so far been distributed under FDA emergency-use authorization it received in December. The company applied for full approval on May 7… (Excerpts from the National Review)