FDA Signals It Will Expedite Full-Approval Process for COVID Vaccines

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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.

“We recognize that for some, the FDA approval of Covid-19 vaccines may bring additional confidence and encourage them to get vaccinated,” Capobianco said in a statement. “FDA staff will conduct a thorough review process, while balancing the incredible sense of urgency necessary, both of which are needed to ensure that any vaccine that is authorized or approved meets our rigorous standards for safety, effectiveness, and quality.”

The FDA’s statement comes amid mounting pressure from lawmakers to remove the last major institutional obstacle deterring hesitant Americans who have abstained from vaccination over apprehensions about its quick development and still “experimental” status. Those lobbying for full approval argue it will be more effective at quieting skepticism and encouraging the unvaccinated to get the vaccine than coercion or intrusive mandates.

“This will remove one more layer for the vaccine-hesitant,” Marks said. “If all this does is get five to ten million more people vaccinations down south, that will save lives.”

The CDC recently reversed its mask guidance to recommend that some fully vaccinated individuals resume mask-wearing in regions of the country with high-transmissibility rates, namely the South and Midwest.