FDA Reassigns Staff to Accelerate Full Approval for Pfizer’s COVID-19 Vaccine

The FDA is taking an “all-hands-on-deck” approach to swiftly give full approval to the Pfizer-BioNTech COVID-19 vaccine, an agency spokesperson said Friday.

The FDA is setting aside some other regulatory tasks and reassigning staff to conduct “a thorough review process, while balancing the incredible sense of urgency,” the spokesperson told FDAnews.

 “We have taken an all-hands-on-deck approach, including identifying additional resources such as personnel and technological resources from across the agency and opportunities to reprioritize other activities.”

Currently, the Pfizer-BioNTech and Moderna messenger RNA vaccines and the adenovirus-based Johnson & Johnson vaccine are all authorized for emergency use and are awaiting full approval. Many experts have argued that full approval could help ease vaccine hesitancy amid a surge of cases from the Delta variant and would allow the companies to market the products to consumers.

Peter Marks, director of the Center for Biologics Evaluation and Research, is reportedly personally overseeing the review of Pfizer’s and BioNTech’s Biologics License Application (BLA), which was filed in May (DID, May 10). Marks has not said when he expects the agency to announce its decision, but President Biden has suggested that it would occur in the fall, and a earlier decision cannot be ruled out.

The agency granted Pfizer and BioNTech a Priority Review in mid-July, which set the clock ticking for the FDA to make a decision on the BLA by January 2022 under the normal six-month Prescription Drug User Fee Act decision timeline (DID, July 29).

Moderna is also expected to shortly receive a Priority Review for its BLA filed in June (DID, June 2), while Johnson & Johnson expects to file a BLA later this year. And AstraZeneca said it won’t pursue an Emergency Use Authorization for its vaccine but will instead seek a BLA later in the year. ― Jason Scott