The FDA was scheduled to release its decision on Novavax’s updated, protein-based COVID-19 vaccine on April 1, but the agency’s principal deputy commissioner intervened.
The FDA has missed its deadline for issuing a decision regarding the 2024-2025 formulation of Novavax’s COVID-19 vaccine, several media outlets reported on Wednesday.
In a Wednesday statement, Novavax confirmed that the FDA should have released its verdict on Tuesday, April 1. “We had responded to all of the FDA’s information requests and we believe that our [Biologics License Application] is ready for approval,” the company noted. “We continue to wait on action from the agency and have not yet received an official decision from the U.S. FDA.”
“We are confident our well-tolerated vaccine represents an important alternative to mRNA COVID-19 vaccines for the U.S.,” the company said in its statement.
Sara Brenner, the FDA’s principal deputy commissioner, directly intervened on review of Novavax’s vaccine, according to Politico. The FDA has not given a specific reason for Brenner’s actions, though an FDA official speaking to Politico said that she did not ask for more data on the vaccine.
The missed deadline, which was first broken by the Wall Street Journal, comes just days after Peter Marks, the regulator’s top vaccines expert, stepped down from his post. Marks served as head of the FDA’s Center for Biologics Evaluation and Research before he was asked over the weekend to either resign or be fired, as per media reports.
Marks’ exit triggered a sweeping selloff across the biopharma space, sending stocks of several companies crashing on Monday. In his resignation letter, Marks warned that Robert F. Kennedy Jr., recently confirmed as Secretary of Health and Human Services, doesn’t seem to be open to learning more about vaccines.
“It has become clear that truth and transparency are not desired by the secretary, but rather he wishes subservient confirmation of his misinformation and lies,” Marks wrote. During his confirmation hearings, lawmakers blasted Kennedy for what Senator Michael Bennet (D-CO) called “peddling half-truths,” and questioned how having a known vaccine critic as HHS head would affect public health in the U.S.
Since Kennedy’s confirmation, U.S. health agencies have suffered several setbacks, most of which involve vaccines.
In February, for instance, a meeting for the Centers for Disease Control and Prevention’s vaccine advisory panel was postponed to April. A few days later, a meeting for the FDA’s advisory panel on vaccines was canceled. The regulator nevertheless came out with new flu immunization recommendations without convening its expert advisors.
Novavax is seeking approval for a new formulation of its COVID-19 vaccine, to be used in the upcoming 2024-2025 season. This latest formulation is designed to target the JN.1 strain, which is the parent of the currently circulating variants.
In an August 2024 announcement, the biotech said it was working with the FDA to facilitate the review of the COVID-19 shot, and claimed that the regulator “has committed to moving swiftly on regulatory action.”
Editor’s note (April 3): This piece has been updated with reporting from Politico on the FDA’s intervention to hold back approval on Novavax’’s vaccine.
