The Food and Drug Administration review deadline for Novavax’s COVID-19 vaccine has come and gone without a decision amid a major organizational shakeup that has already resulted in the resignation of the nation’s top vaccine regulator.
Novavax’s shot in 2022 was granted an emergency use authorization, a special approval handed out during a public health emergency. By April 1, however, the agency was scheduled to decide whether to convert that clearance to the type of standard approval already given to rival COVID-19 vaccine makers Pfizer and Moderna.
In a short Wednesday statement, though, Novavax said that the deadline had passed without any word from the FDA, despite the fact that the company believes it’s responded to all of the agency’s requests and that its application is “ready for approval.”
“As of today, we continue to wait on action from the agency and have not yet received an official decision,” Novavax said, adding that its application included “robust Phase 3 clinical trial data” showing its vaccine could safely and effectively prevent COVID-19.
Novavax added that it is “confident” its shot, which uses a protein-based approach, “represents an important alternative” to the messenger RNA vaccines from Pfizer and Moderna.
The company didn’t provide any additional details as to what may have caused the delay. However, published reports from Politico and the Wall Street Journal indicated that new senior leaders at the FDA have taken the unusual step of intervening to seek more information about the application.
In an email to BioPharma Dive, Department of Health and Human Services spokesperson Andrew Nixon called that information "false and inaccurate.”
The delayed decision comes days after Peter Marks, the longtime director of the Center for Biologics Evaluation and Research, resigned over disagreements with HHS secretary Robert F. Kennedy Jr. Marks was the architect of Operation Warp Speed, a cross-government initiative that enabled the U.S. to quickly develop, review and bring to market several safe and effective COVID-19 vaccines. His abrupt departure sent shares of vaccine makers plummeting and sounded new alarms about how Kennedy — who has spread misinformation about vaccines for years — might impact the review and regulation of new shots.
The potential conversion of Novavax’s emergency clearance to a full approval was the first such review on the FDA’s docket. That decision now be overseen by Scott Steele, who was named CBER’s acting director earlier this week.
Kennedy in 2021 petitioned the FDA to revoke its authorizations of COVID vaccines and, as HHS secretary, has the power to cancel them as well as other emergency clearances currently in place. A major restructuring of HHS initiated by the Trump administration has also led to concern among industry watchers that the FDA may struggle to meet drug review deadlines.
Novavax shares fell about 5% Thursday morning to trade at just over $5 apiece.
