By The Epoch Times | Created at 2025-04-03 19:05:02 | Updated at 2025-04-05 01:12:27
1 day ago
A health official said delays stem from a desire to ensure safety.
The Food and Drug Administration (FDA) missed a deadline for Novavax’s COVID-19 vaccine, just days after the agency’s top vaccine official announced his resignation.
The FDA was supposed to decide on Novavax’s application for a license for its COVID-19 shot by April 2, the Maryland-based company said in a statement.
Novavax said that as of April 1, it had responded to all of the FDA’s requests for information and believed its Biologics License Application (BLA) was ready for approval.
“As of today, we continue to wait on action from the agency and have not yet received an official decision from the U.S. FDA,” the company said on Wednesday.
The FDA referred a request for comment to the Department of Health and Human Services. An official with that department did not deny that the deadline had passed.
“Any delays to the FDA’s independent review process for the Novavax are a result of scientific review to ensure safety and efficacy,” the official told The Epoch Times in an email.
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Novavax’s COVID-19 vaccine was granted emergency authorization in 2022 by the FDA. It is currently available for Americans 12 years of age and older.
The evidentiary bar for approval is higher than for the authorization.
Novavax said that its application included “robust Phase 3 clinical trial data that showed our vaccine is safe and effective for the prevention of COVID-19.”
“We are confident our well-tolerated vaccine represents an important alternative to mRNA COVID-19 vaccines for the U.S,” it said.
The only COVID-19 vaccines available in the United States besides Novavax’s protein-based shot are those from Moderna and Pfizer that utilize messenger ribonucleic acid, or mRNA.
The overwhelming majority of Americans who received a COVID-19 vaccine, according to federal data, received a Moderna or Pfizer shot.
The FDA approved a license for Pfizer’s vaccine in 2021 and for Moderna’s vaccine in 2022.
Authorization for a fourth vaccine, from Johnson & Johnson, was rescinded in 2023. The Department of Health and Human Services also recently stopped work on a separate shot, from Vaxart Inc., on an oral COVID-19 vaccine.
Dr. Peter Marks, a key figure in the COVID-19 vaccine clearance process, said in late March that he was stepping down as the head of the FDA’s Center for Biologics Evaluation and Research. The center regulates vaccines and other biological products.
Marks said in his resignation letter that he was willing to address concerns from new Health Secretary Robert F. Kennedy Jr. about vaccine safety but alleged that Kennedy wanted “subservient confirmation of his misinformation and lies” rather than “truth and transparency.”
Marks did not respond to requests for more details.
Kennedy has not reacted publicly to Marks’s stepping down, and the Department of Health and Human Services did not return inquiries on the matter.
