FDA Deadline for Novavax’s COVID-19 Vaccine Expires Without a Decision
A health official indicated that the delays are due to a commitment to ensure safety.
As of April 1, Novavax reported that it had complied with all of the FDA’s requests for information and believed that its Biologics License Application (BLA) was prepared for approval.
“As of today, we await a response from the agency and have not yet received an official decision from the U.S. FDA,” the company stated on Wednesday.
The FDA directed inquiries for comments to the Department of Health and Human Services, where an official did not contest that the deadline had elapsed.
“Any delays in the FDA’s independent review process for Novavax are attributable to scientific evaluations intended to confirm safety and efficacy,” the official informed The Epoch Times via email.
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Novavax’s COVID-19 vaccine received emergency authorization in 2022 from the FDA and is currently available for individuals aged 12 and older in the U.S.
The approval requirements are more stringent than those previously established for authorization.
Novavax asserted that its application contained “robust Phase 3 clinical trial data confirming the safety and effectiveness of our vaccine in preventing COVID-19.”
“We believe our well-tolerated vaccine represents a significant alternative to mRNA COVID-19 vaccines in the U.S.,” the company stated.
Currently, the only COVID-19 vaccines accessible in the United States, aside from Novavax’s protein-based option, are those developed by Moderna and Pfizer that utilize messenger ribonucleic acid, or mRNA technology.
According to federal data, most COVID-19 vaccinations received by Americans were from either Moderna or Pfizer.
The FDA granted licensure for Pfizer’s vaccine in 2021 and for Moderna’s in 2022.
Dr. Peter Marks, a key player in the COVID-19 vaccine approval process, announced his departure as the head of the FDA’s Center for Biologics Evaluation and Research in late March. This center is responsible for regulating vaccines and other biological products.
In his resignation letter, Marks expressed his willingness to address concerns from the new Health Secretary Robert F. Kennedy Jr. regarding vaccine safety but claimed that Kennedy sought “subservient confirmation of his misinformation and lies” rather than “truth and transparency.”
Marks has not commented further on this issue.
Kennedy has not publicly responded to Marks’s resignation, and the Department of Health and Human Services did not provide feedback on the situation.