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.
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.
