CNN
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The U.S. Food and Drug Administration discussed the need for additional trials of the Covid-19 vaccine as a post-approval commitment with vaccine maker Novavax.
The terms must be negotiated before the Novavax vaccine is fully approved, sources said they refused the name because they were not allowed to speak on behalf of the FDA.
Novavax had anticipated full approval of the vaccine by April 1, but the FDA delayed the decision as it sought more data, sources told CNN at the time.
“We have confirmed that we have responded to FDA’s Post-Marketing Commitment (PMC) requests and are waiting for feedback from our agents,” said Silvia Taylor, Vice President and Chief Corporate Affairs and Advocacy Officer at Novavax on Friday. “PMC is not uncommon for many approved drugs/biology with at least one PMC or requirement. We continue to believe our applications are approved and look forward to our continued involvement with the FDA on PMC requests.
The FDA parent company, a spokesman for the U.S. Department of Health and Human Services, said Friday that “we are committed to our promises: to ensure products that are safe for Americans and are based on the science of gold standards.”
The Novavax Covid-19 vaccine, which uses traditional protein-based technology over Pfizer/Biontech and Moderna’s new mRNA vaccines, has been subject to emergency use permits since 2022.
The missed deadline came just as Dr. Scott Steele, acting director of the Center for Biological Evaluation and Research, who oversees vaccine regulations, days after former director Peter Marks was kicked out. In his letter of resignation, Marks cited “Efforts are underway regarding the adverse health effects of vaccinations.”
Longtime anti-vaccine advocate, HHS secretary Robert F. Kennedy Jr., misrepresented the Covid-19 vaccine as “the deadliest vaccine ever made,” and recently issued a misleading statement about the safety of the measles vaccine amid a deadly launch concentrated in West Texas.
