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FDA May Require Novavax to Conduct Extra Trials for Full COVID-19 Vaccine Approval

The US Food and Drug Administration has discussed with vaccine-maker Novavax the need for an additional trial of its Covid-19 vaccine as a post-approval commitment, a source familiar with the matter told Folknewsid.

Before Novavax’s vaccine can receive full approval, the conditions must undergo negotiations, according to a source who chose not to be identified as they were unauthorized to comment on behalf of the FDA.

Novavax expected complete authorization for its vaccine by April 1st; however, the FDA postponed this decision as they requested additional information at that point, according to a source cited by Folknewsidat.

We can verify that we have addressed the FDA’s Post Marketing Commitment (PMC) request and are currently waiting for their response," stated Silvia Taylor, executive vice president and chief corporate affairs and advocacy officer at Novavax, in a recent press release on Friday. "It's common for numerous approved medications/biologics to be subject to such commitments. We remain confident in the approvability of our submission and eagerly anticipate further discussions with the FDA regarding their PMC requests, aiming towards swift approval.

A representative from the U.S. Department of Health and Human Services, which oversees the FDA, stated on Friday that they remain dedicated to their commitment "to ensure product safety for Americans based on rigorous scientific standards."

The Novavax COVID-19 vaccine employs a more conventional protein-based approach rather than the cutting-edge mRNA technology utilized by newer vaccines. Pfizer/BioNTech and Moderna has been under emergency use authorization since 2022 . But with FDA action, it would be the third vaccine against Covid-19 to receive full FDA approval, which could provide additional reassurance to people seeking the shot.

The overdue deadline coincided with the FDA's timing. named Following the departure of Dr. Peter Marks as director, Dr. Scott Steele has taken over as acting director of the Center for Biologics Evaluation and Research, an organization responsible for regulating vaccines. This change occurred just days ago. forced out In his resignation letter, Marks pointed out "initiatives being pushed by certain individuals regarding the detrimental health impacts of vaccinations" which he described as "disturbing."

HHS Secretary Robert F. Kennedy Jr., a longtime anti-vaccine advocate, has falsely called vaccines for Covid-19 “the deadliest vaccine ever made” and more recently made misleading statements about the safety of the measles vaccine amid a deadly outbreak centered in West Texas.

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