The President Donald Trump administration’s request for Novavax Inc. NVAX to conduct new clinical trials for its COVID-19 vaccine.
What Happened: Novavax announced Monday that the Food and Drug Administration requested a new clinical trial before granting full approval for its protein-based COVID-19 shot, despite the company believing its vaccine remains “approvable.”
The requirement came shortly after FDA Commissioner Marty Makary characterized the annually updated vaccine as “a new product” requiring new studies.
The situation developed following leadership changes at the FDA, including the departure of the agency’s longtime Vaccine Chief over disagreements with Health Secretary Robert F. Kennedy Jr.
Industry experts note the FDA had been on track to approve Novavax’s application by April 1, but Trump appointees directed a pause, the Associated Press reported, citing anonymous sources.
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Why It Matters: A United States Department of Health and Human Services spokesman suggested all COVID-19 vaccines could face stricter requirements, stating: “The urgency to rush approval of boosters without normal oversight no longer exists.”
Preliminary results from the SHIELD-Utah study showed Novavax’s 2024-2025 formula targeting the JN.1 strain produced fewer and less severe side effects compared to Pfizer Inc. PFE and BioNTech SE‘s BNTX mRNA shots.
Former Health Secretary Xavier Becerra defended the safety record of COVID-19 vaccines, noting: “We had put some 700 million COVID vaccines into the arms of Americans. That’s a pretty good size clinical trial.”
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Disclaimer: This content was partially produced with the help of AI tools and was reviewed and published by Benzinga editors.
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