FDA Chief Narrows Use of Moderna, Novavax Covid Vaccines Over Staff Objections

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Updated Jul 3, 2025, 01:16 AM

Internal memoranda released this week show that Dr. Vinay Prasad, the newly installed head of the U.S. Food and Drug Administration’s vaccine division, overruled career scientists on the scope of two Covid-19 vaccine approvals. Staff reviewers had recommended that Moderna’s updated mRNA shot, mNexspike, and Novavax’s protein-based Nuvaxovid be cleared for everyone aged 12 and older who had previously received at least one Covid inoculation.

In a five-page override dated 2 July, Prasad limited both vaccines to adults 65 and older, or to people under that age with underlying medical conditions such as asthma or obesity. He argued that falling hospitalisation and death rates, combined with rare but potentially serious side effects including myocarditis, tip the risk-benefit balance away from blanket use. Last week the agency added stronger myocarditis warnings to labels for Moderna and Pfizer shots.

Senior FDA officials seldom reverse product-specific recommendations, making the decision noteworthy inside the agency. Prasad, an oncology researcher who gained attention for criticising broad booster campaigns, was appointed in May after the resignation of Dr. Peter Marks and reports directly to Health Secretary Robert F. Kennedy Jr., a longtime vaccine sceptic. The move aligns with draft FDA guidance that future Covid boosters should target primarily higher-risk Americans. Covid-19 still caused an estimated 32,000 to 51,000 U.S. deaths and more than 250,000 hospitalisations over the past year, according to the Centers for Disease Control and Prevention.

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