STAT+: Prasad overruled FDA staff to reject Moderna’s flu vaccine application

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Source: STAT News

Original: https://www.statnews.com/2026/02/11/moderna-flu-vaccine-application-rejected-by-...

Published: Wed, 11 Feb 2026 15:30:40 +0000

Vinay Prasad, director of the FDA's Center for Biologics Evaluation and Research, echoed the views of FDA staff and denied Moderna's request for approval of the flu vaccine. The decision is the latest time Prasad has pushed for stricter vaccine scrutiny against the recommendations of career FDA scientists. In July, he issued a memo opposing the approval of the Spikevax Moderna vaccine for all healthy children 6 months to 11 years of age because the data did not show that the benefits outweighed the risks. He approved it only for children with at least one high-risk disease that increases the risk of a severe course of COVID-19. According to Prasad, Moderna did not show a reduction in severe cases, hospitalizations, ICU stays or deaths in children in a randomized trial, where such events are extremely rare. Since his appointment in May, he has made similar unilateral decisions on the Novavax Nuvaxovid and Moderna MNEXSPIKE vaccines, limiting use to seniors over 65 and at-risk people ages 12-64.