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STAT+: FDA’s rejection of Moderna threatens to stifle broader vaccine industry
The Food and Drug Administration’s refusal to review Moderna’s flu vaccine this month has renewed fears that Trump administration policies could paralyze the vaccine industry, dissuading companies from developing new shots in the U.S. and leaving the country flat-footed in the event of future pandemics.
“I consider it an unprecedented action that really violates the basic principles of a data-driven regulatory agency and the fundamentals of public health, and it’s that simple,” said Gary Nabel, former head of the National Institutes of Health’s Vaccine Research Center and chief scientist at Sanofi, who now runs a vaccine and cancer startup. “It’s a destructive precedent that will undermine the future of vaccine development and the preeminence of American research.”
Executives at large vaccine developers were already grappling with a litany of changes to vaccine policy. Under Robert F. Kennedy Jr., a longtime vaccine critic, the Department of Health and Human Services has unilaterally removed six shots from the childhood vaccination schedule, canceled hundreds of millions of dollars in grants for mRNA shots, and fired and replaced a key immunization advisory board.
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© John Tlumacki/Globe Staff
