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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Moderna said Wednesday afternoon that its experimental vaccine for cytomegalovirus, a cause of disability in newborns, failed in a Phase 3 trial, a significant setback for a company already facing pressure from Wall Street and the federal government.

The CMV vaccine had been the company’s lead program prior to the Covid-19 pandemic. Leadership had repeatedly said it could bring in between $2 billion and $5 billion in peak annual sales. Analysts polled by Visible Alpha forecast peak sales of $1.6 billion for the product.

“It’s obviously disappointing,” said Stephen Hoge, Moderna’s president, in an interview.

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An experimental gene therapy from Sarepta Therapeutics increased levels of the gene missing in an ultra-rare form of muscular dystrophy, according to data the company presented Friday.

The company has said it plans to file for approval in the disease, known as limb-girdle muscular dystrophy (LGMD) 2E. That would make it the first approved treatment in LGMD, a broad collection of highly rare diseases that can deprive patients of the ability to walk and in some cases shorten life. But it is likely to face a significant uphill battle. 

The LGMD 2E therapy relies on the same gene-ferrying virus that Sarepta uses in its other treatments, including its approved gene therapy for Duchenne muscular dystrophy, Elevidys, and experimental gene therapies for several other LGMD subtypes. 

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