Vaccines
Vinay Prasad, the FDA’s Center for Biologics Evaluation and Research head, is accused of interpersonal impropriety as pushback builds against his decision to reject Moderna’s influenza vaccine candidate.
Moderna’s mRNA-1010 was expected to contribute $1 billion to the company’s coffers by 2028. That plan is now out the window after the FDA refused to even look at the application.
The sudden departure stands in contrast to other EU pharma leaders who have been given much longer transitions in recent months, including GSK’s Emma Walmsley and Novo Nordisk’s Lars Fruergaard Jørgensen.
An unnamed FDA official also told reporters that it would be good for Moderna to “show some humility” and admit that it didn’t follow the regulator’s recommendations in testing its mRNA flu vaccine.
The FDA issued a rare Refusal-to-File letter to Moderna over its mRNA-based influenza vaccine application, in an unusual move that sent the biotech’s shares tumbling.
After receiving a letter directly from CBER Director Vinay Prasad, Moderna said the FDA had previously signed off on the use of a licensed flu vaccine as a comparator for a Phase 3 study of mRNA-1010.
After advancing in lockstep through the pandemic, the fortunes of the biotechs have diverged as their use of COVID-19 windfalls has taken shape.
Despite Sanofi CEO Paul Hudson’s confidence in vaccines, the French pharma has cut at least one mRNA flu shot program.
Sanofi’s vaccine sales dipped 2.5% in 2025, with almost all immunization products declining. Nevertheless, CEO Paul Hudson doubled down on his support for vaccine development.
Roche’s obesity candidate achieves 22.5% weight loss in Phase II; Moderna pulls the plug on late-stage vaccine trials as Health Secretary Robert F. Kennedy’s anti-vaccine policies and rhetoric continues; and embattled gene therapy maker Sarepta announces new data in Duchenne muscular dystrophy.
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