Vaccines
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.
Growing opposition to vaccines in the U.S., driven by recent government policy changes, makes it difficult to see a return on investment in vaccine development, Moderna CEO Stéphane Bancel said this week.
“I don’t like established science,” ACIP chairperson Kirk Milhoan said in an interview on the Why Should I Trust You? podcast. “Science is what I observe.”
Pfizer CEO Albert Bourla said that the main thing getting in the way of changing vaccine discussions in the U.S. is the Secretary of Health, Robert F. Kennedy, Jr.
In November, Pfizer was reportedly looking to divest its stake in BioNTech, though the German biotech at the time denied these rumors.
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