FDA says it will review Moderna’s new mRNA-based flu vaccine after reversing course
The FDA reversed course and said it would review Moderna’s application for a new mRNA-based flu vaccine. The move followed growing concern about federal vaccine policy and came after HHS canceled nearly $500 million in mRNA vaccine contracts.
The Food and Drug Administration this week reversed course and said it would review Moderna’s application for a new mRNA-based flu vaccine after all. After a week of bad press, the agency announced it would review Moderna’s application for a new flu vaccine.
The agency’s original refusal fits a pattern of agency decision-making based on individual officials’ views rather than set guidelines and reinforces a precedent that’s problematic for drug development. The reversal followed growing concern about the administration’s actions on vaccines in particular.
The change comes as some top HHS officials are changing seats and as the Senate prepares for the long-delayed confirmation hearing of the president’s nominee for surgeon general, Casey Means. Polling shows Americans are increasingly concerned about federal vaccine policy.
In August 2025, HHS canceled nearly $500 million in contracts that were funding mRNA vaccine development. When the next pandemic strain of influenza takes hold, mRNA is the only known technology capable of quickly producing an effective vaccine, according to one source article.