📰 Full Story
The U.S. Food and Drug Administration has refused to start a review of Moderna's application to license its mRNA influenza vaccine candidate, mRNA-1010, the company said on Feb. 10, 2026.
In a refusal-to-file letter signed by Vinay Prasad, director of the FDA's Center for Biologics Evaluation and Research, the agency said Moderna's 40,000-person pivotal trial was not an “adequate and well‑controlled” study because it compared the candidate to a standard-dose seasonal influenza vaccine rather than the “best‑available standard of care” in the United States at the time of the study.
Moderna said the FDA raised no safety or efficacy concerns, that its trials met primary endpoints (including data showing about 26.6% greater effectiveness in adults 50+ versus an approved shot), and that it had previously received agency feedback it says allowed the chosen comparator.
Moderna has requested an urgent meeting with the FDA and is pursuing parallel regulatory reviews in the EU, Canada and Australia; the company previously indicated potential approvals outside the U.S. in late 2026 or 2027.
The refusal-to-file, a rare step for new vaccines, comes amid wider shifts in U.S. vaccine policy under Health Secretary Robert F. Kennedy Jr.

















:max_bytes(150000):strip_icc():focal(834x260:836x262)/christina-applegate-060425-b649d2a0561645f7b40462e53dda8c55.jpg)

💬 Commentary