Full Breakdown
Moderna's mRNA Flu Vaccine Outperforms Standard Shot in Late-Stage Trial
5/7/2026, 3:58:32 AM
Trial Shows Superior Efficacy
More than 40,000 adults aged 50 and older were randomized at 301 sites in 11 countries to receive Moderna’s mRNA-1010 flu vaccine or a standard-dose GSK shot during the 2024-2025 season. Laboratory-confirmed influenza occurred in 2 % of mRNA recipients versus 2.8 % of standard-dose recipients, a 26.6 % relative improvement.
Data & Statistics
The trial reported 1.9 % infection in participants 65 + receiving mRNA versus 2.6 % with the standard shot. Common side effects—fatigue, headache, arm pain—were modestly higher with mRNA; severe events occurred in 2.2 % versus 1.9 %.
Key Figures & Groups
Moderna conducted the study. The U.S. Food and Drug Administration reviews the application. Health Secretary Robert F. Kennedy Jr. leads HHS opposition. Commentators include Dorit Reiss (UCSF), Dr. Jesse Goodman (Georgetown), Dr. Peter Hotez (Baylor), and Dr. Isabel Leroux-Roels (Ghent).
Official Statements & Responses
Dorit Reiss said the results were strong and would make an arbitrary FDA refusal unlikely; Jesse Goodman said the data should support licensure. The FDA, after an initial rejection, accepted an amended filing that splits approval by age and requires a follow-up for 65 +.
Criticism & Opposition
Health Secretary Robert F. Kennedy Jr. has labeled mRNA Covid vaccines “the deadliest vaccine ever made” and cancelled nearly $500 million in HHS funding for mRNA research, intensifying political scrutiny of Moderna’s flu shot.
Conflicting Reports & Gaps
The FDA’s original denial cited the use of a standard-dose comparator instead of the high-dose flu shot recommended for adults 65 +, arguing the design could overstate efficacy. Moderna’s trial did not directly test against the high-dose product, and a follow-up study for the 65 + cohort remains pending.
Impact
If approved, Moderna’s vaccine would be the first U.S. mRNA seasonal flu shot, offering faster strain updates and potentially higher protection for older adults, and could accelerate mRNA use for other diseases.
What’s Next
The FDA is slated to decide by Aug 5, likely granting standard approval for ages 50-64 and accelerated approval for 65 +, contingent on a post-marketing study. Reviews continue in the EU, Canada and Australia.
Verbatim Quotes
- “These are strong results, and would likely make it hard for the FDA to refuse in a way that withstands arbitrary and capricious review,” — Dorit Reiss, vaccine policy expert, University of California Law San Francisco.
- “The ability to make vaccine in shorter time periods may help better match new vaccines to emerging influenza viruses,” — Dr. Jesse Goodman, infectious disease specialist, Georgetown University Medical Center, former FDA chief scientist.
- “The lesson learned is that we need to keep as many technologies in play as possible and to cut one of them out for ideological reasons limits our ability to protect the American people.” — Dr. Peter Hotez, dean, National School of Tropical Medicine, Baylor College of Medicine.
