U.S. News: FDA Clears The First mRNA Flu Vaccine

 

 

“The Food and Drug Administration approved Moderna's mRNA-based flu vaccine for adults ages 50 and older, clearing the first shot of its kind after a review process that nearly collapsed in February.

 

The vaccine, called mFlusiva, uses the same mRNA technology as Moderna's Covid-19 shots. It could reach pharmacies in time for the coming flu season, which typically starts in the fall.

 

Health Secretary Robert F. Kennedy Jr. has questioned mRNA vaccine technology, and the Department of Health and Human Services canceled about $500 million in mRNA research contracts last year in moves that health officials questioned as politically motivated and not rooted in science.

 

In February, the FDA initially refused to review Moderna's application at all, a rare move signed by the agency's then head of vaccine development, Vinay Prasad, who has left the agency. Prasad cited the fact that Moderna tested its experimental vaccine for seniors measuring case counts against a standard-dose flu shot rather than Fluzone High-Dose, the version the FDA normally recommends for that age group.

 

Moderna was surprised by the FDA's decision in February. "It does feel like the rules of the game are being changed after it's been played," Moderna President Stephen Hoge said at the time.

 

The agency reversed course days later after Moderna proposed a revised plan that included another trial.

 

In June, an FDA advisory committee voted unanimously to recommend mFlusiva for adults 50 and older.

 

Even with FDA approval, the vaccine's commercial prospects are uncertain. The Centers for Disease Control and Prevention panel that makes national vaccine recommendations remains tied up in litigation after Kennedy replaced its members last year with some outspoken vaccine opponents and a federal judge ruled most of his appointees were unqualified to serve.

 

Wall Street doesn't expect the vaccine to generate meaningful sales until the 2027-28 flu season because commercial contracting for seasonal flu shots takes place earlier in the year. The company expects to have mFlusiva available for eligible populations in the U.S. for the 2026-2027 season.” [1]

 

The more we use mRNA in humans, the more we know about it. mRNA could become an useful entry point for therapies in many diseases, so this knowledge is a positive thing.

 

The growing clinical use of mRNA technology expands our understanding of how it works in the human body. This progress helps researchers design better treatments for a wide range of genetic, infectious, and acquired diseases.

Benefits of Expanded mRNA Research

•           Broad Applications: Beyond vaccines, mRNA platforms are studied for rare genetic disorders, protein replacement therapies, and oncology.

•           Safety Data: Each clinical trial and rollout provides large-scale safety profiles, adverse-event tracking, and pharmacokinetic data. Observation after trial helps too.

•           Rapid Iteration: Scientists can modify mRNA sequences quickly to address new variants or optimize cellular delivery methods.

Current Technical Challenges

•           Delivery Systems: Delivering fragile mRNA molecules to the right cells requires advanced lipid nanoparticles that avoid rapid clearance by the liver or immune system.

•           Immune Response: Unwanted systemic inflammation can occur, requiring chemical modifications to the nucleotides and backbone.

•           Stability: Cold-chain storage requirements complicate global distribution, pushing research toward thermostable formulations.

 

 

1. U.S. News: FDA Clears The First mRNA Flu Vaccine. Martinez, Xavier

.  Wall Street Journal, Eastern edition; New York, N.Y.. 06 Aug 2026: A3.