FDA Approves Moderna mRNA Flu Shot Despite Safety Questions
The FDA on Wednesday approved mFlusiva, Moderna's mRNA flu vaccine, for adults 50 and older. It is the first flu vaccine using mRNA technology to receive FDA approval.
- 26.6% more effective than a standard-dose flu vaccine in a 40,000-person trial.
- Traditional approval covers adults 50–64; accelerated approval covers adults 65 and older.
- Moderna must run an additional study to confirm benefit in adults 65 and older.
- $750 million in projected U.S. sales of the flu shot and a combo COVID-flu vaccine by 2030, per Jefferies analysts.
Why it matters: mRNA vaccines take two to three months from strain selection to rollout, versus about six months for traditional egg-based shots, potentially allowing a closer match to circulating strains each season.
- Traditional flu shot effectiveness ranges from 22% to 56%, per the Mayo Clinic.
- Without a CDC advisory committee recommendation, private insurers likely won't cover mFlusiva and federal distribution programs cannot direct its use, according to Dr. Ofer Levy of Boston Children's Hospital.
How 40 sources split on this story
Where they split: Coverage divides on whether the approval marks a public health advance or a fraught regulatory process shaped by political pressure on mRNA technology.
Center coverage, 11 sources: The center treats the approval as a business and regulatory story, noting the FDA's turbulent leadership changes and the commercial pressure on Moderna to prove mRNA's long-term viability.
Left coverage, 13 sources: The left frames the approval as a hard-won scientific milestone undermined by the Trump administration's hostility to mRNA technology and RFK Jr.'s dismantling of the vaccine advisory process.
Right coverage, 16 sources: The right reports the approval as straightforward regulatory news, foregrounding the trial data, competitive market landscape, and Moderna's revenue outlook.
What’s next: The CDC's Advisory Committee on Immunization Practices is scheduled to meet in October, but a federal judge has blocked it from convening after RFK Jr. replaced all its members.
- Moderna does not expect meaningful revenue until the second half of 2027, having missed the 2026 contracting cycle.
- Will the ACIP convene in October, and will it formally recommend mFlusiva in time to affect coverage for this flu season?
- Can Moderna secure insurer and federal program coverage before the fall rollout without an ACIP recommendation?
- Will the FDA eventually grant full rather than accelerated approval for adults 65 and older, pending the additional trial?

































