FDA Approves First mRNA Flu Shot from Moderna
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 33 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, 10 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.
Associated Press9hNew kind of flu shot is on the way as the FDA approves Moderna's mRNA-based vaccine
Engadget13hFDA Approves Moderna's mRNA Flu Vaccine After Initially Refusing To Review It
Forbes14hFDA Approves First mRNA Flu Vaccine For Older Adults
NPR4hA new flu vaccine geared to older people is coming soon
PBS NewsHour5hNew kind of flu shot is on the way as the FDA approves Moderna's mRNA-based vaccine
Reuters19hUS FDA approves first mRNA flu shot from ModernaTCThe Conversation3hFirst mRNA flu shot approved by FDA bodes well for improving drugs of the future – though a few hurdles remain before mRNA can move beyond vaccines
The Hill11hFDA approves first mRNA flu vaccine
USA Today4hFDA approves 1st flu shot using same technology as COVID vaccinesLeft coverage, 12 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.
CNN19hFDA approves first mRNA-based flu vaccine
NBC News19hFDA approves 1st mRNA flu shot, from Moderna
The Independent3hFDA approves first-of-its-kind flu vaccine for adults over 50
ABC News18hFDA approves Moderna's mRNA seasonal flu vaccineBosBoston.com3hNew kind of flu shot is on the way as the FDA approves Moderna's mRNA-based vaccine
CBS News18hFDA approves Moderna's mRNA flu vaccine after initial pushback
Political Wire10hFDA Approves the First mRNA-based Flu ShotTBGThe Boston Globe8hFDA approves Moderna’s mRNA flu vaccine
The Guardian8hThe mRNA technology behind Moderna’s Covid vaccine reaches the flu
The New York Times19hF.D.A. Approves Moderna’s mRNA Flu Vaccine
Time8hFDA Approves the First mRNA Flu Vaccine
Vox1hThe flu shot finally gets an upgradeRight coverage, 11 sources: The right reports the approval as straightforward regulatory news, foregrounding the trial data, competitive market landscape, and Moderna's revenue outlook.
NTD14hFDA Approves First mRNA Flu Vaccine From Moderna
The Epoch Times22hModerna’s mRNA Flu Vaccine Approved by FDA
ZeroHedge5hModerna's mRNA Flu Vaccine Approved By FDA
American Greatness13hMorning Greatness: FDA Approves Moderna’s mRNA Seasonal Flu Vaccine
Daily Mail5hNew mRNA flu shot set to roll out - adults over 50 urged to get shot which uses same tech as controversial Covid vaccine
Fox News3hFDA approves first-ever mRNA flu vaccine for millions of older Americans
New York Post1hFDA approves Moderna’s mRNA-based flu vaccine
PJ Media12hFDA Greenlights Novel Moderna mRNA Flu Shots
RedState11hDespite RFK Jr.'s Opposition, FDA Approves First mRNA Flu Vaccines
The Washington Times4hFDA approves first mRNA flu vaccine after reversing its own rejection
Washington Examiner9hFDA approves first mRNA flu vaccineWhat’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?