FDA reverses course, will review Moderna’s mRNA-based flu shot
Moderna revised its application to seek full approval for ages 50-64 and accelerated approval for 65+, aiming for FDA decision by Aug. 5 for 2026-27 flu season availability.
- The U.S. Food and Drug Administration on Feb 18, 2026 agreed to review Moderna's mRNA seasonal influenza vaccine after the company amended its application, reversing last week's refusal.
- The FDA's `refuse-to-file` decision stemmed from Dr. Vinay Prasad citing issues with the control vaccine and study design in a trial of about 41,000 people.
- Moderna proposed splitting approvals by age, seeking full approval for adults 50 to 64 and accelerated approval for adults 65 and older with a post-marketing study, while the FDA targets a decision by Aug. 5 for the 2026-2027 flu season.
- Shares of Moderna rose more than 5% after the news amid intense mRNA scrutiny by Robert F. Kennedy Jr., U.S. Health Secretary, who canceled $500 million funding.
- Regulators abroad are also reviewing the filing, with regulators in Europe, Canada and Australia assessing Moderna's vaccine while the company spent hundreds of millions and secured a $750 million Blackstone investment.
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Moderna (NASDAQ:MRNA) Shares Gap Up Following Analyst Upgrade
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Moderna Spikes After FDA’s About-Face on mRNA Flu Vaccine
That was an unexpected and much-needed shot in the arm for Moderna. On Wednesday, the US Food and Drug Administration announced it would begin reviewing the biotech firm’s new mRNA-based flu vaccine — just a week after the agency initially rejected Moderna’s application, citing flaws in the company’s research design. The reversal is not just a major win for Moderna, but the entire vaccine-making industry, which has struggled in an era of a, shal…
FDA’s abrupt flip-flop on Moderna’s mRNA flu shot highlights growing risks to drug-makers of investing in vaccines
Federal health officials have raised safety concerns about mRNA vaccines, although they have provided no credible data on health risks. NurPhoto via Getty ImagesThe Food and Drug Administration’s decision, made public on Feb. 10, 2026, to not review an application to approve Moderna’s proposed mRNA-based flu vaccine set off a firestorm of criticism from public health experts. But just a week later, on Feb. 18, the FDA backtracked on its decision…
FDA reverses course, will review Moderna’s flu vaccine application | Honolulu Star-Advertiser
Moderna said today the Food and Drug Administration changed course and will review an amended application for its new flu vaccine, a week after rejecting the original submission and fueling drugmaker and investor concerns over policy changes at the agency under President Donald Trump.
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