US FDA Reverses Decision, Agrees to Review Moderna's Flu Vaccine for 50+ Age Group
February 19, 2026
The US Food and Drug Administration (FDA) will review Moderna’s application for its new flu vaccine after initially rejecting it. The company said the vaccine targets adults aged 50 to 64 with full approval and seniors 65 and above with expedited approval. Moderna CEO Stephane Bancel expressed optimism, saying, "Pending FDA approval, we look forward to making our flu vaccine available later this year so that America’s seniors have access to a new option to protect themselves against flu." The FDA's flip came after Moderna revealed on February 10 that their vaccine review was denied. This refusal raised concerns due to recent changes in US vaccine guidelines under President Donald Trump’s administration. Some officials, like Health Secretary Robert F Kennedy Jr, questioned vaccine safety and cut over $500 million in mRNA vaccine research funding last year. Moderna’s clinical trial included 40,000 adults 50 and older and showed the new vaccine was more effective than the standard flu shot. The FDA initially rejected the application because it lacked comparison with a high-dose vaccine brand, a step Moderna said had already been recommended during trial approval. As a compromise, Moderna agreed to complete another study after the vaccine is launched. The FDA aims to decide on the revised application by August 5. This vaccine uses mRNA technology, often criticized by some US officials, but marks a big step toward new flu protection options.
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Tags:
Moderna
Flu vaccine
Fda
Mrna Technology
Vaccine Approval
Us Health Policy
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