FDA Reverses Decision to Review Moderna’s mRNA Flu Vaccine Application
February 18, 2026
The Food and Drug Administration (FDA) announced on Wednesday it will review Moderna’s application for the first mRNA-based flu vaccine. This reverses the agency’s decision made just a week ago to reject the company’s filing. Moderna is seeking full approval for adults aged 50 to 64 and accelerated approval for those 65 and older. CEO Stéphane Bancel said, “We appreciate the FDA’s engagement in a constructive Type A meeting and its agreement to advance our application for review.” The FDA aims to complete its review by August 5, potentially allowing the vaccine to be ready before the next flu season. The agency’s earlier rejection triggered criticism and concern about new vaccine policies under the Trump administration. The refusal was linked to the company not using a higher-strength vaccine in the control group during clinical trials, a point Moderna disputes. FDA Commissioner Dr. Marty Makary explained the initial rejection citing the company's failure to follow FDA guidance. A senior FDA official even described Moderna’s trial as a “brazen failure.” The controversy grows amid the vaccine skepticism of Health Secretary Robert F Kennedy Jr., who canceled a $500 million federal contract for mRNA vaccine development against bird flu and other threats. This swirling debate has alarmed health experts who worry about an “anti-vaccine agenda” affecting vaccination rates in the US. With this reversal, the FDA moves forward cautiously but opens the door for Moderna’s innovative flu shot to soon reach seniors in America.
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Tags:
Fda
Moderna
Mrna Flu Vaccine
Vaccine Approval
Us Health Policy
Covid-19 Vaccines
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