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FDA approves Moderna’s mRNA flu vaccine mFLUSIVA for older adults

scienceAug 6, 2026171,359

The Food and Drug Administration approved Moderna's mRNA seasonal flu vaccine mFLUSIVA on Wednesday for use in adults 50 and older, with the shot expected to be available for the 2026-2027 respiratory illness season. In a clinical trial of people aged 50 to 64, mFLUSIVA produced 27 percent fewer confirmed flu cases than the current standard vaccine. The safety profile matched the standard vaccine, though more mFLUSIVA recipients reported mostly mild side effects that lasted two days or less. Moderna said it will collect data this winter comparing mFLUSIVA to the currently recommended high-dose vaccine for people 65 and older and submit those results to the FDA to determine whether approval will continue for that population. The FDA had earlier declined to review Moderna's application but reversed course after Moderna agreed to run an additional postapproval study. Stéphane Bancel, Moderna's chief executive officer, said the approval reflects the mRNA platform's potential to address public health challenges. The Centers for Disease Control and Prevention currently recommends annual flu vaccination for everyone six months and older and advises receiving the shot before the end of October.

Dr. Lucky Tran
@luckytran.com

Fantastic news! The FDA has approved the first mRNA flu vaccine. Using mRNA technology will make it easier to update each season’s flu vaccine to keep up with new variants.

10024h ago
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