US FDA approves first mRNA flu shot from Moderna
- On Wednesday, August 5, 2026, the Food and Drug Administration approved mFLUSIVA, Moderna's mRNA-based influenza vaccine for adults aged 50 and older, marking the first U.S. authorization of an mRNA flu vaccine.
- Unlike traditional egg-based flu vaccines requiring six months to produce, mRNA technology allows manufacturing in two to three months, enabling faster updates to target evolving flu strains more effectively.
- In a trial of 40,700 participants, mFLUSIVA demonstrated 26.6% greater effectiveness than standard shots, though roughly 66% of recipients reported injection-site pain compared to 30% for standard vaccines.
- The approval arrived despite an initial FDA refusal to review the application earlier this year and HHS Secretary Robert F. Kennedy Jr.'s cancellation of $500 million in mRNA research projects last year.
- Authorization for seniors 65 and older remains provisional pending further studies, though Moderna Chief Executive Stéphane Bancel called the vaccine an 'important new option' for America's seniors.
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Moderna’s mRNA Flu Shot Receives US Government Approval
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Side effects reported with U.S.-approved flu shot may scare people away, expert warns
The first approval in the U.S. for a messenger RNA-based flu vaccine was signed off on by the U.S. Food and Drug Administration on Wednesday. The new vaccine, mFlusiva, will be available for adults aged 50 and older.
“Unlike conventional manufacturing, the mRNA platform allows optimized development and rapid responses to emerging mutations in viruses,” the paper notes.
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