US FDA approves first mRNA flu shot from Moderna
The shot reduced flu cases by about 27% in a trial of more than 40,000 adults, Moderna said.
- 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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