health
February 18, 2026
FDA Reverses Course and Will Review Moderna's mRNA-Based Flu Vaccine
US drug regulator originally refused to consider application, fueling critics' concern about alleged 'anti-vaccine agenda'
TL;DR
- The FDA will now review Moderna's application for its mRNA-based flu vaccine.
- The agency had initially rejected the application, citing concerns about the clinical trial's control group.
- Moderna is seeking full approval for adults aged 50-64 and accelerated approval for those 65 and older.
- The FDA's earlier rejection had amplified worries about changes in US vaccine policy and declining vaccination rates.
- The health secretary, Robert F Kennedy Jr, has been a critic of mRNA technology and previously oversaw the cancellation of a federal contract for mRNA vaccine development.
- Health experts and advocates expressed concern that the initial refusal was part of a broader 'anti-vaccine agenda'.
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