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First mRNA flu vaccine reaches US pharmacies for older adults

Moderna’s mFlusiva has launched for adults 50 and older, NBC News reports.

The short version

  • Moderna's mFlusiva has become the first mRNA-based influenza vaccine available in the United States, restricted to individuals aged 50 and older.[NBC News]
  • FDA regulators granted standard approval for people aged 50 to 64 and accelerated clearance for those 65 and older.[NBC News]
  • The rollout proceeds without formal guidance from the CDC or its advisory panel, leaving potential coverage hurdles.[NBC News]
  • Moderna is obligated to perform a follow-up trial specifically covering the population aged 65 and older.[NBC News]

Key facts

  • Moderna’s mFlusiva is the first influenza vaccine in the United States built on messenger RNA technology.[NBC News]
  • The FDA cleared mFlusiva exclusively for adults aged 50 and older, granting traditional approval for ages 50 to 64 and accelerated approval for ages 65 and up.[NBC News]
  • In a late-stage clinical trial involving more than 40,000 adults, the vaccine proved approximately 27% more effective than standard influenza vaccines.[NBC News]
  • The list price is roughly $171 per dose without insurance, though discounts can bring it to around $154.[NBC News]
  • Moderna claims the shot can be manufactured in two to three months compared to about six months for conventional vaccines.[NBC News]

What remains uncertain

  • MFlusiva is arriving at pharmacies without a formal recommendation from the CDC or its vaccine advisory committee, which normally ensures zero-cost insurance coverage.[NBC News]
  • Accelerated approval requires Moderna to conduct an additional clinical trial focused specifically on people aged 65 and older.[NBC News]

Sources

Outlet counts describe coverage, not independent confirmation. Reports may share a wire service or original source.