Health
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.
- The first mRNA flu shot is now available. Here’s who can get it.NBC News - Top Stories