What we know
What we know: New kind of flu shot is on the way as the FDA approves Moderna's mRNA-based vaccine
Compiled Aug 7
What we know
- The FDA approved a new mRNA-based flu vaccine called mFlusiva, made by Moderna, for adults age 50 and older
- mFlusiva is the first flu vaccine made with mRNA technology, the same platform used in COVID-19 vaccines
- The FDA granted full approval for use in people ages 50-64 based on a study showing 27% fewer flu cases compared with a different common flu vaccine
- For people 65 and older, the FDA granted accelerated approval based on a smaller study showing a strong immune response compared with an existing high-dose vaccine for seniors
- Moderna's data showed no major safety issues, though the shot caused somewhat more temporary reactions like injection site pain, fever, headache, tiredness and aches than current flu shots
- Earlier this year a then-top FDA official blocked Moderna's application, then the agency reversed course after Moderna publicly challenged the ruling
What we don’t know yet
- Moderna is conducting an additional study for the 65-and-older accelerated approval, the outcome of which is not yet known
Open questions
- When exactly will mFlusiva become available at retailers?
- What were the specific reasons the FDA official initially blocked the application?
- What will the additional study for the 65+ accelerated approval show?
- How will mFlusiva's price or availability compare with existing flu vaccines?
Drawn from the Associated Press report. “What we don’t know” lists only what the reporting itself flags as unresolved.