FDA panel considers a first-of-its-kind flu vaccine using mRNA technology
Summary
US health advisers are reviewing Moderna’s new flu vaccine, mFlusiva, which uses mRNA technology like the Covid-19 vaccines. The vaccine is designed for people 50 and older, and the FDA is considering its approval before the winter flu season.Key Facts
- Moderna’s mFlusiva flu vaccine uses mRNA technology to help the body fight the flu virus.
- The vaccine is intended for people aged 50 and older.
- mRNA vaccines can be made faster than traditional vaccines, which is useful if the flu virus changes quickly.
- In a study of 40,000 people 50 and older, mFlusiva reduced flu cases by about 27% compared to a standard flu vaccine.
- The FDA noted no safety concerns based on the study data.
- Moderna wants full approval for people 50 to 64 years old and conditional use for those 65 and older while more testing continues.
- Earlier, FDA officials debated if Moderna should have compared its vaccine to a high-dose flu vaccine given to seniors, leading to a delay.
- A smaller study showed mFlusiva created similar antibody responses to a high-dose senior flu vaccine.
- The FDA said more data is needed for very frail older adults and those with weak immune systems.
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