Moderna has announced that the US Food and Drug Administration (FDA) has approved its new mRNA flu vaccine, mFlusiva, for adults aged 50 and older. This is the first flu vaccine to utilise the mRNA technology that was central to the Covid-19 pandemic response.
For individuals aged 50 to 64, the FDA granted full approval based on a study involving 40,000 people. This study indicated that mFlusiva reduced flu cases by approximately 27% when compared to another commonly used flu vaccine brand. For those aged 65 or older, the FDA granted accelerated approval, based on a smaller study showing a strong immune response compared to an existing high-dose vaccine for seniors.
Moderna expects some doses of mFlusiva to be available soon at select retailers ahead of the autumn vaccination season. The company's data indicated no major safety concerns, although temporary reactions such as injection site pain, fever, headache, tiredness, and aches were reported somewhat more frequently than with current flu shots.