FDA advisory panel reviews Moderna's mRNA flu vaccine for adults 50 and older
The FDA's vaccine advisory committee is evaluating Moderna's mFlusiva, an mRNA-based influenza shot, after data showed a modest reduction in flu cases and no safety concerns.
U.S. health advisers are meeting Thursday to assess Moderna's mRNA influenza vaccine, mFlusiva, which is being considered for people aged 50 and older. The advisory committee's review is a step toward possible FDA approval before the upcoming flu season.
The vaccine uses messenger RNA technology, which allows faster manufacturing compared with traditional flu vaccines. In a trial of about 40,000 participants aged 50 and up, the mRNA shot lowered flu incidence by roughly 27% relative to a commonly used vaccine, and the FDA's preliminary review found no safety issues.
Moderna seeks full approval for use in adults 50-64 and conditional authorization for those 65 and older while additional studies are conducted. The panel will also examine a smaller study that compared the mRNA vaccine with a high-dose flu shot recommended for seniors, which showed comparable antibody responses.
The FDA noted that data are limited for very frail older adults and individuals with weakened immune systems. The agency's decision will inform whether the mRNA vaccine can become an additional option alongside existing flu vaccines for the elderly population.