The FDA has reversed its decision and agreed to review Moderna’s mRNA flu vaccine, just a week after initially rejecting it due to trial design concerns. This reconsideration is significant as it could lead to the first mRNA-based flu vaccine, following the success of mRNA COVID-19 vaccines. Moderna aims for full approval for adults aged 50-64 and accelerated approval for those 65 and older, with a post-marketing study to follow. A final decision is expected by August 5, potentially allowing distribution before the fall flu season.
