FDA Highlights Safety Concerns in Moderna's Pediatric RSV Vaccine Trials, Calls for Further Testing

In Moderna's pediatric RSV vaccine trials, significant safety concerns have surfaced, leading to a partial pause in testing. The FDA advisory panel reported severe RSV lower respiratory tract infections, including five hospitalizations in infants vaccinated with Moderna's investigational RNA vaccines, mRNA-1345 and mRNA-1365[1][3]. These issues have prompted the FDA to recommend gathering more data to fully understand the risks associated with these vaccines and have paused clinical trials for certain RSV shots in young children[2]. Despite the concerns, the FDA advisory emphasizes the need for continued trials with careful monitoring to resolve the safety challenges[3].