In the news now: Vinay Prasad, FDA-related shake-ups figure after leadership turmoil at the agency. Hematologist-oncologist and health researcher, once FDA CBER director.
Moderna has sought FDA approval for mFlusiva, an mRNA flu vaccine for people 50 and older. An FDA advisory panel is weighing the request ahead of the winter flu season. In a 40,000-person study, the vaccine reduced flu cases by about 27% versus a routinely used vaccine. FDA's premeeting review found no safety concerns, and Moderna is seeking full approval for ages 50–64 and authorization for 65+ while continuing testing. Earlier this year, a public dispute over trial design highlighted heightened FDA scrutiny of vaccines.