Regulatory drama ends with unanimous FDA advisory vote for Moderna's mRNA flu vaccine
FDA advisors voted 9-0 to approve Moderna’s mRNA-1010 seasonal flu vaccine (mFlusiva) after a Trump-era official briefly blocked review; Phase 3 data show ~27% higher efficacy than standard flu vaccines in adults 50+, with strong immune responses in older adults and a generally favorable safety profile. A final FDA decision is due by August 5, and CDC/ACIP recommendations would follow for coverage, though ACIP is currently affected by an injunction tied to vaccine-administration policy.