VRBPAC votes 9-0 for mRNA-1010 approval after Prasad rejection reversal

VRBPAC reviewed Phase 3 data from 40,000 adults aged 50+ showing 27% relative efficacy gain versus standard inactivated vaccine and a second trial in 3,000 adults 65+ demonstrating superior hemagglutination inhibition titers against high-dose comparator. FDA reviewers presented supportive briefing documents that aligned with prior agency agreement on trial endpoints. Safety signals matched established mRNA profiles with no new signals identified.

The vote reverses Prasad's February refusal to file the BLA on grounds that the 65+ arm lacked direct efficacy comparison; that decision contradicted earlier FDA feedback and was reversed within a week after internal and external pushback. Prasad's parallel rejection of UniQure's Huntington's gene therapy was also overturned the prior week. Both episodes occurred during a period of elevated turnover among career vaccine regulators.

Operational impact centers on manufacturing scale-up and lot-release timelines. mRNA-1010 uses the same lipid nanoparticle platform as Spikevax, allowing potential strain update cycles measured in weeks rather than months. CDC ACIP will next consider preferential recommendation language versus existing high-dose and adjuvanted options for the 2026-2027 season.

Full FDA approval remains contingent on final chemistry, manufacturing, and controls review plus any post-marketing commitments on real-world effectiveness.