The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) meets today — June 18, 2026 — to evaluate Moderna’s biologics license application (BLA) for MFLUSIVA (mRNA-1010), a quadrivalent mRNA-based seasonal influenza vaccine for adults 18 years and older. If ultimately approved, MFLUSIVA will be the first mRNA vaccine licensed in the United States for influenza, and the first mRNA platform product to expand beyond COVID-19.

What FDA’s briefing documents say

The agency released its briefing documents on June 16, 2026. Reviewers found no major deficiencies in the clinical data package and did not request additional studies as a condition of approval. The briefing notes that MFLUSIVA demonstrated noninferiority to licensed comparator quadrivalent influenza vaccines on hemagglutination inhibition (HAI) titers for all four strains in the pivotal immunogenicity program and met pre-specified seroconversion thresholds across age strata.

The 2026 label under review covers adults 18 years and older; Moderna’s pediatric program is ongoing under a separate development plan.

P303 IGNITE: the immunogenicity pivot trial

The primary immunogenicity data came from the P303 IGNITE trial (NCT05827978), a randomized, observer-blind, active-controlled study that compared MFLUSIVA with licensed quadrivalent inactivated influenza vaccine (QIV-HD or standard-dose QIV, by age stratum) in adults. The trial enrolled across multiple seasons and countries, measuring day-29 HAI titers and seroconversion rates as the primary endpoints. Moderna published the pivotal immunogenicity and efficacy data in the New England Journal of Medicine on May 6, 2026 (online-first).

The VRBPAC today will vote on whether MFLUSIVA is safe, whether it is effective, and whether the benefit-risk profile supports approval — three separate roll-call votes under the standard committee format.

CBER jurisdiction and the Prasad factor

Jurisdiction over influenza vaccines sits with the Center for Biologics Evaluation and Research (CBER), not CDER. CBER Director Vinay Prasad, MD, MPH, whose tenure began in 2025 after his appointment by HHS Secretary Robert F. Kennedy Jr., has publicly questioned whether post-COVID-era mRNA platform extrapolation is scientifically warranted without strain-matched efficacy trials. Prasad has not made a public statement on MFLUSIVA specifically, but his past commentary on surrogate endpoints for influenza vaccines is expected to frame the committee’s discussion of how HAI titer rises translate to clinical protection.

A PDUFA date of August 5, 2026 is set for the agency’s final action.

Platform implications

The mRNA platform’s key structural advantage in influenza is speed: while conventional egg-based or cell-based vaccine manufacturing requires 6–9 months to produce a strain-matched seasonal lot, mRNA vaccines can — in principle — compress that to 2–3 months. Regulators and public health officials have long sought that speed advantage for a scenario in which the circulating strain drifts substantially from the vaccine strain in a given season, or in which a novel influenza pandemic strain requires rapid mass production.

Fluzone HD (Sanofi), Flublok (Pfizer), and several adjuvanted formulations currently dominate the high-dose adult market. A positive VRBPAC recommendation does not guarantee FDA approval, but no mRNA BLA has been rejected after a favorable advisory committee vote.