Vaccines and Related Biological Products Advisory Committee June 18, 2026 Meeting Announcement - 06/18/2026
The Vaccines and Related Biological Products Advisory Committee (VRBPAC) is scheduled to meet on June 18, 2026, to discuss and provide recommendations regarding BLA STN 125869/0 for MFLUSIVA. The committee will evaluate the vaccine's safety and effectiveness for preventing influenza subtypes A and B in individuals aged 50 and older.
The manufacturer of MFLUSIVA, regulatory professionals managing influenza vaccine portfolios, and clinical operations teams focused on geriatric or middle-aged preventative care.
The VRBPAC recommendation is a critical milestone in the Biologics License Application (BLA) process. The focus on a specific age demographic (50+) suggests that the committee will scrutinize age-stratified clinical data. A positive recommendation generally influences the final FDA approval decision and any necessary Risk Evaluation and Mitigation Strategies (REMS) or phase 4 commitments.
Regulatory and clinical teams should monitor the June 18 committee meeting for specific feedback on safety and efficacy data. Post-meeting briefings should be analyzed to identify potential post-marketing commitments or labeling restrictions for the 50+ age demographic.
The Committee will meet in open session to discuss and make recommendations on the safety and effectiveness of MFLUSIVA, with a requested indication in BLA STN 125869/0 for the prevention of influenza disease caused by influenza virus subtypes A and type B represented in the vaccine, in persons 50 years of age and older.
Open in openFDA / FDA.gov