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# GSK BLA Accepted for Meningococcal Vaccine
- URL: https://www.fdaweb.com/gsk-bla-accepted-for-meningococcal-vaccine/
- Published: 2024-04-16T12:00:00.000Z
- Updated: 2026-09-14T14:28:20.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5156790

FDA has accepted for review a GSK BLA for its 5-in-1 meningococcal ABCWY (MenABCWY) vaccine candidate. The user fee review action target date is 2/14/2025.

The vaccine combines the antigenic components of the company’s two established meningococcal vaccines — Bexsero (meningococcal Group B vaccine) and Menveo (meningococcal \[Groups A, C, Y, and W-135\] oligosaccharide diphtheria vaccine), GSK says. It is intended to target the five groups of the bacteria *Neisseria meningitidis* (Men A, B, C, W, and Y) that cause most invasive meningococcal disease cases globally.

The submission is based on data from the a Phase 3 trial ([NCT04502693](https://clinicaltrials.gov/study/NCT04502693?ref=fdaweb.com)) that met all primary endpoints, including immunological non-inferiority to one dose of GSK’s Meningococcal Groups A,C,Y and W Vaccine, and non-inferior immune responses against 110 diverse MenB invasive strains (representing 95% of MenB strains circulating in the U.S.) as compared to two doses of GSK’s Meningococcal Group B Vaccine, the company says.