Meningococcal ABCWY Vaccine Candidate Under FDA Review

The Food and Drug Administration has accepted for review the Biologics License Application for GSK’s 5-in-1 meningococcal ABCWY (MenABCWY) vaccine candidate.

The MenABCWY vaccine combines the antigenic components of Bexsero (meningococcal Group B vaccine) and Menveo (meningococcal Groups A, C, Y, and W-135 oligosaccharide diphtheria CRM₁₉₇ conjugate vaccine), reducing the number of injections to simplify immunization against invasive meningococcal disease. 

The application is supported by data from a phase 3 trial (ClinicalTrials.gov Identifier: NCT04502693) in which study participants received MenABCWY administered as 2 doses 6 months apart or 2 doses of Bexsero plus 1 dose of Menveo. Findings showed MenABCWY met the primary endpoint demonstrating noninferiority to 2 doses of Bexsero and 1 dose of Menveo for all 5 Neisseria meningitidis serogroups (A, B, C, W and Y).

In a separate confirmatory arm of the trial, MenABCWY demonstrated immunological effectiveness against 110 diverse meningococcal serogroup B invasive strains. The safety profile of MenABCWY was reported to be similar to Bexsero and Menveo.

A regulatory decision is expected on February 14, 2025.