Research & Development
GSK's meningitis vaccine candidate accepted for FDA review
16 April 2024 -

Biopharmaceutical company GSK plc (LSE/NYSE: GSK) announced on Tuesday that the US FDA has accepted its 5-in-1 meningococcal ABCWY vaccine candidate for regulatory review. The Prescription Drug User Fee Act (PDUFA) action date is set for 14 February 2025.

This vaccine aims to simplify immunisation by providing broad coverage against the five most common meningococcal bacteria groups, potentially reducing the number of injections needed.

GSK's vaccine combines antigenic components from GSK's established meningococcal vaccines, Bexsero and Menveo, targeting the five meningococcal bacteria groups (A, B, C, W, and Y). If approved, it could simplify the vaccination process and increase series completion rates, potentially reducing the burden of invasive meningococcal disease (IMD).

IMD is a serious illness with life-threatening complications, particularly affecting adolescents and young adults. Despite vaccine recommendations, immunisation rates for IMD remain low in the US, partly due to complex schedules. GSK's phase III trial showed promising results, meeting all primary endpoints and demonstrating immunological non-inferiority.

The trial involved approximately 3,650 participants aged 10-25 across multiple countries. The vaccine candidate was well tolerated with a safety profile consistent with GSK's licensed vaccines. GSK's Bexsero and Menveo have received regulatory approvals in numerous countries, providing extensive evidence of immunogenicity and safety. GSK continues its commitment to advancing healthcare through innovative vaccines and treatments.