GSK’s Penmenvy Approved: New 5-in-1 Meningococcal Vaccine Enters U.S. Market
FDA approved GSK's Penmenvy on February 15, 2025, for individuals aged 10-25 years12.
Penmenvy protects against five major serogroups of Neisseria meningitidis:
A, B, C, W, and Y12.
The vaccine combines components from GSK's existing vaccines Bexsero (MenB) and Menveo (MenACWY)15.
Penmenvy's approval was based on two Phase III trials involving over 4,800 participants16.
GSK follows Pfizer in the 5-in-1 meningococcal vaccine market, with Pfizer's Penbraya approved in October 20234.
Penmenvy is expected to simplify the meningococcal vaccination schedule and potentially improve vaccine uptake25.
The vaccine's safety profile is consistent with GSK's licensed meningococcal vaccines610.
Invasive meningococcal disease (IMD) is rare but can be life-threatening, with a 10-15% fatality rate even with treatment5.
Adolescents and young adults are at higher risk for IMD due to behaviors like living in close quarters and sharing drinks15.
The CDC's Advisory Committee on Immunization Practices is expected to vote on recommendations for Penmenvy's use on February 26, 20251.
Sources:
1. https://www.biopharminternational.com/view/fda-approves-gsk-5-in-1-meningococcal-vaccine-patients-aged-10-25
2. https://www.fiercepharma.com/pharma/gsk-joins-pfizer-5-1-meningococcal-vaccine-ring-fda-approval
4. https://www.fiercepharma.com/pharma/pfizer-laps-gsk-fda-nod-first-5-1-meningitis-shot
5. https://www.contemporarypediatrics.com/view/breaking-down-invasive-meningococcal-disease-vaccines-including-menabcwy
6. https://www.idse.net/FDA-News/Article/02-25/FDA-Approves-Penmenvy-GSKs-5-in-1-Meningococcal-Vaccine/76286
10. https://medicalxpress.com/news/2025-02-fda-broadly-meningococcal-vaccine.html