FDA

Pentavalent meningococcal vaccine approved

February 24, 2025

Brand name: Penvenmy

Generic name: meningococcal Groups A, B, C, W, and Y vaccine

Manufacturer: GSK plc

Approval date: February 15, 2025

FDA approved Penmenvy (Meningococcal Groups A, B, C, W, and Y Vaccine) for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroups A, B, C, W, and Y in individuals 10 through 25 years of age.

Penmenvy is supplied as one vial of Lyophilized MenACWY Component (powder) and one prefilled syringe of MenB Component (liquid), which must be combined before administration.

Efficacy

Approval was supported by data from two phase 3 trials (NCT04502693; NCT04707391), which evaluated the vaccine’s safety, tolerability, and immune response in >4,800 participants aged 10 to 25 years.

Safety

The vaccine has a safety profile consistent with GSK’s licensed meningococcal vaccines.

Sources:

Penmenvy, GSK’s 5-in-1 meningococcal vaccine, approved by US FDA to help protect against MenABCWY. GSK. 2025. https://www.gsk.com/en-gb/media/press-releases/penmenvy-gsk-s-5-in-1-meningococcal-vaccine-approved-by-us-fda-to-help-protect-against-menabcwy/

Penmenvy. Package insert. FDA. 2025. https://www.fda.gov/media/185479/download