The U.S. FDA has approved GSK’s new combination vaccine, Penmenvy, for meningococcal disease in individuals aged 10 to 25 years.

This MenABCWY vaccine is an injectable suspension for intramuscular use, combining a lyophilized MenACWY component (powder) with a liquid MenB component, reconstituted at the time of administration. It provides active immunisation against invasive Neisseria meningitidis infections caused by serogroups A, B, C, W, and Y.

A late-stage trial involving 3,650 participants confirmed Penmenvy’s effectiveness, showing it performed as well as its component vaccines while maintaining a consistent safety profile. Experts highlight its potential to improve vaccination rates by simplifying the immunisation process and reducing long-term complications such as brain damage and hearing loss.1

GSK’s Bexsero vaccine, approved in over 55 countries, is part of 18 national immunisation programmes and has distributed over 110 million doses since 2015. It is clinically proven to protect against diverse disease-causing MenB strains with a well-characterised safety profile.

Meningococcal disease cases in the U.S. have risen sharply since 2021, surpassing pre-pandemic levels. GSK’s approval follows Pfizer’s 2023 release of Penbraya, another pentavalent meningococcal vaccine. However, Pfizer recently withdrew Penbraya’s marketing authorisation in the EU due to commercial considerations.