GSK has received the US Food and Drug Administration (FDA) approval for Penmenvy, a five-in-one meningococcal vaccine to help protect against invasive meningococcal disease (IMD).
The Meningococcal Groups A, B, C, W, and Y Vaccine is now approved for adults aged 10-25 years.
Penmenvy targets five major serogroups of Neisseria meningitidis (A, B, C, W, Y), which cause IMD.
The vaccine combines components of GSK’s two meningococcal vaccines, Bexsero and Menveo, targeting MenB and MenACWY respectively, to provide broader coverage in fewer doses.
The FDA approval was supported by positive results from two Phase 3 trials.
These trials tested the vaccine’s safety, tolerability, and immune response in over 4,800 participants aged 10-25 years.
According to the data, the combination vaccine proved as effective as Bexsero and Menveo in protecting against the five common meningococcal strains.
Safety data showed that Penmenvy has a profile like GSK’s licensed meningococcal vaccines.
GSK chief scientific officer Tony Wood said: “We are excited about the opportunities ahead to help improve meningococcal vaccination coverage in the US, especially for IMD caused by serogroup B.
“Building on our global leadership in meningococcal vaccination and our longstanding commitment to address unmet need in disease prevention, we aim to help protect more teens and young adults at a life stage when they are at an increased risk.”
The US Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) will vote on GSK’s MenABCWY vaccine recommendations for adolescents and young adults on 26 February.
GSK’s MenABCWY vaccine is an injectable suspension for intramuscular use. It comes as a vial of lyophilised MenACWY Component (powder) and is reconstituted with the accompanying prefilled syringe of MenB Component (liquid) at the time of use.
In 2023, the FDA approved Pfizer’s Penbraya, the first vaccine to protect against five meningococcal bacteria groups.
However, the European Medicines Agency withdrew its marketing authorisation for Penbraya in January at Pfizer’s request, citing commercial reasons.
