GSK has secured approval from the US Food and Drug Administration (FDA) for its new vaccine, Penmenvy, to protect against five meningococcal serogroups for individuals aged ten to 25.
The vaccine is designed to target serogroups of Neisseria meningitidis (A, B, C, W and Y), which are the known causes of invasive meningococcal disease (IMD).
GSK鈥檚 MenABCWY vaccine is an injectable suspension intended for intramuscular use. It comes with a vial of lyophilised MenACWY powder, mixed with a prefilled syringe of MenB liquid before use.
Penmenvy is a combination of antigens from GSK’s established vaccines: Bexsero (Meningococcal Group B vaccine) and Menveo (Meningococcal [Groups A, C, Y, and W-135] Oligosaccharide Diphtheria CRM197 Conjugate Vaccine).
The company鈥檚 regulatory application for the vaccine was supported by data from two Phase III trials involving 4,800 participants.
The studies confirmed that the vaccine has a safety profile consistent with the licensed meningococcal vaccines of GSK.
The integration of the MenABCWY vaccine into healthcare practices is expected to streamline the vaccination process.
GSK chief scientific officer Tony Wood stated: 鈥淲e are excited about the opportunities ahead to help improve meningococcal vaccination coverage in the US, especially for IMD caused by serogroup B.
鈥淏uilding 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.鈥�
The CDC [Centers for Disease Control]’s Advisory Committee on Immunization Practices (ACIP) is set to vote on the use of GSK’s MenABCWY vaccine on 26 February 2025.
In January 2025, GSK embarked on a new research partnership with the University of Oxford for an immuno-prevention programme to explore cancer prevention through vaccination.
The partnership will invest in translational research to understand pre-cancer biology and potentially develop new vaccination strategies for cancer prevention.
