GSK’s Penmenvy Vaccine Approved for Prevention of Invasive Meningococcal Disease
Saturday, February 15, 2025
GSK has received approval from the US Food and Drug Administration (FDA) for its Penmenvy (MenABCWY) vaccine, designed for individuals aged 10 to 25 years.
Penmenvy is an injectable vaccine supplied as a lyophilised MenACWY component (powder) that is reconstituted before use with a MenB component (liquid) provided in a prefilled syringe.
It is approved in the US for the prevention of IMD caused by Neisseria meningitidis serogroups A, B, C, W, and Y in individuals aged 10 to 25 years.
IMD is a rare but severe bacterial infection that can progress rapidly, leading to death in up to one in six cases despite treatment. Early symptoms are often mistaken for flu, making diagnosis challenging.
Survivors may experience lasting complications, including brain damage, hearing loss, or limb amputations. Adolescents and young adults, particularly those living in shared spaces such as university halls, face a higher risk of infection due to close contact and shared items.
The vaccine offers protection against five major serogroups of Neisseria meningitidis—A, B, C, W, and Y—which are responsible for causing invasive meningococcal disease (IMD).
Penmenvy combines components from GSK’s existing vaccines, Bexsero (MenB) and Menveo (MenACWY).
The approval follows results from two Phase III clinical trials involving over 4,800 participants, which assessed safety, tolerability, and immune response.
Data from these studies showed a consistent safety profile in line with GSK’s established meningococcal vaccines.
The introduction of Penmenvy is expected to simplify meningococcal vaccination for healthcare providers in the US, increasing protection for adolescents and young adults.
Although serogroup B is a leading cause of IMD in this age group, uptake of the recommended two-dose MenB vaccine remains low.
The US Centres for Disease Control and Prevention (CDC) is set to review the vaccine at its Advisory Committee on Immunization Practices (ACIP) meeting on 26 February 2025 to determine recommendations for its use in adolescents and young adults.
Currently, GSK manufactures three-quarters of all MenB vaccine doses administered in the US.
Source: gsk.com
