Biopharmaceutical company GSK plc (LSE/NYSE: GSK) announced on Monday that it has received approval from the US Food and Drug Administration (FDA) for Penmenvy, its 5-in-1 meningococcal vaccine. The vaccine, designed for individuals aged 10 to 25 years, targets five serogroups of Neisseria meningitidis (A, B, C, W, and Y) that cause invasive meningococcal disease (IMD).

Penmenvy combines the antigenic components of GSK's two existing vaccines, Bexsero and Menveo. The approval follows positive phase III trial results involving over 4,800 participants, demonstrating the vaccine's safety, tolerability, and immune response. The new vaccine aims to simplify meningococcal vaccination and improve immunisation rates in the US, addressing the CDC's recommendations for protection against these common disease-causing serogroups.

The vaccine's approval is timely, as IMD poses a significant health threat, particularly to adolescents and young adults, a group at higher risk due to close-contact behaviours. A CDC Advisory Committee on Immunization Practices (ACIP) vote on the vaccine's usage is expected on 26 February 2025.

GSK is poised to strengthen its leadership in the US meningococcal vaccine market, with a substantial share of MenB vaccine doses administered in the country.