FDA Approves GSK's 5-in-1 Meningococcal Vaccine For Adolescents Ahead Of CDC Advisory Committee Vote Meeting Next Week

On Saturday, the FDA approved GSK plc’s GSK Penmenvy (Meningococcal Groups A, B, C, W, and Y Vaccine) for use in individuals aged 10 through 25. 

The vaccine targets five major serogroups of Neisseria meningitidis (A, B, C, W, and Y), which commonly cause invasive meningococcal disease (IMD).

The vaccine combines the antigenic components of GSK’s two well-established meningococcal vaccines, Bexsero (Meningococcal Group B Vaccine) and Menveo (Meningococcal [Groups A, C, Y, and W-135] Oligosaccharide Diphtheria CRM197 Conjugate Vaccine).

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The regulatory application was supported by results from two phase 3 trials, which evaluated the vaccine’s safety, tolerability, and immune response in over 4,800 participants aged 10-25. 

The safety data demonstrated that the vaccine has a safety profile consistent with GSK’s licensed meningococcal vaccines.

Integrating GSK’s MenABCWY vaccine into healthcare provider practices could simplify meningococcal vaccination delivery and help protect more U.S. adolescents against the five common disease-causing serogroups—A, B, C, W, and Y—for which the US Centers for Disease Control and Prevention (CDC) have issued recommendations.

Although MenB is the leading cause of IMD among this population, less than 13% receive the recommended two-dose vaccination series; around 32% receive at least one dose. GSK manufactures three of every four MenB doses currently administered in the U.S., positioning the company well to lead in the U.S. market as MenB-containing vaccinations must be completed with the same manufacturer’s MenB vaccine.

At its meeting on February 26, 2025, the CDC’s Advisory Committee on Immunization Practices (ACIP) is expected to vote on recommendations for the appropriate use of GSK’s MenABCWY vaccine in adolescents and young adults.

Price Action: GSK stock is up 0.64% at $36.41 during the premarket session on last check Tuesday.

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