GSK’s Penmenvy gets FDA approval for teens in US

USA—British pharmaceutical giant GSK has received a significant boost with the recent approval from the US Food and Drug Administration (FDA) for its new meningococcal vaccine, Penmenvy.

This innovative vaccine, now approved for individuals aged 10 to 25, is designed to protect against five major serogroups of Neisseria meningitidis—specifically A, B, C, W, and Y—which are known to cause invasive meningococcal disease (IMD).

GSK’s MenACWY vaccine has received regulatory approval in over 60 countries, including the US, with more than 80 million doses distributed worldwide since 2010.

 The new vaccine is the result of GSK’s efforts to combine the strengths of two well-established vaccines.

Penmenvy merges the antigenic components of Bexsero, which targets serogroup B, with those of Menveo, which has been effective against serogroups A, C, W, and Y.

This integrated approach aims to simplify immunization practices by providing broader protection in a single shot, thereby reducing the number of injections required for comprehensive coverage.

The approval followed the submission of robust clinical data from two phase III trials involving over 4,800 participants aged between 10 and 25.

Penmenvy demonstrated a safety profile consistent with GSK’s previously licensed meningococcal vaccines in these studies.

Its safety and tolerability were comparable to those of established products, ensuring that the new vaccine meets high efficacy and patient well-being standards.

Tony Wood, GSK’s chief scientific officer, expressed his enthusiasm about the approval, emphasizing that it represents a major advancement in protecting adolescents and young adults from IMD, particularly diseases caused by serogroup B.

He noted that GSK is well-positioned to expand vaccination coverage in the United States by leveraging its global expertise in meningococcal vaccination, thereby addressing an unmet need in public health.

Furthermore, integrating Penmenvy into routine healthcare practices could simplify the vaccination process.

 This is particularly important because, despite serogroup B being the leading cause of IMD in this age group, less than 13% of adolescents complete the recommended two-dose series, while around 32% receive at least one dose.

 GSK currently supplies three out of every four MenB doses in the US, putting the company in a strong position to lead the market, especially since current guidelines require that MenB vaccinations be completed with the same manufacturer’s product.

In addition, Judy Klein, President and Founder of Unity Consortium—a nonprofit organization dedicated to adolescent health and immunization—highlighted the potential impact of this new vaccine.

She explained that the consequences of meningococcal disease can be devastating, affecting not only patients but also their families and communities.

Klein welcomed the introduction of pentavalent MenABCWY vaccines as a valuable tool for simplifying the immunization process and protecting more young people from potentially life-threatening diseases.

Looking ahead, the US Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) is scheduled to meet on February 26, 2025, to discuss recommendations for using GSK’s MenABCWY vaccine.

The committee’s forthcoming decision is expected to guide further how this vaccine will be integrated into routine immunization schedules, ensuring that more US adolescents receive the essential protection they need against meningococcal disease.

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