FDA Approves GSK’s PENMENVY, a 5-in-1 Meningococcal Vaccine for MenABCWY Protection
GSK plc has announced that the U.S. Food and Drug Administration (FDA) has granted approval for PENMENVY (Meningococcal Groups A, B, C, W, and Y Vaccine) for use in individuals aged 10 through 25 years. This innovative vaccine is designed to protect against five major serogroups of Neisseria meningitidis—A, B, C, W, and Y—each of which is a leading cause of invasive meningococcal disease (IMD), a potentially life-threatening condition that can lead to severe complications, including meningitis and bloodstream infections.1,2
PENMENVY combines the antigenic components of two well-established GSK meningococcal vaccines, BEXSERO (Meningococcal Group B Vaccine) and MENVEO (Meningococcal [Groups A, C, Y, and W-135] Oligosaccharide Diphtheria CRM197 Conjugate Vaccine). This combined formulation offers a comprehensive solution for preventing meningococcal disease caused by the five most common serogroups. The regulatory approval for PENMENVY was based on positive results from two large-scale Phase III clinical trials—NCT04502693 and NCT04707391—that involved over 4,800 participants aged 10 to 25 years. These trials evaluated the vaccine’s safety, tolerability, and immune response. The results demonstrated that PENMENVY has a safety profile consistent with GSK’s previously licensed meningococcal vaccines, such as BEXSERO and MENVEO.3-5
Tony Wood, Chief Scientific Officer at GSK, expressed enthusiasm about the potential of this vaccine to help improve meningococcal vaccination coverage in the United States, particularly with respect to invasive meningococcal disease (IMD) caused by serogroup B. “We are excited about the opportunities ahead to help improve meningococcal vaccination coverage in the United States, especially for IMD caused by serogroup B,” said Wood. “Building on our global leadership in meningococcal vaccination and our longstanding commitment to addressing unmet needs in disease prevention, we aim to help protect more teens and young adults at a life stage when they are at an increased risk.”
The approval of PENMENVY comes at a critical time, as there remains a significant gap in vaccination coverage among adolescents, particularly for MenB, the leading cause of IMD in this age group. Although the Centers for Disease Control and Prevention (CDC) have issued guidelines recommending vaccination against meningococcal disease for adolescents, the uptake of the recommended vaccines has been insufficient. Less than 13% of adolescents in the U.S. have received the recommended two-dose vaccination series for MenB, and approximately 32% have received at least one dose.7,8 The approval of PENMENVY, which provides protection against all five of the most common serogroups (A, B, C, W, and Y) in one vaccine, is expected to help close this gap. As MenB is the leading cause of IMD in adolescents, this new pentavalent vaccine could play a crucial role in reducing the burden of the disease.
A key advantage of the new vaccine is that it combines the components of two existing GSK vaccines, BEXSERO and MENVEO, making it easier for healthcare providers to integrate into their practices. By offering protection against all five serogroups in a single shot, PENMENVY could simplify the vaccination process and make it more accessible to U.S. adolescents. This convenience may encourage more adolescents to complete the vaccination regimen, helping to increase vaccination rates and reduce the risk of meningococcal disease. In fact, about 75% of all MenB doses currently administered in the U.S. are manufactured by GSK.9 This puts the company in a strong position to lead the U.S. meningococcal vaccination market, as the MenB-containing vaccination series must be completed with the same manufacturer’s MenB vaccine.
Judy Klein, President and Founder of the Unity Consortium, a non-profit organization focused on adolescent health and immunization, highlighted the importance of the new vaccine in preventing the devastating consequences of invasive meningococcal disease. “The consequences of IMD can be devastating for those who contract it, for their families, and for their friends,” said Klein. “We welcome new tools to help protect more adolescents from meningococcal disease. Pentavalent MenABCWY vaccines could help address the disease by providing protection against the five vaccine-preventable serogroups in one vaccine and making it easier for adolescents to get the coverage they need.”
The CDC’s Advisory Committee on Immunization Practices (ACIP) is expected to meet on February 26, 2025, to discuss and vote on recommendations for the use of GSK’s MenABCWY vaccine in adolescents and young adults. This meeting is an important step in determining how best to incorporate the new vaccine into existing vaccination guidelines and to ensure that more adolescents benefit from its protection. If the ACIP votes to recommend the use of MenABCWY, the vaccine could become an essential part of the U.S. vaccination schedule for adolescents and young adults, helping to prevent the spread of meningococcal disease and protect vulnerable populations.
The approval of PENMENVY marks an important milestone for GSK, which has long been a leader in meningococcal vaccination. The company’s commitment to advancing immunization science and addressing unmet needs in disease prevention is evident in its development of this new vaccine. With its comprehensive coverage of meningococcal disease-causing serogroups and its strong safety profile, PENMENVY has the potential to significantly reduce the incidence of IMD in the U.S. and beyond.
Meningococcal disease remains a serious public health threat, especially among adolescents and young adults, who are at increased risk due to behaviors such as close living conditions in dormitories or other communal settings. The availability of a pentavalent vaccine like PENMENVY is a promising step toward improving overall meningococcal vaccination rates and protecting adolescents from the potentially devastating consequences of invasive meningococcal disease.
In conclusion, the FDA’s approval of PENMENVY represents a significant advancement in the fight against meningococcal disease. This new vaccine offers protection against five of the most common and dangerous serogroups of Neisseria meningitidis, and its approval provides a new tool for healthcare providers to help protect adolescents and young adults. With the backing of positive Phase III trial data and the support of organizations like the Unity Consortium, PENMENVY has the potential to play a critical role in reducing the incidence of meningococcal disease in the U.S. and around the world. GSK’s ongoing leadership in the field of meningococcal vaccination positions the company to continue making a meaningful impact on global public health and to help address one of the most pressing unmet needs in adolescent health.
