FDA Approves GSK’s 5-in-1 Meningococcal Vaccine for Patients Aged 10 Through 25

Text sign showing Industry News. Business photo text delivering news to the general public or a target public | Image Credit: © Artur - stock.adobe.com

GSK announced on Feb. 15, 2025 that FDA approved its vaccine for meningococcal groups A, B, C, W, and Y (MenABCWY), marketed as Penmenvy, for use in individuals aged 10 through 25 in the United States (1). A, B, C, W, and Y, according to GSK, are five major, common disease-causing serogroups of Neisseria meningitidis, any of which can cause invasive meningococcal disease (IMD).

The US Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices is expected to vote on recommendations for the appropriate use of this vaccine in the 10-to-25 age group at its meeting on Feb. 26, 2025 (1).

Although altogether uncommon, IMD is a serious illness which, in up to one in six who contract it, can lead to death in as little as 24 hours from onset, even despite treatment (1). Adolescents and young adults between the ages of 16 and 23 are most at risk, GSK said, due to common behaviors including living in close quarters—such as college dormitories—kissing, and sharing drinks, utensils, or smoking devices. Early symptoms are often mistaken for the flu.

Even one in five survivors may experience long-term complications including brain damage, amputations, hearing loss, or nervous system issues (1).

“The consequences of IMD can be devastating for those who contract it, for their families and friends,” Judy Klein, president and founder of Unity Consortium, a nonprofit organization focused on adolescent health and immunization in the United States, said in a GSK press release (1). “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 five-in-one GSK vaccine combines the antigenic components of two of the company’s already well-established vaccines, Bexsero for group B, and Menveo for groups A, C, Y, and W-135 (1). Results from two Phase III trials, which informed FDA’s decision, positively evaluated Penmenvy’s safety, tolerability, and immune response in more than 4800 participants.

“We are excited about the opportunities ahead to help improve meningococcal vaccination coverage in the United States, especially for IMD caused by serogroup B,” Tony Wood, GSK chief scientific officer, said in the press release. “Building on our global leadership in meningococcal vaccination and our longstanding commitment to address unmet need in disease prevention, we aim to help protect more teens and young adults at a life stage when they are at an increased risk.”

GSK said the leading cause of IMD in adolescents and young adults comes from serogroup B, and yet less than 13% of this population in the US receives the recommended two-dose vaccine series, with less than a third (32%) receiving just one dose (1).

Aside from regulatory approvals, GSK has been announcing numerous new partnerships throughout the fourth quarter of 2024 and into the first quarter of 2025.

In October 2024, the company announced that it was investing £50 million (approximately US$65 million) into a five-year partnership with the University of Cambridge and Cambridge University Hospitals, nominally to treat immune-related diseases with existing as well as newly-developed therapies, but particularly in the two specific categories of kidney and respiratory diseases (2). Strategic deals with two companies were announced in December 2024: with Relation, for the identification and validation of novel therapeutic targets for fibrotic diseases and osteoarthritis, and with Muna Therapeutics, to identify and validate novel drug targets for treating Alzheimer’s disease (3,4).

And as 2025 began, GSK said in January that it has entered into a new research collaboration with the University of Oxford that will focus on the potential of cancer prevention through vaccination (5).

References

1. GSK. Penmenvy, GSK’s 5-in-1 Meningococcal Vaccine, Approved by US FDA to Help Protect Against MenABCWY. Press Release. Feb. 15, 2025.
2. GSK. GSK and Cambridge University Announce New Five-Year Collaboration in Kidney and Respiratory Disease. Press Release. Oct. 21, 2024.
3. Relation. Relation Announces Two Strategic Collaborations with GSK to Advance Therapeutics for Fibrotic Diseases and Osteoarthritis. Press Release. Dec. 10, 2024.
4. Muna Therapeutics. Muna Therapeutics Announces Strategic Alliance with GSK to Accelerate Development of Novel Treatments for Alzheimer’s Disease. Press Release. Dec. 5, 2024.
5. GSK. GSK and Oxford Establish the GSK-Oxford Cancer Immuno-Prevention Programme to Advance Novel Cancer Research. Press Release. Jan. 27, 2025.