FDA approves GSK's Penmanbee vaccine targeting meningococcal serum groups A, B, C, W, and Y

GSK is a biopharma company focused on developing medicines and vaccines to address health challenges.

GSK PLC has announced that the US Food and Drug Administration (FDA) has approved the Penmenbie (Menococcal Groups A, B, C, W, and Y vaccines) for individuals aged 10 to 25 years old. This vaccine is designed to protect against five major serogroups of Neisseria Meningitidis (a, b, c, w, y) causes invasive meningococcal disease (IMD).¹

MENABCWY combines the protective ingredients of two existing vaccines from GSK. Meningococcal Group B Vaccine Bexin Bexilo and Meningococcus (Groups A, C, Y, and W-135) Oligosaccharide Diphtheria CRM₁₉₇ Joint Vaccine Menbeo. With approval from MENABCWY, a second pentagonal meningococcal vaccine will be available, and Penbraya will join Penbraya, targeting the same five meningococcal serogroups.¹

In the international observer-blind, three-phase 3 clinical trial (NCT04502693), Menabcwy showed promising results. The study included 3,650 participants aged 10 to 25 in the United States, Canada and other countries. The vaccine fulfilled all 11 key endpoints and was shown to have not violated the combination of Vexero and Menveo in terms of immunological efficacy.²

Specifically, MENABCWY produced a strong immune response against a panel of 110 diverse membrane strains, covering 95% of US circulating strains, with no significant safety concerns. ,b,c,w,y). These results position Menabcwy as an important tool in reducing the incidence of invasive meningococcal disease, especially among adolescents and young adults at higher risk.²

MENABCWY is administered as two intramuscular (IM) injections, as it is 6 months apart, followed by a similar dosing regimen as Penblaya. MENABCWY approval is expected to enhance primary care and protection of pediatric populations, providing an effective option to prevent meningococcal disease in a wider age group.¹

In a press release, Tony Wood, GSK's Chief Science Officer, said: Our long-standing commitment to addressing unmet needs in vaccination and disease prevention, We aim to protect more teens and young people at a high-risk life stage. ”¹

What you need to know

GSK's Penmanby vaccine is FDA approved to protect individuals aged 10-25 years from five meningococcal serum groups (A, B, C, W, and Y).

MENABCWY combined the Bexsero and Menveo elements to demonstrate a strong immune response and met all key endpoints in Phase 3 trials.

MENABCWY approval provides enhanced protection against meningococcal disease in adolescents and young adults, particularly in high-risk environments such as dormitories.

IMD is a serious, often rapidly progressing disease, and can lead to death in just 24 hours. The symptoms can be similar to those of the flu, so they are often misdiagnosed early on.¹ However, it can lead to fatal infections such as meningitis (inflammation of the brain and spinal cord) and bloodstream infections.³ Adolescents, especially those who live in close-knit living environments such as dormitories, are at a higher risk of contracting illness.¹

The CDC Advisory Committee on Vaccination Practices (ACIP) will meet on February 26, 2025 to discuss recommendations for vaccine use in target age groups.¹

reference

1. GSK. Penmenvy, GSK's 5-in-1 meningococcal vaccine, approved by the US FDA. February 14, 2025. Accessed on February 14th, 2025. https://us.gsk.com/en-us/media/press-releases/penmenvy-gsk-s-5-in-1-meningoccal-vaccine-approved-by -us-fda-to-help-protect- Against-menabcwy/

2. GSK achieves the primary endpoint meningococcal ABCWY vaccine for phase 3 trials. Condensation. March 15, 2024. February 14, 2024.
https://www.contagionlive.com/view/gsk-achieves-primary-endpoints-meningococcal-abcwy-vaccine-for-phase-3-trial

3. Centers for Disease Control and Prevention. Meningococcal disease. Centers for Disease Control and Prevention. Updated on February 1st, 2024. Accessed February 14, 20252025.https://www.cdc.gov/meningoccal/about/index.html

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