GSK Plc’s Penmenvy vaccine backed by US Advisory Panel

GSK plc (LON/NYSE: GSK) has announced that the US Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) has voted to recommend use of Penmenvy (Meningococcal Groups A, B, C, W, and Y Vaccine) as part of the adolescent meningococcal vaccination schedule. Recommendations made by the ACIP are reviewed and, if adopted, are published as official CDC recommendations.

·      Vaccine recommended to help protect persons over 10 years old in the United States (US) against disease-causing serogroups of Neisseria meningitidis (A, B, C, W and Y)

·      Broad serogroup coverage in one vaccine reduces injections to help improve vaccination rates and help protect more US adolescents and young adults

·      Vaccine doses will be ready for use in the US from Summer 2025

ACIP voted to recommend that persons over 10 years old receive a single dose of Penmenvy as an alternative to separate administration of meningococcal serogroups A, C, W and Y (MenACWY) and meningococcal serogroup B (MenB) vaccinations when both vaccines would be given on the same clinic visit, typically at age 16. This recommendation, if adopted, will allow for vaccination against serogroups A, B, C, W and Y in fewer doses, could simplify meningococcal vaccination delivery and could improve immunisation rates, helping protect more US adolescents against these five disease-causing serogroups for which the US CDC has previously issued recommendations.¹

GSK’s MenABCWY vaccine combines the antigenic components of the Company’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). On 14 February 2025, the US Food and Drug Administration (FDA) approved GSK’s MenABCWY vaccine for use in individuals aged 10 through 25 years.²

Tony Wood, Chief Scientific Officer at GSK, said: “We welcome this positive recommendation that can help  strengthen disease prevention efforts in the US. Pentavalent vaccines can reduce the number of injections required to help protect against invasive meningococcal disease – especially disease caused by serogroup B. Their use could improve immunisation rates among adolescents and young adults in the US, who are at an age with increased risk.”

Although MenB is the leading cause of invasive meningococcal disease (IMD) among this population, less than 13% of 17-year-olds received the recommended two-dose vaccination series; around 32% received at least one dose according to 2023 CDC survey data.^3,4 Three of every four MenB doses currently administered in the US are manufactured by GSK,⁵ positioning the company well to lead in the US market as MenB-containing vaccination schedules must be completed with the same manufacturer’s MenB vaccine.⁶

References:

1. Centers for Disease Control and Prevention. About Meningococcal Vaccines. Available at: https://www.cdc.gov/vaccines/vpd/mening/hcp/about-vaccine.html. Accessed April 2025.
2. GSK. Penmenvy, GSK’s 5-in-1 meningococcal vaccine, approved by US FDA to help protect against MenABCWY. Available at: https://www.gsk.com/en-gb/media/press-releases/penmenvy-gsk-s-5-in-1-meningococcal-vaccine-approved-by-us-fda-to-help-protect-against-menabcwy/. Accessed April 2025.
3. Cheng WY, et al. Determinants of Meningococcal ACWY vaccination in adolescents in the US: completion and compliance with the CDC recommendations. Hum Vaccin Immunother. 2020;16(1):176-188.
4. Centers for Disease Control and Prevention. National Vaccination Coverage Among Adolescents Aged 13-17 Years – National Immunization Survey-Teen, United States, 2023. Available at: https://www.cdc.gov/mmwr/volumes/73/wr/mm7333a1.htm#:~:text=Among%20adolescents%20aged%2013%E2%80%9317%20years%20included%20in%20the%202023,view%2Fcdc%2F159388. Accessed April 2025.
5. GSK Data on File Calculation of GSK share in US MenB market January – December 2024. REF-269547. Based on information licensed from IQVIA: IQVIA, DDD, Meningococcal B market all channels, period January – December 2024, reflecting estimates of real-world activity. All rights reserved.
6. Centers for Disease Control and Prevention. Meningococcal Vaccine Recommendations. Available at: https://www.cdc.gov/meningococcal/hcp/vaccine-recommendations/index.html. Accessed April 2025.