FDA approves GSK’s pentavalent meningococcal vaccine
Key takeaways:
- Penmenvy protects against meningococcal serotypes A, B, C, W and Y.
- CDC vaccine advisors are set to discuss recommendations for the vaccine on Feb. 26.
The FDA approved GSK’s pentavalent meningococcal vaccine to protect children and young adults aged 10 to 25 years against five meningococcal serogroups, the company announced.
The vaccine, branded as Penmenvy, combines components from two of GSK’s existing vaccines: Bexsero, which protects against serogroup B; and Menveo, which protects against serogroup A, C, W and Y.
“We are excited about the opportunities ahead to help improve meningococcal vaccination coverage in the United States, especially for invasive meningococcal disease caused by serogroup B,” Tony Wood, PhD, BSc, GSK’s chief scientific officer, said in a press release.
According to the release, serogroup B is the leading cause of invasive meningococcal disease among adolescents and young adults, but only 32% of this population receive their first dose and less than 13% receive both recommended doses.
The approval was based, in part, on data from two phase 3 trials of more than 4,800 participants, which demonstrated a “clinically meaningful immune response” in participants who received two doses 6 months apart, according to a company report.
Adverse events associated with Penmenvy included pain at the injection site, fatigue, headache, myalgia, nausea, erythema and swelling, the company reported.
GSK’s vaccine is the second pentavalent vaccine to enter the market. Penmenvy and Pfizer’s Penbraya both protect against the five most common serogroups that affect young people.
The CDC’s Advisory Committee on Immunization Practices (ACIP) recommended Penbraya for visits where patients are due to get both a Men B and MenACWY vaccine. The committee also unanimously voted to add the vaccine to the Vaccines for Children program, which offers free vaccines to children whose families are unable to pay for them.
The ACIP is scheduled to discuss recommendations for Penmenvy at its Feb. 26 meeting.
References:
- GSK announces positive pivotal phase III data for 5-in-1 meningococcal ABCWY vaccine candidate. https://www.healio.com/news/pediatrics/20240416/fda-accepts-gsks-pentavalent-meningococcal-vaccine-for-review. Updated May 11, 2023. Accessed Feb. 17, 2025.
- Penmenvy, GSK’s 5-in-1 meningococcal vaccine, approved by U.S. FDA to help protect against MenABCWY. https://us.gsk.com/en-us/media/press-releases/penmenvy-gsk-s-5-in-1-meningococcal-vaccine-approved-by-us-fda-to-help-protect-against-menabcwy/. Published Feb. 14, 2025. Accessed Feb. 17, 2025.
