FDA approves pentavalent meningococcal vaccine for patients aged 10 to 25 years

FDA approves pentavalent meningococcal vaccine for patients aged 10 to 25 years | Image Credit: © Calin - © Calin - stock.adobe.com.

The FDA has approved Pfizer’s investigational pentavalent meningococcal vaccine (PENBRAYA; Pfizer) for individuals aged 10 to 25 years, according to a company press release announcing the approval.¹

The vaccine was developed to prevent meningococcal disease caused by the most common serogroups by combining 2 vaccines into 1, allowing protection against serogroups that causes most of the invasive meningococcal disease (IMD) globally, according to the company. There are approximately 55 million adolescents and young adults in the 11-to-23-year age range for meningococcal vaccination. Though uncommon, meningococcal disease can lead to death within 24 hours and can alter life and leave survivors with significant long-term disabilities. Serogroup B accounts for most of the disease in adolescents and young adults, and the 5 most common serogroups make up 95% of all IMD cases, worldwide.²

Currently, the platform for meningococcal vaccination amongst adolescents and young adults includes 2 doses of MenACWY vaccines, and a separate, shared clinical decision recommendation for 2 doses of MenB-specific vaccines, according to Pfizer. The pentavalent meningococcal vaccine Pfizer developed combines components from meningococcal group B vaccine (Trumenba; Pfizer) and meningococcal groups A, C, W-135, and Y conjugate vaccine. The review of a Biologics License Application for MenABCWY was accepted by the FDA in December of 2022.²

“Nearly 9 out of 10 adolescents have incomplete protection against invasive meningococcal disease caused by the leading serogroups,” said Jana Shaw, MD, pediatrics infectious disease specialist, Upstate Golisano Children's Hospital in Syracuse, New York. “For the first time, we have a single vaccine that helps protect against the five most common serogroups and has the potential to improve coverage and increase protection among adolescents and young adults.”

In September of 2022, Pfizer announced topline results from a phase 3 trial that assessed tolerability, safety, and immunogenicity in individuals aged 10 to 25 years (NCT04440163). Study participants were randomly assigned to receive 2 doses of MenABCWY or the licensed vaccines Trumenba (2 doses) plus Meningococcal (Groups A, C, Y, and W-135) (Menveo; GSK) (1 dose).³

Non-inferiority was demonstrated in all 5 serogroups after 2 doses of MenABCWY compared to 2 doses of Trumenba and 1 dose of Menveo. Non-inferiority critera was met by a single dose of MenABCWY for serogroups A, C, W, and Y compared to one dose of Menveo. For those who had not previously received a meningococcal vaccine, the proportion of individuals with a 4-fold increase or greater in immune responses was higher after either 1 or 2 doses of MenABCWY for A, C, W, and Y serogroups compared to one dose of Menveo.³

References:

1. FDA Approves PENBRAYA, the First and Only Vaccine for the Prevention of the Five Most Common Serogroups Causing Meningococcal Disease in Adolescents. Pfizer. October 20. 2023. Accessed October 20, 2023. https://www.pfizer.com/news/press-release/press-release-detail/fda-approves-penbrayatm-first-and-only-vaccine-prevention
2. US FDA accepts for review of the Biologics License Application for Pfizer’s investigational pentavalent meningococcal vaccine candidate (MenABCWY) in adolescents. Pfizer. Press release. December 28, 2022. Accessed October 19, 2023. https://www.pfizer.com/news/press-release/press-release-detail/us-fda-accepts-review-biologics-license-application-pfizers
3. Pfizer announces positive top-line results from phase 3 trial of pentavalent meningococcal vaccine candidate (MenABCWY) in adolescents. Pfizer. Press release. September 22, 2023. Accessed October 19, 2023. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-announces-positive-top-line-results-phase-3-trial-0