FDA Approves Pentavalent Meningococcal Vaccine from Pfizer for Ages 10 to 25 years

The FDA has approved the Pfizer pentavalent vaccine against meningococcal disease, to be marketed as Penbraya (groups A, B, C, W and Y vaccine). The vaccine is indicated for active immunization against invasive disease caused by Neisseria meningitidis serogroups A, B, C, W, and Y. Penbraya is approved for use in individuals aged 10 to 25 years.¹

^{©Waldenmarus/stock.adobe.com}

“Today marks an important step forward in the prevention of meningococcal disease in the US. In a single vaccine, Penbraya has the potential to protect more adolescents and young adults from this severe and unpredictable disease by providing the broadest meningococcal coverage in the fewest shots,” Annaliesa Anderson, PhD, senior vice president and head, Vaccine Research and Development, Pfizer, said in a company announcement.¹

Penbraya combines the components from two meningococcal vaccines, Trumenba (meningococcal group B vaccine) and Nimenrix (meningococcal groups A, C, W-135, and Y conjugate vaccine) to help protect against the 5 most common meningococcal serogroups that cause the majority of invasive meningococcal disease (IMD) globally, according to the Pfizer statement.¹

Results from phase 2 and phase 3 clinical trials formed the basis for the FDA’s decision. Those studies included a randomized, active-controlled, and observer-blinded phase 3 trial comprised of more than 2400 participants from the US and Europe. Findings from that trial, reported in September 2022, were followed by the FDA’s acceptance of the biologics license application for Penbraya.¹

The pivotal phase 3 study assessed the safety, tolerability, and immunogenicity of the investigational pentavalent meningococcal vaccine, known then as MenABCWY, in healthy individuals aged 10 to 25 years.² Participants in the trial were randomly assigned to receive either 2 doses of MenABCWY or licensed vaccines (2 doses of Trumenba plus 1 dose of Menveo). The results showed non-inferiority for all 5 serogroups following 2 doses of the pentavalent MenABCWY compared to 2 doses of Trumenba and 1 dose of Menveo.²

Pfizer also reported then that a single dose of MenABCWY met the non-inferiority criteria for serogroups A, C, W and Y compared to one dose of Menveo.² Among individuals who had not previously received a meningococcal vaccine, the proportion of participants with 4-fold or greater increases in immune responses was higher following either 1 or 2 doses of MenABCWY for serogroups A, C, W and Y compared to a single dose of Menveo.²

Finally, the proportion of study participants with 4-fold or greater increases in immune responses was also observed to be higher against all 4 serogroup B strains following 2 doses of MenABCWY compared to 2 doses of Trumenba. The pentavalent vaccine candidate was well-tolerated, with a safety profile consistent with licensed vaccines.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, NY, in the press statement.¹ “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.”¹

The CDC Advisory Committee on Immunization Practices (ACIP) will meet on October 25 to discuss recommendations for the appropriate use of Penbraya in adolescents and young adults.¹

References

1. FDA approves Penbraya, the first and only vaccine for the prevention of the five most common serogroups causing meningococcal disease in adolescents. News release. Pfizer. October 20, 2023. Accessed October 24, 2023. https://www.pfizer.com/news/press-release/press-release-detail/fda-approves-penbrayatm-first-and-only-vaccine-prevention
2. Pfizer announces positive top-line results from phase 3 trial of pentavalent meningococcal vaccine candidate (MenABCWY) in adolescents. News release. Pfizer. September 15, 2022. Accessed October 224, 2023. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-announces-positive-top-line-results-phase-3-trial-0