FDA Approves Pentavalent Vaccine for Most Common Serogroups That Cause Meningococcal Disease

The FDA has approved Penbraya (Pfizer Inc) as the first and only pentavalent immunization that confers protection against the 5 most common meningococcal serogroups—A, B, C, W-135, and Y—in individuals 10 through 25 years of age. The vaccine combines the components from the meningococcal group B vaccine Trumenba and the meningococcal groups A, C, W-135, and Y conjugate vaccine Nimenrix. Penbraya was found to protect against these 5 meningococcal serogroups, which cause the most cases of global invasive meningococcal disease.¹

“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,” said Annaliesa Anderson, PhD, senior vice president and head, Vaccine Research and Development, Pfizer, in a press release.¹

The FDA based its approval on results from a pivotal phase 3 trial (NCT04440163) that evaluated more than 2400 patients from the United States and Europe.² The randomized, active-controlled, observer-blinded trial evaluated the safety, tolerability, and immunogenicity of Penbraya vs currently licensed meningococcal vaccines to analyze immunologic noninferiority. The trial achieved all primary and secondary endpoints, as Penbraya demonstrated non-inferiority to licensed vaccines for the 5 meningococcal serogroups.²

A single dose of the vaccine achieved non-inferiority criteria for serogroups A, C, W, and Y compared to a single dose of Menveo.² Additionally, among participants who were not previously administered a meningococcal vaccine, the proportion of those with ≥4-fold increases in immune responses was higher after receiving either 1 or 2 doses of Penbraya for serogroups A, C, W and Y compared to 1 dose of Menveo, according to the study.²

Further, the proportion of participants with ≥4-fold increases in immune responses was higher against all 4 serogroup B strains after 2 doses of Penbraya vs 2 doses of Trumenba. Penbraya was also found to be well-tolerated, with a safety profile consistent with licensed vaccines, according to Pfizer.

Current US vaccination recommendations for adolescents and young adults include a meningococcal group B vaccine and a separate vaccine for meningococcal groups A, C, W-135, and Y, for a total of 4 doses, to achieve the broadest protection available. Data show that fewer than one-third of US adolescents receive a single dose of the group B vaccine, and even fewer complete the 2-dose series.

Today’s approval could help to simplify the meningococcal vaccination schedule by lowering the total number of doses needed to be fully protected against the 5 serogroups, according to Pfizer.

The CDC Advisory Committee on Immunization Practices is expected to meet on October 25, 2023, to address recommendations for the appropriate use of Penbraya in adolescents and young adults.

“Nearly 9 out of 10 adolescents have incomplete protection against invasive meningococcal disease caused by the leading serogroups,” pediatrics infectious disease specialist Jana Shaw, MD, of Upstate Golisano Children's Hospital, said in a press release.¹ “For the first time, we have a single vaccine that helps protect against the 5 most common serogroups and has the potential to improve coverage and increase protection among adolescents and young adults.”

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. News release. October 20, 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. Pfizer. News release. September 25, 2022. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-announces-positive-top-line-results-phase-3-trial-0