FDA Approves Penbraya Vaccine to Prevent Against Meningococcal A, B, C, W, and Y

The FDA has approved meningococcal groups A, B, C, W, and Y vaccine Penbraya, the first and only pentavalent vaccine against the most common meningococcal disease-causing serogroups in adolescents and young adults, according to a news release from Pfizer.¹ Penbraya is administered in a 2-dose series, with shots given 6 months apart.

Although meningococcal disease is uncommon, it is a serious illness that can lead to death within 24 hours of infection; survivors may experience “life-altering, significant, long-term disabilities,” the press release noted. Despite these risks, “nearly 9 out of 10 adolescents have incomplete protection against invasive meningococcal disease caused by the leading serogroups,” said Jana Shaw, MD, a pediatric infectious disease specialist at Upstate Golisano Children’s Hospital in Syracuse, New York. “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.”

According to the CDC, combining vaccines into fewer shots may lead to more adolescents and young adults receiving recommended vaccines on time. For meningococcal disease, Penbraya reduces the total number of doses needed to be fully immunized against the disease.

The FDA’s approval decision was based on positive results from phase 2 and phase 3 clinical trials, including a randomized, active-controlled, observer-blinded phase 3 trial assessing safety, tolerability, and immunogenicity associated with the pentavalent vaccine vs the currently licensed vaccines “with the goal of determining immunologic noninferiority.” The phase 3 trial (NCT04440163) included more than 2400 adolescent and young adult patients from across the United States and Europe.

Positive results of that phase 3 clinical trial were announced in September 2022; the FDA accepted the Biologics License Application for Penbraya in December 2022.

Reference

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 20, 2023. https://www.businesswire.com/news/home/20231019164717/en/FDA-Approves-PENBRAYA%E2%84%A2-the-First-and-Only-Vaccine-for-the-Prevention-of-the-Five-Most-Common-Serogroups-Causing-Meningococcal-Disease-in-Adolescents