First Pentavalent Vaccine Approved for the Prevention of Serogroups Causing Meningococcal Disease in Adolescents

Pfizer Inc. recently announced that the U.S. Food and Drug Administration (FDA) approved PENBRAYA™, the first and only pentavalent vaccine that provides coverage against the most common serogroups causing meningococcal disease in adolescents and young adults 10 through 25 years of age.

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 five most common meningococcal serogroups that cause the majority of invasive meningococcal disease (IMD).

The FDA's decision is based on the positive results from the Phase 2 and Phase 3 trials, including a randomized, active-controlled, and observer-blinded Phase 3 trial assessing the safety, tolerability, and immunogenicity of the pentavalent vaccine candidate compared to currently U.S. licensed meningococcal vaccines, to determine immunologic noninferiority.

"Nearly 9 out of 10 adolescents have incomplete protection against IMD caused by the leading serogroups," said Jana Shaw, MD, Pediatrics Infectious Disease Specialist, Upstate Golisano Children's Hospital in Syracuse, NY, in a Pfizer press release on October 20, 2023.

"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."

Meningococcal disease is an uncommon but serious illness that can lead to death within 24 hours and, for survivors, can result in life-altering, significant long-term disabilities.

The U.S. CDC Advisory Committee on Immunization Practices is scheduled to meet on October 25, 2023, to discuss recommendations for the appropriate use of PENBRAYA in adolescents and young adults and other vaccines.

Various meningococcal vaccines are approved by the CDC in 2023.