• 25 Oct 2023
• Admin
• News Article

FDA approves PENBRAYA™, the first and only vaccine for the prevention of the five most common serogroups causing meningococcal disease in adolescents

Pfizer Inc announced that the U.S. Food and Drug Administration (FDA) has approved PENBRAYA™ (meningococcal groups A, B, C, W and Y vaccine), 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) globally.(1)

"As a pioneer in vaccines, one of our goals is to deliver vaccines that evolve the paradigm and help simplify the standard of care in the U.S.," said Annaliesa Anderson, Ph.D., Senior Vice President and Head, Vaccine Research and Development, Pfizer. "Today marks an important step forward in the prevention of meningococcal disease in the U.S. 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."

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.(2) PENBRAYA reduces the total number of doses needed for individuals to be fully vaccinated against the five most common serogroups, thereby streamlining the standard of care and potentially increasing the number of adolescents and young adults vaccinated.(3) According to the U.S. Centers for Disease Control and Prevention (CDC), combining vaccines into fewer shots may mean that more adolescents and young adults get their recommended vaccines on time, resulting in fewer delays in protection against serious diseases.(4) Routine use of PENBRAYA could also reduce IMD cases and associated mortality, the rate of long-term consequences of infection (sequelae) in survivors and costs associated with controlling outbreaks.(5)

"Nearly 9 out of 10 adolescents have incomplete protection against invasive meningococcal disease caused by the leading serogroups(6)," said Jana Shaw, MD, Pediatrics Infectious Disease Specialist, Upstate Golisano Children's Hospital in Syracuse, NY. "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."

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, with the goal of determining immunologic noninferiority. The Phase 3 trial (NCT04440163) evaluated more than 2,400 patients from the U.S. and Europe.

The CDC Advisory Committee on Immunization Practices (ACIP) will meet on October 25, 2023, to discuss recommendations for the appropriate use of PENBRAYA in adolescents and young adults.

About PENBRAYA Regulatory Review

In September 2022, Pfizer announced positive results from a randomized, active-controlled and observer-blinded Phase 3 trial assessing the safety, tolerability, and immunogenicity of the PENBRAYA compared to currently licensed meningococcal vaccines, with the goal of determining immunologic noninferiority. The Phase 3 trial (NCT04440163) evaluated more than 2,400 patients from the U.S. and Europe. This trial was followed by the FDA's acceptance of PENBRAYA's Biologics License Application (BLA) in December 2022.