FDA approves Pfizer’s Penbraya: The first vaccine to prevent all types of meningitis

The U.S. FDA has approved Pfizer's Penbraya, marking a significant milestone in the world of vaccines. Penbraya is the first-ever pentavalent vaccine designed to combat all five primary serogroups of meningococcal disease. This breakthrough could radically alter the landscape of meningitis prevention.

The U.S. Food and Drug Administration (FDA) has approved Pfizer's Penbraya, the first pentavalent vaccine targeting all five primary meningococcal disease serogroups for individuals aged 10-25. Streamlining protection, Penbraya requires only two doses, potentially boosting vaccination rates. The vaccine's efficacy is backed by extensive research, including phase 3 trials. The CDC will discuss its use on October 25, while GSK is also developing a similar vaccine.

Meningococcal disease is a severe bacterial infection that can lead to meningitis, affecting the brain and spinal cord, and bloodstream infections. Despite its rarity, its rapid progression can result in death within hours, and survivors may grapple with debilitating long-term effects.

“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. 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, ” said Annaliesa Anderson, Ph.D., Senior Vice President and Head, Vaccine Research and Development, Pfizer.

Drawing from Pfizer's established vaccines, Trumenba and Nimenrix, Penbraya offers protection against serogroups A, B, C, W, and Y. These groups are notorious for causing the majority of invasive meningococcal disease cases. Historically, protection against these five serogroups necessitated two different vaccines, translating to four injections. Penbraya, however, streamlines this into just two doses.

This simplified approach hopes to boost vaccination rates, with the CDC noting that fewer shots can lead to more timely vaccinations, reducing protection delays against grave diseases.

Jana Shaw, MD, a Pediatrics Infectious Disease Specialist, UG Children's Hospital, highlighted the alarming statistic that

 “Nearly 9 out of 10 adolescents have incomplete protection against invasive meningococcal disease caused by the leading serogroups. 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.”

This FDA approval springs from extensive research, including phase 2 and phase 3 trials. A pivotal Phase 3 trial (NCT04440163) incorporated over 2,400 patients from the U.S. and Europe. The results showcased Penbraya's strong immunogenicity and a favorable safety profile.

While Pfizer leads the race with this FDA approval, GlaxoSmithKline (GSK) isn't far behind. They too are venturing into the pentavalent vaccine territory with their candidate, MenABCWY. Last year, GSK disclosed a study juxtaposing MenABCWY with a Bexsero and Menveo combination.

Lastly, it's essential to underline the imminent discussions by the CDC's Advisory Committee on Immunization Practices on October 25, where recommendations for Penbraya's appropriate use will be on the table.