FDA Approves Vaccine for Prevention of the Five Most Common Serogroups Causing Meningococcal Disease in Adolescents

On Oct. 20, 2023 Pfizer announced that PENBRAYA, its vaccine for meningococcal groups A, B, C, W, and Y, has been approved by FDA. According to Pfizer, PENBRAYA is the first and only vaccine to protect against the five most common serogroups that cause meningococcal disease in patients aged 10 through 25. PENBRAYA combines components from two meningococcal vaccines, Trumenba (meningococcal group B vaccine) and Nimenrix (meningococcal groups A, C, W-135, and Y conjugate vaccine). It is administered as a two-dose series given six months apart.

Meningococcal disease is an uncommon but serious illness that can be fatal within 24 hours or cause significant long-term disabilities for survivors. PENBRAYA reduces the number of doses to fully vaccinate individuals against the five most common serotypes of the disease, which Pfizer hopes can increase the number of adolescents and young adults vaccinated. This is substantiated by a report from the US Centers for Disease Control and Prevention (CDC), which stated that combining vaccines into fewer shots could mean a higher rate of adolescents and young adults getting vaccinated on time.

The FDA approval was based on data from Phase II and Phase III trials, which included a randomized, actively controlled, and observer-blinded Phase III trial. The trials assessed the safety and efficacy of PENBRAYA in comparison to current US-licensed meningococcal vaccines, with the goal of determining immunologic noninferiority. The Phase III trial evaluated more than 2400 patients from the United States and Europe.

Source: Pfizer, CDC