FDA Approves Vaccine for Meningococcal Disease in Adolescents
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 years.
- By BSTQ Staff
Pfizer’s PENBRAYA, a vaccine for meningococcal groups A, B, C, W and Y, has been approved by the U.S. Food and Drug Administration (FDA). 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 years. The vaccine 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.
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 U.S.-licensed meningococcal vaccines, with the goal of determining immunologic noninferiority. The Phase III trial evaluated more than 2,400 patients from the United States and Europe.
References
Husni, DG. FDA Approves Vaccine for Prevention of the Five Most Common Serogroups Causing Meningococcal Disease in Adolescents. BioPharm, Oct. 30, 2023. Accessed at www.biopharminternational.com/view/fda-approves-vaccine-for-prevention-of-the-five-most-common-serogroups-causing-meningococcal-disease-in-adolescents.
