The FDA granted full-approval to Pfizer's meningococcal disease immunization, Penbraya, on Oct. 20.
The new vaccine provides what Pfizer noted in a press release is the "broadest" protection in a single shot yet, against meningococcal groups A, B, C, W and Y. In its phase 3 trial of more than 2,400 people, Penbraya showed positive results for safety and efficacy, which is what prompted the FDA's approval for its use in individuals between 10 and 25 years old.
"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," Jana Shaw, MD, a pediatrics infectious disease specialist at Upstate Golisano Children's Hospital in Syracuse, N.Y., stated in Pfizer's news release.
Further determinations about the vaccine's recommendations for children and young adults will be discussed Oct. 25 by the CDC's Advisory Committee on Immunization Practices.