FDA approves Penbraya for protection against meningococcal disease in young patients

October 20, 2023

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Pfizer announced that the FDA has approved Penbraya, the first and only pentavalent vaccine for coverage against the most common serogroups causing meningococcal disease in people aged 10 to 25 years, according to a company press release.

Penbraya combines the components from two meningococcal vaccines, Trumenba (meningococcal group B) and Nimenrix (meningococcal groups A, C, W-135, and Y conjugate).

“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,” Annaliesa Anderson, PhD, senior vice president and head, vaccine research and development at Pfizer, said in the release.

The pentavalent vaccine reduces the total number of doses needed for individuals to be fully vaccinated against the disease, and may thereby streamline standard of care, increasing the number of adolescents and young adults vaccinated and result in fewer delays in protection against serious diseases, the release stated.

The FDA based its decision on the positive results from the phase 2 trial and the randomized, active-controlled and observer-blinded phase 3 trial.

A CDC advisory committee will meet Wednesday to discuss recommendations for use of Penbraya in adolescents and young adults.

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