FDA Approves Pfizer’s Vaccine for Meningococcal Disease

The U.S. Food and Drug Administration has approved Pfizer’s application for Penbraya, a vaccine for people 10 through 25 that will offer protection against the five main kinds of bacteria that cause meningitis and blood poisoning.

The new drug will reduce the number of doses that people need to be fully vaccinated, Pfizer said in a news release. Penbraya will be given as a two-dose series administered six months apart, Pfizer said. Medical authorities currently recommend Trumenba for meningococcal group B and Nimenrix for meningococcal groups A, C, W-135, and Y, meaning people need four doses for full protection. “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 of vaccine research and development for Pfizer, said in the release. Penbraya combines Trumenba, which is made by Pfizer, with Menveo, which is made by GSK and is similar to Nimenrix. The FDA based its decision on phase 2 and 3 clinical trials that showed Penbraya was “well-tolerated with a favorable safety profile,” Pfizer said. The FDA published its approval letter on Friday. Pfizer said the CDC’s Advisory Committee on Immunization Practices will meet Oct. 25 to discuss recommendations for the use of Penbraya in adolescents and young adults. Meningococcal meningitis is a rare but serious bacterial infection that infects the lining of the brain and the spinal cord. The CDC says children younger than 1, teens and young adults 16-23, and adults over 65 are most at risk.

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