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FDA approves Pfizer vaccine for meningococcal disease

October 23, 2023 – The U.S. Food and Drug Administration has approved Pfizer's application for Penbraya, a vaccine for people ages 10 to 25 that gives protection against the five major forms of bacteria that cause meningitis and sepsis.

The recent drug will reduce the variety of doses people should be fully vaccinated, Pfizer said in an announcement Press release.

Penbraya will probably be administered as a two-dose series six months apart, Pfizer said. Medical authorities currently recommend Trumenba for group B meningococci and Nimenrix for meningococci groups A, C, W-135 and Y, meaning people need 4 doses for full protection.

“With a single vaccine, PENBRAYA has the potential to protect more adolescents and young adults from this serious and unpredictable disease by providing the most comprehensive meningococcal coverage with the fewest vaccinations,” said Annaliesa Anderson, PhD, senior vp and head of the Vaccine research and development for Pfizer, the press release said.

Penbraya combines Trumenba, made by Pfizer, with Menveo, made by GSK and just like Nimenrix. The FDA based its decision on phase 2 and three clinical trials that showed Penbraya was “well tolerated and with a favorable safety profile,” Pfizer said.

The FDA has published theirs Approval letter on Friday. Pfizer said the CDC's Advisory Committee on Immunization Practices will meet on Oct. 25 to debate recommendations for the usage of Penbraya in adolescents and young adults.

Meningococcal meningitis is a rare but serious bacterial infection that affects the liner of the brain and spinal cord. The CDC says Children under 1 yr old, adolescents and young adults between the ages of 16 and 23, and adults over 65 are most in danger.