Pfizer gets US nod for pentavalent meningococcal vaccine Penbraya
20 Oct 2023
Clinical ResultPhase 3Drug ApprovalVaccine
The FDA on Friday approved Pfizer's pentavalent meningococcal vaccine Penbraya for adolescents and young adults ages 10 through 25 years. Penbraya, which combines the components of Pfizer's Trumenba (meningococcal group B vaccine) and Nimenrix (meningococcal groups A, C, W-135, and Y conjugate vaccine), becomes the first vaccine cleared to prevent the five most common serogroups causing meningococcal disease.
"In a single vaccine, Penbraya has the potential to protect otherwise healthy adolescents and young adults from this severe and unpredictable disease by providing the broadest meningococcal coverage in the fewest shots," commented Annaliesa Anderson, Pfizer's head of vaccine R&D.
The company's submission was supported by results from a randomised Phase III trial comparing Penbraya against currently licensed meningococcal vaccines in more than 2400 participants. Last year, Pfizer reported that the trial succeeded on all of its primary and secondary endpoints. Specifically, Penbraya was found to be non-inferior to licensed vaccines in the US for all five of the serogroups that cause the majority of invasive meningococcal disease. A single dose of Penbraya also met non-inferiority criteria for serogroups A, C, W and Y compared to one dose of GSK's Menveo.
Earlier this year, GSK reported that its own pentavalent meningococcal vaccine candidate met all primary endpoints in a Phase III study, including non-inferiority to Menveo, which protects against meningococcal groups A, C, Y and W-135, and the company's licensed meningococcal B vaccine Bexsero.
An advisory panel to the US Centers for Disease Control and Prevention (CDC) is set to meet on October 25 to discuss recommendations for the appropriate use of Penbraya in adolescents and young adults.
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