FDA Approves Pfizer’s Penbraya, the First Pentavalent Vaccine Targeting All Five Most Common Meningococcal Serogroups

▎WuXi

Edited by Kant Content Team

Pfizer, Inc. announced today,The U.S. FDA has approved the Penbraya meningococcal vaccine for marketing.. The press release pointed out,This is the first pentavalent vaccine that can cover the most common serotypes causing meningococcal disease in adolescents and young adults aged 10 to 25.Penbraya combines the components of two meningococcal vaccines, Trumenba (MenB vaccine) and Nimenrix (MenACWY conjugate vaccine), to help prevent the five most common meningococcal serotypes responsible for the majority of invasive meningococcal disease cases globally.

Meningococcal Disease

Penbraya reduces the total number of doses required for full vaccination against the five most common serotypes, thereby simplifying the standard of care and potentially increasing the number of adolescents and young adults receiving the vaccine.

The approval by the U.S. FDA is based on positive results from Phase 2 and Phase 3 clinical trials, including a randomized, active-controlled, and observer-blinded Phase 3 clinical trial evaluating the safety, tolerability, and immunogenicity of the pentavalent candidate vaccine compared to previously approved meningococcal vaccines. Data analysis found,Participants who received two doses of Penbraya pentavalent vaccine showed non-inferior immune responses across all five serotypes compared to those who received the control group vaccines (two doses of Trumenba plus one dose of Menveo). Additionally, a single dose of Penbraya vaccine demonstrated non-inferiority in immune response against serotypes A, C, W, and Y when compared to a single dose of Menveo vaccine.

Moreover, among individuals who had not previously received a meningococcal vaccine, the proportion of participants who received 1 or 2 doses of Penbraya and developed a ≥4-fold immune response against serogroups A, C, W, and Y was higher than those who received 1 dose of Menveo. Additionally, the proportion of participants who received 2 doses of Penbraya and developed a ≥4-fold immune response against serogroup B was also higher than those who received 2 doses of Trumenba.