Pfizer's Pentavalent Meningococcal Vaccine Candidate Shows Efficacy In Adolescents

Pfizer Inc PFE has announced topline results from the Phase 3 trial of its investigational pentavalent meningococcal vaccine (MenABCWY) in healthy individuals 10 through 25 years of age.
The trial met all primary and secondary endpoints, demonstrating non-inferiority to licensed vaccines for the five meningococcal serogroups that cause the most invasive meningococcal disease.
Currently, MenACWY and MenB vaccines are licensed separately, and no single vaccine is available to help protect against the five serogroups.
Participants in the trial were randomly assigned to receive either two doses of MenABCWY or licensed vaccines (two doses of Trumenba + one dose of GSK plc's GSK Menveo).
Non-inferiority was demonstrated for all five serogroups following two doses of MenABCWY compared to two doses of Trumenba and one dose of Menveo.
Additionally, a single dose of MenABCWY met the non-inferiority criteria for serogroups A, C, W and Y compared to one dose of Menveo.
In individuals who had not previously received a meningococcal vaccine, a higher proportion of subjects in the MenABCWY arm achieved ≥4-fold increases in immune responses than Menveo.
Pfizer intends to submit a marketing application with the FDA in Q4 of 2022.
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