- Pfizer Inc (NYSE: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 (NYSE: 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.
- Price Action: PFE shares are up 0.26% at $46.27 during the premarket session on the last check Thursday.
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