Pfizer's Pentavalent Meningococcal Vaccine MenABCWY Meets Phase 3 Endpoints, Aims for FDA Approval in Q4

According to the Zhicheng Caijing APP, Pfizer (PFE.US) stated that its 5-valent meningococcal vaccine MenABCWY, like its own MenB vaccine Trumenba and GlaxoSmithKline's (GSK.US) meningococcal vaccine Menveo, met the primary and secondary endpoints in Phase III trials conducted among healthy individuals aged 10-25.

Data show that the scientific name of meningococcus is Neisseria meningitidis, which is the pathogen of epidemic meningitis. The early symptoms of meningococcal disease may be misinterpreted as a cold. The disease can lead to death within 24 hours and may cause permanent disability, severely and permanently impacting the patient's life.

Although antibiotic treatment is available, approximately 10%-15% of patients will die; among adolescent patients who survive, up to 60% may experience significant physiological and psychological disabilities. Adolescents remain a critically important group for vaccination, with an estimated 1 in 4 adolescents potentially being asymptomatic carriers of Neisseria meningitidis.

Pfizer stated that currently, there is no single vaccine that can help prevent the five serogroups responsible for most invasive meningococcal diseases — A, B, C, W, and Y. The currently licensed Trumenba is approved for the prevention of invasive meningococcal disease caused by MenB, while Menveo is approved for the prevention of invasive meningococcal disease caused by MenACWY.

Pfizer stated that in the Phase III trial, the participants were divided into two groups: one receiving two doses of MenABCWY and the other receiving two doses of Trumenba plus one dose of Menveo. Pfizer noted that the data showed that, compared to the latter, two doses of MenABCWY demonstrated non-inferiority for all five serogroups. Additionally, Pfizer indicated that MenABCWY was well-tolerated with a safety profile consistent with licensed vaccines.

Pfizer Plans to Submit a Biologics License Application to the U.S. Food and Drug Administration (FDA) in the Fourth Quarter of 2022, Seeking Approval for the Vaccine. Pfizer Noted That if MenABCWY is Approved, the Vaccine Will Help Simplify the Meningococcal Vaccination Schedule and Provide the Broadest Coverage of Meningococcal Serogroups.