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# Pfizer Plans BLA for New Meningococcal Vaccine
- URL: https://www.fdaweb.com/pfizer-plans-bla-for-new-meningococcal-vaccine/
- Published: 2022-09-16T12:00:00.000Z
- Updated: 2026-09-14T17:59:40.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5152756

Pfizer says it will file a BLA before year end for its pentavalent meningococcal vaccine (MenABCWY) seeking use in healthy individuals aged 10 through 25 years. The decision to file is based on new positive top-line results from a Phase 3 trial (NCT04440163) that the company says met all primary and secondary endpoints. The vaccine demonstrated non-inferiority to licensed vaccines for the five meningococcal serogroups that cause the majority of invasive meningococcal disease: serogroups A, B, C, W and Y, Pfizer says. If approved, the vaccine would offer convenience due to current vaccination recommendations for the MenACWY vaccine and a separate MenB vaccine (total four doses) for adolescents and young adults, it says.