By Colin Kellaher

 

Pfizer Inc. on Thursday said it plans to seek U.S. Food and Drug Administration of its pentavalent meningococcal vaccine candidate after a pivotal Phase 3 study hit its key goals.

The New York drugmaker said the study of MenABCWY in healthy individuals ages 10 through 25 met all primary and secondary endpoints, with the investigational vaccine showing non-inferiority to licensed vaccines for the five meningococcal serogroups that cause the majority of invasive meningococcal disease.

Pfizer said that based on the findings, its plans to file later this year for FDA approval of the vaccine, adding that it also plans submissions to regulatory authorities outside the U.S.

Pfizer said there are currently no single vaccines available to help protect against the five serogroups of meningococcal disease, an uncommon but serious illness that can lead to death within 24 hours and leave survivors with significant long-term disabilities.

Current vaccines are approved separately for serogroups A, C, W and Y, and for serogroup B, which accounts for the majority of disease in adolescents and young adults in the U.S. and Europe.

 

Write to Colin Kellaher at colin.kellaher@wsj.com

 

(END) Dow Jones Newswires

September 15, 2022 07:26 ET (11:26 GMT)

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