Pfizer's Five-Way Meningococcal Vaccine Hits Phase 3 Goals
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
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 email@example.com
(END) Dow Jones Newswires
September 15, 2022 07:26 ET (11:26 GMT)
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