Pfizer 20-Valent Vaccine Candidate Meets Study Consistency Goal
May 14 2020 - 10:46AM
Dow Jones News
By Colin Kellaher
Pfizer Inc. on Thursday said a Phase 3 lot-consistency study of
its 20-valent pneumococcal polysaccharide conjugate vaccine
candidate met its primary immunogenicity objective.
The New York drug maker said immune responses elicited by the
vaccine for all 20 serotypes were equivalent across all three lots
in adults 18 through 49 years of age not previously vaccinated
against pneumococcal disease.
Pfizer said the study is the second Phase 3 trial for which it
has positive topline data for the investigational vaccine, which
includes 13 serotypes already included in its Prevnar 13 vaccine,
plus seven new serotypes. The company noted that the 20 serotypes
are responsible for the majority of currently circulating
pneumococcal disease worldwide.
Pfizer said it expects the study will satisfy licensure
requirements for manufacturing consistency by the U.S. Food and
Drug Administration, as well as other regulatory agencies around
the world.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
May 14, 2020 10:31 ET (14:31 GMT)
Copyright (c) 2020 Dow Jones & Company, Inc.
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