Pfizer Gets FDA Priority Review of Prevnar 20 for Kids
January 06 2023 - 7:26AM
Dow Jones News
By Colin Kellaher
Pfizer Inc. on Friday said the U.S. Food and Drug Administration
granted priority review to its application seeking expanded
approval of its Prevnar 20 vaccine for infants and children.
The New York drugmaker's application covers the 20-valent
pneumococcal conjugate vaccine candidate for the prevention of
invasive pneumococcal disease caused by 20 Streptococcus pneumoniae
serotypes, and for the prevention of otitis media caused by seven
of the serotypes.
The FDA granted priority review to medicines that have the
potential to provide significant improvements in the treatment of a
serious disease, and the designation shortens the review period.
Pfizer said the agency has set a target action date in April for
the application.
The FDA previously approved Prevnar 20, which covers the 13
serotypes already included in Pfizer's Prevnar 13 vaccine, along
with seven new serotypes, for adults in June 2021.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
January 06, 2023 07:11 ET (12:11 GMT)
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