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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