By Colin Kellaher
Pfizer Inc. on Friday said the US Food and Drug Administration has granted priority review to its application seeking expanded approval of its Prevnar 20 vaccine for infants and children.
The New York drug application covers the 20-valent pneumococcal conjugate vaccine candidate for the prevention of invasive pneumococcal disease caused by 20 serotypes of Streptococcus pneumoniae, and for the prevention of otitis media caused by seven ‘serotypes.
The FDA has given priority review to drugs that have the potential to provide a significant improvement in the treatment of a serious disease, and the designation shortens the review period. Pfizer said the agency has set a target action date of April for the application.
The FDA previously approved Prevnar 20, which covers the 13 serotypes already included in Pfizer’s Prevnar 13 vaccine, plus seven new serotypes, for adults in June 2021.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
01-06-23 0711ET
