Merck Gets FDA Priority Review of V114 Vaccine for Adults
January 12 2021 - 7:38AM
Dow Jones News
By Colin Kellaher
Merck & Co. on Tuesday said the U.S. Food and Drug
Administration granted priority review to V114, the drug maker's
investigational 15-valent pneumococcal conjugate vaccine, for the
prevention of invasive pneumococcal disease in adults.
Merck's V114 targets 15 serotypes, including two not targeted by
the currently available 13-valent pneumococcal conjugate
vaccine.
The FDA grants 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.
The Kenilworth, N.J., said the agency set a target action date of
July 18 for the application.
Merck, which is also developing V114 for use in children, said
the European Medicines Agency is also reviewing an application for
licensure of the vaccine in adults.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
January 12, 2021 07:23 ET (12:23 GMT)
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