Merck Gets FDA Priority Review of Vaxneuvance Vaccine in Children

By Colin Kellaher

Merck & Co. on Wednesday said the U.S. Food and Drug Administration granted priority review to its application for expanded use of its Vaxneuvance 15-valent vaccine in children six weeks through 17 years of age.

The Kenilworth, N.J., drugmaker in July received FDA approval of the vaccine for the prevention of invasive pneumococcal disease in adults.

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.

Merck said the agency set a target action date of April 1, 2022, for its application.

Write to Colin Kellaher at [e-mail]

(END) Dow Jones Newswires

12-01-21 0721ET