Merck Gets FDA Priority Review For New Pneumococcal Vaccine
December 19 2023 - 7:29AM
Dow Jones News
By Will Feuer
Merck said the Food and Drug Administration has accepted for
priority review the company's V116 investigational pneumococcal
conjugate vaccine.
Merck said the FDA has set a target action date of June 17 for
the review. The FDA grants priority review to drugs and vaccines
that would provide a significant improvement in the safety,
effectiveness of the treatment or prevention of a serious
condition.
"Invasive pneumococcal disease poses a greater risk to older
adults or those with weakened immune systems," said Eliav Barr,
Merck Research Laboratories' chief medical officer.
Barr said V116 would be the first pneumococcal conjugate vaccine
specifically designed to address the serotypes that cause most
adult invasive pneumococcal disease.
Write to Will Feuer at Will.Feuer@wsj.com
(END) Dow Jones Newswires
December 19, 2023 07:14 ET (12:14 GMT)
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