FDA Accepts For Review A Biologics License Application For Merck & Co. And Sanofi Pasteur’s Investigational Pediatric Hexavalent Vaccine

WHITEHOUSE STATION, N.J. & SWIFTWATER, Pa.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, and Sanofi Pasteur, the vaccines division of Sanofi (EURONEXT:SAN and NYSE:SNY), announced today that the Biologics License Application (BLA) filed for the companies’ investigational pediatric hexavalent vaccine, DTaP5-IPV-Hib-HepB1, has been accepted for review by the U.S. Food and Drug Administration (FDA). If approved, it would be the first pediatric combination vaccine in the United States designed to help protect against six important diseases – diphtheria, tetanus, pertussis (whooping cough), polio (poliovirus types 1, 2, and 3), invasive disease caused by Haemophilus influenzae type b (Hib), and hepatitis B.

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