FDA Accepts BLA of Merck & Co. and Sanofi for Pediatric Vaccine

Merck & Co, and Sanofi Pasteur, the vaccines division of Sanofi, report that their biologics license application (BLA) filed for the companies' investigational pediatric hexavalent vaccine, DTaP5-IPV-Hib-HepB, has been accepted for review by the US 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.

The partnership between Merck and Sanofi Pasteur draws upon both companies’ experience in the development, manufacturing, and marketing of individual and combination vaccines. This pediatric hexavalent vaccine includes antigens for diphtheria, tetanus, pertussis (whooping cough), and polio (poliovirus Types 1, 2, and 3) from Sanofi Pasteur and antigens for Haemophilus influenzae Type b and hepatitis B from Merck.

Source: Merck & Co

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