FDA Approves Pediatric Hexavalent Combination Vaccine

Sanofi and Merck’s Vaxelis has been approved by the U.S. Food and Drug Administration. Vaxelis is a hexavalent vaccine indicated for the prevention of diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B and invasive disease due to Haemophilus influenza type b. The vaccine is approved for use as a three-dose series in children ages 6 weeks to 4 years prior to the fifth birthday. It was developed as part of a joint partnership between Sanofi and Merck. However, commercial supply of the vaccine will not be available in the U.S. prior to 2020.