FDA approves Sanofi and Merck's 6-in-1 pediatric vaccine

Jan 02, 2019

The U.S. Food and Drug Administration has approved Vaxelis, a six-in-one vaccine  for use in children from six weeks through four years of age. Vaxelis was developed as part of a joint-partnership between Sanofi and Merck.

The drugmakers will not make commercial supply available prior to 2020 and are working to maximize production of Vaxelis to allow for a sustainable supply to meet anticipated U.S. demand.

Vaxelis is a vaccine indicated for active immunization to prevent diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, and invasive disease due to Haemophilus influenzae type b. Vaxelis is approved for use as a 3-dose series in children 6 weeks through 4 years of age (prior to the 5th birthday). The vaccine is contraindicated in children with a history of severe allergic reaction to a previous dose of Vaxelis, any ingredient of Vaxelis, or any other diphtheria toxoid, tetanus toxoid, pertussis-containing vaccine, inactivated poliovirus vaccine, hepatitis B vaccine or H. influenzae type b vaccine.

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