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Pharmaceuticals / Submissions and Approvals

FDA OK’s Sanofi and Merck’s Pediatric Hexavalent Vaccine

Jan. 9, 2019

The FDA approved Sanofi and Merck’s six-in-one pediatric vaccine Vaxelis for active immunization against diphtheria, hepatitis B, pertussis, poliomyelitis, tetanus and invasive disease due to Haemophilus influenzae type B.

The agency approved the vaccine as a three-dose series in children six weeks to four years of age, prior to their fifth birthday. The treatment consists of three 0.5 mL muscular injections

The vaccine is contraindicated in children with a history of severe allergic reactions to a previous dose of Vaxelis, any ingredient in the drug, or similar vaccines.

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