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FDA Approves Sanofi And Merck's Pediatric Hexavalent Combination Vaccine Vaxelis

The U.S. Food and Drug Administration has approved VAXELIS for use in children from 6 weeks through 4 years of age (prior to the 5th birthday). Vaxelis was developed as part of a joint-partnership between Sanofi and Merck & Co (MRK).

VAXELIS is Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus, Haemophilus b Conjugate [Meningococcal Protein Conjugate] and Hepatitis B [Recombinant] Vaccine.

Sanofi and Merck are working to maximize production of VAXELIS to allow for a sustainable supply to meet anticipated U.S. demand. Commercial supply will not be available in the U.S. prior to 2020.

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).

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