FDA Approves Hexavalent Combination Vaccine for Children

The US Food and Drug Administration has approved Vaxelis, a hexavalent combination vaccine that protects against 6 diseases, for children aged 6 weeks through 4 years.

Specifically, Vaxelis is indicated for the prevention of diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B virus, and invasive disease due to Haemophilus influenzae type b.

Intended for administration in a 3-dose series, Vaxelis contains a combination of Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus, Haemophilus b Conjugate (Meningococcal Protein Conjugate) and Hepatitis B (Recombinant) vaccines.

Vaxelis is contraindicated in children who are allergic to Vaxelis or any of its ingredients. Vaxelis should not be administered to anyone with a history of encephalopathy within 7 days of receiving a pertussis-containing vaccine that cannot be attributed to any other identifiable cause, or in anyone with a history of progressive neurologic disorder prior to the establishment of a treatment regimen and the stabilization of their condition.

Vaxelis was manufactured through a US-based joint partnership between Merck & Co, Inc., and French pharmaceutical company Sanofi. Commercial supply of Vaxelis will not be available in the United States before 2020, Sanofi said.

—Christina Vogt

Reference:

FDA approves VAXELIS(TM), Sanofi and MSD’s pediatric hexavalent combination vaccine [press release]. Paris, FR, and Kenilworth, NJ, USA. December 27, 2018. https://pipelinereview.com/index.php/2018122770184/Vaccines/FDA-Approves-VAXELISTM-Sanofi-and-MSDs-Pediatric-Hexavalent-Combination-Vaccine.html. Accessed on December 27, 2018.