U.S. FDA approves new paediatric hexavalent vaccine

PARIS: The U.S. Food and Drug Administration has approved new paediatric vaccine immunizing children against six diseases. The new vaccine dubbed Vaxelis is being produced by Sanofi a French pharmaceutical company in partnership with Merck.

Vaxelis is designed for children aged 6 weeks to 4 years old and is designed to keep them from contracting diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, and invasive disease due to haemophilus influenzae type B.It is intended for intramuscular injection as a 3-dose series given at 2, 4, and 6 months of age. The first dose may be given as early as 6 weeks of age. Voxels may be used to complete the hepatitis B immunization series. However, the 3-dose series of Vaxelis does not constitute a primary immunization series against pertussis; an additional dose of pertussis-containing vaccine is needed to complete the primary series.

The efficacy of Vaxelis is based on the immunogenicity of the individual antigens compared to US licensed vaccines. The most common adverse reactions following any dose were irritability, crying, injection site pain, somnolence, injection site erythema, decreased appetite, fever (≥38º Celsius), injection site swelling, and vomiting.

Vaxelis will be supplied in a single-dose vial in 10-count packages and Sanofi and Merck are now working on the production and supply of Vaxelis aiming to make it available on the market in 2020 or later.

Vaxelis is contraindicated in patients 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; anyone with a history of encephalopathy within 7 days of a previous dose of a pertussis-containing vaccine; and anyone with a history of progressive neurologic disorder.

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