The Food and Drug Administration (FDA) has approved Vaxelis (diphtheria and tetanus toxoids and acellular pertussis adsorbed, inactivated poliovirus, haemophilus b conjugate [meningococcal protein conjugate] and hepatitis B [recombinant] vaccine; Sanofi and MSD) for active immunization in children aged 6 weeks through 4 years (prior to the 5th birthday).
Vaxelis 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. Vaxelis 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 is contraindicated in anyone 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.
Vaxelis will be supplied in a single-dose vial in 10-count packages; the product is not anticipated to be available in the US before 2020.
For more information call (877) 888-4231 or visit Merck.com.