Medication Monitor

Generic Name (Trade Name—Company)
January 3, 2019

Hexavalent vaccine

(Vaxelis—Sanofi, Merck)
New pediatric hexavalent vaccine will be available in 2020

FDA has approved diphtheria and tetanus toxoids and acellular pertussis adsorbed, inactivated poliovirus, Haemophilus b conjugate [meningococcal protein conjugate] and hepatitis B [recombinant] vaccine for use as a three-dose series in children aged 6 weeks through 4 years (prior to the 5th birthday).

The vaccine, approved under the trade name Vaxelis, prevents diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, and invasive disease due to Haemophilus influenzae type b. The three-dose immunization series consists of a 0.5-mL I.M. injection administered at 2, 4, and 6 months of age.

The series does not constitute a primary immunization series against pertussis; an additional dose of pertussis-containing vaccine is needed to complete the primary series.

Vaxelis is contraindicated in children with a history of severe allergic reaction (e.g., anaphylaxis) to a previous dose of Vaxelis, any of its ingredients, or any other diphtheria toxoid, tetanus toxoid, pertussis-containing vaccine, inactivated poliovirus vaccine, hepatitis B vaccine, or H. influenzae type b vaccine. Adverse reactions are irritability; crying; injection-site pain, erythema, or swelling; somnolence, decreased appetite, fever, and vomiting.

In a news release, Sanofi said the vaccine will be commercially available in 2020.