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Vaxelis FDA Approval History

Last updated by Judith Stewart, BPharm on May 19, 2020.

FDA Approved: Yes (First approved December 21, 2018)
Brand name: Vaxelis
Generic name: diphtheria and tetanus toxoids and acellular pertussis adsorbed, inactivated poliovirus, haemophilus b conjugate [meningococcal protein conjugate] and hepatitis B [recombinant] vaccine
Dosage form: Suspension for Intramuscular Injection
Company: Merck and Sanofi
Treatment for: Diphtheria Prophylaxis, Tetanus Prophylaxis, Pertussis Prophylaxis, Poliomyelitis Prophylaxis, Hepatitis B Prevention, Haemophilus influenzae Prophylaxis

Vaxelis is a hexavalent combination vaccine indicated for active immunization to prevent diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, and invasive disease due to Haemophilus influenzae type b in children from 6 weeks through 4 years of age (prior to the 5th birthday).

  • Vaxelis is administered as a series of three intramuscular injections at 2, 4, and 6 months of age. A three-dose series of Vaxelis does not constitute a primary immunization series against pertussis, and 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 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; a history of encephalopathy within 7 days of a previous dose of a pertussis-containing vaccine; or a history of progressive neurologic disorder.
  • Common adverse reactions were irritability (≥55%), crying (≥45%), injection site pain (≥44%), somnolence (≥40%), injection site erythema (≥25%), decreased appetite (≥23%), fever ≥38.0°C (≥19%), injection site swelling (≥18%), and vomiting (≥9%).

Development timeline for Vaxelis

Dec 26, 2018Approval FDA Approves Vaxelis Pediatric Hexavalent Combination Vaccine

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.