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, 2018||Approval FDA Approves Vaxelis Pediatric Hexavalent Combination Vaccine|
Vaxelis (diphtheria and tetanus toxoids and acellular pertussis adsorbed, inactivated poliovirus, haemophilus b conjugate [meningococcal protein conjugate] and hepatitis B [recombinant] vaccine) Consumer information
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