On December 21, 2018, United States Food and Drug administration has approved VAXELIS" (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus, Haemophilus b Conjugate [Meningococcal Protein Conjugate] and Hepatitis B [Recombinant] 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)30.

The approval also details the numerous warnings and risks that could possibly be associated with Vaxelis:

  • VAXELIS is contraindicated in children with a history of severe allergic reaction (e.g., anaphylaxis) to a previous dose of VAXELIS, any ingredient of VAXELIS, or any other diphtheria toxoid, tetanus toxoid, pertussiscontaining vaccine, inactivated poliovirus vaccine, hepatitis B vaccine, or H. influenzae type b vaccine.
  • Do not administer VAXELIS to anyone with a history of encephalopathy (e.g., coma, decreased level of consciousness, prolonged seizures), within 7 days of a pertussis-containing vaccine, that is not attributable to another identifiable cause.
  • Do not administer VAXELIS to anyone with a history of progressive neurologic disorder until a treatment regimen has been established and the condition has stabilized.
  • Vaccination with VAXELIS may not protect all individuals.
  • Carefully consider benefits and risks before administering VAXELIS to persons with a history of:
    • fever of ≥40.5°C (≥105°F), hypotonic-hypo-responsive episode (HHE) or persistent, inconsolable crying lasting ≥3 hours within 48 hours after a previous pertussis-containing vaccine.
    • seizures within 3 days after a previous pertussis-containing vaccine.
  • If Guillain-Barre syndrome occurred within 6 weeks of receipt of a prior vaccine containing tetanus toxoid, the risk for Guillain-Barre syndrome may be increased following VAXELIS.


VAXELIS includes antigens for diphtheria, tetanus, pertussis (whooping cough), and poliomyelitis from Sanofi and antigens for H. influenzae type b and hepatitis B from MSD. VAXELIS is to be administered as a 3-dose series at 2, 4, and 6 months of age. The first dose may be given as early as 6 weeks of age. Three doses of VAXELIS constitute a primary immunization course against diphtheria, tetanus, H. influenzae type b invasive disease and poliomyelitis31.

Note - VAXELIS was developed as part of a joint-partnership between Sanofi and MSD, known as Merck inside the United States and Canada. Both the companies are working on the production of VAXELIS to make it available in 2020 in U.S. market.


30 https://www.sanofipasteur.com/en/media-room/press-releases/FDA-Approves-VAXELIS-Sanoi-and-MSD-Pediatric-Hexavalent-Combination-VacCine

31 https://www.fda.gov/downloads/BiologicsBloodVaccines/UCM629109.pdf

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