FDA approves Vaxelis 6-in-1 pediatric vaccine

  • FDA

  • curated by Yael Waknine
  • Clinical Essentials
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  • The FDA has approved a 6-in-1 intramuscular vaccine (Vaxelis) for use in children aged 6 weeks through
  • The 3-dose series protects against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, and invasive disease due to Haemophilus influenzae type B.
  • The series should be followed by 1 additional dose of pertussis vaccine.

Why this matters

  • Combination vaccines reduce the number of injections necessary.

Clinical studies

  • Approval was based on noninferiority demonstrated in 2 US clinical studies of children randomly assigned to standard vaccination or Vaxelis at age 2, 4, and 6 months; all received rotavirus and pneumococcal vaccinations.
  • Funding: Joint partnership between Merck & Co., Inc., Kenilworth, NJ, USA and Sanofi.

Key points

  • Use with caution in children with:
    • A history of fever ≥40.5°C (≥105°F), hypotonic-hyporesponsive episode or persistent, inconsolable crying for ≥3 hours within 48 hours after pertussis-containing vaccination.
    • Seizures within 3 days after pertussis-containing vaccination.
  • Guillain-Barré syndrome risk may be increased if prior case was diagnosed within 6 weeks of tetanus toxoid-containing vaccination.
  • Some premature infants have experienced postvaccination apnea.
  • Vaccination may interfere with urine antigen tests for H influenzae type B.
  • Adverse events may include irritability, crying, injection site pain, somnolence, injection site erythema, decreased appetite, fever, injection site swelling, and vomiting.

Prescribing information

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