Licensure of a Diphtheria and Tetanus Toxoids and Acellular Pertussis, Inactivated Poliovirus, Haemophilus influenzae Type b Conjugate, and Hepatitis B Vaccine, and Guidance for Use in Infants

Abbreviations: DTaP = diphtheria and tetanus toxoids and acellular pertussis; Hib = Haemophilus influenzae type b; HepB = hepatitis B; IPV = inactivated poliovirus.
*The DTaP-IPV-Hib-HepB vaccine (Vaxelis; MCM Vaccine Company) was licensed in December 2018 and will not be commercially available in the United States before 2021.
^†If the third dose of DTaP-IPV-Hib-HepB is given before age 24 weeks, an additional dose of hepatitis B vaccine should be given at age ≥24 weeks to complete the hepatitis B series.

Authors and Disclosures

Sara E. Oliver MD¹ and Kelly L. Moore, MD<sup>2

1</sup>Division of Bacterial Diseases, National Center for Immunization and Respiratory Diseases, CDC; ²Department of Health Policy, Vanderbilt School of Medicine, Nashville, Tennessee.

Corresponding author
Sara E. Oliver, seoliver@cdc.gov, 404–639-1204.

All authors have completed and submitted the International Committee of Medical Journal Editors form for disclosure of potential conflicts of interest. Kelly L. Moore reports personal fees from PRIME, Inc., outside the submitted work. No other potential conflicts of interest were disclosed.

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Summary

What is already known about this topic?

Combination vaccines merge equivalent component vaccines into a single product to prevent multiple diseases, which can reduce the number of injections administered and improve vaccination coverage.

What is added by this report?

A new hexavalent vaccine was approved by the Food and Drug Administration to prevent diphtheria, tetanus, pertussis, polio, Haemophilus influenzae type b, and hepatitis B (DTaP-IPV-Hib-HepB). At a recent Advisory Committee on Immunization Practices meeting, members voted unanimously to include this vaccine in the federal Vaccines for Children program.

What are the implications for public health practice?

The vaccine is licensed for use in children aged 6 weeks through 4 years and is indicated for the primary vaccination series in infants at ages 2, 4 and 6 months.