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
- PMID: 32027629
- PMCID: PMC7004397
- DOI: 10.15585/mmwr.mm6905a5
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
Abstract
On December 21, 2018 the Food and Drug Administration (FDA) licensed a hexavalent combined diphtheria and tetanus toxoids and acellular pertussis (DTaP) adsorbed, inactivated poliovirus (IPV), Haemophilus influenzae type b (Hib) conjugate (meningococcal protein conjugate) and hepatitis B (HepB) (recombinant) vaccine, DTaP-IPV-Hib-HepB (Vaxelis; MCM Vaccine Company),* for use as a 3-dose series in infants at ages 2, 4, and 6 months (1). On June 26, 2019, after reviewing data on safety and immunogenicity, the Advisory Committee on Immunization Practices (ACIP)† voted to include DTaP-IPV-Hib-HepB in the federal Vaccines for Children (VFC) program.§ This report summarizes the indications for DTaP-IPV-Hib-HepB and provides guidance for its use.
Conflict of interest statement
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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References
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- Food and Drug Administration. Vaxelis (diphtheria and tetanus toxoids and acellular pertussis adsorbed, inactivated poliovirus, Haemophilus b conjugate [meningococcal protein conjugate] and Hepatitis B [recombinant] vaccine). [Package insert]. Silver Spring, MD: US Department of Health and Human Services, Food and Drug Administration; 2018. https://www.fda.gov/media/119465/download
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- Ezeanolue E, Harriman K, Hunter P, Kroger A, Pellegrini C. General best practice guidelines for immunization. Best practice guidance of the Advisory Committee on Immunization Practices (ACIP). Atlanta, GA: US Department of Health and Human Services, CDC; 2019. https://www.cdc.gov/vaccines/hcp/acip-recs/general-recs/index.html
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