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

Sara E. Oliver MD; Kelly L. Moore, MD


Morbidity and Mortality Weekly Report. 2020;69(5):136-139. 

In This Article

Abstract and Introduction


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.


Combination vaccines merge equivalent component vaccines into a single product to prevent more than one disease. The use of combination vaccines can reduce the number of injections patients receive and improve vaccine coverage rates.[2,3] ACIP has previously stated that the use of a combination vaccine generally is preferred over separate injections of the equivalent component vaccines; considerations can include provider assessment, patient preference, and the potential for adverse events.[4] Until 2018, there were two pentavalent combination vaccines licensed for use in the infant vaccine series: DTaP-HepB-IPV (Pediarix; GlaxoSmithKline) and DTaP-IPV/Hib (Pentacel; Sanofi Pasteur). In late 2018, a new hexavalent combination vaccine (DTaP-IPV-Hib-HepB) from the MCM Vaccine Company, a joint venture between Merck and Sanofi Pasteur, received FDA approval. Each dose of DTaP-IPV-Hib-HepB contains the same amount of diphtheria and tetanus toxoids and pertussis antigens (inactivated pertussis toxin [PT], filamentous hemagglutinin [FHA], pertactin, and fimbriae types 2 and 3) as does Pentacel. The poliovirus component of DTaP-IPV-Hib-HepB contains the same strains of inactivated poliovirus types 1, 2, and 3 as the poliovirus vaccine IPOL (Sanofi Pasteur), but in decreased amounts. The HIB component (Hib capsular polysaccharide polyribosyl-ribotol-phosphate [PRP] coupled to the outer membrane protein complex [OMP] of Neisseria meningitidis) is the same as that in PedvaxHIB (Merck), but in a decreased amount. The HepB component is the same as the pediatric formulation of Recombivax HB (Merck), but in an increased amount. The DTaP-IPV-Hib-HepB vaccine is a fully liquid formulation and requires no reconstitution.

*The manufacturer has stated that vaccine will not be commercially available in the United States before 2021.
Recommendations for routine use of vaccines in children, adolescents, and adults are developed by the Advisory Committee on Immunization Practices (ACIP). ACIP is chartered as a federal advisory committee to provide expert external advice and guidance to CDC Director on use of vaccines and related agents for the control of vaccine-preventable diseases in the civilian population of the United States. Recommendations for routine use of vaccines in children and adolescents are harmonized to the greatest extent possible with recommendations made by the American Academy of Pediatrics (AAP), the American Academy of Family Physicians (AAFP), the American College of Obstetricians and Gynecologists (ACOG), and the American College of Nurse-Midwives (ACNM). Recommendations for routine use of vaccines in adults are harmonized with recommendations of AAFP, ACOG, the American College of Physicians (ACP), and ACNM. ACIP recommendations approved by the CDC Director become agency guidelines on the date published in the Morbidity and Mortality Weekly Report (MMWR). Additional information is available at