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,Kelly L Moore

doi:10.15585/mmwr.mm6905a5

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.

Highlights

Combination vaccines merge equivalent component vaccines into a single product to prevent more than one disease
For the prevention of diphtheria, tetanus and pertussis, children are recommended to receive a 3-dose primary series of DTaP, at ages 2, 4, and 6 months, and booster doses at ages 15–18 months and 4–6 years [12]
For prevention of hepatitis B, children are recommended to receive 3 doses of a HepB vaccine at ages 0, 1–2, and 6–18 months, with variations depending on the maternal hepatitis B infection status, infant birthweight, and vaccine manufacturer [15]

Summary

Introduction

Combination vaccines merge equivalent component vaccines into a single product to prevent more than one disease. 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). 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 DTaP-IPV-Hib-HepB vaccine is a fully liquid formulation and requires no reconstitution

Methods

Summary of Key Findings