The first hexavalent vaccine in the U.S. is expected to be available in June and was included in the 2021 childhood immunization schedule.
Vaxelis is a combined diphtheria and tetanus toxoids and acellular pertussis adsorbed, inactivated poliovirus, Haemophilus influenzae type b conjugated (meningococcal protein conjugate) and hepatitis B (recombinant) vaccine (DTaP-IPV-Hib-HepB). It was licensed Dec. 28, 2018, by the Food and Drug Administration for use in children ages 6 weeks through 4 years (before the fifth birthday) and is indicated for use as a three-dose series in infants at ages 2, 4 and 6 months (https://bit.ly/3fUXutm).
On June 26, 2019, the Centers for Disease Control and Prevention’s (CDC’s) Advisory Committee on Immunization Practices reviewed safety and immunogenicity data, summarized indications and voted to include the vaccine in the federal Vaccines for Children program (https://bit.ly/3mu3Rp3).
No change has been made to AAP and CDC recommendations. Two pentavalent vaccines are currently part of the infant series, and pediatricians administer a pentavalent vaccine plus the HepB or Hib vaccine as a separate component, said James D. Campbell, M.D., FAAP, a member of the AAP Committee on Infectious Diseases.
“For children, the No. 1 benefit for them is they get the same immune response and protection but with one fewer shot each time at 2, 4 and 6 months,” Dr. Campbell said. This likely will appeal to parents, and pediatricians also may see logistical benefits.
Although it is the first U.S. hexavalent vaccine for infants, data are available from use in Europe, Dr. Campbell said.
The vaccine was developed by the MCM Vaccine Co., a joint venture between Merck and Sanofi Pasteur. It takes components of DTaP (Pentacel) and IPV (IPOL) from Sanofi Pasteur. The Hib component is a lower amount of Merck’s PedvaxHIB, and the HepB component is an increased amount of Merck’s Recombivax HB. The DTaP-IPV-Hib-HepB vaccine does not require reconstitution.
The vaccine can be used until just before the 5th birthday for children requiring a catch-up schedule. However, pediatricians should follow table 3-1 of the General Best Practices Guidelines (http://bit.ly/2oLM9hP) for minimum intervals.
Data on antibody response after the first dose of DTaP-IPV-Hib-HepB in American Indian/Alaska Native (AI/AN) infants were not available at the time of review. AI/AN infants should receive a primary series of a Hib vaccine that contains PRP-OMP, which is preferred because it confers early protection and protective antibody response after the first dose.
Pediatricians who are Vaccines for Children program providers should check with their state about supplies and other questions.
When administering Vaxelis to a patient with physician or other qualified health care professional counseling, pediatricians should report:
90697Diphtheria, tetanus toxoids, acellular pertussis vaccine, inactivated poliovirus vaccine, Haemophilus influenza type b PRP-OMP conjugate vaccine, and hepatitis B vaccine (DTaP-IPV-Hib-HepB), for IM use
Vaccine administration codes:
90460 for the administration and the first component (diphtheria)
+90461 with five units for the five additional components (tetanus, pertussis, inactivated polio, Hib and HepB) (report 90461 in conjunction with 90460 only)