vaccination

CDC Releases Guidance on New Hexavalent Vaccine

The Centers for Disease Control and Prevention (CDC) has released new guidance on administration of a new hexavalent vaccine for the prevention of diphtheria, tetanus, pertussis, polio, Haemophilus influenzae type b, and hepatitis B infection (DTaP-IPV-Hib-HepB).

Background

Although the vaccine (Vaxelis) was approved on December 21, 2018, by the Food and Drug Administration, it is currently not expected to be available in the US until 2021. The vaccine is administered as a 3-dose series in infants at ages 2, 4, and 6 months. The vaccine was included in the federal Vaccines for Children program in 2019 by the Advisory Committee on Immunization Practices.

Guidance

  • DTaP-IPV-Hib-HepB may be used for the first 3 doses of the recommended DTaP series but should not be used for the fourth or fifth dose. If DTaP-IPV-Hib-HepB is inadvertently used for the fourth or fifth dose, that does should not be repeated with another DTaP dose.
  • DTaP-IPV-Hib-HepB may be used for the first 3 doses of the IPV series but not for the fourth. If DTaP-IPV-Hib-HepB is inadvertently used for the fourth dose, that does should not be repeated with another DTaP dose.
  • Because DTaP-IPV-Hib-HepB is licensed as a 3-dose series, if DTaP-IPV-Hib-HepB is used for any doses of the H influenzae type b vaccine series, 3 doses of a Hib conjugate-containing vaccine will need to be administered rather than the usual 2 doses.
  • DTaP-IPV-Hib-HepB should not be used for the birth dose of the HepB vaccine series but can be used for doses given at age 6 weeks or older to infants of HBsAg-negative mothers. Additionally, 3 doses of DTaP-IPV-Hib-HepB may be used in infants aged 6 weeks or older born to women who are HBsAg-positive or whose HBsAg status is unknown. The last dose should be given at age 24 weeks or older. If the third dose of DTaP-IPV-Hib-HepB is given before 24 weeks of age, an additional dose of HepB vaccine should be given at age 24 weeks or older.

“Data are limited on the safety and immunogenicity of interchanging vaccines from different manufacturers for the vaccination series in a child. Whenever feasible, the same manufacturer’s product should be used to complete the primary series; however, vaccination should not be deferred if the specific vaccine product previously administered is unavailable or unknown,” CDC wrote.

—Michael Potts

Reference:
Oliver SE, Moore KL. 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. MMWR Morb Mortal Wkly Rep. 2020;69(5):136-139. doi:10.15585/mmwr.mm6905a5.