Health Care Providers
Communicable Diseases, Epidemiology and Immunization
March 23, 2007
Additional information on the use of Pediarix™ (DTaP, IPV, and Hepatitis B combination vaccine) and Interchangeability of DTaP vaccines
The recent introduction of combination vaccines raises new issues and challenges regarding how best to use available supplies of these new formulations. Current and future combination vaccines will have unique considerations related to their “fit” into the immunization schedule. In response to questions from clinicians, Public Health is providing additional information and clarification about our current recommendations for use of Pediarix™ and interchangeability of DTaP vaccine formulations.
Availability of Pediarix™ may be limited due to funding constraints. For example, the currently allocated Washington State supply of Pediarix™ is not sufficient to provide a 3-dose series of Pediarix™ for all children eligible for the vaccine. In order to maximize the number of children who may benefit from this combination vaccine, Public Health recommends administering Pediarix™ at visits when DTaP, IPV and Hepatitis B vaccination is indicated. For example:
- For children who received the birth dose of hepatitis B vaccine, Pediarix™ could be administered at 2 and 6 months, and available DTaP vaccine would be used at 4 months*.
- Availability of Pediarix™ does not change the indication for the birth dose of hepatitis B vaccine, which should be administered. However, for children who have not received the birth dose of hepatitis B vaccine, Pediarix™ could be administered at 2, 4 and 6 months.
*Clinicians are not prohibited from using Pediarix™ at the 4 month visit.
What about using different formulations of DTaP-containing vaccine?
The CDC’s Advisory Committee on Immunization Practices General Recommendations on Immunization (MMWR December 1, 2006 / 55(RR15);1-48, available at: http://www.cdc.gov/nip/publications/acip-list.htm#genrecs), states that although using the same brand of DTaP is desirable whenever feasible, it is permissible to use any DTaP vaccine for the vaccination series. In fact, since 1999, Washington State’s available DTaP formulation has changed 5 times as the contract for state-supplied vaccine has changed. Inevitably, children who began the series with one product received subsequent doses with another, and this is considered acceptable. CDC experts also advise that it is probably a minority of children who receive a complete series with the same formulation of DTaP.
In this context, health care providers should be aware that new formulations of combination vaccines on the horizon in the US will provide additional options with respect to “fit” into the child immunization schedule. For example, Sanofi Pasteur’s DTaP-IPV-Hib combination vaccine, Pentacel™, expected to be licensed for use in the US by the FDA in the near future (already licensed in other countries), is designed to be used in a 4-dose primary series at 2, 4, 6, and 15-18 months (independent of considerations related to the hepatitis B vaccination schedule).
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