August 1998
ATLANTA - In a unanimous vote, members of the Advisory Committee on Immunization Practices (ACIP) recently approved a recommendation statement that had been 18 months in preparation on the use of available childhood combination vaccines.
The committee approved the Combination Vaccines for Childhood Immunization statement after making minor changes to the latest draft. Mary P. Glode, MD, an ACIP member and head of the combination vaccines working group, said additional editorial work will be done before the final version is published.
The statement will be issued jointly and published simultaneously by the Centers for Disease Control and Prevention (CDC) in its Morbidity and Mortality Weekly Report and by the American Academy of Pediatrics and the American Academy of Family Physicians in Pediatrics and American Family Physicians.
"The committee spent a lot of time trying to achieve the right balance in the statement," said Glode, professor of pediatrics, The Children's Hospital, Denver.
The report drafts were coordinated by Bruce G. Weniger, MD, MPH, Vaccine Safety and Development Activity, National Immunization Program, CDC.
The report provides general recommendations for the optimal use of current and expected parenteral combination vaccines, along with relevant background, rationale and discussion of issues raised by the use of these products. However, additional information may be needed to provide clarification, said John R. Livengood, MD, director of the National Immunization Program's Epidemiology and Surveillance Division.
"I think we are going to have to follow up with some instructions and examples," he said. "We've gotten so carefully generic that some readers may get lost at a certain point. Maybe we should come up with a question and answer sheet with specific details."
There are six general recommendations regarding the use of available combination vaccines. The first states the preference for combination vaccines. The report says that, in general, the use of licensed combination vaccines is preferred over the separate injection of their equivalent component vaccines.
The second recommendation addresses the interchangeability of vaccine products. Vaccines from different manufacturers which protect against hepatitis A, hepatitis B and Haemophilus influenzae type b may be administered interchangeably in sequential doses in the immunization series for an individual patient. However, until data supporting the interchangeability of acellular pertussis (DTaP) vaccines are available, vaccines from the same manufacturer should be used for at least the primary series.
Providers who cannot determine which DTaP vaccine was previously used, or who do not have the same vaccine in stock should use any of the licensed acellular pertussis products to continue the immunization series, according to the report.
Vaccine supply is the third issue of the recommendation and states that immunization clinics and providers should maintain a supply of vaccines that will protect children from all the diseases specified in the recommended childhood immunization schedule.
This may be done by stocking a variety of combination and monovalent vaccine products. However, it is acceptable not to stock all available combination and monovalent vaccines, or multiple brands of each.
Next is the issue of extra doses of vaccine antigens. The report states that the use of combination vaccines containing some antigens not indicated at that time for the patient may be justified when: products which contain only the needed antigens are not readily available or would result in extra injections; or, the potential benefits to the child outweigh the risk of adverse events associated with the extra antigens.
However, extra doses given earlier than the recommended interval for certain vaccines such as extraneous toxoid and pneumococcal polysacharide may increase the risk for adverse reactions.
The fifth recommendation addresses improvement of immunization records. The report states that immunization programs should give high priority to improving the convenience and accuracy of transferring vaccine identifying information into medical records and immunization registries, as well as the timely availability to providers of the prior immunization history of their patients.
The final recommendation involves research priorities. Key issues for research include alternative methods of antigen delivery; interchangeability of vaccines; economic and operations research on the frequency of delayed or missed vaccinations, the costs of increased disease burden from missed vaccinations, costs of extra visits and the administrative overhead and cost of errors related to combination products; safety and efficacy of combination vaccines; and the interactive effects on safety and immunogenicity when separate combination and/or monovalent vaccines sharing an antigen are administered simultaneously.
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