Assessment of studies of health outcomes related to the recommended childhood immunization schedule

Background: As the number of routinely recommended vaccines has increased, the routine childhood immunization schedule has become increasingly crowded and complex with both an increased number of vaccine visits and often an increased number of vaccines administered during these visits. In addition to this complexity of vaccine delivery, some parents, other members of the public, and advocacy groups have raised questions about the potential adverse health outcomes that may be a consequence of simultaneous or sequential administration of recommended childhood vaccines, the timing and/or co-administration of vaccines, and the recommended childhood immunization schedule overall. Methods: In response to a request from the National Vaccine Program Office (NVPO), the IOM convened a committee of experts to conduct an independent assessment surrounding the feasibility of -- and issues surrounding -- studying children who may receive or have received different immunization in order to determine if it is possible to detect differences in health outcomes between these groups that can be attributed to the vaccine schedule. The committee is asked to: review scientific findings and stakeholder concerns related to the safety of the recommended childhood immunization schedule; identify potential research approaches, methodologies, and study designs that could inform this question, including an assessment of the potential strengths and limitations of each approach, methodology and design, as well as the financial and ethical feasibility of doing them and; issue a report summarizing their findings. Results & Conclusions: The report, which the speaker will discuss, is expected to be publicly released in October 2012.