The Childhood Immunization Schedule and Safety Stakeholder Concerns, Scientific Evidence, and Future Studies (2013) / Chapter Skim
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7 Conclusions and Recommendations
7 Conclusions and Recommendations
Pages 127-136
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From page 127... ...
The committee did not set a specific numerical target or goal for what should be considered "safe enough." Instead, the committee made a judgment based on the literature that failed to link adverse effects to schedule exposures or multiple immunizations, concluding that there is no evidence that the schedule is not safe. The committee recognized that final decisions about research studies must await knowledge of further evidence, including biological plausibility and/or epidemiological evidence, feasibility, cost, and the exact circumstances of stakeholder concerns, before the planning and conduct of specific research projects.
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From page 128... ...
Additionally, the cited concerns of health care professionals include efficacy of certain vaccines as well as appropriate delivery and communication regarding the recommended childhood immunization schedule. Although the 2010 National Vaccine Plan addresses the need to provide health care providers with more timely, accurate, and transparent information about the benefits and risks of vaccines, the plan does not specifically address strategies to assist providers with questions about the safety of the immunization schedule (HHS, 2010)
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From page 129... ...
Recommendation 4-1: The committee recommends that the National Vaccine Program Office systematically collect and assess evidence re garding public confidence in and concerns about the entire childhood immunization schedule, with the goal to improve communication with health care professionals, and between health care professionals and the public regarding the safety of the schedule. Summary of Scientific Findings The committee's findings and conclusions about the safety of the immunization schedule on the basis of the information in the scientific literature are presented in Chapter 5.
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From page 130... ...
Recommendation 5-1: To improve the utility of studies of the entire childhood immunization schedule, the committee recommends that the National Vaccine Program Office develop a framework that clarifies and standardizes definitions of • key elements of the schedule, • relevant health outcomes, and • populations that are potentially susceptible to adverse events.
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From page 131... ...
ow do child health outcomes compare between those who re H ceive no vaccinations and those who receive the full currently recommended immunization schedule?
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From page 132... ...
The decision to initiate further studies should be based on an evaluation of three considerations that the committee identified through its review of stakeholder concerns and scientific findings: 1. epidemiological evidence of potential adverse health outcomes as sociated with elements of the immunization schedule (such as post marketing signals or indications of elevated risk from observational studies)
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From page 133... ...
In light of the ethical and feasibility requirements and the available evidence, the committee concludes that new randomized controlled trials of the childhood immunization schedule are not justified at this time. Recommendation 6-2: The Department of Health and Human Services should refrain from initiating randomized controlled trials of the child
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From page 134... ...
First, the sample populations often suggested for study (such as some religious populations) may be too small to adequately power such a comparative analysis, particularly for very rare adverse health outcomes.
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From page 135... ...
Although the committee concludes that protection of children from vaccine-preventable diseases is of higher importance than testing of alternative immunization schedules without epidemiological or biological evidence indicating a safety problem, VSD should continue to examine the health outcomes of people who choose alternative schedules. Looking to the future, the committee supports the work of the federal research infrastructure in ensuring that stakeholders are involved in all stages of development, implementation, evaluation, and dissemination of the immunization schedule.
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From page 136... ...
Feasible research approaches to study potential adverse health outcomes will emerge only with a sustained and substantial federal commitment to research on vaccine safety. REFERENCES CDC (Centers for Disease Control and Prevention)
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