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IOM report details strategy for monitoring safety of childhood immunization schedule
Date:1/16/2013

nd adverse events with a greater degree of statistical power.

Although randomized controlled trials are the gold standard for clinical research, such a trial cannot be safely and efficiently performed to compare health outcomes among vaccinated and unvaccinated or differently immunized children, the committee concluded. Among other reasons, children placed in the study group that does not receive vaccines in a timely fashion would be exposed to greater risk for contracting illnesses. Many parents who refuse immunization may object to their children being randomly assigned to the group that gets vaccines.

Some people have suggested comparing vaccinated children with children in "naturally occurring" populations of unimmunized individuals, such as certain religious communities. With less than 1 percent of the American population refusing all immunizations, however, it would be very difficult to recruit enough willing unvaccinated participants, the committee concluded. It can take tens of thousands of study participants to discover uncommon health problems. Moreover, these populations tend to be much less diverse ethnically, racially, socio-economically, and genetically than the general population, and because such factors can influence health, it would be difficult to determine if differences between the study groups are the result of vaccines or these other factors. The costs of conducting this kind of study or a randomized controlled trial likely would be prohibitive.


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Contact: Christine Stencel
news@nas.edu
202-334-2138
National Academy of Sciences
Source:Eurekalert

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