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Institute of Medicine report details for monitoring safety of childhood immunization schedule
Date:1/16/2013

n 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, socioeconomically and genetically than the general population. 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 committee concluded.

"The costs of conducting this kind of study, or a randomized controlled trial, likely would be prohibitive," Rohani said.

Newer data collection and surveillance systems offer great potential to monitor rare adverse events that may be associated with the childhood immunization schedule, the committee said. When fully implemented, the Sentinel Initiative program being developed by the U.S. Food and Drug Administration to monitor the safety of approved drugs and other medical products will complement existing passive vaccine surveillance systems, the report says. FDA's new Post-License Rapid Immunization Safety Monitoring Program is amassing a large amount of health data, offering the potential to analyze vaccine exposures and adverse events with a greater degree of statistical power.


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Contact: Jim Erickson
ericksn@umich.edu
734-647-1842
University of Michigan
Source:Eurekalert

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