White paper on studying the safety of the childhood immunization schedule for the vaccine safety datalink
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White paper on studying the safety of the childhood immunization schedule for the vaccine safety datalink

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  • Alternative Title:
    VSD White Paper
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  • Description:
    Routine vaccination in the United States is widely viewed as one of the greatest public health achievements of the past century. Despite this success, an increasing number of parents have been expressing concerns about vaccine safety over the last two decades. Parental vaccine worries have traditionally focused on specific vaccines, ingredients and types of adverse events. More recently, parents have been voicing concerns about the safety of the recommended immunization schedule as a whole, with opinions that children receive too many vaccines at too young of an age, and that early childhood immunization overwhelms the immune system. These sentiments reflect the number, frequency and timing of recommended vaccines, leading some parents to refuse or delay vaccinations for their children.

    In response to these concerns, the Institute of Medicine (IOM) in 2012 convened a committee to gather stakeholder input and scientific evidence on the safety of the recommended childhood immunization schedule.1 The committee concluded that, while available evidence indicated that the current U.S. immunization schedule was safe, few published investigations had specifically examined the safety of the recommended childhood schedule as a whole. The committee recommended that additional observational studies of the safety of the schedule were warranted, and stated that the Vaccine Safety Datalink (VSD) project2 represents one of the best resources in the nation for conducting such studies. The VSD is an established collaboration of nine managed care organizations (MCOs) where electronic health record (EHR) data on over 9 million people are used to conduct observational studies on vaccine safety.

    Guided by the IOM committee’s assessment of the unique and important role the VSD could play in this area of study, the Immunization Safety Office (ISO) of the Centers for Disease Control and Prevention (CDC) issued a request for a White Paper. The focus of the White Paper was to be determine how the VSD could be used to study the safety of the entire childhood immunization schedule.

    Notice: The project that is the subject of this report was approved and funded by the Immunization Safety Office, Centers for Disease Control and Prevention. The contributors responsible for the content of the White Paper were funded by Task Order contract 200-2012-53582/0004 awarded as a prime contract to Kaiser Foundation Hospitals.

    The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention.


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