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October 17, 2019

Complexity in Assessing the Benefit vs Risk of Vaccines: Experience With Rotavirus and Dengue Virus Vaccines

Author Affiliations
  • 1Tufts Medical Center, Tufts University School of Medicine, Boston, Massachusetts
JAMA. 2019;322(19):1861-1862. doi:10.1001/jama.2019.16206

The remarkable contribution of immunization programs to public health is recognized by most people, including those who express vaccine hesitancy. Vaccine hesitancy often is predicated on the concern of an individual or family members regarding the risk of an adverse event following immunization. But for each licensed vaccine, the relative risk of an untoward event, such as contracting the disease, is greater among those who remain unvaccinated.1 Before US Food and Drug Administration (FDA) licensure, vaccine safety must be determined by demonstration that the benefit from disease prevention exceeds the risk of adverse reactions associated with the vaccine. However, this assessment is not always straightforward and the societal perspective of regulatory and advisory bodies may conflict with the individual perspective of the patient or parent. Experience with rotavirus vaccines and, more recently, the dengue virus vaccine provides insight into the complexity of this assessment.

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