TY - JOUR
AU - Kulldorff, Martin
AB - We agree wholeheartedly with Drs. Rositch and Krakow (1) that vaccine safety epidemiologists need to help bridge the gap between the generation of evidence on vaccine safety and the communication of such evidence to the public. The uptake of human papillomavirus (HPV) vaccines in the United States and elsewhere has indeed suffered from parental concerns about the risks of HPV vaccination, with millions of teenagers and young adults foregoing the opportunity to be protected by these cancer-preventing vaccines. We commend Drs. Rositch and Krakow on their 3 well-considered suggestions for how vaccine safety researchers and the public health community as a whole can and should take responsibility for translating research into accessible information and helping disseminate it to the public. Our data-mining method for evaluating thousands of potentially vaccine-related adverse events not previously assessed is uniquely comprehensive. In the application described in our paper (2), it had excellent statistical power to detect even small excess risks, and thus the finding of only 2 categories of adverse events, both consistent with the known safety profile of the quadrivalent HPV vaccine, is an important addition to the safety record of this vaccine. Such findings indeed need to be better communicated to the public. At the same time, we find it necessary to reiterate 2 possibly important limitations of our evaluation: First, we looked for increased risks of potential adverse events presenting only within the first 42 days after vaccination; thus, potential adverse events with longer latency periods and/or with insidious onset could have been missed. Second, the hierarchical tree of diagnoses we used was organized by International Classification of Diseases, Ninth Revision, codes and body system; thus, potential adverse events characterized by physiologically diverse symptoms (e.g., postural orthostatic tachycardia syndrome, which manifests as neurological, gastrointestinal, and/or cardiovascular symptoms) could have been missed due to the possibility of diagnosis codes for patients with the same syndrome being dispersed among multiple branches of the tree. Ultimately, in order to win and deserve the public’s trust in vaccines, we will need to communicate clearly not only about key safety findings, including those from studies such as this one that evaluate a whole range of potential adverse events with high statistical power, but also about which kinds of health outcomes have been thoroughly assessed as possible vaccine-associated adverse events and which have not. ACKNOWLEDGMENTS Author affiliations: Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, Massachusetts (W. Katherine Yih, Judith C. Maro); and Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Harvard Medical School and Brigham and Women’s Hospital, Boston, Massachusetts (Martin Kulldorff). Conflict of interest: none declared. REFERENCES 1 Rositch AF , Krakow M . Invited commentary: moving from evidence to impact for human papillomavirus vaccination—the critical role of translation and communication in epidemiology . Am J Epidemiol . 2018 ; 187 ( 6 ): 1277 – 1280 . 2 Yih WK , Maro JC , Nguyen M , et al. . Assessment of quadrivalent human papillomavirus vaccine safety using the self-controlled tree-temporal scan statistic signal-detection method in the Sentinel system . Am J Epidemiol . 2018 ; 187 ( 6 ): 1269 – 1276 . © The Author(s) 2018. Published by Oxford University Press on behalf of the Johns Hopkins Bloomberg School of Public Health. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com. This article is published and distributed under the terms of the Oxford University Press, Standard Journals Publication Model (https://academic.oup.com/journals/pages/about_us/legal/notices)
TI - Yih et al. Respond to “Moving From Evidence to Impact for Human Papillomavirus Vaccination”
JF - American Journal of Epidemiology
DO - 10.1093/aje/kwy022
DA - 2018-02-23
UR - https://www.deepdyve.com/lp/oxford-university-press/yih-et-al-respond-to-moving-from-evidence-to-impact-for-human-2KwgBeXAP0
SP - 1
EP - 1281
VL - Advance Article
IS - 6
DP - DeepDyve
ER -