Jennifer Clark Nelson, PhD, is a senior investigator and biostatistician with expertise in methods to assess drug and vaccine safety and effectiveness for studies that use electronic health care data.
Dr. Nelson provides national statistical leadership and strategic direction for the U.S. Food and Drug Administration (FDA)’s Sentinel Initiative, an active surveillance system for monitoring the safety of all FDA-regulated medical products after they have reached the market. She also leads safety research within the Centers for Disease Control and Prevention (CDC)-sponsored Vaccine Safety Datalink (VSD), a national collaboration involving 13 health care organizations that has monitored immunization safety in the United States since 1990. Her CDC service further includes membership on the Advisory Committee on Immunization Practices (ACIP) COVID-19 Vaccine Safety Technical Work Group to help inform recommendations on the use of these vaccines in the U.S.
As part of both the VSD and Sentinel projects, Dr. Nelson works with her Kaiser Permanente Washington Health Research Institute (KPWHRI) colleagues Andrea Cook, PhD, and David Carrell, PhD, to pilot and scale up innovative sequential monitoring, machine learning, and natural language processing approaches that rapidly and accurately identify adverse events not detected in pre-licensure studies. Her 2013 study of the safety of a pentavalent combination DTaP-IPV-Hib (Pentacel) childhood vaccine put some of these ideas into practice and was selected as one of the American Journal of Epidemiology’s 10 best articles of the year. She and her clinical KPWHRI research partner, Lisa Jackson, MD, MPH, lead the CDC’s surveillance effort to proactively monitor the safety of the new herpes zoster vaccine for adults (Shingrix).
Dr. Nelson is an affiliate professor in biostatistics at the University of Washington (UW) and has been KPWHRI’s director of biostatistics since 2014. In collaboration with the UW, she and Dr. Cook co-founded the Seattle Symposium on Health Care Data Analytics, a conference designed to confront challenges and promote learning from electronic health record data. In 2009, Dr. Nelson earned the VSD’s Margarette Kolczak Award for outstanding contributions in biostatistics and epidemiology in vaccine safety. She is also a fellow of the American Statistical Association.
Post-marketing drug and vaccine safety study design and analysis; secondary use and misuse of large electronic health care databases for medical research; vaccine effectiveness study methods; sequential testing in observational data settings; methods to assess interrater variability
Biostatistics; post-marketing vaccine safety study design and analysis; influenza vaccine effectiveness in the elderly; methodological issues in large multi-site health care database studies
Biostatistics; post-marketing drug and vaccine safety study design and analysis; safety signal detection methods; methodological issues in large, multi-site health care database studies
Biostatistics; statistical issues in longitudinal observational cohort studies
McBride CM, Curry SJ, Grothaus LC, Nelson JC, Lando H, Pirie PL. Partner smoking status and pregnant smoker's perceptions of support for and likelihood of smoking cessation. Health Psychol. 1998;17(1):63-9. PubMed
Pingray V, Belizan M, Matthews S, Zaraa S, Berrueta M, Noguchi LM, Xiong X, Gurtman A, Absalon J, Nelson JC, Panagiotakopoulos L, Sevene E, Munoz FM, Althabe F, Mwamwitwa KW, Cairoli FR, Anderson SA, McClure EM, Guillard C, Nakimuli A, Stergachis A, Buekens P. Using maternal and neonatal data collection systems for coronavirus disease 2019 (COVID-19) vaccine active safety surveillance in low- and middle-income countries: an international modified Delphi study. Gates Open Res. 2021; 5:99 (https://doi.org/10.12688/gatesopenres.13305.1).
Li R, Weintraub E, McNeil MM, Kulldorff M, Lewis EM, Nelson J, Xu S, Qian L, Klein NP, Destefano F. Meningococcal conjugate vaccine safety surveillance in the Vaccine Safety Datalink using a tree-temporal scan data mining method. Pharmacoepidemiol Drug Saf. 2018 Feb 15. doi: 10.1002/pds.4397. [Epub ahead of print]. PubMed
KPWHRI researchers analyzed data from more than 640,000 vaccine doses to understand risk of severe reactions.
New study supports a growing body of data that shows the vaccines are safe during pregnancy.
Honors from the Health Care Systems Research Network for early career achievements and manuscript of the year
Jen Nelson, PhD, talks about monitoring reactions to the mRNA vaccines.