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
Yih WKYih WK, Daley MF, Duffy J, Fireman B, McClure D, Nelson JC, Qian L, Smith N, Vazquez-Benitez G, Weintraub E, Williams JTB, Xu S, Maro JC. Tree-based data mining for safety assessment of first COVID-19 booster doses in the Vaccine Safety Datalink. Vaccine. 2023 Jan 9;41(2):460-466. doi: 10.1016/j.vaccine.2022.11.053. Epub 2022 Nov 24. PubMed
Sundaram ME, Kieke BA, Hanson KE, Belongia EA, Weintraub E, Daley MF, Hechter RC, Klein NP, Lewis EM, Naleway AL, Nelson JC, Donahue JG. Extended surveillance to assess safety of 9-valent human papillomavirus vaccine. Hum Vaccin Immunother. 2022 Dec 30;18(7):2159215. doi: 10.1080/21645515.2022.2159215. Epub 2022 Dec 28. PubMed
Yih WK, Daley MF, Duffy J, Fireman B, McClure D, Nelson JC, Qian L, Smith N, Vazquez-Benitez G, Weintraub E, Williams JTB, Xu S, Maro JC. A broad assessment of COVID-19 vaccine safety using tree-based data mining in the Vaccine Safety Datalink. Vaccine. 2023 Jan 16;41(3):826-835. doi: 10.1016/j.vaccine.2022.12.026. Epub 2022 Dec 16. PubMed
Carrell DS, Gruber S, Floyd JS, Bann MA, Cushing-Haugen KL, Johnson RL, Graham V, Cronkite DJ, Hazlehurst BL, Felcher AH, Bejan CA, Kennedy A, Shinde M, Karami S, Ma Y, Stojanovic D, Zhao Y, Ball R, Nelson J. Improving methods of identifying anaphylaxis for medical product safety surveillance using natural language processing and machine learning. Am J Epidemiol. 2022 Nov 4:kwac182. doi: 10.1093/aje/kwac182. [Epub ahead of print]. PubMed
Nelson JC, Ulloa-Perez E, Yu O, Cook AJ, Jackson ML, Belongia EA, Daley MF, Harpaz R, Kharbanda EO, Klein NP, Naleway AL, Tseng HF, Weintraub ES, Duffy J, Yih WK, Jackson LA. Active post-licensure safety surveillance for recombinant zoster vaccine using electronic health record data. Am J Epidemiol. 2022 Oct 4:kwac170. doi: 10.1093/aje/kwac170. [Epub ahead of print]. PubMed
Floyd JS, Bann MA, Felcher AH, Sapp D, Nguyen MD, Ajao A, Ball R, Carrell DS, Nelson JC, Hazlehurst B. Validation of acute pancreatitis among adults in an integrated healthcare system. Epidemiology. 2023 Jan 1;34(1):33-37. doi: 10.1097/EDE.0000000000001541. Epub 2022 Aug 25. PubMed
Tartof SY, Malden DE, Liu IA, Sy LS, Lewin BJ, Williams JTB, Hambidge SJ, Alpern JD, Daley MF, Nelson JC, McClure D, Zerbo O, Henninger ML, Fuller C, Weintraub E, Saydah S, Qian L. Health care utilization in the 6 months following SARS-CoV-2 infection. JAMA Netw Open. 2022 Aug 1;5(8):e2225657. doi: 10.1001/jamanetworkopen.2022.25657. PubMed
Goddard K, Lewis N, Fireman B, Weintraub E, Shimabukuro T, Zerbo O, Boyce TG, Oster ME, Hanson KE, Donahue JG, Ross P, Naleway A, Nelson JC, Lewin B, Glanz JM, Williams JTB, Kharbanda EO, Katherine Yih W, Klein NP. Risk of myocarditis and pericarditis following BNT162b2 and mRNA-1273 COVID-19 vaccination. Vaccine. 2022 Jul 12:S0264-410X(22)00860-X. doi: 10.1016/j.vaccine.2022.07.007. Online ahead of print. PubMed
DeSilva M, Haapala J, Vazquez-Benitez G, Vesco KK, Daley MF, Getahun D, Zerbo O, Naleway A, Nelson JC, Williams JTB, Hambidge SJ, Boyce TG, Fuller CC, Lipkind HS, Weintraub E, McNeil MM, Kharbanda EO. Evaluation of acute adverse events after COVID-19 vaccination during pregnancy. N Engl J Med. 2022 Jun 22. doi: 10.1056/NEJMc2205276. Online ahead of print. PubMed
Hause AM, Shay DK, Klein NP, Abara WE, Baggs J, Cortese MM, Fireman B, Gee J, Glanz JM, Goddard K, Hanson KE, Hugueley B, Kenigsberg T, Kharbanda EO, Lewin B, Lewis N, Marquez P, Myers T, Naleway A, Nelson JC, Su JR, Thompson D, Olubajo B, Oster ME, Weintraub ES, Williams JTB, Yousaf AR, Zerbo O, Zhang B, Shimabukuro TT. Safety of COVID-19 vaccination in US children ages 5-11 years. Pediatrics. 2022 May 18. doi: 10.1542/peds.2022-057313. Online 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.