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 large electronic health care data. Dr. Nelson provides national statistical leadership as a methods core lead for the 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 methodological research within the Centers for Disease Control and Prevention-sponsored Vaccine Safety Datalink (VSD), a national collaboration involving seven managed care organizations that has monitored immunization safety in the United States since 1990.
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 to advance health and health care. In 2009, Dr. Nelson earned the VSD’s Margarette Kolczak Award for outstanding contributions in biostatistics and epidemiology in vaccine safety.
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
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
Xu S, Hong V, Sy LS, Glenn SC, Ryan DS, Morrissette K, Nelson JC, Hambidge SJ, Crane B, Zerbo O, DeSilva MB, Glanz JM, Donahue JG, Liles E, Duffy J, Qian L. Changes in incidence rates of outcomes of interest in vaccine safety studies during the COVID-19 pandemic. Vaccine. 2022 Apr 18:S0264-410X(22)00464-9. doi: 10.1016/j.vaccine.2022.04.037. Online ahead of print. PubMed
Kenigsberg TA, Hause AM, McNeil MM, Nelson JC, Ann Shoup J, Goddard K, Lou Y, Hanson KE, Glenn SC, Weintraub E. Dashboard development for near real-time visualization of COVID-19 vaccine safety surveillance data in the vaccine safety datalink. Vaccine. 2022 Apr 8:S0264-410X(22)00426-1. doi: 10.1016/j.vaccine.2022.04.010. Online ahead of print. PubMed
Hanson KE, Goddard K, Lewis E, Myers TR, Bakshi N, Weintraub E, Donahue JG, Glanz JM, Nelson JC, Williams JTB, Xu S, Klein NP. Incidence of Guillain-Barré syndrome after COVID-19 vaccination in the Vaccine Safety Datalink. JAMA Netw Open. 2022 Apr 1;5(4):e228879. doi: 10.1001/jamanetworkopen.2022.8879. PubMed
Larson EB, Nelson JC. In older adults, use of a recombinant zoster vaccine was associated with Guillain-Barré syndrome. Ann Intern Med. 2022;175(3):JC35. doi: 10.7326/J22-0010. Epub 2022 Mar 1. PubMed
Desai RJ, Matheny ME, Johnson K, Marsolo K, Curtis LH, Nelson JC, Heagerty PJ, Maro J, Brown J, Toh S, Nguyen M, Ball R, Pan GD, Wang SV, Gagne JJ, Schneeweiss S. Broadening the reach of the FDA Sentinel system: a roadmap for integrating electronic health record data in a causal analysis framework. NPJ Digit Med. 2021;4(1):170. doi: 10.1038/s41746-021-00542-0. PubMed
Klein NP, Lewis N, Goddard K, Fireman B, Zerbo O, Hanson KE, Donahue JG, Kharbanda EO, Naleway A, Nelson JC, Xu S, Yih WK, Glanz JM, Williams JTB, Hambidge SJ, Lewin BJ, Shimabukuro TT, DeStefano F, Weintraub ES. Surveillance for adverse events after COVID-19 mRNA vaccination. JAMA. 2021 Oct 12;326(14):1390-1399. doi: 10.1001/jama.2021.15072. PubMed
Pingali C, Meghani M, Razzaghi H, Lamias MJ, Weintraub E, Kenigsberg TA, Klein NP, Lewis N, Fireman B, Zerbo O, Bartlett, J, Goddard K, Donahue J, Hanson K, Naleway A, Kharbanda EO, Yih WK, Nelson JC, Lewin BJ, Williams JTB, Glanz JM, Singleton JA, Patel SA. COVID-19 vaccination coverage among insured persons aged =16 years, by race/ethnicity and other selected characteristics - eight integrated health care organizations, United States, December 14, 2020-May 15, 202. MMWR Morb Mortal Wkly Rep. 2021 Jul 16;70(28):985-990. doi: 10.15585/mmwr.mm7028a1. PubMed
Razzaghi H, Meghani M, Pingali C, Crane B, Naleway A, Weintraub E, Kenigsberg TA, Lamias MJ, Irving SA, Kauffman TL, Vesco KK, Daley MF, DeSilva M, Donahue J, Getahun D, Glenn S, Hambidge SJ, Jackson L, Lipkind HS, Nelson JC, Zerbo O, Oduyebo T, Singleton JA, Patel SA. COVID-19 vaccination coverage among pregnant women during pregnancy - eight integrated health care organizations, United States, December 14, 2020-May 8, 2021. MMWR Morb Mortal Wkly Rep. 2021 Jun 18;70(24):895-899. doi: 10.15585/mmwr.mm7024e2. PubMed
Berrueta M, Ciapponi A, Bardach A, Cairoli FR, Castellano FJ, Xiong X, Stergachis A, Zaraa S, Meulen AS, Buekens P; Scoping Review Collaboration Group. Maternal and neonatal data collection systems in low- and middle-income countries for maternal vaccines active safety surveillance systems: a scoping review. BMC Pregnancy Childbirth. 2021 Mar 17;21(1):217. doi: 10.1186/s12884-021-03686-9. PubMed
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.
Dr. Jennifer Nelson explains how KP scientists are helping the CDC and FDA keep an eye out for rare adverse events.
New funding will establish an innovation center, to be led by Harvard Pilgrim in partnership with KPWHRI and others.