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
Cook AJ, Wellman RD, Nelson JC, Jackson LA, Tiwari RC. Group sequential method for observational data by using generalized estimating equations: application to Vaccine Safety Datalink. J R Stat Soc Ser C Appl Stat. 2015;64(2):319-38. doi: 10.1111/rssc.12075. Epub 2014 Sep 23.
Klein NP, Lewis E, Fireman B, Hambidge SJ, Naleway A, Nelson JC, Belongia EA, Yih WK, Nordin JD, Hechter RC, Weintraub E, Baxter R. Safety of measles-containing vaccines in 1-year-old children. Pediatrics. 2015 Feb;135(2):e321-9. doi: 10.1542/peds.2014-1822. Epub 2015 Jan 5.
Bell C, Chakravarty A, Gruber S, Heckbert SR, Levenson M, Martin D, Nelson JC, Pinheiro S, Psaty BM, Reich CG, Schneeweiss S, Shoaibi A, Toh S, Walker AM. Characteristics of study design and elements that may contribute to the success of electronic safety monitoring systems. Pharmacoepidemiol Drug Saf. 2014 Nov;23(11):1223-5. doi: 10.1002/pds.3712. Epub 2014 Sep 29. PubMed
Hambidge SJ, Newcomer SR, Narwaney KJ, Glanz JM, Daley MF, Xu S, Shoup JA, Rowhani-Rahbar A, Klein NP, Lee GM, Nelson JC, Lugg M, Naleway AL, Nordin JD, Weintraub E, DeStefano F. Timely versus delayed early childhood vaccination and seizures. Pediatrics. 2014 Jun;133(6):e1492-9. doi: 10.1542/peds.2013-3429. PubMed
Xu S, Newcomer SR, Nelson JC, Chan L, McClure D, Pan Yi, Zeng C, Glanz J. Signal detection of adverse events with imperfect confirmation rates in vaccine safety studies using self-controlled case series design. Biom J. 2014 May;56(3):513-25. doi: 10.1002/bimj.201300012. Epub 2014 Jan 9. PubMed
Weiner SD, Ahmed HN, Jin Z, Cushman M, Herrington DM, Nelson JC, Di Tullio MR, Homma S. Systemic inflammation and brachial artery endothelial function in the Multi-Ethnic Study of Atherosclerosis (MESA). Heart. 2014 Jun;100(11):862-6. doi: 10.1136/heartjnl-2013-304893. Epub 2014 Apr 8. PubMed
Daley MF, Yih WK, Glanz JM, Hambidge SJ, Narwaney KJ, Yin R, Li L, Nelson JC, Nordin JD, Klein NP, Jacobsen SJ, Weintraub E. Safety of diphtheria, tetanus, acellular pertussis and inactivated poliovirus (DTaP-IPV) vaccine. Vaccine. 2014 May 23;32(25):3019-24. doi: 10.1016/j.vaccine.2014.03.063. Epub 2014 Mar 31. PubMed
Nelson JC, Shortreed SM, Yu O, Peterson D, Baxter R, Fireman B, Lewis N, McClure D, Weintraub E, Xu S, Jackson LA. Integrating database knowledge and epidemiological design to improve the implementation of data mining methods to evaluate vaccine safety in large healthcare databases. Stat Anal Data Min. 2014;7(5):33751.
Glanz JM, Narwaney KJ, Newcomer SR, Daley MF, Hambidge SJ, Rowhani-Rahbar A, Lee GM, Nelson JC, Naleway AL, Nordin JD, Lugg MM, Weintraub ES. Association between undervaccination with diphtheria, tetanus toxoids, and acellular pertussis (DTaP) vaccine and risk of pertussis infection in children 3 to 36 months of age. JAMA Pediatr. 2013 Nov;167(11):1060-4. doi: 10.1001/jamapediatrics.2013.2353. Epub 2013 Sep 9. PubMed
Jackson ML, Yu O, Nelson JC, Naleway A, Belongia EA, Baxter R, Narwaney K, Jacobsen SJ, Shay DK, Jackson LA. Further evidence for bias in observational studies of influenza vaccine effectiveness: the 2009 Influenza A(H1N1) pandemic. Am J Epidemiol. 2013 Oct 15;178(8):1327-36. doi: 10.1093/aje/kwt124. Epub 2013 Aug 26. 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.