Jennifer Clark Nelson, PhD
“As national statistical leaders, we promote the use of rigorous methods that enhance drug and vaccine safety monitoring in the United States.”
Jennifer Clark Nelson, PhD
Director, Biostatistics; Senior Investigator, Kaiser Permanente Washington Health Research Institute
Affiliate Professor of Biostatistics, University of Washington
Jen.Nelson@kp.org
206-287-2004
Biography
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.
Research interests and experience
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Biostatistics
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
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Vaccines & Infectious Diseases
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
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Medication Use & Patient Safety
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
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Aging & Dementia
Biostatistics; statistical issues in longitudinal observational cohort studies
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Cardiovascular Health
Recent publications
Jackson LA, Yu O, Nelson JC, Dominguez C, Peterson D, Baxter R, Hambidge SJ, Naleway AL, Belongia EA, Nordin JD, Baggs J. Injection site and risk of medically attended local reactions to acellular pertussis vaccine. Pediatrics. 2011 Mar;127(3):e581-e587. Epub 2011 Feb 7. PubMed
Jackson LA, Peterson D, Dunn J, Hambidge SJ, Dunstan M, Starkovich P, Yu O, Benoit J, Dominguez-Islas CP, Carste B, Benson P, Nelson JC. A randomized placebo-controlled trial of acetaminophen for prevention of post-vaccination fever in infants. PLoS One. 2011;6(6):e20102. Epub 2011 Jun 17. PubMed
Dublin S, Walker RL, Jackson ML, Nelson JC, Weiss NS, Jackson LA. Use of proton pump inhibitors and H2 blockers and risk of pneumonia in older adults: a population-based case-control study. Pharmacoepidemiol Drug Saf. 2010 Aug;19(8):792-802. Epub 2010 Jul 7. PubMed
Nelson JC, Bittner RC, Bounds L, Zhao S, Baggs J, Donahue JG, Hambidge SJ, Jacobsen SJ, Klein NP, Naleway AL, Zangwill KM, Jackson LA. Compliance with multiple-dose vaccine schedules among older children, adolescents, and adults: results from a Vaccine Safety Datalink study. Am J Public Health. 2009;99 Suppl 2:S389-97. PubMed
Jackson LA, Yu O, Nelson J, Belongia EA, Hambidge SJ, Baxter R, Naleway A, Nordin J, Baggs J, Iskander J. Risk of medically attended local reactions following diphtheria toxoid containing vaccines in adolescents and young adults: A Vaccine Safety Datalink study. Vaccine. 2009;27(36):4912-6. Epub 2009 Jun 28. PubMed
Jackson ML, Nelson JC, Jackson LA. Risk factors for community-acquired pneumonia in immunocompetent seniors. J Am Geriatr Soc. 2009;57(5):882-8. Epub 2009 Apr 21. PubMed
Nelson JC, Jackson ML, Weiss NS, Jackson LA. New strategies are needed to improve the accuracy of influenza vaccine effectiveness estimates among seniors. J Clin Epidemiol. 2009;62(7):687-94. Epub 2009 Jan 4. PubMed
Dublin S, Jackson ML, Nelson JC, Weiss NS, Larson EB, Jackson LA. Statin use and risk of community acquired pneumonia in older people: population based case-control study. BMJ. 2009;338:b2137. doi: 10.1136/bmj.b2137. PubMed
Jackson LA, Yu O, Belongia EA, Hambidge SJ, Nelson J, Baxter R, Naleway A, Gay C, Nordin J, Baggs J, Iskander J. Frequency of medically attended adverse events following tetanus and diphtheria toxoid vaccine in adolescents and young adults: a Vaccine Safety Datalink study. BMC Infect Dis. 2009;9:165. PubMed
Jackson ML, Nelson JC, Weiss NS, Neuzil KM, Barlow W, Jackson LA. Influenza vaccination and risk of community-acquired pneumonia in immunocompetent elderly people: a population-based, nested case-control study. Lancet. 2008;372(9636):398-405. PubMed
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Honors from the Health Care Systems Research Network for early career achievements and manuscript of the year
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COVID-19 vaccines and serious reactions: 3 questions answered
Jen Nelson, PhD, talks about monitoring reactions to the mRNA vaccines.
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