Postlicensure Evaluation of COVID-19 Vaccines

November 17, 2020, Vol 324, No. 19, Pages 1925-2006


Postlicensure Evaluation of COVID-19 Vaccines
Manish M. Patel, MD; Michael L. Jackson, PhD; Jill Ferdinands, PhD
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JAMA. 2020;324(19):1939-1940. doi:10.1001/jama.2020.19328
This Viewpoint explains the “test-negative” modified case-control design commonly used for evaluating vaccine effectiveness, describes why it may be lead to biased estimates of COVID-19 vaccine effectiveness in patients with severe illness more likely to test negative, and proposes potential approaches to correcting the bias, including incorporation of clinical assessment of cases.