Postlicensure Evaluation of COVID-19 Vaccines—Potential Bias in “Test-Negative” Cases | Infectious Diseases | JN Learning | AMA Ed Hub [Skip to Content]
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Postlicensure Evaluation of COVID-19 Vaccines

Educational Objective
To identify the key insights or developments described in this article
1 Credit CME

After rigorous clinical trials of vaccines for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) have established safety and efficacy, and after vaccines are deployed, evaluating vaccine performance in actual clinical settings will be essential for understanding the risks and benefits of vaccination programs. However, unique aspects of coronavirus disease 2019 (COVID-19) may pose challenges for these postmarketing approaches for evaluating vaccines. This Viewpoint describes potential methodologic challenges with using the commonly applied “test-negative” case-control design1 for evaluating COVID-19 vaccines and proposes potential solutions for consideration.

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Article Information

Corresponding Author: Manish M. Patel, MD, COVID-19 Response Team, Centers for Disease Control and Prevention, 1600 Clifton Rd, MS H-24-7, Atlanta, GA 30333 (mpatel@cdc.gov).

Published Online: October 16, 2020. doi:10.1001/jama.2020.19328

Conflict of Interest Disclosures: Dr Ferdinands reported receiving nonfinancial support from the Institute for Influenza Epidemiology outside the submitted work. No other disclosures were reported.

Disclaimer: The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention.

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