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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CME Disclosure Statement: Unless noted, all individuals in control of content reported no relevant financial relationships. If applicable, all relevant financial relationships have been mitigated.
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 (firstname.lastname@example.org).
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.
Credit Designation Statement: The American Medical Association designates this Journal-based CME activity activity for a maximum of 1.00 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
Successful completion of this CME activity, which includes participation in the evaluation component, enables the participant to earn up to:
It is the CME activity provider's responsibility to submit participant completion information to ACCME for the purpose of granting MOC credit.
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