[Skip to Content]
[Skip to Content Landing]

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.

Sign in to take quiz and track your certificates

Buy This Activity

JN Learning™ is the home for CME and MOC from the JAMA Network. Search by specialty or US state and earn AMA PRA Category 1 Credit(s)™ from articles, audio, Clinical Challenges and more. Learn more about CME/MOC

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.

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.

References
1.
Chua  H , Feng  S , Lewnard  JA ,  et al.  The use of test-negative controls to monitor vaccine effectiveness.   Epidemiology. 2020;31(1):43-64.PubMedGoogle ScholarCrossref
2.
Patel  MM , Glass  R , Desai  R ,  et al.  Fulfilling the promise of rotavirus vaccines: how far have we come since licensure?   Lancet Infect Dis. 2012;12(7):561-570.PubMedGoogle ScholarCrossref
3.
Clemens  J , Brenner  R , Rao  M ,  et al.  Evaluating new vaccines for developing countries: efficacy or effectiveness?   JAMA. 1996;275(5):390-397.PubMedGoogle ScholarCrossref
4.
Hill  AB .  The environment and disease: association or causation?   Proc R Soc Med. 1965;58:295-300. doi:10.1177/003591576505800503PubMedGoogle Scholar
5.
Jackson  ML , Rothman  KJ .  Effects of imperfect test sensitivity and specificity on observational studies of influenza vaccine effectiveness.   Vaccine. 2015;33(11):1313-1316.PubMedGoogle ScholarCrossref
6.
Wiersinga  WJ , Rhodes  A , Cheng  AC , Peacock  SJ , Prescott  HC .  Pathophysiology, transmission, diagnosis, and treatment of coronavirus disease 2019 (COVID-19).   JAMA. 2020;324(8):782-793.PubMedGoogle ScholarCrossref
7.
Sethuraman  N , Jeremiah  SS , Ryo  A .  Interpreting diagnostic tests for SARS-CoV-2.   JAMA. 2020;323(22):2249-2251. doi:10.1001/jama.2020.8259PubMedGoogle ScholarCrossref
8.
Generic Protocol for Monitoring Impact of Rotavirus Vaccination on Rotavirus Disease Burden and Viral Strains. World Health Organization; 2009.
AMA CME Accreditation Information

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:

  • 1.00 Medical Knowledge MOC points in the American Board of Internal Medicine's (ABIM) Maintenance of Certification (MOC) program;;
  • 1.00 Self-Assessment points in the American Board of Otolaryngology – Head and Neck Surgery’s (ABOHNS) Continuing Certification program;
  • 1.00 MOC points in the American Board of Pediatrics’ (ABP) Maintenance of Certification (MOC) program;
  • 1.00 Lifelong Learning points in the American Board of Pathology’s (ABPath) Continuing Certification program; and
  • 1.00 credit toward the CME [and Self-Assessment requirements] of the American Board of Surgery’s Continuous Certification program

It is the CME activity provider's responsibility to submit participant completion information to ACCME for the purpose of granting MOC credit.

Close
Want full access to the AMA Ed Hub?
After you sign up for AMA Membership, make sure you sign in or create a Physician account with the AMA in order to access all learning activities on the AMA Ed Hub
Buy this activity
Close
Want full access to the AMA Ed Hub?
After you sign up for AMA Membership, make sure you sign in or create a Physician account with the AMA in order to access all learning activities on the AMA Ed Hub
Buy this activity
Close
With a personal account, you can:
  • Access free activities and track your credits
  • Personalize content alerts
  • Customize your interests
  • Fully personalize your learning experience
Education Center Collection Sign In Modal Right
Close

Name Your Search

Save Search
With a personal account, you can:
  • Access free activities and track your credits
  • Personalize content alerts
  • Customize your interests
  • Fully personalize your learning experience
Close
Close

Lookup An Activity

or

My Saved Searches

You currently have no searches saved.

Close

My Saved Courses

You currently have no courses saved.

Close