On Measuring Vaccine Effectiveness with Observational Study Designs


  • Farrokh Habibzadeh Global Virus Network, Middle East Region, Shiraz
  • Parham Habibzadeh Division of Clinical Care and Research, Institute of Human Virology, University of Maryland School of Medicine, Baltimore
  • Mahboobeh Yadollahie Freelance Researcher, Shiraz




Vaccines, Research Design, Cohort Studies, Case-Control Studies, SARS-CoV-2


Herein, we present a bird’s eye view of common observational study designs utilized for measurement of vaccine effectiveness. Assessing vaccines effectiveness is an integral part of vaccine research, particularly for the newly developed vaccines. A cohort study is prospective, directing from an exposure to one or more outcomes. The design is the best method to ascertain the attack rate of an infectious disease. A traditional case-control study is retrospective, directing from a given outcome to one or more exposures. The design cannot provide the relative risk, but it can provide the odds ratio, which is a good estimation of the relative risk when the attack rate is low. Critically depending on laboratory test results and performance, the test-negative case-control study design is another type of observational study commonly used nowadays for the evaluation of the vaccine effectiveness. Comparing to cohort and traditional case-control designs, conducting a test-negative case-control study is relatively cheaper and faster. Herein, we describe each of the above-mentioned study designs through examples generated by a Monte-Carlo simulation program assuming real-world conditions.

Conclusion. The simulation shows that regardless of the study design employed, the diagnostic test specificity is of utmost importance in providing a valid estimate of the vaccine effectiveness.


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How to Cite

Habibzadeh, F., Habibzadeh, P., & Yadollahie, M. (2022). On Measuring Vaccine Effectiveness with Observational Study Designs. Acta Medica Academica, 51(2), 134–146. https://doi.org/10.5644/ama2006-124.383



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