Project Summary

Pharmacoepidemiology has largely been concerned with quantification of uncommon harms from medications. Estimating effectiveness is more challenging, because of potentially greater confounding and selection biases. 

Most of the information on Covid-19 vaccine effectiveness we now rely on comes from ‘real world’ studies. As of September 2022, an international database contains details of over 300 effectiveness studies conducted in over 35 countries over approximately 18 months. In the field of pharmaco-epidemiology this is a unique database on the derivation of effectiveness estimates from routinely collected data. These studies have used a variety of different types of data and analytical methods, and results were generally strongly positive in terms of vaccine effectiveness. 

We plan a scoping review of these studies to learn how the research has evolved throughout the pandemic in terms of questions, data, cohort definition, analysis, and techniques to minimise bias when estimating effectiveness. The review findings will be used to guide present and future vaccine effectiveness studies and will help guide real-world effectiveness studies of other medicines being evaluated in our CRE.

Project Date

June 2022 - Dec 2024


Project Lead

Paulia Stehlik headshot

Paulina Stehlik

Senior Lecturer

School of Pharmacy and Medical Sciences, Griffith University; Adjunct at the Institute for Evidence Based Healthcare, Bond University

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Caroline Dorsett – Griffith University

Ms Ximena Camacho – UNSW Sydney

Dr Michael Falster – UNSW Sydney

Dr Renly Lim - University of South Australia

Dr Sharifa Nasreen – University of Toronto and ICES

Prof Nicole Pratt – University of South Australia

Prof Sallie Pearson – UNSW Sydney

Prof David Henry – UNSW Sydney

Research Question

How have research questions, data sources, designs, and analytical methods used in evaluating post-licensing Covid-19 vaccine effectiveness (mortality reduction) studies evolved over the course of the pandemic?

Data Sources

Data will be leveraged from the data compiled in the Johns Hopkins Bloomberg database.

Policy Implications

Developing agreed standards for conduct of real-world effectiveness studies (vaccines and medicines) in Australia. This will be relevant to the planning of epidemic responses in future.  

The results will be of value in the interpretation of contemporary studies of vaccine effectiveness and will have broader relevance to the conduct of pharmaco-epidemiological studies and methods training in the CRE and in pharmacoepidemiology in general. 

End Users

  • Research scientists
  • Regulators
  • Public health clinicians


Stay tuned

Our protocol has been published in the BMJ Open.

This section will be updated throughout the project. Please return in the future to see more impact from this project.

Protocol Publication | 2024

Stehlik P, Dowsett C, Camacho X, et al Evolution of the data and methods in real-world COVID-19 vaccine effectiveness studies on mortality: a scoping review protocol BMJ Open 2024;14:e079071. doi: 10.1136/bmjopen-2023-079071