Quantitative Benefit-Risk Assessment of Vaccination Against COVID-19: A Systematic Review.

Purpose: With the introduction of COVID-19 vaccines, there has been a proliferation of quantitative benefit-risk assessments (qBRAs). Prior work on other types of vaccines has found that published qBRAs have not always clearly reported methods and/or results needed to assist in the application of the qBRA findings. The aim was to systematically identify, review, and critically assess published COVID-19 vaccine qBRA. The ultimate goal is to support the future development of robust qBRA for existing, new, and updated vaccines.

Methods: We systematically reviewed COVID-19 vaccine qBRAs identified from multiple sources through April 17, 2023, including literature databases, selected Health Authority websites, and a grey literature search. We critically assessed whether key features typical of qBRA were presented in these reports.

Results: We identified 37 COVID-19 vaccine qBRAs from screening 2220 publications and 18 other sources. The qBRAs were conducted on two mRNA and two adenoviral vector COVID-19 vaccines. Only one qBRA represented low- and middle-income countries. Although many qBRAs used simple calculations (n = 25), more complex models were presented in 15 reports. Simple approaches were able to employ stratification by age and/or sex to highlight safety issues affecting specific demographic groups and scenarios to account for changes in viral transmission and vaccine effectiveness over time. Details regarding data sources and analytic methods were missing or limited in some reports.

Conclusions: This comprehensive description and critical assessment of COVID-19 vaccine qBRAs together with available guidance can be used to support the development of robust and transparent future vaccine qBRAs.