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

IF 2.4 4区医学 Q3 PHARMACOLOGY & PHARMACY

Pharmacoepidemiology and Drug Safety Pub Date : 2025-02-01 DOI:10.1002/pds.70099

E Claire Newbern, Lea Wildisen, Rita Verstraeten, Corinne Willame, Kevin Haynes, Bennett Levitan, Nicolas Praet

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引用次数: 0

Abstract

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.

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来源期刊

Pharmacoepidemiology and Drug Safety 医学-药学

CiteScore

4.80

自引率

7.70%

发文量

173

审稿时长

3 months

期刊介绍： The aim of Pharmacoepidemiology and Drug Safety is to provide an international forum for the communication and evaluation of data, methods and opinion in the discipline of pharmacoepidemiology. The Journal publishes peer-reviewed reports of original research, invited reviews and a variety of guest editorials and commentaries embracing scientific, medical, statistical, legal and economic aspects of pharmacoepidemiology and post-marketing surveillance of drug safety. Appropriate material in these categories may also be considered for publication as a Brief Report. Particular areas of interest include: design, analysis, results, and interpretation of studies looking at the benefit or safety of specific pharmaceuticals, biologics, or medical devices, including studies in pharmacovigilance, postmarketing surveillance, pharmacoeconomics, patient safety, molecular pharmacoepidemiology, or any other study within the broad field of pharmacoepidemiology; comparative effectiveness research relating to pharmaceuticals, biologics, and medical devices. Comparative effectiveness research is the generation and synthesis of evidence that compares the benefits and harms of alternative methods to prevent, diagnose, treat, and monitor a clinical condition, as these methods are truly used in the real world; methodologic contributions of relevance to pharmacoepidemiology, whether original contributions, reviews of existing methods, or tutorials for how to apply the methods of pharmacoepidemiology; assessments of harm versus benefit in drug therapy; patterns of drug utilization; relationships between pharmacoepidemiology and the formulation and interpretation of regulatory guidelines; evaluations of risk management plans and programmes relating to pharmaceuticals, biologics and medical devices.