Quantitative Benefit-Risk Assessment of COVID-19 Vaccines Using the Multi-Criteria Decision Analysis

In the early SARS-CoV-2 (COVID-19) pandemic, four major vaccines were approved despite limited efficacy and safety data through short regulatory review periods. Thus, it is necessary to assess the benefit-risk (BR) profiles of the COVID-19 vaccines. We conducted a quantitative BR assessment for four...

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Bibliographic Details
Published in:Vaccines (Basel) 2022-11, Vol.10 (12), p.2029
Main Authors: Son, Kyung-Hwa, Kwon, Sun-Hong, Na, Hye-Jung, Baek, Youngsuk, Kim, Inok, Lee, Eui-Kyung
Format: Article
Language:English
Subjects:
Clinical trials
Coronaviruses
COVID-19
COVID-19 vaccine
COVID-19 vaccines
Data collection
Decision analysis
Decision making
FDA approval
Health aspects
Immunization
Medical personnel
mRNA
multi-criteria decision analysis
Multiple criterion
Observational studies
Pandemics
quantitative benefit-risk assessment
Risk assessment
SARS-CoV-2
Severe acute respiratory syndrome coronavirus 2
Vaccines
Viral diseases
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Summary:In the early SARS-CoV-2 (COVID-19) pandemic, four major vaccines were approved despite limited efficacy and safety data through short regulatory review periods. Thus, it is necessary to assess the benefit-risk (BR) profiles of the COVID-19 vaccines. We conducted a quantitative BR assessment for four COVID-19 vaccines (mRNA-based: mRNA-1273 and BNT162b2; viral vector-based: Ad26.COV.2 and ChAdOx1-S) using multi-criteria decision analysis. Three benefit criteria and two risk criteria were considered: preventing COVID-19 infection for (1) adults aged ≥18 years; (2) seniors aged 60 years or older; and (3) severe COVID-19, adverse events (AEs), and serious AEs. Data were retrieved from clinical trials, observational studies, and county-specific AE monitoring reports. Based on the collected data, vaccines were scored for each criterion. 22 professionals weighted each criterion. The overall BR score was calculated using scores and weights. mRNA-1273 was the most preferred vaccine in pre-authorization and BNT162b2 in post-authorization. We found that the mRNA vaccine had a good balance between the benefits and risks. Using this BR assessment, the benefit-risk profile of COVID-19 vaccines can be updated with cumulated data. It will contribute to building evidence for decision making by policy makers and health professionals.
ISSN:2076-393X
2076-393X
DOI:10.3390/vaccines10122029