During the COVID-19 pandemic, vaccines, including messenger ribonucleic acid (mRNA) vaccines, were rapidly developed, manufactured, and delivered. Even if very safe and effective vaccines are developed for the next infectious disease pandemic, populations may not be protected without a good acceptance of the new vaccine based on a solid scientific benefit-risk assessment. In this four-manuscript dissertation, a model development of vaccine risk and benefit evaluation for an infectious disease with pandemic potential was prepared followed by discussions regarding policy and practical implications of vaccine benefit risk assessment to prepare for the next infectious disease pandemic. The overarching research objective in this dissertation was to develop a model for vaccine risk and benefits for an infectious disease with pandemic potential to rapidly compare the risk and benefit of a new vaccine using a single health outcome scale.
In the first aim, the global risk of myocarditis, pericarditis and myopericarditis attributable to COVID-19 vaccination was evaluated. Young males had the highest risk attributable to COVID-19 vaccination. The quantitatively evaluation of attributable risks of myocarditis stratified by age group, sex, vaccine dose, and vaccine type helped develop a model with quantitative estimation of burden associated with vaccine adverse reactions. In the second aim, health utility of outcomes related with infectious diseases with pandemic potentials and associated vaccine adverse reactions were evaluated.
Following two systematic reviews, this study developed a model for vaccine benefit risk assessment stratified by age, sex, and the presence of medical comorbidity by country or region level. A quantitative benefit risk assessment of vaccination can facilitate a straightforward comparison of vaccine benefits and risks. While the societal perspective is fundamental to evaluating vaccine benefits and risks as a population, it may not always support individual vaccine decision making. Benefit risk assessment of vaccination from an individual perspective may be helpful for some individuals. In the next pandemic, a rapid vaccine benefit risk assessment is required, followed by sequential analyses to update dynamic changes regarding epidemiology as well as vaccine effectiveness and safety data
