Risk and benefit of mRNA COVID-19 vaccines for Omicron variant by age, sex and presence of comorbidity: a quality-adjusted life years analysis

Abstract The replacement with the Omicron mutant variant raised the importance of re-evaluating risk and benefit of COVID-19 vaccines. With a decision tree model, the benefit-risk ratio and the benefit-risk difference of receiving monovalent mRNA COVID-19 vaccines (primary 2-doses, a third dose and a fourth dose) in the 4–5 months after vaccination were calculated using quality-adjusted life years. The analysis was stratified by age, sex and the presence of comorbidities. Evidence from peer-reviewed publications and gray literature was used to inform the study. Benefit-risk ratios ranged from 6.8 for males ages 12–17 without comorbidities for the primary doses, to 221.3 for females ages 65+ with comorbidities for the third dose in BNT162b2 and from 7.2 for males ages 18–29 without comorbidities for the primary doses, to 101.4 for females ages 65+ with comorbidities for the third dose in mRNA-1273. In all scenarios of the one-way sensitivity analysis, the benefit-risk ratios were more than 1, irrespective of age, sex, presence of comorbidity and type of vaccine, for both primary and booster doses. The benefits of mRNA COVID-19 vaccines in protecting against the Omicron variant outweigh the risks, irrespective of age, sex and the presence of comorbidities.