Risk and Benefit of mRNA COVID-19 Vaccines for the Omicron Variant by Age, Sex, and Presence of Comorbidity: A Quality-Adjusted Life Years Analysis.

The development of the mutant omicron variant of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) during the coronavirus disease 2019 (COVID-19) pandemic raised the importance of reevaluating the risk and benefit of COVID-19 vaccines. With a decision tree model, we calculated the benefit-risk ratio and the benefit-risk difference of receiving monovalent messenger RNA (mRNA) COVID-19 vaccine (primary 2 doses, a third dose, and a fourth dose) in the 4-5 months after vaccination using quality-adjusted life years. The analysis was stratified by age, sex, and the presence of comorbidity. Evidence from peer-reviewed publications and gray literature was reviewed on September 16, 2022, to inform the study. Benefit-risk ratios for receipt of the BNT162b2 vaccine (Pfizer-BioNTech) ranged from 6.8 for males aged 12-17 years without comorbidity for the primary doses to 221.3 for females aged ≥65 years with comorbidity for the third dose. The benefit-risk ratios for receipt of the mRNA-1273 vaccine (Moderna) ranged from 7.2 for males aged 18-29 years without comorbidity for the primary doses to 101.4 for females aged ≥65 years with comorbidity for the third dose. In all scenarios of the one-way sensitivity analysis, the benefit-risk ratios were more than 1, irrespective of age, sex, comorbidity status, 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 comorbidity.