Effectiveness of mRNA Vaccine Booster against SARS-CoV-2 Infection and COVID-19 in the Adult Population during the First Three Months of the Omicron Wave in Sicily

Background: In Italy, the administration of the COVID-19 vaccine booster dose started on 27 September 2021, supported by clinical trials corroborating its efficacy. Given the paucity of real-world effectiveness data, this study aims to estimate the vaccine effectiveness of the booster dose against SARS-CoV-2 infection, severe disease, and death in the adult Sicilian population. Methods: This retrospective cohort study was carried out from 1 January to 31 March 2022 and included all residents in Sicily aged >= 18 years without previous SARS-CoV-2 infection and with a complete mRNA vaccine primary cycle. The cohort was split into two groups (booster and primary cycle) matched by age, gender, vaccine type, and month of completion of the primary vaccination cycle. Results: 913,382 subjects were observed in the study: 456,690 (50%) were vaccinated with two doses and 456,692 (50%) with three doses. There were 43,299 cases of SARS-CoV-2 among the two-doses vaccinees (9.5%) and 10,262 (2.2%) among the three-doses counterpart. Vaccine effectiveness in the booster cohort was 76.5% and 74.4% against SARS-CoV-2 infection, 85.7% and 79.7% against severe disease, and 84.1% and 73.1% against intubation or death, for BNT162b2 and mRNA-1273, respectively. Conclusions: This study confirmed the remarkable efficacy profile of the SARS-CoV-2 vaccine booster dose against infection, severe disease, and death attributable to the virus. Overall, the results of this study provide important real-world data to support the continued roll-out of the COVID-19 booster dose and have the potential to inform public health policy and guide decisions on vaccination strategies in countries around the world.