Expert Review of Global Real-World Data on COVID-19 Vaccine Booster Effectiveness & Safety During the Omicron-dominant Phase of the Pandemic

Abstract Introduction COVID-19 vaccines have been highly effective in reducing morbidity and mortality during the pandemic. However, the emergence of the Omicron (B.1.1.529) variant and subvariants as the globally dominant strains have raised doubts about the effectiveness of currently-available vaccines and prompted debate about potential future vaccination strategies. Areas covered Using the publicly available IVAC VIEW-hub platform, we reviewed 52 studies on vaccine effectiveness (VE) after booster vaccinations. VE data were reported for SARS-CoV-2 symptomatic infection, severe disease and death and stratified by vaccine schedule and age. In addition, a non-systematic literature review of safety was performed to identify single or multi-country studies investigating adverse event rates for at least two of the currently-available COVID-19 vaccines. Expert opinion Booster shots of the current COVID-19 vaccines provide consistently high protection against Omicron-related severe disease and death. Additionally, this protection appears to be conserved for at least 3 months, with a small but significant waning after that time. The positive risk-benefit ratio of these vaccines is well established, thus increasing confidence in administering additional doses as required. Future vaccination strategies will likely include a combination of schedules based on a person's risk profile, as overly frequent boosting may be neither beneficial nor sustainable for the general population.