Abstract Background Despite the availability of multiple COVID-19 vaccines, challenges remain in prevention and control. This systematic review and meta-analysis assess the safety and efficacy of BCG vaccination in COVID-19 prevention. Methods A comprehensive search was conducted in PubMed, Cochrane, Scopus, Web of Science, and Embase until March 2024. Primary outcomes included COVID-19 infection rate, mortality, hospitalization rate, and ICU admission. Secondary outcomes focused on adverse events. Results Fifteen RCTs with 16,347 participants were included. BCG vaccination did not significantly reduce COVID-19 infection (RR = 1.06, 95% CI 0.96–1.17, p = 0.27), ICU admission (RR = 0.44, 95% CI 0.14–1.42, p = 0.17), or hospitalization rate (RR = 0.90, 95% CI 0.60–1.36, p = 0.62). There were fewer deaths in the BCG group (RR = 0.52, 95% CI 0.25–1.08, p = 0.08). Regarding adverse events, BCG vaccination was strongly associated with erythema and may slightly increase cough risk, while other systemic symptoms (nausea, muscle/joint pain, sore throat) showed no significant association. Conclusion BCG vaccination does not significantly reduce the risk of COVID-19 infection, hospitalization, or ICU admission. While there is a potential reduction in mortality, the result is not statistically significant. Adverse event analysis confirms a strong association with erythema and a slight increase in cough risk, but no consistent association with other systemic symptoms. These findings suggest that BCG vaccination does not provide substantial protection against COVID-19 but is generally well tolerated. Disclosures All Authors: No reported disclosures
Nada et al. (Thu,) studied this question.