Efficacy of Bacille Calmette–Guérin Against COVID-19 Hospitalisation: A Meta-Analysis and Systematic Review of Randomised Control Trials

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dc.contributor.authorInauen, J.
dc.contributor.authorLaBroome, S.
dc.contributor.authorMaldari, A.
dc.contributor.authorStevens, N.E.
dc.contributor.authorGeake, J.B.
dc.contributor.authorLynn, D.J.
dc.contributor.authorBarry, S.
dc.date.issued2025
dc.description.abstractBackground: The BCG vaccine has long been hypothesised to have non-specific protective effects, and early epidemiological studies on COVID-19 suggested a possible protective effect against SARS-CoV-2 infection and COVID-19 severity. This systematic review and meta-analysis assesses the effect of the BCG vaccine on preventing severe COVID-19 disease, based on the rate of hospitalisation for COVID-19 related disease. Methods: We performed a literature search of randomised control trials comparing BCG vaccine to placebo in adult participants using EMBASE, MEDLINE, and Web of Science. A random effects model was used to generate summary estimates. Risk of bias was assessed regarding randomisation, allocation sequence concealment, blinding, incomplete outcome data, selective outcome reporting, and other biases. Results: We included 11 studies involving 18,412 participants, reporting COVID-19 incidence. The hospitalisation rate was sought from the authors of papers that did not report on this statistic. There was no significant reduction in COVID-19-related hospitalisation across all studies (relative risk 0.85, 0.51–1.40, p = 0.335), COVID-19 incidence across all studies (relative risk 1.07, 0.94–1.21, p = 0.264), deaths reported in six studies (relative risk 0.67, 0.36–1.26, p = 0.733), and COVID-19-related critical care admissions reported in four studies (relative risk 0.43, 0.13–1.46, p = 0.746). Conclusions: The findings from this meta-analysis, involving a large number of participants, suggest no protective effect of BCG vaccination against severe COVID-19 outcomes or overall SARS-CoV-2 incidence. Further research may be needed to explore the potential non-specific effects of BCG vaccination in other specific populations and against other infections.
dc.description.statementofresponsibilityJoseph Inauen, Sam LaBroome, Antonietta Maldari, Natalie E. Stevens, James B. Geake, David J. Lynn, and Simone Barry
dc.identifier.citationVaccines, 2025; 13(3):267-1-267-15
dc.identifier.doi10.3390/vaccines13030267
dc.identifier.issn2076-393X
dc.identifier.issn2076-393X
dc.identifier.orcidGeake, J.B. [0000-0003-3864-8518]
dc.identifier.urihttps://hdl.handle.net/2440/146395
dc.language.isoen
dc.publisherMDPI AG
dc.relation.granthttp://purl.org/au-research/grants/nhmrc/GNT2019988
dc.rights© 2025 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/ licenses/by/4.0/).
dc.source.urihttps://doi.org/10.3390/vaccines13030267
dc.subjectBCG; COVID-19; SARS-CoV-2; systematic review; meta-analysis
dc.titleEfficacy of Bacille Calmette–Guérin Against COVID-19 Hospitalisation: A Meta-Analysis and Systematic Review of Randomised Control Trials
dc.typeJournal article
pubs.publication-statusPublished online

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