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Journal of Diabetes and Clinical Research

ISSN: 2689-2839

Commentary Open Access
Volume 7 | Issue 1 | DOI: https://doi.org/10.33696/diabetes.6.069

BCG Immunotherapy:  Promising Protection from COVID-19 and Other Infectious Diseases in Type 1 Diabetics

Denise L Faustman1,*, Miriam Davis2, Willem M Kuhtreiber1
  • 1Massachusetts General Hospital, Laboratory of Immunobiology and Harvard Medical School, Boston, MA
  • 2Massachusetts General Hospital, Laboratory of Immunobiology, Boston, MA, USA
+ Affiliations - Affiliations

Corresponding Author

Denise L Faustman, dfaustman@mgh.harvard.edu

Received Date: May 16, 2025

Accepted Date: August 06, 2025

Citation:

Faustman DL, Davis M, Kühtreiber WM. BCG Immunotherapy: Promising Protection from COVID-19 and Other Infectious Diseases in Type 1 Diabetics. J Diabetes Clin Res. 2025;7(1):38–43.


Copyright: © 2025 Faustman DL, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Abstract

Individuals with type 1 diabetes are more vulnerable than the general population to morbidity and mortality from infectious disease, including COVID-19. Over the last 20 years, the >100-year-old tuberculosis vaccine, known as Bacille Calmette-Guerin (BCG), has been observed in global populations to protect from viral, bacterial and parasitic infections, among others. Our laboratory conducted the first and only trials in type 1 diabetics (T1Ds) to determine whether infectious disease protection could be conferred by multi-dose BCG vaccine as an immunotherapy. In two back-to-back randomized, placebo-controlled, double-blinded trials covering the entire course of the COVID-19 pandemic, we found that up to six doses of BCG were safe and protected against developing COVID-19 and other infections. Like other BCG-related off-target effects, these benefits took a minimum of 3 years to begin to materialize, yet they potentially may last for decades. A total of 12 worldwide clinical trials have evaluated largely single-dose BCG vaccines for COVID-19 prevention in other high-risk populations, like the elderly and health care workers. Five found BCG to be efficacious, while seven did not. The BCG trials that failed to find benefit were often too short in duration to obtain protection. We show, in a US T1D population, that full infectious disease protection takes up to 5 years. Also, many negative trials testing BCG efficacy were actually BCG booster (re-vaccination) trials in which placebo groups had also received prior neonatal BCG vaccines, thereby obscuring the possibility of finding a large benefit in the treatment group. Further, not all clinical trials utilized the most potent BCG strains. On the basis of our successful trials of multi-dose BCG in a vulnerable US population of T1D subjects, we conclude that this population stands to benefit from multi-dose BCG immunotherapy for protection from COVID-19 and other infectious diseases.

Keywords

BCG, COVID-19, Type 1 diabetes, High-risk population, Infectious disease, Platform vaccines

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