Recent research from Cell Reports Medicine shown that type 1 diabetics may be protected by the new severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants and other pathogenic illnesses by receiving the Bacillus Calmette-Guerin (BCG) vaccine.
Background
Randomized clinical trials and epidemiological studies conducted over the past 17 years have demonstrated the effectiveness of the BCG vaccine against tuberculosis in preventing a variety of infections, including leprosy, malaria, upper respiratory tract infections, and bacterial and viral infections. The BCG vaccine may also protect people from immune diseases like type 1 diabetes and multiple sclerosis.
Platform vaccines that are efficient and secure are needed to immunise people against SARS-CoV-2 infection and other dangerous diseases.
The BCG vaccine may also protect people from immune diseases like type 1 diabetes and multiple sclerosis.
Platform vaccines that are efficient and secure are needed to immunise people against SARS-CoV-2 infection and other dangerous diseases. As the SARS-CoV-2 pandemic spread, epidemiological research on a country-by-country basis began to link neonatal BCG vaccination with decreased COVID-19 (coronavirus disease) mortality and morbidity, even in elderly persons decades after the typical newborn injections. Different neonatal exposure groups from throughout the world, BCG strains, and other communities, on the other hand, did not show these advantages.
A randomised investigation of BCG for potential COVID-19 protection provides a clear comparison in a vaccine-naive US adult population because adults or neonates in the US have never received the BCG vaccine.
Concerning the study
The effectiveness and safety of the multi-dose BCG vaccinations for preventing COVID-19 and other infectious diseases were evaluated in the current placebo-controlled, double-blinded, randomised phase II/III research in a SARS-CoV-2-unvaccinated, high-risk community-based group over a 15-month period, from 1 January 2020 to April 2021.
The authors sought to determine whether the BCG vaccine might serve as a platform vaccine strategy to protect against a variety of infectious illnesses, such as SARS-CoV-2 infection in the population at risk.
Adults with type 1 diabetes were regarded as the study’s high-risk population. The group enrolled 144 individuals, and then randomly assigned 48 to the placebo arm and 96 to the BCG arm. Additionally, no subjects left the study throughout the 15-month period.
The current parallel trial was generated from an ongoing randomised, double-blinded investigation of BCG for the treatment of adult type 1 diabetes that has been present for a very long time. Therefore, at the start of the SARS-CoV-2 pandemic in the US on January 1, 2020, all participants had received a complete course of vaccination with three BCG or placebo shots.
Results
Contrary to antigen-specific COVID-19 immunizations, the study’s findings showed that no participants had any systemic side effects from BCG during the vaccine period. The BCG vaccine is known to cause localised skin responses, which normally begin between two and four weeks after administration.
The BCG vaccine is known to cause localised skin responses, which typically appear two to four weeks following inoculation. No disproportionate local responses or negative effects were recorded. It should be noted that additional SARS-CoV-2 vaccinations were not yet available during the trial’s duration and had no bearing on the study.
With a cumulative frequency of 1% of BCG-treated participants and 12.5% of placebo-treated volunteers satisfying the criteria for a confirmed COVID-19 diagnosis based on symptoms and positive serologies, the BCG vaccine was 92% effective against SARS-CoV-2 infection. Additionally, the investigators found zero polymerase chain reaction (PCR)-positive symptomatic people in the BCG arm, or 0%, as opposed to five symptomatic, PCR-positive subjects in the placebo cohort, or 10.4%.
These results showed that the BCG vaccine was 100% effective against SARS-CoV-2 infection with 0.99 posterior probability if just the PCR data were taken into account. Additionally, neither the BCG group nor the placebo group saw any fatalities brought on by SARS-CoV-2.
The majority of SARS-CoV-2 domains included in the heatmap comparisons showed a considerably larger accumulation of antibody reactivity in the placebo group compared to the BCG arm, the researchers reported, with the exception of the COVID-19 viral epitope II. In addition, compared to the placebo group, the BCG vaccine reduced the duration and intensity of all infectious disease symptoms.
Furthermore, the results of the study demonstrated that all of the symptoms of infectious diseases in BCG recipients were comparable to or less severe than those in their home.
However, compared to their family members, the majority of placebo participants had a more serious condition. Patients who received BCG frequently experienced less symptoms than those who received placebos or non-diabetic home controls.
Conclusions
The study’s findings demonstrated that the BCG vaccine provides adults with type 1 diabetes in the US effective protection against COVID-19 and complete protection against other infectious illnesses.
Given its extensive protection against other illnesses, the BCG vaccination was shown in the study results to be efficacious, safe, and cost-effective as well as perhaps protective against the SARS-CoV-2 strain of the COVID-19 pandemic, which is continually changing. Although the BCG vaccine’s effectiveness takes one to two years to become apparent, the scientists noted that immunity may persist for decades.
- Faustman, D. et al. (2022) “Multiple BCG vaccinations for prevention of COVID-19 and other infectious diseases in Type 1 diabetes”, Cell Reports Medicine, p. 100728. doi: 10.1016/j.xcrm.2022.100728. https://www.cell.com/cell-reports-medicine/fulltext/S2666-3791(22)00271-3