Massachusetts General Hospital plans on launching a clinical trial based on a century-old tuberculosis vaccine that can offer protection against a variety of other infections and potentially be applicable to COVID-19. A small but vocal group have identified a potential pattern that shouldn’t be ignored: those countries that systematically implemented Bacillus Calmette-Guerin (BCG) vaccines are evidencing far lower COVID-19-related mortality rates than those countries that did not implement systematic vaccine programs. Spain, Italy, and the United States are examples of the latter. Other studies in Netherlands and Australia have commenced to investigate this question.
The BCG Vaccine
The Bacillus Calmette-Guerin (BCG) vaccine has been widely used in developing countries to protect against tuberculous since 1921. In fact, the World Health Organization (WHO) reports it to be the most widely administered vaccine in the history of medicine. A decade or so ago, researchers discovered “off-target effects” and explored use in the other therapeutic areas. This vaccine was never available in America and was never administered there, reports the Boston Herald. This is verified by other sources.
As it turns out, BCG was found to work against respiratory, viral, parasitic and bacterial infections reported Dr. Denise Faustman, director of immunobiology at Massachusetts General Hospital. Dr. Faustman has been leading clinical trials where the vaccine drug is used to treat type I diabetes.
COVID-19 Pattern of Mortality & Lack of BCG Vaccine
Of note, there have been some indications that those countries that have been hardest hit by COVID-19 never received the vaccine. The mortality rates from COVID-19 are higher in countries that never had formal BCG programs. In fact, according to Dr. Faustman, “In the countries where BCG was never given or stopped 50, 60 years ago—the mortality is off the charts noting Spain and Italy. But the U.S. never had such formal programs either and is now the epicenter.
And conversely, countries such as Japan, Taiwan and India, where vaccine programs were in place, “there’s very little effect so far with COVID-19.” The BCG vaccination studies reveal the drug impacts the body by modifying the primary, innate immune system, which purportedly triggers stronger infection response. For example, some clinical trials reveal BCG reduce the incidence of acute respiratory tract infections in adults by 70% to 80%. In yet another mortality study, BCG reduced all-cause infant mortality by over 33%.
The Massachusetts General Hospital BCG Study
Dr. Faustman at Massachusetts General Hospital will commence a clinical trial involving BCG within a month if all goes according to plan. Including high-risk health care workers, the goal would be to observe positive results within a year. She noted, “We have a strain of BCG that is known to be extraordinarily potent so now we are in the process of getting things started.”
Other BCG/COVID-19 Clinical Trials
Currently, there are two studies published in Clincialtrials.gov involving BCG and COVID-19.
In one study sponsored by the Murdoch Children’s Research Institute in collaboration with Royal Children’s Hospital, the sponsors will assess the assess the impact of the BCG vaccination on a study population of 4,170 healthcare workers. The subjects will be randomized to receive a single dose of BCG vaccine, or no vaccine. Participants will be followed up for 12 months with regular mobile phone text messages and surveys to identify and detail COVID-19 infection. The study team will collect additional information on severe disease from hospital records and government databases. Moreover, blood samples will be collected prior to randomization at 12 moths to determine exposure to acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The study began March 20, 2020 and ends on March 2022. Professor Nigel Curtis from Murdoch Children’s Research Institute serves as the principal investigator.
In another study involving BCG vaccinations, study sponsor UMC Utrecht in the Netherlands is concerned with health absenteeism involving COVID-19. Specifically the concern is that as COVID-19 spreads rapidly throughout the world, a large epidemic could seriously challenge the availability of healthcare workers and thus threaten actual capacity of the healthcare system. The sponsor seeks to determine if the BCG vaccine can reduce healthcare worker absenteeism during the pandemic. This study will target 1,500 workers and commenced March 25, 2020 and concludes December 2020. This study includes several sites and is led by two investigators including Thomas van der Vaart, MD and Thijs ten Doesschate, MD.
Massachusetts General Hospital Study
Dr. Denise Faustman, Director of immunobiology at Massachusetts General Hospital
UMC Ultrecht Study
Murdoch Children’s Research Institute Study
Professor Nigel Curtis, Group Leader, Infection & Immunity
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