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Will the existing Bacillus Calmette-Guerin (BCG) vaccine for tuberculosis be approved for use as a SARS-CoV-2 vaccine in the United States or European Union before 2022?

The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) virus is a novel betacoronavirus that likely emerged late last year from an animal reservoir in China. There is little to no pre-existing immunity against it in the human population. The clinical picture for the disease it causes, coronavirus disease 2019 (COVID-19), ranges from very mild to fatal. The virus is highly transmissible and has spread globally.

As of 20 March 2020, the WHO (World Health Organization) is reporting that it is tracking the development of forty-four SARS-CoV-2 candidate vaccines.

Studies investigating an alternative route to a SARS-CoV-2 vaccine are also underway. In particular, there are ongoing studies looking at the efficacy of an existing tuberculosis vaccine in protecting against SARS-CoV-2. Previous observational and clinical studies have shown that the Bacillus Calmette-Guerin (BCG) vaccine induces a generalized immune response that provides some protection to pathogens other than the tuberculosis bacterium. Specifically, the BCG vaccine is thought to stimulate a process called trained immunity in which innate immune cells undergo long-term changes via epigenetic reprogramming in such a way that there is improved capacity to eliminate infection.

Will the existing Bacillus Calmette-Guerin (BCG) vaccine for tuberculosis be approved for use as a SARS-CoV-2 vaccine in the United States or European Union before 2022?

Resolution will be determined via the first relevant press release made by the FDA, EMA, or European Commission regarding the approval of the BCG vaccine for use as a SARS-CoV-2 vaccine. In the United States, approval means that the vaccine candidate has been licensed by the FDA. In the European Union, approval means that the EMA has recommended the vaccine candidate for approval and the European Commission has granted that approval via marketing authorization. Approval under any other emergency procedures, such as expanded access, would not count.


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