WHO Report: No Evidence BCG Vaccine Protects Against COVID-19
There is no evidence that the Bacille Calmette-Guérin vaccine (BCG) protects people against infection with COVID-19 virus, according to a WHO scientific report. Two clinical trials addressing this question are underway, and WHO will evaluate the evidence when it is available. In the absence of evidence, WHO does not recommend BCG vaccination for the prevention of COVID-19. WHO continues to recommend neonatal BCG vaccination in countries or settings with a high incidence of tuberculosis.1
There is experimental evidence from both animal and human studies that the BCG vaccine has non-specific effects on the immune system. These effects have not been well characterized and their clinical relevance is unknown.2,3
On 11 April 2020, WHO updated its ongoing evidence review of the major scientific databases and clinical trial repositories, using English, French and Chinese search terms for COVID-19, coronavirus, SARS-CoV-2 and BCG. The review yielded three preprints (manuscripts posted online before peer-review), in which the authors compared the incidence of COVID-19 cases in countries where the BCG vaccine is used with countries where it is not used and observed that countries that routinely used the vaccine in neonates had less reported cases of COVID-19 to date. Such ecological studies are prone to significant bias from many confounders, including differences in national demographics and disease burden, testing rates for COVID-19 virus infections, and the stage of the pandemic in each country. The review also yielded two registered protocols for clinical trials, both of which aim to study the effects of BCG vaccination given to health care workers directly involved in the care of patients with COVID-19.4,5 BCG vaccination prevents severe forms of tuberculosis in children and diversion of local supplies may result in neonates not being vaccinated, resulting in an increase of disease and deaths from tuberculosis.6-8 In the absence of evidence, WHO does not recommend BCG vaccination for the prevention of COVID-19. WHO continues to recommend neonatal BCG vaccination in countries or settings with a high incidence of tuberculosis.
On 11 April 2020, WHO updated its ongoing evidence review of the major scientific databases and clinical trial repositories, using English, French and Chinese search terms for COVID-19, coronavirus, SARS-CoV-2 and BCG. The review yielded three preprints (manuscripts posted online before peer-review), in which the authors compared the incidence of COVID-19 cases in countries where the BCG vaccine is used with countries where it is not used and observed that countries that routinely used the vaccine in neonates had less reported cases of COVID-19 to date. Such ecological studies are prone to significant bias from many confounders, including differences in national demographics and disease burden, testing rates for COVID-19 virus infections, and the stage of the pandemic in each country. The review also yielded two registered protocols for clinical trials, both of which aim to study the effects of BCG vaccination given to health care workers directly involved in the care of patients with COVID-19.4,5 BCG vaccination prevents severe forms of tuberculosis in children and diversion of local supplies may result in neonates not being vaccinated, resulting in an increase of disease and deaths from tuberculosis.6-8 In the absence of evidence, WHO does not recommend BCG vaccination for the prevention of COVID-19. WHO continues to recommend neonatal BCG vaccination in countries or settings with a high incidence of tuberculosis.
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