Wait for trial results before using BCG vaccine for COVID-19, Tedros writes

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Tedros and others caution that using BCG vaccine on health-care workers for COVID-19 should be only after safety and efficacy are tested through randomised controlled trials. BCG vaccine, which ramps up the immune system, can exacerbate COVID-19 in a small population of patients with severe disease, they warn.

In a letter published in The Lancet on April 30, Director-General of World Health Organization Tedros A Ghebreyesus and others highlight a few critical issues surrounding the use of BCG vaccine for coronavirus disease (COVID-19). They underscore the importance of carrying out randomised controlled trials using the vaccine to understand the safety and efficacy before using it on health-care workers.

Currently, randomised controlled trials using BCG vaccine are under way in the Netherlands and Australia to assess whether the vaccine can reduce the incidence and severity of COVID-19 in health-care workers.

The authors do state that BCG vaccine, which “enhances the innate immune response to subsequent infections, might reduce viral load after SARS-COV-2 exposure, with consequent less severe COVID-19 and more rapid recovery”.

A study posted on March 28 in a preprint server medRxiv found an association between countries that have a universal BCG vaccination and reduced coronavirus cases and even deaths. Preprints are yet to be peer-reviewed and published in scientific journals.

They authors cite five reasons why countries should wait for the results of BCG vaccine randomised controlled trials. According to them, the association of fewer coronavirus cases in countries that have a universal BCG vaccination programme is based on population rather than individual data. Second, the beneficial effects of BCG vaccine given at birth are “unlikely” to reduce the severity of COVID-19 decades later. “One reason for this is that the beneficial off-target effects of the BCG vaccine might be altered by subsequent administration of a different vaccine,” they write.

Third, there is a possibility, even if remote, that BCG vaccine ramps up the immune system leading to exacerbation of COVID-19 in a small population of patients with severe disease. It is already known that the virus induces cytokine storm in some patients leading to further complications and even death. Fourth, if not effective against coronavirus, BCG vaccination is likely to give a false sense of security to people, especially during the pandemic. And finally, using the vaccine without evidence of its benefits could further jeopardise vaccine supply, which is already in short supply, to protect children against disseminated TB in high-risk countries.

“BCG given early in life does improve the immune system. The vaccine can prevent intracellular infections. So the protective effect of BCG against COVID-19 is a biologically plausible hypothesis,” Prof. Gagandeep Kang, executive director of the Translational Health Science and Technology Institute (THSTI), Faridabad had earlier told The Hindu.

Published in The Hindu on May 1, 2020