King Edward Memorial (KEM) Hospital in Parel will soon to start clinical trial on anti-tuberculosis vaccination (TB) — Bacille Calmette-Guérin vaccine (BCG) to treat Covid-19 patients. The Indian Council of Medical Research (ICMR) has selected the hospital for the trial which will be conducted on 200 people of the age group of 60-75 years.

KEM Hospital, the biggest civic-run hospital in Mumbai, has been treating the highest number of severely-ill Covid-19 patients since the outbreak of the virus in March. Last week, ICMR informed the hospital about the trial and the proposal to conduct the trial has been sent to the ethics committee of the hospital for final approval.

In India, BCG vaccination started in 1949 under the national immunisation programme. The vaccine, an annual vaccine administered to newborns, protects against disseminated tuberculosis and meningitis in childhood.

In the clinical trial, the vaccine will be administered to citizens aged above 60 years to examine if it can stimulate the immune response among older people against Covid-19.

“ICMR has initiated a multi-centric study to see if BCG can reduce the severity of Covid-19 infection among individuals above 60 years of age. The vaccine is effective among children to control TB, but the study will see its implications on elder people and its correlation with Covid-19,” said Suresh Kakani, additional commissioner, the Brihanmumbai Municipal Corporation (BMC).

Despite repeated calls, Dr Hemant Deshmukh, dean of the hospital, didn’t respond to HT.

The trial will be conducted on 1,000 healthy volunteers aged above 60 years of age in six states —Tamil Nadu, Maharashtra, Gujarat, Madhya Pradesh, Rajasthan and Delhi.

“Volunteers will be tested for antigens to check if they are infected with Covid-19. They will have to undergo antibody test to see if they were infected with the virus in the past,” said Kakani.

Often Covid-19 patients develop inflammatory reactions which lead to severity of their infection and even death. In this backdrop, doctors have opined that BCG vaccination, by enhancing innate immune response, may have deleterious effects on coronavirus.

“Several researches have shown a correlation that people who received BCG vaccination did not get sick more often or become seriously ill. It has long-lasting effects to boost the immune system. It is believed that despite having such a huge population, Covid-19 fatality rate in India is low because of BCG vaccine which is given to all children since the early 90s,” said Dr Lalit Anande, medical superintendent of Sewri TB Hospital.

“Impact of routine infant BCG vaccination in the young generation on prevention of local Covid-19 spread in Japan” — a study published on August 11 — suggested that BCG vaccination does play an influential role in protecting against the spread of infection on a mass scale. In the conclusion, the authors wrote, “Our findings suggest that routine infant BCG vaccination coverage in the young generation had a significant impact on prevention of local Covid-19 spread in Japan.”

Another study, Safety and COVID-19 Symptoms in Individuals Recently Vaccinated with BCG: a Retrospective Cohort Study, published on August 5 in Cell Reports Medicine showed the vaccine is safe and induces immune responses. The study was conducted on people who have received a BCG vaccine in the past five years in Netherlands. “BCG vaccination might be associated with a decrease in the incidence of sickness during the Covid-19 pandemic, as well as lower incidence of extreme fatigue…(sic),” reads the report.

However, the World Health Organization (WHO) overruled the significance of BCG vaccine in April. In a statement on its official website, it stated, “There is no evidence that BCG protects people against infection with Covid-19 virus. 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.”

Meanwhile, KEM Hospital expects to receive approval from the ethics committee to run the clinical trial on Covishield within the next two days.

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