What is the BCG vaccine, studied by ICMR?

In this illustration, taken on April 10, 2020, you see small vials labeled with a “COVID-19 Vaccine” sticker and a medical syringe. (Reuters illustration: Dado Ruvic)

In a growing list of global trials on the efficacy of tuberculosis vaccines in preventing Covid-19, one is an upcoming 10-month trial conducted by the Indian Council of Medical Research (ICMR) on BCG vaccine.

What is the BCG vaccine?

Abbreviation for Bacillus Calmette-Guérin, BCG is a vaccine that uses a live attenuated strain (potency of the pathogen with artificial disability, but identifying retained characters) derived from an isolate of Mycobacterium Bovis. It has been used worldwide, including in India for decades, against tuberculosis.

India, like many other Asian, African and Latin American countries, has a national BCG vaccination policy for everyone at birth. Countries that have ended their policies or only recommend the vaccine for specific groups are found mainly in Europe and North America.

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In India, 91.9 percent of children between the ages of 12 and 23 months have received the vaccine, according to the National Survey of Family Health. Outside of some Northeast states, almost all states have a BCG vaccination rate of over 90%. According to the National Health Profile, India has a production capacity of 2,800 lakh of BCG vaccine dose.

What will the next ICMR study on the BCG vaccine look at?

It will focus on the vaccine’s potential to reduce the chance of Covid-19 death among people over the age of 60. With new details finalized from this study, the results could be seen as early as March 2021, said ICMR chief scientist Suman Kanungo.

The study will cover 1,450 older people in six red and orange areas: King Edward Memorial Hospital (KEM), Mumbai; All India Institute of Medical Sciences (AIIMS), New Delhi; National Institute for Tuberculosis Research (NIRT), Chennai; National Institute for Occupational Health (NIOH), Ahmedabad; National Institute of Environmental Health (NIREH), Bhopal; and the National Institute for the Implementation Research of Noncommunicable Diseases (NIIRNCD), Jodhpur.

With the paperwork in progress, recruiting should take four months, while the follow-up results will take six months after that, Kanungo said. The study will be carried out in conjunction with NIRT.

In mid-April, ICMR chief epidemiologist R R Gangakhedkar had said the ICMR would not recommend the BCG vaccine until the “definitive results” of one study showed possible anti-Covid immunity. Kanungo said, “The study will start as the paperwork progresses. We should have results in 10 months.” Outside of the ICMR studies, the institutional trials in Rohtak, Pune, Visakhapatnam and Bhubaneswar are also evaluating the potential.

What is known about the action of this vaccine in patients with Covid?

The BCG vaccine has been studied in research on Covid around the world. A preprinted population-level study by New York researchers on March 28 suggested that countries with lower vaccination and no universal BCG vaccination (such as Italy and the US) reported higher Covid-19 mortality. The study compared this pattern with countries such as South Korea and Japan, which have permanent policies on the subject.

“While these data may suggest a protective effect of the BCG vaccine, such studies cannot provide definitive proof of causation, due to various inherent biases,” the scientists wrote in an article in Nature on April 27. “Despite these problems, the link to BCG and COVID-19 from these studies is intriguing … One possible explanation is that children who have been vaccinated with BCG are less susceptible to SARS-CoV-2 infection and, therefore, there is less spread of the virus to older populations, although this would need to be demonstrated. “

Are other countries investigating this?

Yes. The World Health Organization (WHO) has started trials to determine the possible vaccine, but has not recommended it for the prevention of Covid-19. Studies are underway in Australia, the Netherlands, Germany, the United States, and several other countries. An article published in The Lancet on April 30, whose authors included the WHO Director-General, stated: “The BCG vaccine has been shown to reduce the severity of infections by other viruses with a structure (similar to SARS-CoV- 2) in controlled trials. “

A recent study in the Journal of the American Medical Association found no effectiveness for BCG vaccines in Israel, which used to have a universal policy and then changed in 1982 to vaccinate immigrants.

What other ICMR studies are ongoing?

A study seeks to assess the incidence of Covid-19 among health workers taking the antimalarial drug hydroxychloroquine (HCQ), as well as any side effects of using the medicine. The results will be available in late July, Kanungo said. In addition, ICMR has accepted applications across the country to study the effectiveness of plasma therapy, which injects antibodies from a recovered patient into a critically ill patient.

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In the HCQ study, researchers are analyzing 1,200 to 1,500 health workers who don’t have Covid-19 to find out how many of those who took the drug develop Covid-19, compared to those who didn’t. Starting this month, the study was conducted at five sites: AIIMS Bhubaneswar, AIIMS Jodhpur, AIIMS Patna, Apollo Hospital in Chennai, Maulana Azad Medical College in Delhi, and Sir Ganga Ram Hospital in Delhi. Kanungo said ICMR intends to recruit at least two more hospitals.

On March 23, the Covid-19 National Task Force recommended the use of HCQ as prophylaxis (protective and preventive) against Covid-19 infection for asymptomatic healthcare workers and asymptomatic household contacts of positive cases.

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