Serum Institute’s recombinant BCG vaccine to be tried on humans

Serum Institute’s recombinant BCG vaccine would be the first vaccine candidate in India to start human trials within the next two weeks. This is to test if the BCG vaccine, administered at birth to Indians to fight tuberculosis, can also boost immunity in adults against the novel coronavirus.

If all goes well, the vaccine, which has a proven safety track record, can be in the market by the end of this year. Serum Institute can make 300-400 million doses of this vaccine.

The Bacillus Calmette-Gurein (BCG) vaccine named after French microbiologists Albert Calmette and Camille Guérin, is given to infants in India upon birth. Globally, the practice is to administer it to children below one year of age. Now this 100-year-old vaccine (developed in 1919) is being tested to check if it is able to increase the immunity to fight against another respiratory illness, the Covid-19.

Speaking to Business Standard, Adar Poonawalla, CEO of Pune’s Serum Institute of India, the world’s largest vaccine manufacturer in terms of doses administered, said: “We are working on a recombinant BCG vaccine, which is supposed to be better than the existing BCG vaccine. This is an extremely safe vaccine, since it is given to newborn babies, and has been selling this in more than 100 countries worldwide for more than two decades. The trial for this, to prove the immunity is being improved in human beings, will start within two weeks in India. And then we will know for sure whether it’s working.”

He added: “There is a demand for this vaccine, and we can make 300-400 million doses of this vaccine. But, until the trials are over, we are not officially prescribing it.”

“In May 1948, the government of India issued a press note stating that tuberculosis was ‘assuming epidemic proportions’ in the country, and that it had ‘after careful consideration’ decided to introduce BCG vaccination on a limited scale and under strict supervision as a measure to control the disease,” according to Chandrakant Lahariya’s publication A brief history of vaccines & vaccination in India.

BCG, now a part of the National Immunisation Programme, has been administered to Indians over decades. The efficiency rate of the vaccine is around 60 per cent and the results also vary between countries. But, for the time being, it can be the best shot that people have to fight the coronavirus, given its safety profile is already well established.