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The recombinant BCG vaccine from the Serum Institute would be the first candidate vaccine in India to start human trials in the next two weeks. This is to test whether the BCG vaccine, administered at birth to Indians to combat tuberculosis, can also increase immunity in adults against the new coronavirus.
If all goes well, the vaccine, which has a proven safety record, may be on the market later this year. Serum Institute can make 300-400 million doses of this vaccine.
Named after French microbiologists Albert Calmette and Camille Guérin, the Bacillus Calmette-Gurein (BCG) vaccine is administered to babies in India at birth. Worldwide, the practice is to administer it to children under one year of age.
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Now this 100-year-old vaccine (developed in 1919) is being tested to see if it can boost immunity to fight another respiratory disease, Covid-19.
Speaking to Business StandardAdar Poonawalla, CEO of India’s Pune Serum Institute, the world’s largest vaccine maker 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 as it is administered to newborns and has been sold in more than 100 countries worldwide for more than two decades.The trial to demonstrate that immunity is improving in humans will begin within two weeks in India. And then we’ll know for sure if 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.”
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The other candidate vaccines in the country that are being developed by around six pharmaceutical companies have not yet reached the human testing phase. Most are in the animal testing stage.
The serum is likely to begin testing in Maharashtra with 2,000-3,000 high-risk individuals. The elderly and people with comorbidities (such as diabetes, asthma, hypertension) will be given the recombinant BCG vaccine. Health workers would also receive a BCG injection.
Testing can start from Pune, which is one of the country’s worst affected cities.
Healthcare experts said that some recent studies have shown that countries that did not have a universal BCG vaccination policy have seen a higher incidence of Covid-19 cases. The United States and Italy, for example, do not administer BCG as part of their universal vaccination policy.
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“In May 1948, the Government of India issued a press release saying that tuberculosis was” assuming epidemic proportions “in the country, and that” after careful consideration “it decided to introduce the BCG vaccine 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 and Vaccination in India.
BCG, now part of the National Immunization Program, has been administered to Indians for decades. The vaccine’s efficiency rate is around 60 percent, and results also vary between countries. But, for now, it may be the best opportunity for people to fight the coronavirus, given that its safety profile is already well established.
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