New Delhi, May 30: Monoclonal antibody drug production in India at reasonable price could be a "game changer" for the country in its fight against COVID-19, said Dr Arvinder S Soin, Chairman, Institute of Liver Transplant and Regenerative Medicine at Medanta Hospital on Sunday.

"If these (Monoclonal antibody drug) are made in large enough quantities at a reasonable price. The monoclonal antibodies could be a game changer for India and the world, and especially for high risk elderly patients and children. There may come a time of the year when anyone testing positive can have monoclonal antibodies, and to avoid serious disease, we should adopt these early," Dr Soin told ANI here. US FDA Authorises GSK-Vir Monoclonal Antibody Drug ‘Sotrovimab’ That Claims To Reduce Hospitalisation and Death Among COVID-19 Patients by 85%.

Dr Soin also pointed out 3 specific drugs (monoclonal antibodies drug) authorised by the US Food and Drug Administration (FDA) and one by India's Central Drugs Standard Control Organisation (CDSCO) can 'nip COVID infection in the bud'.

He further said, "There are three specific drugs in the form of monoclonal antibodies against the viral spike protein that have been authorised for emergency use by the US FDA, and one by the CDSCO, India. These can nip COVID infection in the bud, if given soon after testing positive but certainly in the first week. So these can prevent severe disease and deaths, if given at home early during the infection."

Further elaborating the drug combinations, Dr Soin said, "First is the Casirivimab and Imdevimab combination that is available in India. It's been tested in over 20,000 patients and is 70 per cent effective in preventing hospitalisation and death. Similarly, two more treatments is a combination of bamlanivinab and Etesevimab is 70 per cent effective and the latest one Sotrovimab is 85 per cent effective in preventing severe disease, if given early."

Echoing the similar sentiment, Dr Nirmal K Ganguly, former Director-General, ICMR expressed that Monoclonal antibodies work as they are made against targeted epitopes.

"Since this (monoclonal antibody) is a highly expensive product, don't use it for all COVID-infected individuals. Use it only for those with severe infection, are hospitalised, at very high risk and with higher chances of mortality," Dr Ganguly added.

The former ICMR DG further said that there are six receptor-binding domain points that are important in spike protein, which undergo mutation/functional enhancement to create specific monoclonal antibodies.

Former head scientist epidemiology and communicable disease at ICMR, Dr Raman R Gangakhedkar said, "We can't say they (rational use of plasma and Remdesivir) are the only reasons for variants. In the next few days, we will get to know how monoclonal antibodies will work against COVID and its variants."

The antibody cocktail shot came into the limelight after it was used to treat former United States President Donald Trump last year. The therapy is said to reduce the chance of hospitalisation by 70 per cent in patients with mild to moderate COVID-19 symptoms.

The therapy is a cocktail of two monoclonal antibodies. Antibodies are proteins that the body generates to defend itself against any disease. Monoclonal antibodies are artificially created in a laboratory and tailor-made to fight a particular disease.

Casirivimab and imdevimab, which are part of the antibody cocktail produced by Switzerland-based Roche, are specifically directed against the spike protein of SARS-CoV-2.

They block the virus' attachment and its subsequent entry into human cells. Use of two antibodies protects against the body's resistance to them.

An antibody cocktail is administered intravenously or subcutaneously (under the skin) as an injection.

Presently, it is being administered at Medanta Hospital in Gurugram, Haryana and Delhi's Fortis Escorts Heart Institute and Apollo Hospital. Zydus Cadila has also sought approval for early-to late-stage human trials of its antibody cocktail candidate, ZRC-3308, to treat mild COVID-19 patients.

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