Human Trials For COVID Vaccine Initiated In India: Top Medical Body ICMR

4 months ago 21
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 Top Medical Body ICMR

Human trials of the coronavirus vaccines have been initiated with 1,000 volunteers (Representational)

New Delhi:

Human clinical trials for a vaccine for COVID-19 has been initiated in the country with approximately 1,000 volunteers participating in the exercise for each of the two indigenously developed vaccine candidates, the ICMR said on Tuesday.

Since India is one of the largest vaccine producers in the world, it is the country's "moral responsibility" to fast-track vaccine development process to break the chain of coronavirus transmission, ICMR Director General Dr Balram Bhargava said referring to the two vaccine candidates developed indigenously.

The Drugs Controller General of India (DCGI) has permitted two vaccines -- one developed by Bharat Biotech International Limited in collaboration with the Indian Council of Medical Research and another one by Zydas Cadila Healthcare Limited to go in for the first and second phase of human clinical trials.

There are two Indian vaccine candidates that have undergone successful toxicity studies in rats, mice and rabbits and these data was submitted to the DCGI, following which both got clearance to start an early phase human trials earlier this month, Dr Bhargava said at a press briefing.

"Two indigenous Indian candidate vaccines have got clearance to start early phase human trials this month. They have got their sites ready and are doing the clinical study on approximately 1,000 human volunteers each at different sites. They are trying to do early clinical testing for these two indigenous vaccine candidates," Dr Bhargava said.

"... it is a moral duty to develop them as fast as possible because more than half a million people have succumbed to the disease across the world. So, fast-tracking these vaccine becomes very important," he said.

A recent letter by Dr Bhargava envisaging the launch of a COVID-19 vaccine by August 15 had created quite a flutter with many experts stating such a timeline may not be realistic.

Dr Bhargava stated that India is considered as the "pharmacy of the world", saying 60 per cent of the drugs utilised in the US are of Indian-origin.

"The important fact that is not known is that 60 per cent of the vaccines supplied in the world whether it be Africa, Europe or Southeast Asia or any where are of Indian-origin," he said.

India is perceived and is an important player in the supply of vaccines for the world, Dr Bhargava noted.

"Any vaccine candidate that is produced or developed in any part of the world will ultimately have to be scaled up by India or by China because these two are major producers of vaccines in the world and that every developed nation or everyone trying to develop a vaccine are aware of it and therefore they are in communication with India for the vaccine distribution ultimately if is developed," he said.

"From India's perspective, we have two vaccine candidates. We are trying all out efforts to fast-track it and it is the moral duty that there should not be a delay not even by a day for regulatory clearances for these vaccines so that we can break the transmission of the virus as soon as possible," Dr Bhargava said.

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