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Two indigenous Indian vaccines cleared to start human trials, each has 1,000 volunteers

India is perceived and is an important player in the global vaccine supply, fast-tracking COVID-19 vaccine development is a moral duty, ICMR chief Balram Bhargava said.

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Two indigenous Indian candidate vaccines have got clearance to start early phase human trials this month with both having approximately 1,000 human volunteers each, the Indian Council of Medical Research (ICMR) said on Tuesday. 

Speaking a media briefing of the Ministry of Health and Family Welfare on COVID-19 situation in the country, Balram Bhargava, DG, ICMR said 60% of the vaccines supplied in the world are of Indian origin. 

India is perceived and is an important player in the global vaccine supply, fast-tracking COVID-19 vaccine development is a moral duty, Bhargava said. 

He further stated that any COVID-19 vaccine produced or developed in any part of the world will ultimately have to be scaled up either by India or by China. Every country which is developing a vaccine is in communication with India since they are aware India is a major producer, the ICMR chief said. 

Bhargava said two indigenous Indian vaccine candidates have undergone successful toxicity studies in rats, mice and rabbits and the toxicity data has been shared with the Drug Controller General of India (DCGI). 

They have got clearance to start human trials early this month, he said, adding that approximately 1,000 human volunteers are participating in clinical trials for each of the two indigenous vaccine candidates and pre-clinical experiments for these as well as other vaccines are also being done at NIV, Pune. 

On the issue of fast-tracking COVID-19 vaccine development, Bhargava said it is a moral duty. 

"Russia and China have fast-tracked the process, USA and UK too are trying to fast-track the development programme. India too is trying to fast-track its two indigenous vaccine candidates," he added. 

"Every country has to work together to develop these vaccines for everyone so that the chain of transmission of the pandemic can be arrested. Efforts are being taken to ensure that not a single day is wasted for regulatory or approval purpose, without compromising on the science, quality and ethics part of it," Bhargava further stated.

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