Human clinical trials for COVID-19 vaccine initiated in India: ICMR

• 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 Ltd to go in for the first and second phase of human clinical trials.
  
• 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.
• A recent letter by 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.

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 Ltd 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, 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," 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 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.

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, 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.

Bhargava said that recently Russia had fast-tracked a vaccine, which has been successful in its early phases, and they have also accelerated its development and the whole world has applauded it.

"The US again, as you read today has fast-tracked two of its vaccine candidates and the UK is also looking at how it can fast-track the Oxford vaccine candidate, for human use.

"From India's perspective, we have two vaccine candidates. We are trying all out efforts to fast-rack 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," Bhargava said.

He emphasised that still 60 per cent of the other vaccines whether it be polio, measles-rubella they are all manufactured in India and are given to the international agencies to supply to the world so this becomes an important aspect for India to fast-track its vaccine development and work together to develop these vaccines for the entire world.

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