New Delhi: Human clinical trials for a vaccine for COVID-19 have been initiated in India. Approximately 1,000 volunteers are participating in the exercise for each of the two indigenously developed vaccine candidates. This information was provided by Indian Council of Medical Research (ICMR), 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. It will process to break the chain of coronavirus transmission, ICMR Director General Dr Balram Bhargava said. He was referring to the two vaccine candidates developed indigenously.
The Drugs Controller General of India (DCGI) has permitted two trials of two vaccines. One has been developed by Bharat Biotech International Limited in collaboration with the ICMR. The other one has been done by Zydas Cadila Healthcare Ltd. It will 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. The data was then submitted to the DCGI. Then 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. 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. More than half-a-million people have succumbed to coronavirus across the world. So, fast-tracking these vaccines become very important,” Bhargava added.
A recent letter by Bhargava envisaging the launch of a COVID-9 vaccine by August 15 had created quite a flutter. Many experts said that such a timeline may not be realistic.
Bhargava stated that India is considered as the ‘pharmacy of the world’. He pointed out that 60 per cent of the drugs utilised in the US are of Indian origin. 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. These two countries are major producers of vaccines in the world. Every developed nation or everyone trying to develop a vaccine is aware of it. 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. 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. The UK is also looking at how it can fast-track the Oxford vaccine candidate, for human use,” Bhargava said.
From India’s perspective, we have two vaccine candidates. We are trying all out efforts to fast-track it. It is the moral duty that there should not be a delay not even by a day for regulatory clearances for these vaccines. It is necessary to break the transmission of the virus as soon as possible,” Bhargava asserted.
