E-Paper
Clinical study of Covid-19 vaccine on human volunteers now in India
Two pharmaceutical companies are carrying out clinical studies on approximately 1,000 human volunteers each at different sites.
A clinical study involving human volunteers in India for a vaccine for Covid-19 is currently underway in India, Balram Bhargava, Director General of the Indian Council of Medical Research (ICMR) said Tuesday.
Two vaccine candidates in the fray were shortlisted after successful toxicity studies in animals. India’s Covid-18 tally on Tuesday was almost 8.8 lakh.
“There are 2 Indian indigenous candidate vaccines. They have undergone successful toxicity studies in rats, mice and rabbits. Data was submitted to the Drugs Controller General of India following which both these got clearance to start early phase human trials early this month,” Bhargava said at a briefing of the health ministry on the Covid-19 situation in the country.
“These candidates have got their sites ready and they are doing their clinical study on approximately 1,000 human volunteers each at different sites,” he said.
The ICMR head said countries such as the US, UK and Russia have also fast-tracked their vaccine candidates.
“Russia has fast-tracked a vaccine which has been successful in its early phases. … The US, as your 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, how it can fast track it for human use,” he said.
The ICMR had come under fire earlier this month after it said it planned a mid-August launch of a Covid-19 vaccine by compressing three phases of clinical trials into five weeks.
It later clarified that it only attempted to speed up the development of a potential Covid-19 vaccine by cutting red tape.
But experts said the ICMR’s clarification on cutting red tape did not address how the accelerated timeline could be achieved. The timeline appeared unrealistic even by the best global standards and involved potential risks, they said.
