The phase III human clinical trials, which began mid-November, target 26,000 volunteers across India.
India’s first and only phase III trial of a COVID-19 vaccine has crossed 13,000 subjects – the half-way mark – and proceeding successfully across multiple sites in India, Bharat Biotech, the maker of the inoculant, Covaxin, announced today. The trials in the first and second phases had led to promising results.
The phase III human clinical trials, which began mid-November, target 26,000 volunteers across India. Covaxin was evaluated in approximately 1,000 subjects in the first two phases, with the results receiving acceptance in international peer-reviewed scientific journals, a statement from Bharat Biotech said today.
“This is an unprecedented vaccine trial ever to take place in India, and we are overwhelmed with the steady rise in participation. We sincerely thank all the 13,000 volunteers across the country for their support in enabling us to bring out a safe and efficacious Indian vaccine for COVID-19,” Suchitra Ella, Joint Managing Director of Bharat Biotech, said in the statement.
Reports had last week suggested that some trial sites were struggling to reach intended recruitment targets. A study at New Delhi’s All India Institue of Medical Sciences, for instance, had signed up only around 200 participants, compared with a goal of 1,500-2,000, NDTV had reported.
Covaxin, manufactured in collaboration with the Indian Council of Medical Research and the National Institute of Virology, in a Vero cell manufacturing platform has an excellent safety track record of more than 300 million doses, the company said.
India today added 19,556 new coronavirus infections in the past 24 hours, the lowest since July 2, according to Health Ministry data. The country’s total infection number now stands at 1,00,75,116, with the number of recoveries at 96,36,487. The total number of Covid-related fatalities stands at 1,46,111.
These figures come at a time when global worries over a new, more rapidly transmitting strain of the virus detected in the UK are growing.