The Indian Council of Medical Research (ICMR) is helping the Serum Institute of India (SII) in conducting phase 2 and 3 clinical trials for two covid-19 vaccine candidates developed by the University of Oxford and US-based company Novavax.
The apex biomedical research agency is also helping Zydus Cadila conduct lab tests to detect antibody response, shows documents reviewed by Mint. On Wednesday, the ICMR made a presentation, detailing all covid-related measures it has been taking, before members of the parliamentary sta-nding committee on home affairs.
According to people in the know, ICMR director general Dr Balram Bhargava told the panel that the Oxford University vaccine candidate will start phase 2 trials in India by the end of this week, and around 1,600 subjects have been identified across 17 centres.
In clinical trials, every site is monitored by a committee ensuring ethical guidelines and trial protocols are followed, and principal investigators of all sites are mandated to conform with its views.
The ICMR also informed the parliamentary committee that Bharat Biotech’s inactivated vaccine candidate, co-developed with the National Institute of Virology, and Zydus Cadila Ltd’s DNA plasmid vaccine are currently in phase 1 clinical trials.
“The ICMR is supporting both companies in parallel, pre-clinical studies on safety, immunogenicity and efficacy in non-human primates and lab assays for antibody detection and immunological response assessment,” it added.
Meanwhile, SII is conducting the phase 3 clinical trial for the adenovirus-based covid-19 vaccine candidate developed jointly by AstraZeneca and University of Oxford.
Bhargava indicated that an emergency authorization could be considered for covid-19 vaccines, after the government takes the final call. However, the ICMR also hinted that it will rigorously follow the ethical and safety protocols before taking any decision.
“Vaccine trials need to follow all ethics and science required for that. Vaccine trials are in process and we can speak only when some results will be available,” said Dr Rajni Kant, head, research management, policy, planning and coordination division, ICMR.
The government had said that India was not following a pre-set benchmark for selecting a covid-19 vaccine, and is exploring options for mass immunization. The National Expert Group on Vaccine Administration was constituted to select a vaccine, besides providing the required logistics and financial support for mass administration when a vaccine is approved.
Officials said they were looking at various benchmarks, such as cost, ease of administration and efficacy, to determine a covid-19 vaccine.
On Thursday, India added 68,555 new covid cases, taking the total to 2,873,173, with 54,438 fatalities. With the ICMR ramping up diagnostic capacity, India tested 918,470 samples in the past 24 hours, with cumulative tests at 32,661,252, officials said. Tests per million saw a sharp increase to 23,668. With the national positivity rate fell below 8% on Thursday, 26 states/UTs reported lower rates.
Leroy Leo contributed to this story.