The ICMR has asked these institutes to fast-track clinical trials of the vaccine as it is being considered as one of the “top priority projects”.
The Indian Council of Medical Research (ICMR) has partnered with Bharat Biotech International Limited (BBIL) for clinical trials of indigenous vaccine for the coronavirus disease.
BBIL is using the virus strain isolated at ICMR’s National Institute of Virology (NIV) in Pune to develop the vaccine.
The clinical trials will be held in 12 institutes across the country. The ICMR has asked these institutes to fast-track clinical trials of the vaccine as it is being considered as one of the “top priority projects” which are being “monitored at the topmost level of the government”.
In a letter to these institutes, the ICMR said that it is envisaged to launch the vaccine for public health use latest by August 15, after completion of all clinical trials.
“BBIL is working expeditiously to meet the target, however, the final outcome will depend on the cooperation of all clinical trial sites involved in this project,” it further said in the letter.
It has also asked the institutes to ensure that the subject enrolment is initiated during the first week of July.
Apart from IMS and SUM Hospital here, the other institutes selected for the clinical trial are located in Visakhapatnam, Rohtak, New Delhi, Patna, Belgaum (Karnataka), Nagpur, Gorakhpur, Kattankulathur (Tamil Nadu), Hyderabad, Arya Nagar, Kanpur (Uttar Pradesh) and Goa.
Meanwhile, the Drug Controller General of India (DCGI) on Thursday granted permission to pharma giant Zydus Cadila to conduct phase I and phase II human clinical trials for Covid-19 vaccine.
The potential vaccine showed a “strong immune response” in animal studies, and the antibodies produced were able to completely neutralise the wild type virus, Zydus, part of Cadila Healthcare Ltd, said in a statement to Indian stock exchanges.
Zydus will begin human trials this month in over 1,000 subjects in multiple sites in India, it said.
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