Indian Council of Medical Research (ICMR) expects to launch Bharat Biotech's COVAXIN by August 15. ICMR has selected 12 institutes for the clinical trial, according to an official.
In a letter to the selected institutes, ICMR has said that it expects to launch the vaccine candidate for public health use by August 15, after completion of the clinical trials. The institutes have also been asked by ICMR to fast track the trials and to consider it as one of the top priority projects monitored by the topmost government authorities.
"The vaccine is derived from a strain of SARS-CoV-2 isolated by ICMR-National Institute of Virology, Pune. ICMR and BBIL are jointly working for the pre-clinical as well as clinical development of this vaccine," stated the ICMR in its letter to the institutes.
The launch will depend on the cooperation of all clinical trial sites involved in this project. ICMR asked the institutes to ensure that all the subjects are enrolled starting this week and to speed up approvals. "Non-compliance will be viewed very seriously. Therefore, you are advised to treat this project on highest priority and meet the given timelines without any lapse," said ICMR in its letter.
Institutes from New Delhi, Hyderabad, Patna, Visakhapatnam, Nagpur, Gorakhpur, Rohtak, Belgaum (Karnataka), Kattankulathur (Tamil Nadu), Arya Nagar, Kanpur (Uttar Pradesh) and Goa have been enlisted by ICMR.
Meanwhile, BBIL, the company behind the candidate, is also working expeditiously to meet the target. The vaccine candidate COVAXIN has been developed in Bharat Biotech's BSL-3 (Bio-Safety Level 3) High Containment facility located in Genome Valley, Hyderabad. The Drug Controller General of India and Ministry of Health & Family Welfare granted permission to conduct Phase I and II of human clinical trials after the company's results demonstrated safety and immune response of the candidate.