ICMR-Bharat Biotech to expedite clinical trials of COVID-19 vaccine, plan launch by August 15
Presently, 12 clinical trial sites have been identified and ICMR has asked the institutions to enable subject enrolment by the first week of July
A letter issued by Dr Balram Bhargava, Director General, ICMR reveals plans to launch the COVID-19 vaccine being developed in collaboration with Bharat Biotech by August 15.
The letter states, “This is the first indigenous vaccine being developed by India and is one of the top priority projects which is being monitored at the topmost level of the Government. The vaccine is derived from a strain of SARS-CoV-2 isolated by ICMR-National lnstitute of Virology, Pune. ICMR and BBIL are jointly working for the preclinical as well as clinical development of this vaccine. It is envisaged to launch the vaccine for public health use latest by August 15, 2020, after completion of all clinical trials. BBIL is working expeditiously to meet the target, however, final outcome will depend on the cooperation of all clinical trial sites involved in this project.”
Presently, 12 clinical trial sites have been identified and ICMR has asked the institutions to enable subject enrolment by the first week of July.
“You are strictly advised to fast track all approvals related to initiation of the clinical trial and ensure that the subject enrolment is initiated no later than July 7, 2020. And non-compliance will be viewed very seriously. Therefore, advised to treat this project on the highest priority and meet the given timelines without any lapse,’ ICMR informs through the letter.
Last week, Bharat Biotech has received approval from the Drug Controller General of India (DCGI) to conduct phase I and II human clinical trials.
Express Pharma reached out to Dr Krishna Ella, Chairman and Managing Director, Bharat Biotech but he hasn’t responded yet.
Reportedly, the clinical trial sites are as follows:
1) King George Hospital Vishakhapatnam
2) University of Health Science, Rohtak
3) AIIMS Ansari, Nagpur
4) AIIMS Phulwarisarif, Patna
5) Jeevan Rekha Hospital, Dr BR Ambedkar Road, Opp. Civil Hospital, Belagavi, Karnataka
6) Gillukar Multispeciality Hospital, Nagpur
7) Rana Hospital, Rail Vihar Medical College Road, Gorakhpur
8) SRM Medical College Hospital and Research Centre, Kattankulathur, Tamilnadu
9) Nizam Institute of Medical Science. Pungutta, Hyderabad
10) Dr E Venkata Rao, B 704, Palm Heights Shampur, Orissa
11) Prakhar Hospital, Kanpur, Uttar Pradesh
12) Dr Sagar Vivek Redkar, Consultant Physician, Mumbai