Hyderabad: Telangana could well become the first Indian State to successfully complete the human clinical trials of ‘BBV152 COVID Vaccine’, the first indigenously developed Covid-19 vaccine candidate by Indian Council of Medical Research (ICMR) and Bharath Biotech International Limited (BBIL).
The Nizam’s Institute of Medical Sciences (NIMS) has been chosen as a human clinical trial site for the prestigious Covid-19 vaccine. Apart from NIMS, the ICMR has also chosen 12 other health care institutions in the country for the human clinical trials of Covid-19 vaccine.
The Director General (DG) of ICMR, Dr. Balram Bhargava has written a letter to Director, NIMS, Dr K Manohar, advising to fast track all approvals related to the initiation of the clinical trials on patients and ensure that their enrolment to participate in the clinical trials are completed before July 7.
‘You have been chosen as a clinical trial site of the BBV152 COVID Vaccine. In view of the public health emergency due to Covid-19 pandemic and urgency to launch the vaccine, you are strictly advised to fast track all approvals related to initiation of the clinical trials and ensure subject enrolment is initiated no later than July 7,’ Dr. Bhargava in his letter said.
Dr. K. Manohar told Telangana Today that the hospital ethics committee will meet in a day or two to take the Covid-19 vaccine clinical trials forward. “Our hospital has the required pedigree and if all goes well Telangana will be the first in the country to have successfully tested the human clinical trials of the vaccine.”
The BBV152 vaccine for Covid-19 is derived from a strain of SARS-CoV-2 isolation of ICMR-National Institute of Virology (NIV), Pune. ‘It is envisaged to launch the vaccine for public health use latest by August 15, 2020, after completion of all the 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,’ Dr. Bhargava said in his communication.
The ICMR DG stressed the need for clinical trial sites to hasten the clinical trials due to the ongoing Covid-19 pandemic. ‘Non-compliance will be viewed very seriously. You are advised to treat this project on highest priority and meet the given timelines without any lapse,” Dr. Bhargava said.
Last year, the ICMR had chosen NIMS to set-up its prestigious National Centre for Product Development, which is a first of its kind in South India and one among five other similar centres that are being planned to be set-up in Mumbai, Chandigarh, Lucknow and Hyderabad.
As part of this initiative, ICMR has set-up a state-of-the-art ‘Pharmacodynamics and Pharmacokinetics’ laboratory-cum research centre on the seventh floor of NIMS Millennium Block. The ICMR also is providing financial support to the research institute at NIMS and last year it had released close to Rs. 41 crore towards research.
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