The Indian Council of Medical Research has selected 12 institutes, including one from Odisha, for clinical trial of the country's first indigenous COVID-19 vaccine, an official said on Thursday.
Bhubaneswar-based Institute of Medical Sciences and SUM Hospital under the SOA Deemed to be University, has been chosen by the ICMR for undertaking human clinical trials of India's first coronavirus vaccine, an official of the institute said.
ICMR has developed the indigenous COVID-19 vaccine (BBV152 COVID vaccine) partnered with Bharat Biotech International Limited (BBIL).
The 12 institutes have been asked by the ICMR 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.
"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," an official said.
In a letter to the selected institute where the clinical trial is to be done, the ICMR also informed that 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, the final outcome will depend on the cooperation of all clinical trial sites involved in this project, the ICMR told the selected institutes.
In view of the public health emergency due to COVID-19 pandemic and urgency to launch the vaccine, the selected institutes are strictly advised to fast track all approvals related to the initiation of the clinical trial and ensure that the subject enrolment is initiated during the first week of July.
Apart from IMS and SUM Hospital in Bhubaneswar, 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.
Potential COVID-19 vaccine by Zydus Cadila gets DCGI nod for human clinical trials
A potential COVID-19 vaccine indigenously developed by the Ahmedabad-based Zydus Cadila Healthcare Ltd has got the nod from the Drugs Controller General of India (DCGI) for human clinical trials, according to a government source.
The approval process was fast-tracked following recommendation by the subject expert committee on COVID-19, considering the emergency and unmet medical need during the pandemic.
"DCGI Dr V G Somani has given approval for the phase I and II clinical trials (on humans) of the potential novel coronavirus vaccine developed by Zydus Cadila Healthcare Ltd on Thursday after its animal studies were found to be successful," an official source in the know of the developments told PTI.
The assent for human trials was given after the company submitted data of clinical trial on animals to the DCGI, in which the vaccine candidate was found to be successful with respect to safety and immunogenicity, the source said.
The company is likely to start enrolment of subjects soon.
"The phase I and II trials will take around three months to be completed," the source said.
The country's 'first' indigenous COVID-19 vaccine candidate Covaxin, developed by Hyderabad-based Bharat Biotech in collaboration with the Indian Council of Medical Research and National Institute of Virology (NIV), had recently got the nod for human clinical trials from the DCGI.