New Delhi, July 3 (PTI): Aiming to launch an indigenous COVID-19 vaccine by August 15, the Indian Council of Medical Research has written to select medical institutions and hospitals to fast-track clinical trial approvals for the vaccine candidate Covaxin being developed in collaboration with Bharat Biotech.
12 clinical trial sites have been identified at present and the apex health research body has asked the medical institutions and principal investigators to ensure that the subject enrolment is initiated no later than July 7.
The COVID-19 vaccine candidate Covaxin, developed by the Hyderabad-based Bharat Biotech in collaboration with the ICMR and the National Institute of Virology (NIV), had recently got the nod for human clinical trials from the Drugs Controller General of India (DGCI).
Noting that this was the first indigenous vaccine being developed by India, ICMR Director General Dr Balram Bhargava in his letter to principal investigators of the 12 sites said that it is one of the 'top priority projects which is being monitored at the top-most level of the government'.
'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, final outcome will depend on the cooperation of all clinical trial sites involved in this project.
'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 trial and ensure that the subject enrolment is initiated no later than July 7,' Bhargava said in the letter.
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 preclinical as well as clinical development of this vaccine, the letter mentions.
The letter warned that any non-compliance will be viewed very seriously.
'Kindly note 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,' the letter stated.
A copy of the letter has been sent to the Bharat Biotech.
India's COVID-19 cases soared by over 20,000 in a day for the first time taking the country's total tally to 6,25,544 on Friday while the death toll climbed to 18,213 with 379 new fatalities, according to the Union Health Ministry data.
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.
