Twelve clinical trial sites have been identified at present and ICMR has asked the medical institutions and principal investigators to ensure that the subject enrolment is initiated no later than July 7.
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.
Twelve 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 DCGI.
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.