Looking at launching the country’s first indigenous COVID-19 vaccine for public health use latest by August 15, 2020 after completion of all clinical trials, the Indian Council of Medical Research (ICMR) has directed “strict fast track for all approvals related to initiation of the clinical trial and ensure that the subject enrolment is initiated no later than 7th July 2020.”
In its letter, the ICMR said that the Council had partnered with Bharat Biotech International Limited (BBIL) to fast-track clinical trials of the COVID-19 vaccine.
“This is the first indigenous vaccine being developed by lndia 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 Institute of Virology, Pune. ICMR and BBIL are jointly working for the preclinical as well as clinical development of this vaccine,” noted the letter.
It adds that the government is looking at launching of 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,” the communication notes.
The letter has directed selected groups which has been chosen as a clinical trial site informing them that all approvals related to initiation of the clinical trial should be fast tracked and that “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 notes.