New Delhi: The Indian Council of Medical Research (ICMR), the country’s apex health research body, has decided to fast-track clinical trials of the indigenous Covid-19 vaccine, which it is producing with Bharat Biotech international Limited (BBIL).
According to a letter written by director-general of ICMR, Dr Balram Bhargava, dated 2 July, the Narendra Modi government is aiming to launch the vaccine for public health use by 15 August.
“It is envisaged to launch the vaccine for public health use latest by 15 August 2020 after completion of all clinical trials,” reads the letter sent to 12 institutions selected for conducting the clinical trials.
Among the institutes allowed to conduct vaccine trials include the All India Institute of Medical Sciences (AIIMS) in New Delhi and Bihar, the Andhra Pradesh-based King George Hospital, the Rohtak-based Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences and the Hyderabad-based Nizam’s Institute of Medical Sciences.
“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 letter adds.
The vaccine — BBV152 COVID — is a “top priority” project being monitored at the highest levels of the Modi government, the letter pointed out.
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The vaccine has been derived from a strain of SARS-CoV-z isolated by the ICMR-run National Institute of Virology, Pune. ICMR and BBIL are jointly working for the preclinical as well as clinical development of this vaccine.
“ln 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 enrollment is initiated no later than 7th July 2020,” the letter states.
It, however, warns that guidelines and protocols must be followed.
“Kindly note 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 states.
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