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The first indigenous Covid-19 vaccine by Bharat Biotech is likely to be launched by August 15.
To step up efforts for a possible vaccine for Covid-19 by August 15, India's top health research body -Indian Council of Medical Research (ICMR) joined hands with the Bharat Biotech International Limited (BBIL).
The ICMR has selected 12 institutes for clinical trials of the country's first indigenous Covid-19 vaccine. In a letter written on July 2, the DG ICMR asked the institutes 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 ICMR has written to all stockholders. “It is envisaged to launch the vaccine for public health use latest by 15 August 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,” ICMR’s D-G Balram Bhargava said in a letter dated July 2.
Hyderabad-based Bharat Biotech has successfully developed Covaxin in collaboration with the ICMR and National Institute of Virology (NIV).
“In view of the public health emergency due to Covid-19pandemic 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,” the letter further said.
The indigenous, inactivated vaccine was developed and manufactured in Bharat Biotech’s BSL-3 (Bio-Safety Level 3) High Containment facility located in Genome Valley, Hyderabad, India.
The Drug Controller General of India- Central Drugs Standard Control Organisation and Ministry of Health & Family Welfare last week had granted permission to initiate Phase I & II Human clinical trials after the company submitted results generated from preclinical studies, demonstrating safety.
https://economictimes.indiatimes.co...e-released-by-aug-15/articleshow/76763154.cms
