COVID-19 vaccine: ICMR urges institutes chosen for Bharat Biotech's COVAXIN to complete recruitment for human trials by 7 July

The Indian Council of Medical Research has selected 12 institutes across the country to carry out clinical trials of the indigenous vaccine COVAXIN to prevent COVID-19 infection. ICMR had urged the chosen clinical trial sites to expedite approvals and complete recruiting for the trails by 7 July, as per an internal letter from ICMR to the institutions. In the letter, ICMR says that both ICMR and Bharat Biotech are working on the development of the vaccine and preclinical trials presently, it adds. “This is the first indigenous vaccine being developed by India and is one of the top priority projects which is being monitored at the topmost level of the Government,” the statement says. “ICMR and BBIL are jointly working for the preclinical as well as clinical development of this vaccine.” ICMR also urges the institutions to fast track any and all approvals needed to initiate the trials and to finish enrolling subjects in five days of receiving the notice. “Kindly note that non-compliance will be viewed seriously,” the letter concludes, adding that the institutions ought to “treat the project on highest priority” and “meet the given timelines without any lapse.” Firstpost reached out to ICMR and Bharat Biotech, neither of whom were prepared to comment.

ICMR Letter to institutes t… by Tech2 on Scribd

The vaccine, named COVAXIN at the time **Bharat Biotech announced its vaccine candidate, is being trialled in humans** starting July 2020. India’s first vaccine candidate against the novel coronavirus, received a nod from the Drug  Controller General of India (DCGI) for further clinical trials Phase I and 2 in infected people a week ago. The vaccine is under development by Hyderbad-based biotechnology firm Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV). [caption id=“attachment_8541611” align=“alignnone” width=“1280”] An illustration of COVAXIN, the vaccine candidate for COVID-19 developed by Bharath Biotech. Image: Bharath Biotech[/caption] The clinical trials of the experimental COVID-19 vaccine in humans are scheduled to begin in July 2020, Bharat Biotech  said in a note. COVAXIN has been expedited through national regulatory protocols, and subjected to “comprehensive pre-clinical studies” according to the company, which reports that the results are “promising” and “show extensive safety and effective immune responses”. In the past, Bharat Biotech has manufactured the H1N1 vaccine during the swine flu outbreak, and has over 140 global patents and 16 vaccines in its portfolio. The most significant of their developments is arguably the  rotavirus vaccine Rotavac, a next-gen vaccine against a viral gastroenteritis that got pre-approval from the WHO after an Oxford laboratory found it safe and efficacious. Also read:  **First COVID-19 vaccine candidate COVAXIN from India, gets DCGI approval for human trials**