Last Updated : Jul 03, 2020 05:58 PM IST | Source: Firstpost.com
COVID-19 vaccine | Passed mandated protocols, animal testing and now in clinical development stage: Bharat Biotech's Dr Krishna Ella
Hyderabad-based Bharat Biotech, which is one of seven Indian companies involved in the indigenous production of a vaccine for the novel coronavirus, received the green signal from the Central Drugs Standard Control Organisation (CDSCO) to begin human trials of 'Covaxin' last week.
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Bharat Biotech chairman and managing director Dr Krishna Ella on July 3 said that the company, which is the first Indian firm to have received approval to begin human trials of its COVID-19 vaccine candidate, had developed the first version of the vaccine within 40 days, after which the pre-clinical trials began.
Hyderabad-based Bharat Biotech, which is one of seven Indian companies involved in the indigenous production of a vaccine for the novel coronavirus, received the green signal from the Central Drugs Standard Control Organisation (CDSCO) to begin human trials of 'Covaxin' last week.
Phase 1 and 2 clinical trials of Covaxin in COVID-19 patients will begin this month. The vaccine candidate was developed in collaboration with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV) in Pune.
The ICMR has selected 12 institutes across the country to carry out clinical trials of Covaxin and on July 3, urged the chosen clinical trial sites to expedite approvals and complete recruiting for the trails by July 7, as per an internal letter from ICMR to the institutions.
The letter also reportedly said that Covaxin should be "launched for public use" by August 15, however, Bharat Biotech spokespersons refused to comment on the statement.
The letter by ICMR director general Balram Bhargava read, "It is envisaged to launch the vaccine for public health use latest by 15th August 2020 after completion of all clinical trials. BBIL (Bharat Biotech International Limited) is working expeditiously to meet the target, however, final outcome will depend on the cooperation of all clinical trial sites involved in this project."
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".