Phase II Trials Of Covaxin To Begin Tomorrow: Report
New Delhi: Phase II trials of the indigenously developed COVID-19 vaccine, Covaxin, is likely to begin on Monday, according to a media report on Sunday.
Covaxin has been developed by Hyderabad-based Bharat Biotech in collaboration with ICMR and the National Institute of Virology (NIV).
According to a report in Times Now, Bharat Biotech has received approval from the Central Drug Standard Control Organisation under the Directorate General of Health Services to conduct the trials.
The approval came in a letter written by Joint Drugs Controller Dr S Eswara Reddy to the Hyderabad-based company, the report said.
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The Phase II trials of Covaxin will be conducted on 380 participants, who will have to be screened four days after the vaccine is administered to them.
Many centers were bracing for the selection of candidates for Phase II human trials, which was earlier scheduled to begin in the first week of September.
Earlier, 375 volunteers at 12 sites across the country participated in the Phase I trials. The volunteers were given two doses of the vaccine, with a gap of around 14 days.
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