HYDERABAD: Bharat Biotech, which is developing Covaxin, a candidate vaccine for Covid-19, said on Friday that it has successfully completed interim analysis of phase I and II trials and is initiating phase III trials in 26,000 participants.
“After successfully completing the interim analysis of Covaxin Phase 1 and 2 clinical trials, Bharat Biotech received approval from DCGI for Phase 3 clinical trials in 26,000 participants at more than 25 centers in India,” said the vaccine manufacturer in a statement.
Covaxin is being developed by BharatBiotech in collaboration with the Indian Council for Medical Research (ICMR) – National Institute of Virology (NIV).
The city-based vaccine manufacturer had applied on Oct. 2 for permission from the Controller General of Drugs of India (DCGI) to conduct a multicenter, randomized, double-blind, placebo-controlled phase 3 trial of its Covid- 19, the sources said.
In July, DCGI had given Bharat Biotech permission to conduct phase 1 and 2 clinical trials of its Covid-19 vaccine.
“After successfully completing the interim analysis of Covaxin Phase 1 and 2 clinical trials, Bharat Biotech received approval from DCGI for Phase 3 clinical trials in 26,000 participants at more than 25 centers in India,” said the vaccine manufacturer in a statement.
Covaxin is being developed by BharatBiotech in collaboration with the Indian Council for Medical Research (ICMR) – National Institute of Virology (NIV).
The city-based vaccine manufacturer had applied on Oct. 2 for permission from the Controller General of Drugs of India (DCGI) to conduct a multicenter, randomized, double-blind, placebo-controlled phase 3 trial of its Covid- 19, the sources said.
In July, DCGI had given Bharat Biotech permission to conduct phase 1 and 2 clinical trials of its Covid-19 vaccine.
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