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Bharat Biotech recruits 23,000 volunteers for Covaxin phase 3 clinical trial


Bharat Biotech announced the successful recruitment of 23,000 volunteers and continued progress towards achieving the goal of 26,000 participants for the phase 3 clinical trial of its Covaxin coronavirus vaccine at multiple sites in India, the ANI news agency said, citing the pharmaceutical firm on Saturday.

The announcement came hours after the subject matter expert committee of the Central Drug Standards Control Organization (CDSCO) recommended the vaccine for emergency restricted use.

Covaxin, the indigenous Covid-19 vaccine, is being developed by Hyderabad-based Bharat Biotech, in partnership with the Indian Council for Medical Research and the National Institute of Virology. It is the second vaccine in India that has approached final approval for emergency use against the deadly disease. Covishield of the Serum Institute of India received the recommendation on Friday and now both vaccine candidates await final approval from the Comptroller General of Medicines of India (DCGI).

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Bharat Biotech had applied for the emergency use authorization for the first time on 7 December. The panel had then asked the company to submit its safety and efficacy data from the ongoing phase 3 clinical trial for further consideration.

The third phase of the Covaxin trial is still underway, while the company has already published the findings from the first two rounds. It followed a double-linked, randomized, multicenter phase two clinical trial that also included children.

Also read: Day 1 of the trial concludes when two Covid-19 vaccines await final approval

Although there is no official information on the price of the vaccine, Dr. Krishna Ella, MD of Bharat Biotech, had previously said that it would be inexpensive. “Cheaper than a bottle of water,” he had said at a conference, pointing to a bottle of water. Since your comment, it has been estimated that it will cost less than Rs 100.

Hindustan Times