Bharat Biotech announced the successful recruitment of 23,000 volunteers and continued progress towards achieving the goal of 26,000 participants for phase 3 clinical trial of its coronavirus vaccine Covaxin across multiple sites in India, news agency ANI quoted the pharma firm as saying on Saturday.
The announcement came hours after the subject expert committee of the Central Drugs Standard Control Organisation (CDSCO) recommended the vaccine for restricted emergency use.
Covaxin, the indigenous Covid-19 vaccine, is being developed by Hyderabad-based Bharat Biotech in association with the Indian Council of Medical Research and National Institute of Virology. It is the second vaccine in India that has moved closer to the final approval for emergency use against the deadly disease. Serum Institute of India’s Covishield was given the recommendation Friday and now both the vaccine candidates await the final approval from the Drug Controller General of India (DCGI).
Bharat Biotech had applied for emergency-use authorisation first on December 7. The panel had then asked the firm to submit its safety and efficacy data from the ongoing phase 3 clinical trial for further consideration.
The third phase of Covaxin trial is still underway while the company has already published the findings of the first two rounds. It followed a double-bind, randomised, multi-centre phase two clinical trial which included children as well.
Though there is no official word on the price of the vaccine, Dr Krishna Ella, the MD of Bharat Biotech, had earlier said that it will be inexpensive. “Cheaper than a water bottle”, he had said in a conference, pointing to a water bottle. Since his comment, it has been estimated that it will come at a cost lower than Rs 100.