Hyderabad-based Bharat Biotech has already recruited 8,000 volunteers for a 22,000 subjects Phase 3 clinical trial, Krishna Ella, Chairman and Managing Director of the company said on Saturday. The homegrown vaccine major last week applied for an emergency use authorisation for its vaccine candidate, Covaxin, based on Phase 1 and 2 trial data.
Covaxin is India's indigenous coronavirus vaccine developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) - National Institute of Virology (NIV). The vaccine is undergoing Phase 3 clinical trials in over 25 centres across India. The vaccine has already successfully completed the interim analysis from the Phase 1 and 2 clinical trials.
Speaking virtually at a programme organised by the industry body FICCI, Ella said, "Out of 22,000 volunteers, we have already recruited around 8,000 volunteers. In the last fifteen days we have recruited actively."
On progress on the vaccine development, Ella said that everything has been done as per the international standards. Assuring that the vaccine is safe, he said that the company was 200 per cent transparent in case of any serious adverse events.
"We are not inhuman people, we are sensitive about our volunteers. But we cannot disclose their names due to confidentiality. Transparency means whether we report events to the regulator, the Data and Safety Monitoring Board, and the ethics committee," Ella reportedly said.
As per reports, the government has sought more data from vaccine maker on the safety and efficacy of its shots, thereby deferring recommending them for emergency use. The Subject Expert Committee (SEC), a government panel tasked with vetting coronavirus vaccines, has asked Bharat Biotech to submit updated country-specific trial data of its vaccine candidates Covaxin.
The panel has asked Bharat Biotech to provide data from its phase-3 clinical trial, along with phase-1 and 2 trial information, according to minutes of the meeting published on Wednesday on the Central Drugs Standard Control Organisation's website.
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