The Drugs Controller General of India (DCGI) on Sunday approved the restricted emergency use of the indigenously-developed coronavirus vaccine, Covaxin, by the Hyderabad-based pharmaceutical firm Bharat Biotech. Besides, India's top drug regulator also granted permission to the company to conduct vaccine trials on children above the age of 12.
Meanwhile, Bharat Biotech MD Krishna Ella on Monday said the approval "is a giant leap for innovation & novel product development in India". He added that it is a proud moment for the country and "a great milestone in India’s scientific capability".
"Approval of Covaxin for emergency use is a giant leap for innovation & novel product development in India. It is a proud moment for the nation & a great milestone in India’s scientific capability, a kickstart to the innovation ecosystem in India," news agency ANI quoted Krishna Ella as saying.
"While this vaccine addresses an unmet medical need during this pandemic, our goal is to provide global access to populations that need it the most. COVAXIN has generated excellent safety data with robust immune responses to multiple viral proteins that persist," added Bharat Biotech MD.
Addressing a press conference, Krishna Ella also answered questions raised over the approval of Covaxin which is still under Phase 3 trials. Mainly, senior Congress leader Shashi Tharoor and Jairam Ramesh had raised doubts over DCGI's restricted emergency use approval for Covaxin. This had led to a war of words between the Congress and the BJP leaders.
"We have manufactured 16 vaccines. We function globally, not just in India. We are doing clinical trials in Pakistan, Nepal, Bangladesh and other countries. We are not just an Indian company, we are truly a global company," said Ella. "We are not a company without experience in vaccines. We have tremendous experience in vaccines. We are touching 123 countries. We are the only company that has got such extensive experience and extensive publication in review journals," he added.
