The Drugs Controller General of India (DCGI) on Sunday authorized the restricted emergency use of the indigenously-created coronavirus vaccine, Covaxin, by the Hyderabad-primarily based pharmaceutical firm Bharat Biotech. Besides, India’s major drug regulator also granted permission to the enterprise to conduct vaccine trials on youngsters above the age of 12.
Meanwhile, Bharat Biotech MD Krishna Ella on Monday mentioned the approval “is a giant leap for innovation & novel product development in India”. He added that it is a proud moment for the nation 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 concerns raised more than the approval of Covaxin which is nevertheless beneath Phase 3 trials. Mainly, senior Congress leader Shashi Tharoor and Jairam Ramesh had raised doubts more than DCGI’s restricted emergency use approval for Covaxin. This had led to a war of words among 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,” mentioned 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.