New Delhi: Hours after Bharat Biotech received approval to conduct its vaccine trials on children above the age of 12 years, the vaccine company on Monday called it a giant leap for innovation and novel product development in India.Also Read - Omicron Scare: Serum Institute Seeks DCGI's Approval for Covishield as Booster Dose

“The approval of COVAXIN for emergency use is a giant leap for innovation and novel product development in India. It is a proud moment for the nation and a great milestone in India’s scientific capability, a kickstart to the innovation ecosystem in India,” Bharat Biotech MD Krishna Ella said. Also Read - Omicron Scare: Bharat Biotech Studying If Covaxin Shot Will Work on New Covid Variant

He said it is wrong to say that the Bharat Biotech is not transparent in giving information on vaccine. Also Read - Nepal, India to Recognise Covid Vaccine Certification

“Many people say that I am not transparent in my data. I think people should have patience to read on the internet and how many articles we have published. More than 70 articles have been published in various international journals,” Ella added.

He further added that the Bharat Biotech is 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 said.

He said the Bharat Biotech is not just conducting clinical trials in India but also done clinical trials more than 12 countries including UK. “We are doing clinical trials in Pakistan, Nepal, Bangladesh & other countries. We are not just an Indian company, we are truly a global company,” he added.

He added that the COVAXIN addresses an unmet medical need during this pandemic and its 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,” he added.

Talking about politicisation of the vaccine, he said, “Now that vaccine is being politicized, I want to state very clearly that none of my family members is associated with any political party.”

Yesterday, Bharat Biotech received emergency approval for its Covid-19 vaccine only in “clinical trial mode” and today, it is allowed to conduct its trials on children who are above the age of 12 years. The vaccine has already been used for children above 12 in the last round and has been found safe.  The Hyderabad-based firm is conducting Phase 3 trials.

However, Union Health Minister Dr Harsh Vardhan made it clear that the emergency approval for Covaxin is different from the one given for Serum Institute’s Covishield because Covaxin’s use will be in clinical trial mode. All its recipients will be tracked and monitored as if they are participating in a trial.

The government’s green signal for Covaxin, which is yet to complete clinical trials and submit data on efficacy, had turned into a political controversy which stretched late into the evening.