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Hyderabad-based Bharat Biotech, which received emergency approval for its coronavirus vaccine only in "clinical trial mode", virtually addressed a press conference at 5 pm on Monday.

Dr Krishna Ella, the founder and chairman of Bharat Biotech, has hailed the decision of the Indian drug regulator to approve Covaxin for emergency restricted use and termed it as a giant leap for innovation and novel product development in India.

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The 51-year-old addressed the concerns being raised over Covaxin and said, "People are talking to backlash on Indian companies. That is not done for us. I don't know why Indian companies are targetted by everyone in the world."

At the press conference, the Bharat Biotech CMD said that they are "no way" inferior to Pfizer in terms of coronavirus vaccine. Dr Krishna Ella also said that Bharat Biotech is the only firm to have published five articles on the Covid-19 vaccine process.

'We're a global company'

The Bharat Biotech CMD said that the firm is not just conducting clinical trials in India. "We have done clinical trials in over 12 countries, including the UK. 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," he added.

On data transparency, he said, "Many people say that I am not transparent in my data. I think people should have the patience to read on the internet and how many articles we have published. More than 70 articles have been published in various international journals."

He further added: "Many people just gossiping, it's just a backlash against Indian companies. That is not right for us. We don't deserve that. Merck's Ebola vaccine never completed a human clinical trial at all but WHO gave emergency authorization for Liberia and Guinea."

"We are proud to say that we have the only BSL-3 production facility in the world, even the US doesn't have it. We are here to help any of the public health emergency in any part of the world," Dr Ella said.

"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," the Bharat Biotech CMD said.

'Vaccine getting political now'

On vaccine getting political now, he said, "Now that vaccine is being politicised, I want to state very clearly that none of my family members is associated with any political party."

"We are a company with vaccine experience and have made 16 vaccines," he said.

On the credibility of Covaxin, he said, "Why is nobody questioning the UK trials? Because Indian trials are easy to be bashed."

Dr Ella further added: "In India, we do everything systematically and we get bashing from the news media. Some company has branded me as water. It hurts as a scientist and we don't deserve that," he added."

This comes a day after the Drugs Controller General of India (DCGI) approved 'Covaxin' for restricted use in emergency situations in the country, paving the way for a massive inoculation drive.

Meanwhile, the drug regulator has also allowed Bharat Biotech to conduct its trials on children who are above the age of 12 years.

The Covid-19 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 in India.

Following the formal approval by the DCGI, several questions were raised on the emergency use permission given to Covaxin without its phase 3 trials.

However, the drug regulator, while announcing its approval to the Bharat Biotech vaccine, said that Covaxin is "safe and gives a robust immune response".

The drug regulator also asserted that no vaccine with even the slightest safety concern would be approved for administration and said the vaccines are 110% safe.

Bharat Biotech's Covaxin will be administered in two doses, the DCGI said in its permission letter.

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