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'Carried out 200% honest clinical trials': Bharat Biotech Chairman hits out at critics

BusinessToday.In     January 5, 2021

Bharat Biotech Chairman Krishna Ella has hit out at critics for questioning the efficacy of its "Covaxin" vaccine against coronavirus. Ella said that his firm has carried out "200 per cent honest clinical trials", and that it has a track record of producing safe and efficacious vaccines.

Without naming Serum Institute CEO Adar Poonawalla, who had termed vaccines other than that of Pfizer, Moderna and Oxford-AstraZeneca as "just like water", Ella said, "We do 200 per cent honest clinical trials and yet we receive backlash. If I am wrong, tell me. Some companies have branded me like water."

He alleged that AstraZeneca, which has developed a vaccine for COVID-19, was administering Paracetamol to volunteers along with the antidote, leading to suppression of "adverse reaction" if any.

In a press conference, Ella assured that he will give confirmed data within a week. Covaxin addresses an unmet medical need and has generated excellent safety data with robust immune response to multiple viral proteins that persist, he asserted. He further pointed out that his company has manufactured 16 vaccines.

"We are not just an Indian company; we are truly a global company. People should not accuse us that we don't know clinical research...," he said.

He also said the Bharat Biotech vaccine is not inferior to that developed by Pfizer. "You look at Pfizer. They have five publications of vaccine data. Bharat Biotech has five publications. We are no way inferior to Pfizer in terms of publication of data," Ella said.

"I think we are the only company I can categorically say (which) has got extensive research experience and extensive publication (in) peer-reviewed journals. Many people say that I am not transparent in my data. I think people should have the patience to read (on) the internet and look at what our articles are," he said.

The Indian drug regulator nod to Covaxin, without revealing its efficacy results, has been questioned by industry experts and opposition leaders.

On Sunday, Congress chief spokesperson Randeep Surjewala lauded scientists and researchers of Bharat Biotech for the indigenous vaccine but the party's senior leaders like Anand Sharma, Jairam Ramesh and Shashi Tharoor raised concerns over the grant of approval to its vaccine without the phase 3 trials, saying it is "premature" and can prove dangerous.

Reacting to the allegations, Ella said he does not have any political affiliations and he is a scientist. "Don't accuse us of inexperience... we are not just an Indian company, we are truly a global company," Ella said.

He said Covaxin is currently undergoing phase-3 clinical trials involving 24,000 volunteers with less than 10 per cent side effects and the efficacy data is expected to be published in March.

Ella also said the clinical trials for children would also be taken up, and that no interim analysis of efficacy in Phase 3 has been done so far.

Defending the decision to award Covaxin emergency approval, he said the emergency use authorisation was based on 2019 rules of the government.

Bharat Biotech was the first to identify the Zika virus and the first to file global patents for the Zika and Chikungunya vaccines, he said.

Also read: Covaxin side effects recorded in real time; efficacy data out soon: Krishna Ella

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