His retort comes amid questions and aspersions being raised by industry experts and opposition parties on the emergency approval to Bharat Biotech’s coronavirus vaccine Covaxin without the publication of vaccine’s efficacy data.
Speaking at a media conference, Ella said that Bharat Biotech was not only conducting trials in India, but in over 12 countries including the UK, and that his firm has a track record of producing safe and efficacious vaccines.
He said his firm was transparent with all data, and quoted, “Many people are just gossiping everything in a different direction to just backlash on Indian companies, that is not right for us. We don’t deserve that.”
Regarding providing the trial data, Ella said Bharat Biotech has conducted “200 per cent honest clinical trials” and he will provide confirmed data in a week. And by March Covaxin Phase-3 efficacy data will be available, he said.
Buttressing his point further, Ella said that Bharat Biotech has manufactured 16 vaccines, and added, “Don’t accuse us of inexperience. We are a global company.”
Covaxin addresses an unmet medical need and has generated excellent safety data with robust immune response to multiple viral proteins that persist, he further stated.
Bharat Biotech’s response comes after Serum Institute of India’s CEO Adar Poonawalla reportedly termed Covid-19 vaccines other than that of Pfizer, Moderna and Oxford-AstraZeneca as “just like water”.
Without naming any company, 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 also added the Bharat Biotech vaccine is not inferior to that developed by Pfizer.
Ella said it was wrong to say Bharat Biotech was not transparent with data and went on to cite the number of publications by the company in comparison with industry peers. “People should have the patience to read and see how many articles we have published,” he said. “We are the only company that has got such extensive experience and publication (in peer reviewed journals).”
The approval by the Indian drug regulator to Covaxin without revealing its efficacy results has been questioned by industry experts and opposition Congress.
Defending the decision to award Covaxin emergency approval, he said the emergency use authorisation was based on 2019 rules of the Government of India and went on to state that even the US grants emergency authorisation to a company with good immunisation data.
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. “It is not correct to say that we are not transparent with data… we don’t deserve the backlash.”
He further said the company has already produced 20 million doses of Covaxin and is aiming to achieve 700 million doses capacity in four facilities — three in Hyderabad and one in Bengaluru by 2021.