Amid questions raised by industry experts and opposition parties on the emergency approval to its coronavirus vaccine without publication of efficacy data, Bharat Biotech’s chairman on Monday hit out at critics saying his firm had carried out “200 per cent honest clinical trials”. At a media conference, Krishna Ella said his firm has a track record of producing safe and efficacious vaccines and was transparent with all data. “We are not just conducting clinical trials in India. We have done clinical trials in more than 12 countries including the UK,” he said. “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.” Covaxin addresses an unmet medical need and has generated excellent safety data with robust immune response to multiple viral proteins that persist, he said.
Ella said his company had carried out “200 per cent honest clinical trials”. “Give me one week’s time, I will give you confirmed data,” he said. Bharat Biotech has manufactured 16 vaccines, he said. “Don’t accuse us of inexperience. We are a global company.” 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 also said 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.
“Don’t accuse us of inexperience… we are not just an Indian company, we are truly a global company,” Ella said, adding Covaxin Phase-3 efficacy data will be available by March. No interim analysis of efficacy in Phase 3 has been done so far, he said. 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.