Hyderabad :
Amid questions raised by industry experts and opposition parties on the emergency approval to its coronavirus vaccine Covaxin 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”. Speaking to reporters at a virtual press 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 pointed out. ”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.
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. ”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.
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. ”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) internet and look at what our articles are,” he said.
The approval by the Indian drug regulator to Covaxin without revealing its efficacy results has been questioned by industry experts and opposition Congress. 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 for the vaccine and no interim analysis of efficacy in Phase 3 has been done so far.
Stating that Covaxin has been developed on a proven and safe technological platform using inactivated vaccine, he said emergency licence is allowed globally under certain circumstances. 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.
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. 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.” On the manufacturing capabilities, he said the company is setting up four vaccine production facilities — three in Hyderabad and one in Bengaluru — with a combined capacity of 700 million doses per annum. According to him, the firm is ready with 20 million dosages of Covaxin and would scale it up to 150 million by July-August. Asked if the company is in talks with the government for vaccine supply, Ella said, ”Government is in talks with us.” PTI
