Bharat Biotech Chairperson Krishna Ella on Monday hit back at those criticising the granting of emergency use approval to its coronavirus vaccine candidate, saying that the vaccine was safe and the firm has conducted “200% honest clinical trials,” reported PTI.

Drugs Controller General of India had on Sunday approved Covaxin, Bharat Biotech’s vaccine candidate, for restricted emergency use. Various critics, including the Congress, had raised questions on the approval as the company has not published the efficacy data for the vaccine.

“Give me one week’s time, I will give you confirmed data,” Ella said, speaking at a virtual press conference. The biotechnology company chief said that his firm has a track record of producing safe and efficacious vaccines and was transparent with all data. Bharat Biotech has manufactured 16 vaccines, he said.

“We are not just conducting clinical trials in India. We have done clinical trials in more than 12 countries including the UK. 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.”

— Bharat Biotech Chairperson Krishna Ella

The company’s chief pointed out that Covaxin addresses an unmet medical need and has generated excellent safety data with a robust immune response to multiple viral proteins that persist. “We are not just an Indian company, we are truly a global company,” he said. “People should not accuse us that we don’t know clinical research.”

Ella also hit out at Serum Institute of India Chief Executive Officer Adar Poonawalla, who had said that vaccines other than that of Pfizer, Moderna and Oxford-AstraZeneca was “just like water”. “We do 200% honest clinical trials and yet we receive backlash,” he said without naming Poonawalla. “If I am wrong, tell me. Some companies have branded me like water.”

Ella said it was wrong to say Bharat Biotech was not transparent with data and cited the number of publications by the company as compared to its 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,” the Bharat Biotech chief 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 look at what our articles are.”

He also pointed out that Covaxin was not inferior to the Pfizer/BioNTech vaccine. “They [Pfizer] have five publications [of vaccine data],” Ella said. “Bharat Biotech [has] five publications. We are no way inferior to Pfizer in terms of publication [of data].”

Covaxin is the country’s first indigenous vaccine developed by Bharat Biotech, a company based in Hyderabad, with backing from the Indian Council of Medical Research and the National Institute of Virology.

On Sunday, the Congress had expressed concerns over Covaxin as it had not yet completed the phase 3 trials but got restricted emergency use approval. Rajya Sabha MP Anand Sharma said that the matter of granting authorisation to the vaccine use needs to be taken carefully as no country has done away with the mandatory phase 3 trials and verification of data. Jairam Ramesh asked Union Health Minister Harsh Vardhan to clarify why internationally-accepted protocols on phase 3 trials were being modified. The party’s Lok Sabha MP Shashi Tharoor also tweeted saying that the “approval was premature and could be dangerous”.

Meanwhile, India registered 16,504 new coronavirus cases on Monday morning, taking the tally to 1,03,40,469. The country’s toll rose by 214 to 1,49,649. India’s active cases stood at 2,43,953, below the 3-lakh mark for 14 straight days. As many as 99,46,867 people have recovered from the infection in the country so far.