Bharat Biotech CMD slams criticism against indigenous vaccine and its emergency approval

Amid questions raised by experts and Opposition over the restricted use approval given to Covaxin despite no efficacy data from Phase III trials, Bharat Biotech MD Krishna Ella Monday said the company had “tremendous experience” in developing vaccines and that criticism against it was a “backlash against Indian companies”. Addressing a virtual press conference, Ella said his company’s work was no less than Pfizer’s, which also came out with a vaccine for coronavirus.

“Now that vaccine is being politicised, I want to state very clearly that none of my family members is associated with any political party. Many people are just gossiping, it is just a backlash against Indian companies. That is not right for us. We don’t deserve that. Merck’s Ebola vaccine never completed a human clinical trial at all but WHO gave emergency authorization for Liberia and Guinea,” Ella said.

“Covaxin has shown less than 10 per cent adverse reactions, while others have 60-70 per cent adverse reactions. AstraZeneca was giving 4g paracetamol to volunteers to suppress such reactions. We haven’t given paracetamol to any volunteer. I can assure our vaccine is a 200 per cent safe,” he further said.

The remarks come on the backdrop of some Opposition leaders questioning the drug regulator’s “premature” approval for Bharat Biotech’s Covaxin, pointing out that the indigenously-developed Covid-19 vaccine was yet to complete the final stage of human clinical trials.

Ella further said sufficient data on the Covid-19 vaccine had already been revealed and was available on the net. “We are not a company without experience in vaccines. We have tremendous experience. We are



touching 123 countries. We are the only company that has got such extensive experience and extensive publication in review journals,” he said, adding that clinical trials of Covaxin had been done in over 12 countries, besides India.

“We are not just conducting clinical trials in India. We have done clinical trials more than 12 countries including the UK. We are doing clinical trials in Pakistan, Nepal, Bangladesh & other countries. We are not just an Indian company, we are truly a global company,” Ella said.

Health Minister Harsh Vardhan has said Bharat Biotech’s vaccine was more likely to work against newer variants of the virus, including the UK variant, “as it contains immunogens (epitopes) from other genes in addition to those from spike protein”.

Addressing questions on the lack of data on Phase III trials, which began in November, Ella said Covaxin generated “excellent safety data with robust immune responses to multiple viral proteins that persist”.

“Many people say that I am not transparent in my data. I think people should have patience to read on the internet and how many articles we have published. More than 70 articles have been published in various international journals,” he said.

Covaxin, India’s only indigenous Covid-19 vaccine, has been developed by Hyderabad-headquartered Bharat Biotech in collaboration with the Indian Council of Medical Research’s National Institute of Virology, Pune.

Ella also refuted statements that the Covaxin was a “back-up vaccine” to be used only in “clinical trial mode”. “It is a vaccine. It is not a backup. People should be responsible before making such statements,” he said.