Amid questions raised by consultants and Opposition over the restricted use approval given to Covaxin regardless of no efficacy knowledge from Phase III trials, Bharat Biotech MD Krishna Ella Monday mentioned the corporate had “tremendous experience” in creating vaccines and that criticism in opposition to it was a “backlash against Indian companies”. Addressing a digital press convention, Ella mentioned his firm’s work was a minimum of Pfizer’s, which additionally got here 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 mentioned.
“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 additional mentioned.
The remarks come on the backdrop of some Opposition leaders questioning the drug regulator’s “premature” approval for Bharat Biotech’s Covaxin, declaring that the indigenously-developed Covid-19 vaccine was but to finish the ultimate stage of human scientific trials.
Ella additional mentioned ample knowledge on the Covid-19 vaccine had already been revealed and was accessible on the web. “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 mentioned, including that scientific trials of Covaxin had been completed in over 12 nations, in addition to 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 mentioned.
Health Minister Harsh Vardhan has mentioned Bharat Biotech’s vaccine was extra prone to work in opposition to newer variants of the virus, together with the UK variant, “as it contains immunogens (epitopes) from other genes in addition to those from spike protein”.
Addressing questions on the shortage of information on Phase III trials, which started in November, Ella mentioned 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 mentioned.
Covaxin, India’s solely 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 additionally refuted statements that the Covaxin was a “back-up vaccine” for use solely in “clinical trial mode”. “It is a vaccine. It is not a backup. People should be responsible before making such statements,” he mentioned.
On Sunday, the heads of AIIMS and ICMR, a part of the National Covid-19 job pressure, instructed The Indian Express that Covaxin could be used as a “back-up”, provided that the nation wants additional doses to vaccinate numerous individuals.
“This is like a back-up. If we find that cases don’t rise, then we stick to the SII, till the Bharat Biotech data comes early next month. And if that data is found to be good enough, then they will get the same approval as the SII. Indirectly, looking at the safety profile, that (Covaxin) is a safe vaccine, although we don’t know how efficacious it is. They (the regulators) have given, I would say, a green signal to start stockpiling in case we need it,” mentioned AIIMS Director Dr Randeep Guleria.
India’s prime drug regulator authorized Covishield and Covaxin vaccines for restricted use in opposition to Covid-19 within the nation, paving the best way for mass vaccination in opposition to the virus that has up to now contaminated greater than a crore individuals and killed almost 1.5 lakh.
Some unbiased scientists have mentioned that whereas knowledge from Covaxin’s Phase 1 and Phase 2 trials was very encouraging, the method of approval when efficacy knowledge from the vaccine’s Phase 3 trials hadn’t are available in. Efficacy knowledge is a sign of how efficient the vaccine is in stopping the virus assault.
