Some experts and Opposition leaders have raised concerns over the grant of approval to Covaxin, without its efficacy trials being over.
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.
On Sunday, the heads of AIIMS and ICMR, part of the National Covid-19 task force, told The Indian Express that Covaxin would be used as a “back-up”, only if the country needs extra doses to vaccinate a large number of people.
“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,” said AIIMS Director Dr Randeep Guleria.
India’s top drug regulator approved Covishield and Covaxin vaccines for restricted use against Covid-19 in the country, paving the way for mass vaccination against the virus that has so far infected more than a crore people and killed nearly 1.5 lakh.
Some independent scientists have said that while data from Covaxin’s Phase 1 and Phase 2 trials was very encouraging, the process of approval when efficacy data from the vaccine’s Phase 3 trials hadn’t come in. Efficacy data is an indication of how effective the vaccine is in preventing the virus attack.
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