Amid questions raised by experts and opposition about the restricted-use approval given to Covaxin despite no efficacy data from phase III trials, Dr. Krishna Ella of Bharat Biotech said Monday that the The company had “tremendous experience” in vaccine development and the criticism against it was a “backlash.” against Indian companies ”. In a virtual press conference, Ella said that her company’s work was no less than that of Pfizer, which also presented a vaccine for the coronavirus.
“Now that the vaccine is being politicized, I want to make it very clear that none of my relatives is associated with any political party. A lot of people are just gossiping, it is just a backlash against Indian companies. That is not correct for us. We don’t deserve it. Merck’s Ebola vaccine never completed a human clinical trial, but the WHO granted an emergency authorization for Liberia and Guinea, ”Ella said.
“Covaxin has shown less than 10 percent adverse reactions, while others have between 60 and 70 percent adverse reactions. AstraZeneca was administering 4 g of paracetamol to volunteers to suppress such reactions. We have not given paracetamol to any volunteers. I can assure you that our vaccine is 200% safe, ”he also said.
The comments come in the context of some opposition leaders questioning the drug regulator’s “premature” approval for Bharat Biotech’s Covaxin, noting that the indigenously developed Covid-19 vaccine has not yet completed the final stage of the tests. human clinical trials.
She further said that enough data about the Covid-19 vaccine had already been revealed and was available online. “We are not a company without experience in vaccines. We have a tremendous experience. We are touching 123 countries. We are the only company that has such extensive experience and extensive publication in review journals, ”he said, adding that Covaxin clinical trials have been conducted in more than 12 countries in addition to India.
“We are not just conducting clinical trials in India. We have conducted clinical trials in more than 12 countries, including the UK. We are conducting clinical trials in Pakistan, Nepal, Bangladesh and other countries. We are not just an Indian company, we are truly a global company, ”said Ella.
Health Minister Harsh Vardhan has said that the Bharat Biotech vaccine is more likely to work against newer variants of the virus, including the UK variant, “as it contains immunogens (epitopes) from genes other than those of the spike protein “.
Answering questions about the lack of data in the phase III trials, which began in November, Ella said that Covaxin generated “excellent safety data with strong immune responses to multiple viral proteins that persist.”
“Many people say that I am not transparent in my data. I think people should be patient 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-based Bharat Biotech in collaboration with the National Institute of Virology of the Indian Council for Medical Research, Pune.
She also refuted claims that Covaxin was a “backup vaccine” to be used only in “clinical trial mode.” “It is a vaccine. It is not a backup. People must 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 “backup,” only if the country needs additional doses to vaccinate large numbers of people. .
“This is like a backup. If we find that the cases are not increasing, then we stick to IBS, until the Bharat Biotech data comes in early next month. And if that data is found to be good enough, it 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 effective it is. They (regulators) have given, I would say, a green signal to start stockpiling in case we need it, ”said Dr. Randeep Guleria, Director of AIIMS.
India’s top drug regulator approved the 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 million people and killed. to almost 1.5 lakh.
Some independent scientists have said that while the data from the phase 1 and phase 2 trials of Covaxin were very encouraging, the approval process when the efficacy data from the phase 3 trials of the vaccine had not arrived. Efficacy data is an indication of how effective the vaccine is in preventing virus attack. .
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