Without naming Serum Institute of India Executive Director Adar Poonawala, Ella said: “We do 200% honest clinical trials and yet we get backlash. If I’m wrong, tell me. Some companies have labeled me (our vaccine) as “water”. I want to deny that. We are scientists. ”
Poonawala had said in a television interview on Sunday that there were only three vaccines with proven efficacy: Pfizer, Moderna and Oxford-AstraZeneca and the rest were simply “safe as water.”
She said the United States and Europe had refused to accept the UK AstraZeneca-Oxford vaccine trial data because they were not “clean,” but no one questioned the Oxford data.
He claimed that volunteers in the AstraZeneca-Oxford trials were given acetaminophen tablets before receiving the vaccine injection and that if his company had done such a thing, Indian regulators would have shut it down. “We have not administered paracetamol to the volunteers, so any adverse reaction detected is exactly 100%, even if it is good or bad. It is captured in real time, ”he said.
When contacted to react to Ella’s comments, an SII spokesperson said: “There are no comments. We do not get into public arguments.”
She also appeared to clash with AIIMS chief Dr. Randeep Guleria, who suggested Sunday that Covaxin could be a backup for other vaccines. “It is a vaccine. It is not a backup. People must be responsible before making such statements, ”he said.
She claimed that Covaxin had as many publications in international peer-reviewed journals as Pfizer and more than many of the other Covid-19 vaccine candidates.
He said that the phase III trials of Covaxin were being managed by a US multinational IQVIA, formerly Quintiles, and IMS Health Inc and that patients in the phase III trials will be monitored for 12 months after dosing. “As an Indian company, Bharat Biotech has been fighting alone without any backing from multinational companies like AstraZeneca or Pfizer,” he said.
“We put all (the data) in a transparent way. We went through each committee and then got approval, ”he said. “I put everything in black and white and people still question me why Indian scientists are cheap people. People ask why we don’t have data in the public domain. In fact, we are the only company that has published five articles. We are the only Bio-Safety Level 3 (BSL-3) production facility in the world. We’re proud to say that even the US government doesn’t have that, even the UK government doesn’t. ”
He insisted that his work was in no way inferior to Pfizer’s in terms of publication. “It’s there on the Internet, someone has to go there and read it and then come back and ask questions. They don’t read that and immediately say on television that it is not in the public domain, they create a doubt, they throw stones at Indian science. ”
He said that Covaxin had less than 15% adverse effects. “As we move forward … we find less than 10% of the side effects … we have already vaccinated more than 24,000 people.”
.
