Bharat Biotech Chairperson Krishna Ella on Monday, January 4, said that Covaxin is safe and the firm has conducted 200% honest clinical trials. The comments came amid incessant criticism against giving emergency use approval to its coronavirus vaccine candidate.
Drug Controller General of India (DCGI) Dr V G Somani on Sunday granted restricted use approval "in clinical trial mode" to Covaxin "in the public interest.
Several health experts, scientists and opposition leaders have questioned the haste in approving the vaccine even as the company had not published the efficacy data for the vaccine. Many called it a violation of scientific protocol and claimed that a 'premature' clearance could risk lives and fuel vaccine hesitancy in India.
The Congress expressed concerns over Covaxin as it had not yet completed the phase 3 trials but received restricted emergency use approval. The party's Lok Sabha MP Shashi Tharoor tweeted saying that the "approval was premature and could be dangerous".
"Give me one week's time, I will give you confirmed data," Ella said, speaking at a virtual press conference on Monday.
He also said that their vaccine candidate will be effective on mutant strains of the novel coronavirus, The Indian Express reported.
"We are not just conducting clinical trials in India. We have done clinical trials in more than 12 countries including the UK. Many people are just gossiping everything in a different direction to just backlash on Indian companies, that is not right for us. We don't deserve that," Ella said.
"Don't accuse us of inexperience. We are a global company... have manufactured 16 vaccines. It is not correct to say we are not transparent with data. We conduct clinical trials in many countries, including the UK. The point is we are not an Indian company... but a global one," he said.
Ella also claimed that the vaccine was being targeted because it is a product of an Indian company. He asserted that sufficient data has already been revealed and is available online for people to access.
Hitting out at Serum Institute of India Chief Executive Officer Adar Poonawalla, who had said that vaccines other than that of Pfizer, Moderna and Oxford-AstraZeneca were "just like water", the Bharat Biotech chief said, "We do 200% honest clinical trials and yet we receive backlash. If I am wrong, tell me. Some companies have branded me like water."
The company chief said that his firm has a track record of producing safe and efficacious vaccines. Bharat Biotech has manufactured 16 vaccines, he said.
Dr Ella also said Bharat Biotech would be "ready with Phase III data in some days", pointing out that the trial with nearly 24,000 volunteers was underway.
"Bharat Biotech, which has sent around 5 million doses of its candidate for quality checks and clearances at the Central Drugs Laboratory in Kasauli, hopes to be able to roll out the vaccine for use among the public as soon as possible. It has stockpiled around 10 million doses, and will be ready with another 10 million by February," Dr Ella said. "We will be ready with 150 million doses by July-August," he added.