Bharat Biotech today stoutly defended the indigenously developed Covaxin saying it was “no backup but another vaccine in the market,” following criticism over the emergency authorisation it was granted despite the lack of phase three trial data.
Bharat Biotech chairman cum managing director Dr Krishna Ella openly hit out at detractors and said his company was a globally reputed one with adequate vaccine experience boasting of the only BSL-3 production facility in the world. Dedicating their success to the volunteers, he claimed the phase III trial would be over in the next two-three days and the data will be available by February and March.
Phase III trials will also involve children over the age of 12.
Dr Ella cited the case of Ebola vaccine which was granted authorisation for emergency use by WHO in countries like Liberia without any clinical trials.
He argued that the Central Drugs Standard Control Organisation guidelines issued in 2019 state “If your platform is proven, safe and phase I and phase II clinical data is available then you can license the product,” and Bharat Biotech had applied under this guideline.
He also lambasted AIIMS director Dr Ranadeep Guleria for stating that Covaxin will be the back-up.
He retorted: “I don’t know what is backup? There is no back up for humans, no back up for virus. It will be another vaccine in the market.”
He said that Bharat Biotech did not get any funds from Gates Foundation or Government of India but took the risk alone to manufacture 20 million doses.
“Covaxin has shown less than 10 per cent adverse reactions while others like AstraZeneca were giving 4 gram paracetamol to suppress such reactions,” claimed Dr Ella.
He further stated that in hamsters and monkeys Covaxin has shown remarkable result providing 100 per cent protection to upper lung and lower lung.
When it came to publication, the Indian vaccine was no way inferior to Pfizer. The company aims to roll out 700 million doses capacity in its four facilities including three in Hyderabad and one in Bengaluru despite encountering problems of logistics and so on.
Denouncing the politics over the vaccine he claimed he was a scientist and not a businessman nor a politician.
“India can innovate. We are not a copycat country. We don’t deserve a backlash because we are an Indian company, we do everything systematically yet we get bashed by the media.”
He said: “A company has branded our vaccine as water. It hurts as a scientist and we don’t deserve that.” As he wondered about Serum Institute’s vaccine which was given license based on UK data, “Where is their Indian data?” he asked.
While adding that he admires the Congress MP Shashi Tharoor, Dr Ella wondered why didn’t he talk about the “lousy clinical trial of the vaccine from UK”.
According to him, Covaxin was not being tested only in India but 12 countries including the UK. Their partner in the US was also talking about vaccinating children as it is the most effective technology for vaccination.