New Delhi: Bharat Biotech MD Dr Krishna Ella on Monday refused to take criticism on Covaxin and said the company had carried out ‘200 per cent honest clinical trials’, had an established track record in producing 16 safe and efficacious vaccines, and was transparent with all data.
Covaxin has been given permission for “restricted use in emergency situation in public interest”.
Addressing a virtual presser Dr Ella said “We don’t deserve this backlash.” Answering the critics he called upon them not to accuse the company 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 stressed.
“We were the first to identify the Zika virus and the first to file a global patent for the Zika vaccine and the Chikungunya vaccine. It is not correct to say that we are not transparent with data… we don’t deserve the backlash,” Dr Ella added as per a report in NDTV.
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.
On Sunday the Drug Controller General of India granted emergency approval to Covaxin and AstraZeneca-Oxford University’s Covishield, which will be produced by Pune-based Serum Institute.
The decision to green-light Covaxin triggered a row, with critics pointing to a lack of efficacy data at this time. Covaxin has completed only two of three required trial phases; the third – which tests for efficacy – began in November. The two earlier phases only ensured that the drug is safe.
Covishield, meanwhile, has completed all three phases, with trials taking place in India and around the world, and submitted data to the DCGI, which said the drug was 70.42 per cent effective.
