Bharat Biotech Chairman Krishna Ella said on Monday that the company does not deserve the backlash it is receiving in the light of India's drugs regulator granting its coronavirus vaccine Covaxin approval for emergency use without Phase three clinical trial data and questioning on the vaccine’s efficacy.
"Don't accuse us of inexperience. We are a global company... have manufactured 16 vaccines," he said, highlighting that "200 per cent honest" clinical trials were conducted.
Ella said the company conducts clinical trials not only in India but also in many other countries. “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.
His comments assume significance as Covaxin has been given an emergency approval despite allegedly only two of the required three trial phases being completed.
However, Ella pointed at the number of journal articles Bharat Biotech published and claimed that it was the first to identify the Zika virus and file a patent for Zika and Chikungunya viruses.
Bharat Biotech was the only company to have a Bio Safety Level 3 (BSL- 3) production facility, he noted.
"We do 200 per cent honest clinical trials and yet we receive a backlash. If I am wrong, tell me. Some companies have branded me 'water'. I want to deny that. We are scientists," he said.
The decision to green-light Covaxin triggered a dispute, 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. Earlier, the two phases only assured that the drug is safe.
Responding to the criticism, Dr Ella cited a 2019 CDCSO notification that said "good quality immunogenicity data" from Phase I and II trials could be presented, among other data, to get an emergency license, adding that Bharat Biotech will be ready with the Phase three data in a few days pointing out that a massive trial was underway involving nearly 24,000 volunteers by far.