Bharat Biotech rejects criticism on ‘Covaxin’ approval

The approval to Covaxin has been questioned by industry experts and some opposition Congress leaders who have expressed concern over the absence of phase 3 trial data

New Delhi/Hyderabad: Hyderabad-based Bharat Biotech on Monday rejected criticism over the grant of emergency use authorisation by India’s drug regulator to its Covid-19 vaccine, asserting that it has a track record of producing safe and efficacious vaccines and has been transparent with all data.

The approval to Covaxin has been questioned by industry experts and some opposition Congress leaders who have expressed concern over the absence of phase 3 trial data, cautioning that “sidestepping” processes and giving “premature” clearance could risk lives and fuel vaccine hesitancy in India.

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However, Krishna Ella, chairman of Bharat Biotech, said sufficient data has already been revealed and is available online for people to access. He suggested that the vaccine was being targeted as it was a product of an Indian company.

Covaxin addresses an unmet medical need and has generated excellent safety data with a robust immune response to multiple viral proteins that persist, he said. He said Covaxin phase-3 efficacy data will be available by March. No interim analysis of efficacy in phase 3 has been done so far.

“We do 200 percent honest clinical trials and yet we receive backlash,” he said, asserting that Bharat Biotech’s vaccine is not inferior to the one developed by Pfizer.

He said Indian companies are being targeted and called “inferior”. Ella said it was wrong to say Bharat Biotech was not transparent with data and cited the number of publications by the company in comparison with industry peers.

He said the emergency use authorisation was based on the 2019 rules of the Government of India and went on to state that even the US grants emergency authorisation to a company with good immunisation data. Bharat Biotech was the first to identify the Zika virus and the first to file global patents for the Zika and Chikungunya vaccines, he said.