Days after two COVID-19 vaccines were granted restricted emergency use approval by India’s drug regulator, a national association of doctors and scientists on Tuesday said they suspect “profit and political gains took precedence over science”. In a statement, the Progressive Medicos and Scientists Forum said India was quick to criticise China and Russia for granting emergency approvals to vaccines without efficacy data, but it “failed to exercise diligence when its turn arrived”.
“There are many reasons to suspect that profit and political gains have taken precedence over science,” the Progressive Medicos and Scientists Forum said. The Drugs Controller General of India (DCGI) had on Sunday approved Oxford COVID-19 vaccine Covishield, manufactured by the Serum Institute, and indigenously developed Covaxin of Bharat Biotech for restricted emergency use in the country, paving the way for a massive inoculation drive.
Industry experts and some opposition leaders have expressed concern over the absence of Phase 3 trial data on Covaxin. The critics have cautioned that “sidestepping” processes and giving “premature” clearance could risk lives and fuel vaccine hesitancy in India. However, Bharat Biotech has rejected criticism over the grant of emergency use authorisation by India’s drug regulator to its COVID-19 vaccine, asserting it has a track record of producing safe and efficacious vaccines and has been transparent with all data.
Krishna Ella, chairman of Bharat Biotech, said the company has done “200 per cent honest clinical trials” and yet it was receiving “backlash”. Covaxin addresses an unmet medical need and has generated excellent safety data with a robust immune response to multiple viral proteins that persist, Ella has said.
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