New Delhi/Hyderabad: Hyderabad-based Bharat Biotech rejected Monday criticism over the grant of emergency use authorisation by India’s drug regulator to its COVID-19 vaccine. Bharat Biotech asserted that it has a track record of producing safe and efficacious vaccines. The company also said it has been transparent with all data.
The approval to ‘Covaxin’ has been questioned by industry experts and some opposition Congress leaders. They have expressed concern over the absence of Phase 3 trial data. They have cautioned that ‘sidestepping’ processes and giving ‘premature’ clearance could risk lives and fuel vaccine hesitancy in India.
However, Krishna Ella, chairman of Bharat Biotech, said sufficient data has already been revealed. “We do 200 percent honest clinical trials and yet we receive backlash,” Ella said. He asserted that Bharat Biotech’s vaccine is not inferior to the one developed by Pfizer.
Ella 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. 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.
The approval Sunday to Oxford University’s COVID-19 vaccine ‘Covishield’, manufactured by the Serum Institute, and indigenously developed Covaxin has been hailed by the Indian leadership as a major achievement for the scientists and India.
The ‘Covishield’ vaccine will cost USD 3-4 per shot (Rs 219-292) to the Indian government. It will be priced at double that rate in the private market once such sales open up, said Adar Poonawalla, the CEO of Serum Institute of India (SII).
The world’s largest vaccine manufacturer, SII, has a licence to produce the shot. It has already manufactured close to 50 million doses.
“We want the vaccine to be affordable and accessible to all. The government of India will receive it at a far more affordable price of USD 3-4 since they will be buying in a larger volume,” Poonawalla said. “The efficacy results of the vaccine are quite high if it is administered in 2-doses within a gap of 2–3 months,” he added.