HYDERABAD: Bharat Biotech, which is developing India’s first indigenous Covid-19 vaccine, Covaxin, expects critical Phase III trials to be completed after April 2021. Only after that will the company apply for the commercial license and WHO prequalification, a senior company official said.
However, Covaxin could be available for emergency use sooner if the government decides not to wait for Phase III studies to be completed and invokes an emergency use authorization (EUA), Sai Prasad, CEO of Bharat Biotech told TOI. International Ltd.
“We expect Phase III studies to begin in November and the first set of efficacy readings will be available only for April or May 2021. We have been providing all information on all aspects of our projects to the government … there have been discussions within the government on when to potentially introduce the vaccine, so whether they (the government) will wait for our Phase III data or will introduce it earlier is their prerogative, ”he explained.
Prasad said they can produce 150 million doses per year from their existing facilities.
However, Covaxin could be available for emergency use sooner if the government decides not to wait for Phase III studies to be completed and invokes an emergency use authorization (EUA), Sai Prasad, CEO of Bharat Biotech told TOI. International Ltd.
“We expect Phase III studies to begin in November and the first set of efficacy readings will be available only for April or May 2021. We have been providing all information on all aspects of our projects to the government … there have been discussions within the government on when to potentially introduce the vaccine, so whether they (the government) will wait for our Phase III data or will introduce it earlier is their prerogative, ”he explained.
Prasad said they can produce 150 million doses per year from their existing facilities.
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