Bharat Biotech Expects Covaxin’s Phase 3 trials

Bharat Biotech Expects Covaxin’s Phase 3 trials

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Bharat Biotech’s homegrown Covid-19 vaccine, Covaxin, has shown an interim vaccine efficacy of 81 per cent in late-stage clinical trials, the company announced on Wednesday.

The Drugs Constroller General of India (DCGI) gave permission to Covaxin in January “for restricted use in an emergency situation.” However, a huge backlash followed as the vaccine had yet not completed Phase III trials.

To remain unbiased, Bharat/ICMR cannot access any data. Our service provider IQVIA has started the final statistical analysis. After submitting efficacy and 2 months of safety to CDSCO (July), it is expected to instantly reach a pre-print server. Peer review takes 2-4 months, he tweeted.

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