Bharat Biotech’s vaccine Covaxin gets expert panel’s approval for restricted use

“Grant of permission for restricted use in emergency situation in public interest as an abundant precaution, in clinical trial mode, specially in the context of infection by mutant strains, to M/s Bharat Biotech International Ltd., Hyderabad,” statement by Union Health Ministry reads.

This came a day after the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO), India’s drug regulator, recommended conditional use of the vaccine.

This is the second Covid-19 vaccine which has been recommended for emergency use approval after Serum Institute of India’s locally produced Oxford Covid-19 vaccine ‘Covishield’.

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The drugmaker has already produced about 10 million doses of its Covaxin shot, ahead of an anticipated roll out by the middle of next year. It has a current annual capacity of 300 million shots and expects the first 100 million to be deployed by India.

Bharat has spent about $60 million to $70 million so far developing Covid vaccines. The early trial data suggested Covaxin has efficacy rates of at least 60%, according to reports.

The final decision will be taken by the Drugs Controller General of India (DCGI) on vaccine approval.