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Covaxin | Bharat Biotech

Expert panel recommends approval for Bharat Biotech's Covaxin

| @indiablooms | Jan 03, 2021, at 06:10 am

New Delhi/IBNS: A government-appointed panel of experts on Saturday cleared  emergency use of indigenous COVID-19 vaccine Covaxin manufactured by Hyderabad-based Bharat Biotech, which will be sent for approval to the regulator Drugs Controller General of India (DCGI).

The recommendation for the home grown vaccine came a day after the expert panel cleared Covishield developed by Oxford University and pharma major AstraZeneca to be manufactured by Serum Institute of India (SII).

The Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) recommended the Drugs Controller General of India (DCGI) to grant permission to Bharat Biotech's Covaxin.

According to reports, the SEC met on January 1 and 2 and made the recommendations for the consideration and final decision of DGCI, said the Union Health Ministry.

The Serum Institute of India (SII) is making the vaccine Covishield developed by Oxford University and pharma major AstraZeneca, while Bharat Biotech has partnered with the Indian Council of Medical Research (ICMR) for its indigenous Covaxin.

The final decision to recommend Bharat Biotech's Covaxin after it presented updated data and justification and request for consideration of their proposal amid cases of mutant Coronavirus strain.

The SEC stated that the firm should continue with phase 3 clinical trial and submit the results emerging from the trial whenever available, sources said, reported the India Express.

The committee noted that the vaccine has potential to target mutated coronavirus strains,the report added. 

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