DCGI approves Serum, Bharat Biotech vaccine for emergency use

DCGI approves Serum, Bharat Biotech vaccine for emergency use

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DCGI approves Serum, Bharat Biotech vaccine for emergency use

New Delhi: Eleven months after the first case of deadly coronavirus was detected in India, Drug Controller General of India (DCGI) V.G. Somani on Sunday approved Serum Institute of India’s ‘Covishield’ vaccine and Bharat Biotech’s ‘Covaxin’ for emergency use, paving way for its roll-out and administration to millions.

“After adequate examination, the CDSCO has decided to accept the recommendations of the Subject Expert Committee and accordingly, vaccine of Serum and Bharat Biotech are being approved for restricted use in emergency situation,” the Drugs Controller General of India Dr. V.G. Somani said.

Covishield and Covaxin have to be administered in two doses and can be stored at 2-8 degree Celsius. The Drugs Controller General of India has also granted permission to Cadila healthcare for phase 3 clinical trial in India.

This is a major relief for India which has the second highest number of infections in the world after the US. The Central government plans to vaccinate nearly 30 crore people in the first phase of drive in the next six to eight months.

The vaccine will be first offered to one crore healthcare workers, along with two crore frontline and essential workers and 27 crore elderly, mostly above the age of 50 years with co-morbidities.

On Saturday, Union Health Minister Harsh Vardhan had announced that one crore healthcare workers, along with two crore frontline workers will get the vaccine for free.

The Subject Expert Committee, tasked with vetting the vaccine proposals, had recommended Oxford-Astra Zeneca’s ‘Covishield’ and Bharat Biotech’s indigenous ‘Covaxin’ for emergency use approval on January 1 and 2, respectively. The final call was to be taken by the DCGI.

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