DCGI approves Coronavirus vaccine by SII, Bharat Biotech 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 the way for their roll-out and administration to millions.

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.

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.

The expert panel recommended granting permission for restricted emergency use of 'Covaxin' in "public interest as an abundant precaution, in clinical trial mode, specially in the context of infection by mutant strains.

Pune-based Serum Institute of India has partnered with Oxford-AstraZeneca for conducting clinical trials and manufacturing 'Covishield', while Bharat Biotech has collaborated with the Indian Council of Medical Research (ICMR) for 'Covaxin'.

Serum and Bharat Biotech Pfizer had applied for the accelerated approval on December 6 and 7, respectively.

The UK and Argentina have already approved the Oxford-AstraZeneca vaccine. More than five crore doses of the vaccine have already been stockpiled by its manufacturer, Serum Institute of India.

Oxford-AstraZeneca vaccine will play a major role in India's plan to vaccinate its population against Covid-19 due to several factors -- low-cost, ease of storage and transport.

Serum Institute of India this week said it has a stockpiled 40-50 million doses of its Covid-19 vaccine. India is likely to receive a majority of these 50 million doses.

As far as Bharat Biotech's Covaxin is concerned, it is India's first indigenous vaccine for coronavirus. The inactivated virus vaccine is being developed in collaboration with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV).