Covishield vaccine: India's drug regulator approves AstraZeneca/Oxford vaccine

Other News Materials 2 January 2021 15:01 (UTC +04:00)
Covishield vaccine: India's drug regulator approves AstraZeneca/Oxford vaccine

The 10-member Subject Expert Committee of India's Central Drug Standard Control Organisation on Friday approved emergency use authorisation of the Oxford-AstraZeneca coronavirus vaccine 'Covishield'.

The expert panel had convened a meeting to take a call on the emergency use authorisation sought by the Serum Institute of India, the manufacturer of Covishield, and Bharat Biotech for its Covaxin.

Once the vaccines are cleared by the committee, the application will be sent to Drugs Controller General of India (DCGI) V.G. Somani for final approval.

The decision paved the way for the vaccine's rollout in India, which also has the highest number of infections in the world, after the US.

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

The Serum Institute 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) to make 'Covaxin'.

America's Pfizer was the first one to apply for the accelerated approval on December 4, followed by Serum and Bharat Biotech on December 6 and 7, respectively. Pfizer has, however, sought more time to present the data.

The Central government plans to vaccinate nearly 30 crore people in the first phase of drive. It will be offered to one crore healthcare workers, along with 2 crore frontline and essential workers and 27 crore elderly, mostly above the age of 50 years with co-morbidities.