A subject expert committee of India’s Central Drug Standard Control Organisation has recommended ‘Covishield’, the COVID-19 vaccine co-developed by British pharmaceutical firm AstraZeneca and the University of Oxford for emergency usage within the country.
Central Drug Standard Control Organisation (CDSCO) works in concurrence with the Drugs Controller General of India (DCGI) to validate and approve the use of any pharmaceuticals or medical devices in the country.
The recommendation will now be sent to the Drugs Controller General of India (DCGI) Mr. V.G. Somani for further approvals.
COVID-19 vaccine developed by US-based drug maker Pfizer as well as ‘Covaxin’, the indigenously developed vaccine from the collaboration of Hyderabad-based Bharat Biotech and Indian Council of Medical Research (ICMR) are the other two vaccines awaiting approvals from the body.
While Pfizer had submitted the application for accelerated approval on December 4, it had sought more time to present the data.
Pune-based Serum Institute of India (SII), one of the largest vaccine manufacturers in the world by the number of doses produced and sold globally had represented AstraZeneca and Oxford University to made their submission.
SII had earlier facilitated clinical trials for the AstraZeneca-Oxford vaccine and will be manufacturing ‘Covishield’ in its facilities.
One of the most affected countries across the globe, India is all set to immunize nearly 300 million people in the first phase of its vaccination drive. The vaccine, when approved and made available for the public will be first offered to the 10 million healthcare workers along with 20 million frontline and essential workers.
Some 270 million elderly Indian citizens mostly above the age of 50 years with co-morbidities are also inline to receive the vaccine first.