Bharat Biotech's Covaxin Gets CDSCO Panel Nod, India's 2nd Vaccine Candidate to Receive Emergency Use Approval: Reports
This comes a day after Covishield, the Indian version of Oxford-AstraZeneca vaccine being manufactured domestically by Pune-based Serum Institute of India. Both Covisheild and Covaxin, despite initial clearances, await the final nod from Drug Controller Regulator of India -- the apex regulatory authority for healthcare products.
New Delhi, January 2: An expert committee of the Central Drugs Standard Control Organisation (CDSCO) on Saturday recommended granting approval for restricted emergency use of Bharat Biotech's indigenous COVID vaccine Covaxin in India, government sources were quoted by ANI. The Covaxin vaccineis jointly developed by Hyderabad-based vaccine manufacturer Bharat Biotech and Indian Council of Medical Research (ICMR). The final decision on its approval will, however, be taken by the Drug Controller General of India (DCGI). Covishield Gets Approval in India; AstraZeneca-Oxford COVID-19 Vaccine Being Produced by Serum Institute of India, Approved For Emergency Use.
The Subject Expert Committee of the Central Drug Standard Control Organisation (CDSCO) on Friday had said that the data provided by Bharat Biotech for its COVID-19 vaccine is not sufficient for grant of emergency use approval and asked for more information. Reports inform that the committee had convened a meeting to take a call on emergency use authorisation sought by the Serum Institute of India and Bharat Biotech for their respective vaccine candidates.
Update by ANI
The panel however, recommended emergency licensure for the Serum Institute of India-manufactured 'Covishield'. In India, it become the first vaccine to secure recommendation for emergency use. The nod of the DCGI is, however, awaited on the recommendation. The Pune-based 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) for 'Covaxin'.
(The above story first appeared on LatestLY on Jan 02, 2021 07:38 PM IST. For more news and updates on politics, world, sports, entertainment and lifestyle, log on to our website latestly.com).