The Subject Expert Committee (SEC) of Central Drug Standard Control Organization (CDSCO) on Saturday (January 2) recommended Bharat Biotech’s ‘Covaxin’ for emergency use in India. The final decision on its approval will, however, be taken by the Drug Controller General of India (DCGI).
The committee of experts assessing Coronavirus vaccines had called Hyderabad-based Bharat Biotech for a meeting in the afternoon on Saturday, a day after the firm was asked to present more data to get a nod, a top source said on Saturday.
On Friday, the Subject Expert Committee of the Central Drug Standard Control Organisation (CDSCO) had held that the data provided by Bharat Biotech for its Coronavirus vaccine is not sufficient for grant of emergency use approval and asked for more information.
The expert committee, tasked with vetting Covid-19 vaccine proposals, 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.
Notably, the panel recommended emergency licensure for the Serum Institute of India-manufactured ‘Covishield’. It becomes the first vaccine to secure recommendation for emergency use in India. 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’.
America’s Pfizer was the first one to apply for the accelerated approval on December 4, followed by the Serum Institute and Bharat Biotech on December 6 and 7, respectively. 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 above the age of 50 years most of whom have co-morbidities.