The Subject Expert Committee of Central Drug Standard Control Organization on Saturday (2 January) 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 today, a day after the firm was asked to present more data to get a nod, a top source said on Saturday.
On Friday (1 January), the Subject Expert Committee (SEC) of the 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.
After assessing the data, the SEC recommended the DCGI to approve Bharat Biotech's Covaxin for "restricted use in emergency situation in public interest as an abundant precaution, in clinical trial mode, specially in the context of infection by mutant strain".
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', "subject to multiple regulatory conditionalities". It became 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'.
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.
(With inputs from IANS)
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