A committee of experts assessing the coronavirus vaccines has called Hyderabad-based Bharat Biotech for a meeting at 1.30 pm on Saturday, a day after the firm was asked to present more data on its ‘Covaxin’ to get the go-ahead, a top source said.
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 was not sufficient for the grant of approval for emergency use and sought more information.
The expert committee, tasked with vetting Covid-19 vaccine proposals, had convened a meeting to take a call on authorisation for emergency use 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’s ‘Covishield’ vaccine, making it the first in India to secure approval for emergency use. Nod of the Durg Controller General of India 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 US’s Pfizer was the first company to apply for 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 persons in the first phase of the immunisation 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 with co-morbidities.