The Subject Expert Committee of Central Drug Standard Control Organization on Saturday recommended granting permission to Bharat Biotech's indigenously-developed coronavirus disease (COVID-19) vaccine 'Covaxin' for 'restricted emergency use authorisation' in India.
The final decision on its approval will, however, be taken by the Drug Controller General of India (DCGI).
According to news agency IANS, the committee of experts assessing the 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.
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 as 'not sufficient' for granting emergency use approval and had asked for more information instead.
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 10-member panel recommended emergency licensure for the Serum Institute of India-manufactured 'Covishield'. It become the first vaccine to secure a 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.
As the country awaits for a silver bullet against coronavirus with bated breath, the Drug Controller General of India, on Thursday hinted at the approval of vaccine and said that the country will have a 'happy new year with something in hand.'
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 crores elderly above the age of 50 years most of whom have co-morbidities.
Notably, the dry-run of the vaccine was conducted today in almost all the states and union territories to equip the administration in the management of vaccine supply, storage and logistics including cold chain management.
(With inputs from IANS)
