Serum Institute of India has concluded its presentation before the 10-member Subject Expert Committee of the Drug Regulator for the approval of its coronavirus vaccine. Bharat Biotech will commence presentation of its data shortly, an official source said on Friday.
"Serum Institute of India has concluded its presentation. Bharat Biotech will start presenting its data shortly," the source told IANS.
A key meeting of the Subject Expert Committee of the Central Drug Standard Control Organization is currently underway to take a call on the emergency use authorisation sought by Serum Institute of India and Bharat Biotech for their coronavirus vaccines candidates. The panel is likely to take call on the approval today.
The Subject Expert Committee had, on Wednesday deliberated and analysed the additional data and information submitted by both the firms. Once the vaccines are cleared by the committee, the application will be sent to the Drugs Controller General of India (DCGI) V.G. Somani for approval.
Serum Institute of India 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) to make 'Covaxin'.
America's Pfizer was the first one to apply for the accelerated approval on December 4, followed by Serum and Bharat Biotech on December 6 and 7, respectively. Pfizer had, however, twice sought more time to present the data. It is likely to present its data on Friday.
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 meeting comes a day before dry-run of the vaccine is slated to commence in all the states and union territories to equip the administration in management of vaccine supply, storage and logistics including cold chain management.
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, mostly above the age of 50, with co-morbidities.