Oxford-AstraZeneca vaccine cleared by expert panel, DCGI nod awaited
New Delhi, January 1, 2021
India is one step away from its first coronavirus vaccine, with the nod of the Drug Controller General of India (DCGI) awaited on the Subject Expert Committee's recommendation for emergency use of Oxford-AstraZeneca's Covishield vaccine.
According to official sources, the panel's recommendation, which came at its meeting here on Friday, has been sent to DCGI V. G. Somani for approval.
The approval will pave the way for the vaccine's rollout in India, which also has the highest number of infections in the world, after the US. The rollout will begin from January 6, according to ministry sources.
The UK and Argentina have already approved Covishield. More than five crore doses of the vaccine have already been stockpiled by its manufacturer, the Pune-based Serum Institute of India.
The expert panel had convened a meeting on Friday afternoon to take a call on the emergency use authorisation sought by the Serum Institute and Bharat Biotech for their coronavirus vaccine candidates.
The Serum Institute had 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 has, however, sought more time to present the data.
The SEC held that the data provided by Bharat Biotech for Covaxin was not sufficient for grant of emergency use approval and has asked for more information, top sources said.
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 years with co-morbidities.
As India awaits a silver bullet against coronavirus with bated breath, the DCGI, on Thursday, hinted at the approval of vaccine and said that the country will have a "Happy New Year with something in hand".