In what comes as a positive development for the coronavirus disease (COVID-19) vaccine progress in India, the central government has finally approved emergency use authorisation of the Oxford-AstraZeneca coronavirus vaccine 'Covishield'.
The 10-member Subject Expert Committee of India's Central Drug Standard Control Organisation on Friday approved the emergency use authorisation sought by Serum Institute of India (SII), the manufacturer of 'Covishield'.
Since the vaccine has been cleared by the committee, the application will now be sent to Drugs Controller General of India (DCGI) V.G. Somani for final approval.
The expert panel had convened the key meeting today to take a call on the pleas sent in by SII and indigenous pharmaceutical firm Bharat Biotech, for its 'Covaxin' coronavirus candidate.
The Subject Expert Committee had, on Wednesday deliberated and analysed the additional data and information submitted by both the firms.
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.'
Notably, the dry-run of the vaccine is slated to commence tomorrow 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.
(With agency inputs)
