Key meeting of drug regulator’s expert panel is currently underway to take a call on the emergency use approval sought by Serum Institute of India, Bharat Biotech and Pfizer for their Coronavirus vaccines.
Serum, which is making ‘Covishield’ vaccine developed by Oxford-AstraZeneca, and Bharat Biotech, which had collaborated with ICMR to make ‘Covaxin’, presented their data before Subject Expert Committee of Central Drug Standard Control Organization on December 30. America’s Pfizer had sought more time to present their data.
Following the meeting on Wednesday, the expert panel had said that they are analysing the additional data and information submitted by Serum Institute of India and Bharat Biotech. The next meeting was kept on January 1.
America’s Pfizer was the first one to apply for the accelerated approval on December 4, followed by Serum and Bharat Biotech who applied on December 6 and 7, respectively. Once the vaccines are cleared by the Subject Expert Committee, their application will be sent to Drugs Controller General of India (DCGI) V.G. Somani for approval.
As India awaits for a silver bullet against coronavirus with bated breath, 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 objective of the dry run for vaccine introduction is to assess operational feasibility in the use of Co-WIN application in field environment, to test the linkages between planning and implementation and to identify the challenges and guide way forward prior to actual implementation.
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.