Hyderabad: The Oxford-AstraZeneca COVID-19 vaccine manufactured by the Serum Institute of India has been cleared by a government-appointed Subject Expert Committee of the Central Drug Standard Control Organisation on January 1 for the conditional emergency approval after examining the application.
It will be sent for approval to the regulator Drugs Controller General of India (DCGI). The Serum Institute of India (SII) is making the vaccine, Covishield, developed by Oxford University and pharma major AstraZeneca, while Bharat Biotech has partnered with the Indian Council of Medical Research (ICMR) for its Covaxin.
Bharat Biotech and Pfizer applications will be considered for approval again with certain conditions.
A key meeting of the Subject Expert Committee took a call on the emergency use authorisation sought by Serum Institute of India and Bharat Biotech for their COVID vaccine candidates.
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.