No vaccine approval yet, drug regulator analysing SII, Bharat Biotech data

New Delhi, Dec 30 : The analysis of the additional data and information submitted by Serum Institute of India (SII) and Bharat Biotech is still being conducted by regulator Central Drug Standard Control Organisation’s (CDSCO) Subject Expert Committee and their next meeting will be held on January 1.
The Subject Expert Committee met on Wednesday to consider the Emergency Use Authorisation (EUA) request of Pfizer, SII and Bharat Biotech Private Ltd.
Further time was requested on behalf of Pfizer, while the additional data and information presented by the SII and Bharat Biotech was perused and analysed by the SEC.
“The analysis of the additional data and information is going on. SEC will convene again on 1st January 2021 (Friday),” the Centre said in a statement.
America’s Pfizer was the first one to apply for the accelarated approval on December 4, followed by the SII and Bharat Biotech who applied on December 6 and 7, respectively.
On December 9, the Subject Expert Committee had asked the SII and Bharat Biotech to submit more data and information to get approval.