The Subject Expert Committee (SEC) in Central Drugs Standard Control Organisation (CDSCO) met on Wednesday to consider the Emergency Use Authorisation (EUA) request of Pfizer, Serum Institute of India (SII) and Bharat Biotech Pvt Limited.
According to the statement by the SEC, the Emergency Use was not authorized on Wednesday. They need more data and further time to discuss. The SEC will meet again on January 1. After reviewing further details, they will take a decision about Emergency use of COVID-19 vaccine in India.
Pfizer had asked for more time. “Further time was requested on behalf of Pfizer. The additional data and information presented by SII and Bharat Biotech Pvt Ltd. was perused and analysed by SEC.
“The analysis of the additional data and information is going on. SEC will convene again on January 1,” read the statement.
The Serum Institute had applied for Emergency Use Authorisation for the Oxford-AstraZeneca vaccine in the United Kingdom. It was approved by the UK. Even the AstraZeneca was not approved earlier.
The SEC confirmed that they need all the details. Proper research, details on quality and safety of the vaccine is necessary before providing authorization. They will meet again on January 1st, 2021.