Just two weeks after the expert committee scrutinising applications for emergency use authorisation (EUA) of Pune-based Serum Institute of India’s Covid-19 vaccine sought additional late-stage safety and efficacy data, the firm has submitted fresh data to the regulator, government sources said.
“Serum Institute India has submitted additional data. The regulator’s office, internally, will review these documents. Only then they will request the Subject Expert Committee (SEC) to meet,” sources told The Indian Express.
Significantly, the media has reported that the UK regulator is set to “clear” the Oxford-AstraZeneca vaccine, “possibly on December 28 and December 29”. In India, SII which sought EUA from the Drugs Controller General of India (DGCI) on December 10 was asked to submit safety data on Phase 2/3 clinical trials in India of its vaccine candidate named Covishield, developed by Oxford-AstraZeneca.