[ad_1]
Just two weeks after the skilled committee scrutinising purposes for emergency use authorisation (EUA) of Pune-based Serum Institute of India’s Covid-19 vaccine sought extra late-stage security and efficacy data, the agency has submitted fresh data to the regulator, authorities sources stated.
“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 instructed The Indian Express.
Significantly, the media has reported that the UK regulator is about 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 requested to submit security data on Phase 2/three scientific trials in India of its vaccine candidate named Covishield, developed by Oxford-AstraZeneca.
During the weekly briefing, Dr V Ok Paul, who co-chairs the high-level committee on vaccine administration, with out naming the Pune-based agency, Tuesday stated the method of analyzing extra data has begun. “As everyone knows, there are three applications before the DGCI; they include Pfizer, Serum Institute and Bharat Biotech. Pfizer has not yet submitted data. The other two companies had presented the data and the regulator sought additional data. This is a normal process,” Paul stated.
Paul additional reiterated that the choice for granting approval for EUA might be primarily based on established scientific norms.
The SEC, which consists of a panel of specialists, had earlier stated that SII has introduced their proposal alongside “with the interim safety data from Phase II/III clinical trial carried out in the country and the interim safety and efficacy results of Phase II/III and Phase III clinical trials carried out in the UK, other countries & India before the committee”.
[ad_2]
Source hyperlink