NEW DELHI, Jan 1: An expert panel of India’s drug regulator today recommended emergency use approval for Oxford-AstraZeneca vaccine Covishield, being manufactured by the Serum Institute of India, paving the way for the roll-out of the first COVID-19 shot in the country in the next few days.
As for Bharat Biotech’s vaccine, official sources said, the Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organisation (CDSCO) asked the firm to expedite volunteer recruitment for the ongoing clinical trial and recommended it may conduct interim efficacy analysis for further consideration of restricted emergency use approval for Covaxin.
NEW DELHI: The Subject Expert Committee of the Central Drug Standard Control Organisation on Friday has held that the data provided by Bharat Biotech for its coronavirus vaccine Covaxin is not sufficient for grant of emergency use approval and has asked for more information, top sources said.
Earlier on Friday, the expert committee, which is tasked with vetting covid-19 vaccine proposals, recommended emergency licensure for the Serum Institute of India-manufactured Covishield . It become the first vaccine to secure recommendation for emergency use in India.
The Pune-based Serum Institute has partnered with Oxford-AstraZeneca for conducting clinical trials and manufacturing Covishield while Bharat Biotech has collaborated with the Indian Council of Medical Research (ICMR) for Covaxin .
URL copied
Expert panel meeting today to review Covid vaccines
A day before a pan-India dry run of Covid vaccination by Center, the subject expert committee of the national drugs regulator Central Drugs Standard Control Organisation (CDSCO) is meeting on Friday to take a decision on the emergency-use authorization (EUA) application of Serum Institute of Indiaâs Oxford-AstraZeneca and Bharat Biotechâs Covid vaccine candidates.
Serum Institute which is making the vaccine Covishield developed by Oxford University and pharma major AstraZeneca and Bharat Biotech which has partnered with the Indian Council of Medical Research (ICMR) for its Covaxin had made presentations before the panel on Wednesday. Pfizer had sought more time to present their data.
Oxford-AstraZeneca Covishield vaccine likely to get nod in India daijiworld.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from daijiworld.com Daily Mail and Mail on Sunday newspapers.