BackWHO to decide on Covaxin's emergency approval next month
Bharat Biotech's Covaxin and Serum Institute's Covishield are the two widely used covid vaccines in India
PremiumThe World Health Organisation (WHO) has said that it will decide on emergency use listing (EUL) for India'a Covaxin covid vaccine next month. The latest ‘Status of COVID-19 vaccines within WHO EUL/PQ evaluation process’ guidance document dated September 29 on the WHO website said that the decision date for Bharat Biotech’s Covaxin is “October 2021".
The status of assessment for Covaxin is “ongoing". Bharat Biotech had submitted EOI (Expression of Interest) on April 19 for its vaccine. The WHO, according to its website, began rolling data of the vaccine on July 6. Rolling data allows the WHO to start its review right away, as information continues to come in, to accelerate the overall review process.
Bharat Biotech's Covaxin and Serum Institute's Covishield are the two widely used vaccines in India.
“As a responsible manufacturer with past approvals for our other vaccines, we do not find it appropriate to speculate or comment on regulatory approval process and its timelines. We are diligently working with the WHO to obtain EUL at the earliest," Bharat Biotech said in a September 28 tweet.
Bharat Biotech recently said it submitted all data pertaining to Covaxin to the WHO for EUL and is awaiting feedback from the global health watchdog. “COVAXIN clinical trial data was fully compiled and available in June 2021," it had tweeted.
“We have responded to any clarifications sought by #WHO and are awaiting further feedback."
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