Bharat Biotech on Friday said it has submitted all data related to its COVID-19 vaccine Covaxin on the Emergency Use List (EUL) to the World Health Organization and is awaiting a response from the global health watchdog.
The WHO is currently reviewing the data submitted by the vaccine manufacturer and the date of the decision on the jab “has yet to be confirmed”, according to updates available on the WHO website.
“The #COVAXIN clinical trial data was fully compiled and available in June 2021. All data submitted for Emergency Use List (EUL) application to the World Health Organization in early July. We collected any data requested by #WHO Have replied to the clarification and awaits further response,” Bharat Biotech tweeted.
As a responsible manufacturer with no previous approvals for its other vaccines, the company said it would not be appropriate to speculate or comment on the approval process and its timeline, it added.
“We are continuing to work diligently to achieve the WHO EUL as soon as possible,” the vaccine maker said in a series of tweets.
In an update on its website, the WHO said it began rolling out vaccine data on July 6. Rolling data allows WHO to begin its review immediately, as information continues to come in to accelerate the overall review process.
Bharat Biotech’s Joint Managing Director Suchitra Ella recently said that the EUL process is one step closer to a final decision on ‘global acceptance’ of Covaxin.