Bharat Biotech awaits feedback from WHO for COVAXIN's EUL
What's the story
Bharat Biotech on Friday said it has submitted all the data pertaining to its COVID-19 vaccine COVAXIN to the World Health Organization for EUL and is awaiting feedback from the global health watchdog.
The WHO is currently reviewing the data submitted by the vaccine maker and the date for a decision on the jab is yet "to be confirmed," according to WHO's website.
Quote
Data was submitted in early July
"#COVAXIN clinical trial data was fully compiled & available in June 2021. All Data was submitted for Emergency Use Listing Application to World Health Organization in early July. We have responded to any clarifications sought by #WHO and are awaiting further feedback," Bharat Biotech tweeted.
Twitter Post
You can view the tweet here
#COVAXIN® clinical trial data was fully Compiled available in June 2021. All Data submitted for Emergency Use Listing (EUL) Application to World Health Organization in early July. (1/3) pic.twitter.com/r4CnROpUfP
— BharatBiotech (@BharatBiotech) September 17, 2021
We are working diligently on obtaining the EUL: Bharat Biotech
As a responsible manufacturer with past approvals for its other vaccines, the company said it would not find it appropriate to speculate or comment on the approval process and its timelines, it further said.
"We are continuing to work diligently on obtaining WHO EUL at the earliest," the vaccine maker added in a series of tweets.
Update
A step closer to COVAXIN's global acceptance: Joint Managing Director
The WHO, on its website, said it 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 process.
Suchitra Ella, Joint Managing Director of Bharat Biotech had earlier said the EUL process is a step closer to the final decision on COVAXIN's "global acceptance."
Expectation
COVAXIN's trial data looked promising: NITI Aayog member
NITI Aayog member Dr. VK Paul has said, "COVAXIN's trial data looked promising and the vaccine could soon get emergency-use approval from WHO."
Further, Dr. Paul said that the government has no immediate plan on booster doses, and it is mainly focusing on "vaccinating everyone with two doses." However, he said COVAXIN is undertaking a study to see the need for booster jabs.
Target
Vaccine hesitancy is no longer an issue: Dr. Paul
As India has administered over 75 crore doses, Dr. Paul had said, at this pace, the nation will achieve complete vaccination of the entire adult population by 2021-end.
Dr. Paul said that vaccine hesitancy is no longer an issue in the country.
Stating that there is a "vaccine eagerness," he said making vaccines reach everyone is the new task.