WHO’s approval for the emergency use authorisation (EUA) to COVID-19 vaccine Covaxin, developed by the Hyderabad-based Bharat Biotech, is likely to be delayed till October 5.
New Delhi: As Bharat Biotech awaits the emergency use authorisation (EUA) for its COVID-19 vaccine Covaxin from the World Health Organisation (WHO), the approval is likely to be delayed more till next month. According to the WHO, the Strategic Advisory Group of Experts on Immunization (SAGE) will be meeting on October 5 for granting EUA to India’s indigenous COVID vaccine Covaxin.
Hanna Nohynek, SAGE member will be introducing session objective setting, an update on regulatory decisions and an overview of Working Group deliverables.
The session will recommend EUA based on the clinical data on Covaxin from phase 1, 2, 3 trials and post-marketing studies on safety, immunogenicity, efficacy and effectiveness. It will update on global, regional and country-level plans for vaccine safety monitoring.
The assessment of the SAGE working group on the available pieces of evidence will determine EUA.
On Friday Bharat Biotech said it has submitted all the data pertaining to Covaxin to the WHO for Emergency Use Listing (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 the update available on WHO website.
#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. We have responded to any clarifications sought by #WHO and are awaiting further feedback,” Bharat Biotech tweeted.
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 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.
In an update on its website, the WHO 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 review process.
Suchitra Ella, joint managing director of Bharat Biotech recently had earlier said the EUL process is a step closer to the final decision on Covaxin’s ‘global acceptance.’