Experts of the WHO decide on the issue of granting the EUL authorisation to Bharat Biotech’s COVID-19 vaccine Covexin.
The Hyderabad-based vaccine developer previously provided all documents required by the global health body. After it reportedly approved the EUL signal to Covaxin over some technical queries.
Expert’s meetings show that it will discuss the assessment status of pending applications for vaccine candidates, including Covaxin.
Also top health experts believe that Covaxin’s approval shouldn’t delay after reviewing the data this month.
Earlier reported that WHO’s emergency use approval for Covexin will most likely come in October month.
The Hyderabad-based developer stated that it is ‘working diligently with the WHO to procure EUL at the earliest.’
The EUA is crucial because without it Covexin will not endorsed by most countries. WHO’s SAGE is ready to meet on October 5 to report on EUA to Covexin.
Bharat Biotech, in a statement, mentioned that it is not appropriate to speculate or comment on the regulatory approval process. At an appropriate time it will declare the regulatory approval.
It further stated that all the relevant tested data has submitted to WHO. All explanations by the UN health agency have responded to.
Dr VK Paul, Member (Health), Niti Aayog earlier informed that WHO’s EUA expected in the last week of September. Per Bharat Biotech Phase 3 clinical tests of Covexin demonstrated an efficacy rate of 77.8 per cent.
The WHO already approved COVID-19 vaccines by Pfizer -BioNTech, AstraZeneca, Johnson and Johnson, Moderna and Sinopharm.
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