New Delhi: The WORLD HEALTH ORGANISATION may delay it’s approval for the emergency use of Covaxin till October 5th.
be meeting on October 5 to granting EUA to Covaxin.
A member of SAGE, Hanna Nohynek is going to introduce an update on regulatory decisions and an overview of Working Group deliverables. The meeting will be based on the data collected by the clinical trials phase 1, 2, 3. Also on post-marketing studies on safety, immunogenicity, efficacy and effectiveness on Covaxin. The SAGE working group assessment on the available pieces of evidence will determine EUA.
Meanwhile, Bharat Biotech on Friday (September 17, 2021) said that it has submitted all the data to the WHO. This was for Emergency Use Listing (EUL) of its COVID-19 vaccine Covaxin. The company is awaiting feedback from the UN Public Health Agency.
Bharat Biotech, tweeted that it complied the Covaxin clinical trial and was available in June 2021.
“COVAXIN clinical trial data was fully compiled and available in June 2021.” We have responded to any clarifications sought by WHO and are awaiting further feedback,” Bharat Biotech tweeted.
The WHO has so far approved Covid vaccines developed by Pfizer-BioNTech. US pharma majors Johnson & Johnson, Moderna, China`s Sinopharm and Oxford-AstraZeneca . Thus WHO approved these vaccines.
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