Bharat Biotech has been submitting the data to WHO on a rolling basis and submitted additional information at WHO’s request on September 27.
The World Health Organization’s (WHO's) Technical Advisory Group (TAG) is expected to convene next week to carry out a risk-benefit assessment and come to a final decision on whether to grant emergency-use listing (EUL) to Bharat Biotech’s Covaxin.
A spokesperson for WHO
told Business Standard that the EUL decision on Covaxin is still pending. “Bharat Biotech
has been submitting the data to WHO
on a rolling basis and submitted additional information at WHO’s request on September 27.”
experts are currently reviewing this information. If it addresses all questions raised, WHO-TAG will carry out a risk-benefit assessment and come to a final decision whether to grant EUL to the vaccine, said the spokesperson.
TAG is expected to convene next week, clarified WHO.
The EUL process is centred on determining if a manufactured product is quality-assured, safe, and effective. The WHO Strategic Advisory Group of Experts on Immunization (SAGE) is centred on issuing evidence-based policy recommendations for the best use of vaccines against Covid-19, said WHO.
“Such product-specific recommendations are issued once a vaccine is authorised through a regulatory process, including the assessment of safety and efficacy from Phase III clinical trials,” said the spokesperson.
SAGE is having its regular meeting between October 4 and October 8. On Tuesday, the Hyderabad-based vaccine maker made a 25-minute presentation before the SAGE working group on the clinical data on Covaxin from Phases I, II, and III and post-marketing studies on safety, immunogenicity, efficacy, and effectiveness.
The presentation by Raches Ella, project lead, Covid-19 vaccines, Bharat Biotech, gave an outline of the ongoing and planned studies on safety and effectiveness.
“SAGE is holding its regular meeting (October 4-8), during which it will examine the latest evidence in preparation of policy recommendations for the best use of Covaxin , to be issued once the EUL process has been completed,” said WHO.
noted last week that it does not find it ‘appropriate’ to speculate or comment on the regulatory approval process or timelines.
WHO's EUL assumes significance as this is likely to allow people vaccinated with Covaxin to travel abroad without restrictions.
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