Covaxin is likely to be postponed until October 5
On Friday, Bharat Biotech stated that all data were forwarded to WHO for Covaxin's Emergency Uses Listing (EUL) and now waiting for comment.
While Bharat Biotech is waiting by the Hyderabad-based organisation (WHO) for its indigenous vaccine 'Covaxin' (Covid-19) to receive the much sought-after emergency application permit (EUA), the wait would, apparently, be at least a little longer.
This time up to October 5, the international public health agency is expected to delay its clearance of the covaxin fire again.
The Strategic Immunization Consultative Group (SAGE) is due to meet on 5 October to deliberate on the award according to an ANI news agency report.
According to the report, the SAGE session of the UN specialist agency would endorse EUA based on the phase 1, 2 and 3 Covaxin clinical trials.
The workshop will also consider the effects post-marketing safety, immunogenicity, effectiveness and efficacy studies, as well as updates on global, regional and national vaccine safety monitoring strategies.
The WHO will then consider available evidence to determine EUA based on evaluations by the SAGE working group. Meanwhile, last Friday, Bharat Biotech confirmed it submitted all data for the Covaxin Emergency Use List (EUL) of the WHO and is now waiting to receive feedback. However, the company says the approval procedure and timeline were not "suitable" for comment.
Source: Hindustan Times
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