Meeting with Bharat Biotech International Limited (BBIL) on the status of application for WHO’s Emergency Use Listing (EUL) of COVAXIN. It was noted that COVAXIN had already received regulatory approval from 11 countries: Sources
There was also interest from other 11 companies in 7 countries for technology transfer & production of COVAXIN. On the issue of WHO’s authorization for EUL, BBIL noted that they had submitted 90% documentation required. Remaining is expected to be submitted in June 2021: Sources
BBIL is confident about obtaining WHO EUL subsequently, given its experience of getting its other vaccines pre-qualified by WHO. BBIL is in the final stages of submission of required documents for COVAXIN’s regulatory approvals in Brazil and Hungary: Sources
They've held extensive bilateral consultations with Hungary & Brazil. BBIL is in final stages of negotiations with US's FDA for conducting small-scale Phase-III clinical trials in the US. BBIL clarified that all regulatory approvals have retrospective & prospective effect:Sources
BBIL is in regular touch with regulatory authorities in Hungary & Brazil. They're confident about robustness of their dossier, as they've data for antibody persistence after 6 as well as 8 months. It's one of the few companies that published papers on all 4 Covid variants:Sources
It is important to note that no country has instituted a vaccine passport. Countries have their own requirements for approval, which in most cases involves travel by carrying a negative RT-PCR report: Sources
• • •
Missing some Tweet in this thread? You can try to
force a refresh
