The World Health Organization (WHO) is likely to grant emergency use approval to Bharat Biotech's Covaxin by mid-September. A WHO panel will meet this week to review the data submitted by the vaccine maker.
The WHO global advisory committee on vaccine safety will meet this week to assess immunogenicity, vaccine safety and vaccine effectiveness of Covaxin, people in the know told.
Recognition from the global health body will allow people vaccinated with Covaxin to travel abroad without restrictions as some countries only accept COVID-19 vaccines approved by WHO.
The regulatory approvals are expected by mid-September, the report said.
"A series of meetings are taking place to assess pre-clinical and clinical data, leading to a crucial decision which is likely by September mid," source told the publication.
According to the WHO, its Emergency Use Listing Procedure (EUL) is a risk-based procedure for assessing and listing unlicensed vaccines, therapeutics and in vitro diagnostics with the ultimate aim of expediting the availability of these products to people affected by a public health emergency.
The approval will also enable Covaxin to join the WHO’s COVAX vaccine alliance which is supplying COVID-19 vaccines to multiple low-income countries.
So far, six vaccines have EUL from the WHO – AstraZeneca-Oxford, Moderna, Johnson & Johnson, Pfizer-BioNTech, Sinopharm and Sinovac.
Meanwhile, the daily COVID-19 vaccinations crossed the one crore mark on August 31 for the second time in five days, taking the cumulative doses administered in the country to over 65 crore, the Union Health Ministry said.
A record high of over 1.28 crore COVID-19 vaccine doses were given on Tuesday, according to the CoWIN portal data.
India took 85 days to touch the figure of 10 crore. It then took 45 days to cross the 20-crore mark and 29 more days to reach 30 crore. The country took 24 days to reach 40 crore and then 20 more days to cross 50 crore vaccinations on August 6. It took 19 more days to go past the 60-crore mark on August 25.