With a review process of Covaxin, the indigenous vaccine against COVID-19, commencing at the World Health Organisation (WHO), the Hyderabad-based Bharat Biotech on Monday said it expects to receive emergency use listing (EUL) from the global body at the earliest.
"All documents required for emergency use listing (EUL) of Covaxin have been submitted to WHO as of July 9. The review process has now commenced with the expectation that we will receive EUL from the WHO at the earliest," said Dr Krishna Ella, Chairman and Managing Director, Bharat Biotech.
A WHO pre-qualification, or a EUL, is necessary for a vaccine company to supply vaccines for global facilities such as Covax or international procurement.
COVAXIN® EUL pic.twitter.com/dCilH7KbSk
— BharatBiotech (@BharatBiotech) July 12, 2021The WHO has approved vaccines Pfizer-BioNTech, AstraZeneca- SK Bio/SII, Johnson & Johnson Janssen, Moderna and Sinopharm for emergency use.
The indigenous vaccine showed 63.6 per cent efficacy against the Delta variant of Covid-19, which has spread in many other countries. Covaxin demonstrated 93.4 per cent efficacy against severe symptomatic Covid-19 and 63.6 per cent against asymptomatic Covid-19.
The trial was conducted on 25,800 subjects, and the data submitted to the Subject Expert Committee (SEC) showed the vaccine was "well-tolerated."
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