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Bharat Biotech expects to get WHO approval at the earliest

Hyderabad: World Health Organization (WHO) is reviewing Covaxin, an indigenous vaccine against COVID-19 and Hyderabad-based Bharat Biotech expects to receive an emergency use listing (EUL) at the earliest possible time.

Dr. Krishna Ella, Chairman and Managing Director of Bharat Biotech said, ‘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.’

It is necessary for vaccine companies to get a WHO pre-qualification or a WHO EUL before they can supply vaccines to Covax and international procurements.

Read more: Covid ward fire, 52 dead and 22 wounded

WHO has approved several vaccines for emergency use, including those manufactured by Pfizer-BioNTech, AstraZeneca-SK Bio/SII, Johnson & Johnson Janssen, Moderna and Sinopharm.

This indigenous vaccine showed 63.6% efficacy against the Delta variant of Covid-19, which has spread to other countries. The efficacy of Covaxin against severe symptomatic Covid-19 was 93.4% and against asymptomatic Covid-19, it was 63.6%.

The trial was conducted on 25,800 subjects and data submitted to the Subject Expert Committee (SEC) indicated the vaccine was ‘well tolerated’.

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