Bharat Biotech expects Covaxin to get WHO nod for emergency use by July-September

Serum Institute of India manufactured Covishield received the WHO listing in February

Bharat Biotech, the maker of Covaxin, is expecting the World Health Organization (WHO) regulatory approvals for its Covid-19 vaccine by September.

The Hyderabad-based firm on Tuesday said that it has applied to the WHO-Geneva for the Emergency Use Listing (EUL) of Covaxin and “approvals are expected July-September 2021.”

Serum Institute of India manufactured Covishield, a version of the AstraZeneca/Oxford Covid-19 vaccine, received the WHO listing in February.

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Both Covishiled and Covaxin are part of the ongoing Covid-19 immunization programme in the country.

WHO’s EUL is the green light for a vaccine's roll-out globally. It also allows countries to expedite their own regulatory approval to import and administer Covid-19 vaccines.

The EUL assesses the quality, safety and efficacy of Covid-19 vaccines, as well as risk management plans and programmatic suitability, such as cold chain requirements.

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WHO, according to its website, has listed the Pfizer/BioNTech vaccine emergency use in December 2020; two AstraZeneca/Oxford Covid-19 vaccines in February; and Covid-19 vaccine developed by Johnson & Johnson in March. It also approved China's Sinopharm earlier this month.

Bharat Biotech has said that the regulatory approvals for its Covaxin are in process in more than 60 countries like the USA, Brazil, Hungary.

“Emergency use authorisations have been obtained in 13 countries,” the company said in a statement.