WHO nod for Emergency Use Listing likely in Q3 2021: Bharat Biotech

Regulatory approvals for Covaxin are in process in more than 60 countries including USA, Brazil and Hungary, says the Hyderabad company.

Hyderabad: Hyderabad-based Bharat Biotech, the manufacturer of Covaxin, said the application for EUL (Emergency Use Listing) has been submitted to WHO-Geneva, and regulatory approvals are expected during July-September 2021 period.

The company further stated, “Regulatory approvals for Covaxin are in process in more than 60 countries, (including) USA, Brazil, Hungary etc. Emergency use authorisations have been obtained in 13 countries with more to follow.”

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“Most countries recommend vaccinations against Covid-19. Unvaccinated travellers can travel with negative RT-PCR tests prior to travel, in the absence of any other country specific travel restrictions,” Bharat Biotech said.

A guidance document on WHO website shows that Bharat Biotech submitted its expression of interest (EOI) for EUL on April 19. However, the WHO sought more details from the company.

EUL criteria

WHO’s EUL is a prerequisite for COVAX facility vaccine supply and allows countries to expedite their regulatory approvals to import and administer Covid-19 vaccines. WHO says its EUL is a risk-based procedure for assessing and listing unlicensed vaccines with the ultimate aim of expediting the availability of these products to people affected by a public health emergency.

The EUL will assist United Nations’ procurement agencies and Member States in determining the acceptability of using specific products, based on an essential set of available quality, safety, and efficacy and performance data of vaccines.

The WHO has approved products of Pfizer, Moderna, AstraZeneca, Sinopharm and Serum Institute while others are in different stages of approvals.

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