October 16, 2021

Bharat Biotech expects WHO’s approval for Covaxin’s emergency use by July-September

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Bharat Biotech, the manufacturing pharma company of Covaxin, is expecting to receive the World Health Organization’s (WHO) regulatory approval by the end of September. On Tuesday, Bharat Biotech declared that it has applied to WHO-Geneva for Emergency Use Listing (EUL) of Covaxin and further revealed the approval is anticipated by July-September 2021.

Covishield, the vaccine manufactured by Serum Institute of India (SII), developed by Oxford University – AstraZeneca received WHO listing in February.

Covishield and Covaxin are a part of the ongoing Covid-19 vaccination drive in India.

WHO’s EUL for Covaxin will launch the vaccine globally and other countries will expedite their own regulatory approval for importing and administering the covid-19 vaccine.

The EUL reviews the quality, safety and efficacy of Covid-19 vaccines, along with the risk management plans and programmatic suitability which included cold chain requirements.

According to the website, WHO has given approval for Pfizer-BioNTech for emergency vaccine use in December 2020, two vaccines of AstraZeneca and Oxford got approval in February and Johnson & Johnson vaccine got the approval in March, and China’s Sinopharm got approval in the earlier part of May.

Meanwhile, Bharat Biotech said the regulatory approvals for Covaxin is underway in over 60 countries like the USA, Brazil and Hungary. The company stated, “Emergency use authorizations have been obtained in 13 countries.”

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