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Bharat Biotech’s Covaxin gets WHO approval for Emergency Use Listing

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Shillong, Nov 3: The technical committee of the World Health Organization (WHO) on November 3 granted Emergency Use Listing (EUL) to make in India Covid-19 vaccine Covaxin. This move will allow people inoculated with Covaxin to travel abroad without restrictions.

The committee had on October 26 sought additional clarifications from Covaxin manufacturer Bharat Biotech. Bharat Biotech’s Covaxin and AstraZeneca and Oxford University’s Covishield are the two widely used vaccines in India.

“This marks another successful milestone, more to come shortly,” Raches Ella, clinical lead, Covid-19 vaccines at Bharat Biotech tweeted after the WHO announced the grant of approval to Covaxin.

According to sources, TAG had sought “gender-wise” immunogenicity data on adults aged 60 plus from the company.

The emergency use listing (EUL) procedure assesses the suitability of novel health products during public health emergencies, with the objective of providing rapid access to medicines, vaccines, and diagnostics while adhering to stringent criteria of safety, efficacy, and quality.

Technical Advisory Group, convened by WHO and made up of regulatory experts from around the world, has determined that Covaxin vaccine meets WHO standards for protection against COVID, that benefit of the vaccine far outweighs risks and the vaccine can be used across the world,” said WHO

The Covaxin vaccine was also reviewed by WHO’s Strategic Advisory Group of Experts on Immunization (SAGE), and recommended use of this vaccine in two doses, with a dosing interval of four weeks, in all age groups 18 and above, added WHO.

Countries that have given approval to Covaxin

Guyana, Iran, Mauritius, Oman, Sri Lanka, Estonia, Greece, Mexico, Nepal, Paraguay, Philippines, Zimbabwe, Australia.

Vaccines approved so far

WHO has so far approved Covid-19 vaccines of Pfizer-BioNTech, AstraZeneca-SK Bio/Serum Institute of India, Johnson & Johnson-Janssen, Moderna, and Sinopharm for emergency use.

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