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Bharat Biotech’s Covaxin gets WHO approval

The World Health Organization on November 3 granted Covaxin an emergency use listing, or EUL, which means the ‘made-in-India’ vaccine will finally be recognised by other countries and Indians who received the shot need not self-quarantine or face restrictions when travelling abroad.

Covaxin has been cleared for use in all age groups (18+) over two doses spaced four weeks apart. However, no recommendation has been made for use on children, and available data for use on pregnant women is insufficient to assess safety or efficacy, WHO said.

“The Technical Advisory Group (an independent panel that provides the WHO with vaccine recommendations) has determined Covaxin meets standards for protection against COVID-19… the benefit of the vaccine far outweighs risks (and) the vaccine can be used,” the global health body said.

“Covaxin was also reviewed by WHO’s Strategic Advisory Group of Experts on Immunization (SAGE), and recommended use of this vaccine in two doses, with an interval of four weeks, in all age groups 18+,” the WHO tweeted.

The WHO confirmed Covaxin had been found to be “78 per cent effective against COVID-19 of any severity, 14 or more days after the second dose, and is extremely suitable for low- and middle-income countries due to easy storage requirements”.

Bharat Biotech said grant of the EUL was “a very significant step towards ensuring global access to India’s widely administered, safe and efficacious (vaccine)”.

“As an organisation we have focused on maintaining stringent quality and safety standards that meet rigorous assessment and scientific standards established by WHO… EUL authorisation for Covaxin will enable us to contribute to accelerating the equitable access of COVID-19 vaccines…” said Dr Krishna Ella, CMD, Bharat Biotech.  (Source NDTV)

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