Last Updated on October 14, 2024 by The Health Master
Bharat Biotech‘s Covaxin was granted Emergency Use Authorisation on Wednesday evening after several rounds of discussions on the inactivated-virus vaccine made in India.
The Technical Advisory Group which recommends the vaccine for Emergency Use Listing had earlier sought additional clarifications from the vaccine manufacturer on October 26, subsequently after which it was granted approval.
TAG granted the approval after analysing the risks and benefits involved and drawing the conclusion that the benefits far outweigh the risks of the vaccine and matches WHO standards set for Emergency Use Listing.
Bharat Biotech‘s Covaxin and Serum Institute of India’s Covishield are the two major vaccines driving India’s vaccination campaign. Bharat Biotech had also recently received approval from the Subject Expert Committee for administration of Covaxin in children.
Informing about the development, World Health Organisation tweeted, “WHO has granted emergency use listing (EUL) to COVAXIN® (developed by Bharat Biotech), adding to a growing portfolio of vaccines validated by WHO for the prevention of C-19.”
TAG had sought additional information on “gender wise” immunogenicity data on adults aged 60 plus in the last round of discussion before the approval was granted today.
Speaking on the approval granted to Covaxin, Dr Poonam Khetrapal Singh, Regional Director, WHO South-East Asia said, “Congratulations India for Emergency Use Listing of its indigenously produced C-19 vaccine COVAXIN.”
Union Minister for Health and Family welfare congratulated the citizens and thanked the World Health Organisation for its approval to the indigenously developed vaccine.
Bharat Biotech had submitted application for Emergency Use Listing back on April 19, providing all necessary information including the results of the Phase 3 clinical trials in which it demonstrated 77.8 per cent efficacy and further provided 65.2% protection against the new Delta variant.
Covaxin joins the list of Pfizer-BioNTech, AstraZeneca-SK Bio/Serum Institute of India, Johnson & Johnson-Janssen, Moderna, and Sinopharm C-19 vaccines which have been approved for emergency use.
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