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Covaxin’s policy review completed, technical review coming up: WHO expert group

G Naga Sridhar, PT Jyothi Datta Hyderabad/ Mumbai | Updated on October 12, 2021

A health worker prepare during the vaccination drive at a vaccination center, Government Boy’s Senior Secondary School, Rajouri Garden in West Delhi on Friday, September 17   -  The Hindu

Final decision on EUL for Bharat Biotech’s Covid19 vaccine expected on completion of both reviews

The stage is set for the technical review of Bharat Biotech’s Covaxin, with the World Health Organization’s policy expert group completing its evaluation of the Covid-19 vaccine.

Final decision on EUL of Covaxin next week: WHO

Giving details of the review meeting last week by the WHO’s Strategic Advisory Group of Experts (SAGE) on Immunisation, the agency said, “Bharat Biotech’s COVID-19 Vaccine (Covaxin) was reviewed by SAGE; a policy recommendation will be issued when the vaccine is Emergency Use listed by WHO.”

Representatives clarified that SAGE and the Technical Advisory Group (TAG) evaluate the same evidence on the vaccine, but from two different perspectives. The policy recommendations had been made, but were contingent on the second technical component of the review process involved in approving a vaccine for an Emergency Use Listing (EUL).

Will WHO give emergency-use approval to Covaxin?

The TAG review of Bharat Biotech’s Covaxin is expected this week. A WHO decision on Covaxin ‘s EUL is significant for students and other travellers who had taken the vaccine to be able to travel overseas.

Last week, the WHO’s expert group had reviewed Covaxin data submitted by Hyderabad-based Bharat Biotech on October 5. It was announced after the review that a final decision will be announced in a week after the risk-benefit assessment.

Published on October 12, 2021

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