‘Bharat Biotech submitting data regularly, very quickly’: WHO official on Covaxin approval

United Nations: India’s Bharat Biotech has been submitting data on the EUL of Covaxin “regularly and very quickly” to a technical committee which hopes to have a final recommendation to the WHO next week, a top official of the global health agency said on Thursday (October 28, 2021), stressing that the UN body “trusts” the Indian industry that manufactures high-quality vaccines.

Hyderabad-based Bharat Biotech, which has developed Covaxin, had submitted EOI (Expression of Interest) to the World Health Organisation on April 19 for the vaccine’s Emergency Use Listing (EUL).

A technical advisory group of the UN health agency which met on Tuesday has sought “additional clarifications” from Bharat Biotech for Covaxin to conduct a final “risk-benefit assessment” for Emergency Use Listing of the vaccine.

“Let me say that Bharat has been submitting data regularly and very quickly, but they submitted the last batch of data on the 18th of October,” Dr Mariangela Simao, Assistant Director-General, Access to Medicines and Health Products at WHO, said at a press briefing in Geneva.

She was responding to a question on the delay in granting the Emergency Use Listing to Covaxin while Chinese vaccines Sinopharm and Sinovac were given approval even “with lack of data.”

Simao said that when the technical advisory group met on October 26 to discuss the EUL for Covaxin, they asked Bharat Biotech for additional clarifications. The technical advisory group will reconvene on November 2 for the final risk-benefit assessment of Covaxin EUL.

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