Bharat Biotech has been submitting data regularly, very quickly: WHO on Covaxin EUL

United Nations/Geneva: A top official of the WHO said on Thursday that India's Bharat Biotech has been submitting data on the EUL of Covaxin "regularly and very quickly" to a technical committee and hopes to have a final recommendation by next week.

The UN body also stressed that it "trusts" the Indian industry that manufactures high-quality vaccines.

"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.

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.

"So this is not about moving quicker with one or another vaccine...We really trust the Indian industry. India produces the different majority of vaccines in the world, high-quality vaccines. We are right now at the last stage of the assessment by this external advisory group and we hope to have a final recommendation to the WHO next week. I hope that's well understood," PTI quoted Simao as saying.

She added that once the manufacturer has completed submitting all the data to WHO, it is put through for assessment by an external Technical Advisory Group, which comprises experts from six different nationalities and they look at all the data that has been collected by WHO, provided by the manufacturer in recommending the Emergency Use Listing.

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.

Bharat Biotech's Covaxin and AstraZeneca and Oxford University's Covishield are the two widely used vaccines in India.

The 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.