'Bharat Biotech Submitting Data Regularly': WHO On Covaxin Getting EUL Nod

Dr Simao said the technical advisory group asked Bharat Biotech for additional clarifications when they met on October 26 to discuss the EUL for Covaxin.

Bharat Biotech’s Covaxin

New Delhi: Underlining that the UN body “trusts” the Indian industry that manufactures high quality vaccines, a top official of the global health agency on Thursday said Bharat Biotech has been submitting data on the Emergency Use Listing (EUL) of Covaxin “regularly and very quickly” to a technical committee.

“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,” said Dr Mariangela Simao, Assistant Director General, Access to Medicines and Health Products at WHO, PTI reported.

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Dr Simao said the technical advisory group asked Bharat Biotech for additional clarifications when they met on October 26 to discuss the EUL for Covaxin.

The technical advisory group will reconvene on November 2 for the final risk-benefit assessment of Covaxin EUL.

The official was responding to a poser at a press briefing in Geneva 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”.

Asserting the WHO is in touch with Bharat Biotech and has “daily conversations” and calls and meetings “clarifying what additional data needs” to be submitted to the technical expert group, she said: “Let me just clarify and without wanting to mention any specific manufacturer but saying that we have assessed an Indian manufacturer earlier in the year and it took 30 days.”

“So this is not about moving quicker with one or another vaccine...We really trust the Indian industry. India produces different majority of vaccines in the world, high quality vaccines,” Dr Simao said.

“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,” she added.

Stating it is important to highlight the process that WHO uses for issuing the Emergency Use Listing is a very transparent process, Dr Simao said there are “no secrets” involved except for any confidential information.

Emphasizing that the process is based on the best international standards available, she said: “Everything else, the procedures that WHO uses, are independent of which country is manufacturing the vaccine.”

The Assistant Director General, Access to Medicines and Health Products at WHO, noted the global health agency sometimes needs to inspect the manufacturer if it hasn't done an inspection in the recent term.

“It wasn't the case of Bharat. We did not need to inspect Bharat,” she said.

Dr Simao said that the group had asked for additional clarifications in the case of the two Chinese vaccines, adding the entire process was followed to assess the Chinese vaccines.

Stating Bharat Biotech started the rolling submission on July 6, she said: “We are treating this as a very urgent matter and we have teams working seven by seven on the topic.”

Dr Simao also informed the WHO is assessing eight vaccine candidates at the moment, including Hyderabad-based Bharat Biotech's Covaxin.

Earlier on April 19, Bharat Biotech had submitted EOI (Expression of Interest) to the WHO for the vaccine’s EUL.

The WHO has till date approved for emergency use the vaccines of Pfizer-BioNTech, AstraZeneca-SK Bio/Serum Institute of India, Johnson & Johnson-Janssen, Moderna and Sinopharm.