Covaxin approval: WHO seeks additional clarifications for final 'risk-benefit assessment'

NEW DELHI: The World Health Organisation's technical advisory group on Tuesday sought "additional clarifications" from Bharat Biotech for its Covid-19 vaccine Covaxin to conduct a final “risk-benefit assessment” for Emergency Use Listing of the vaccine.

The technical advisory group will now meet on November 3 for a final assessment.

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

The technical advisory group met on Tuesday to review data on Covaxin for the emergency use listing of India's indigenously-made vaccine.

"The TAG met today (26 October 2021) and decided that additional clarifications from the manufacturer are needed to conduct a final EUL risk-benefit assessment for global use of the vaccine,” the WHO said in an email response to a question by PTI on the decision regarding the Emergency Use Listing of Covaxin.

"The TAG expects to receive these clarifications from the manufacturer by the end of this week, and aims to reconvene for the final risk-benefit assessment on Wednesday, 3 November,” it added.

The approval process for Covaxin ran into rough weather at WHO, blamed on "procedural delays" by manufacturer Bharat Biotech (BB).

It was recommended for use in India by the Central Drugs Standard Control Organisation (CDSCO) on January 3 this year. It received approval without any published efficacy data and incomplete phase-3 trial data.

Some experts have slammed BB for failing to present a watertight case for its Covid vaccine.

Why the delay in WHO approval

The WHO said “more information was required” after BB applied for Emergency Use Listing (EUL) on April 19, submitting an Expression of Interest (EoI).

BB then stated that it had submitted 90% of required documents and that the remaining would be given by June.

In late May, Soumya Swaminathan, WHO’s chief scientist, stated that the company would have to submit the phase-3 clinical trial efficacy data along with data on manufacturing quality, which is mandatory for EUL.

By the middle of June, WHO accepted BB's EoI and scheduled a pre-submission meeting with Bthe company on June 23. Following this meeting, WHO started rolling data on July 6, which allowed it to start the review process right away.

BB stated that all documents required for EUL of Covaxin had been submitted to the WHO by July 9.

EUL decision was said to take up to six weeks after submission of documents. The WHO panel met in the first week of September and approval was expected by mid-September.

BB and India's health ministry kept insisting that there was no problem with the vaccine itself, just a “procedural delay”.

The WHO approval process

Proceedings of the WHO Strategic Advisory Group of Experts (SAGE) on Immunisation are usually closely guarded.

Submissions made by vaccine manufacturers for EUL are strictly confidential and the WHO makes the results available in the public domain if the product meets the criteria for prequalification.

The time taken for EUL depends on the quality of data submitted by the vaccine manufacturer and on the data meeting the WHO criteria.

BB and ICMR point out that they have almost a dozen publications related to the Covaxin's safety and efficacy. However, experts point out that while published data is useful, it is the company’s data on manufacturing and clinical performance that is required.

All India Peoples Science Network (AIPSN) has been critical of Bharat Biotech's approach in seeking WHO approval for Covaxin.

“BB applied to DCGI for EUA with grossly inadequate data from clinical trials inviting rejection. More detailed results of Phase-3 clinical trials were then released by BB in instalments, interim results two months later and complete trial data in June 2021,” stated AIPSN.

(With inputs from PTI)