WHO’s advisory group to deliberate on Covaxin EUL approval

SWITZERLAND – The World Health Organization (WHO) has announced that experts will meet on October 26 to decide whether to grant emergency use status to Bharat Biotech’s Covid-19 vaccine Covaxin.

Harsh Vardhan Shringla, India’s foreign secretary, expressed optimism that the WHO will soon approve Hyderabad-based Bharat Biotech’s Covid vaccine Covaxin.

It is not the administrative or political process, rather it is a technical process of WHO. Technical Committee will evaluate the submissions made by Bharat Biotech which created Covaxin. I am sure the approval of Covaxin from WHO will come at the soonest possible,” he had said.

The WHO and an independent group of experts were scheduled to meet earlier this month to conduct the risk/benefit analysis and make a final decision on whether to grant Covaxin Emergency Use Listing. The meeting, however, was extended.

Bharat Biotech, the manufacturer of covaxin, has been submitting data to WHO on a rolling basis and provided additional information on September 27 in response to a request from the UN Public Health Agency.

Experts are currently reviewing this information, and if it answers all of the questions raised, the WHO assessment will be completed next week, according to the health agency.

On April 19, Bharat Biotech submitted an EOI (Expression of Interest) for its vaccine. On July 6, the WHO stated that it began rolling out vaccine data.

Rolling data enables the WHO to begin its review as soon as new information is received, thereby speeding up the overall review process.

Submissions for pre-qualification or listing under the emergency use procedure are confidential, according to the WHO.

Bharat Biotech announced on July 12 that it had submitted documents to WHO in order to initiate the emergency use listing process.

According to the agency, the duration of the emergency use listing process is determined by the quality of the data submitted by the vaccine manufacturer and the data meeting the WHO’s criteria.

Covaxin, developed in India by Bharat Biotech, is one of six vaccines that have received emergency use authorization from India’s Drug Regulator and is being used in the nationwide anti-COVID-19 inoculation program alongside Covishield and Sputnik V.

Bharat Biotech recently stated that it has submitted all Covaxin data to the WHO for EUL and is awaiting feedback from the global health watchdog.

While WHO has yet to approve the vaccine for emergency use, an expert panel in India has recommended that Covaxin be granted emergency use authorization (EUA) for child vaccination.

The WHO EUL is required for Covax facility vaccine supply. The WHO’s approval is significant because it will allow people immunized with Bharat Biotech’s Covid-19 vaccine to travel freely abroad.

The WHO’s emergency approval will also allow Bharat Biotech to export Covaxin.

Bharat Biotech had presented its phase-3 clinical trials data, demonstrating 77.8% efficacy, to the subject expert committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO).

The data has been thoroughly reviewed by the CDSCO and SEC and have provided their positive recommendations,” the vaccine maker said in the statement.

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