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Covaxin approval: WHO and an independent group of experts are scheduled to meet next week to carry out the risk/benefit assessment and come to a final decision whether to grant Emergency Use Listing to Bharat Biotech's Covid vaccine Covaxin, the World Health Organization informed on Tuesday. 

Covaxin manufacturer, Bharat Biotech, has been submitting data to WHO on a rolling basis and submitted additional info at the UN Public Health Agency’s request on September 27. 

Experts are currently reviewing this information and if it addresses all questions raised, WHO assessment will be finalized next week, the health agency said. 

The Emergency Use Listing process - done by WHO and the Technical Advisory Group of independent experts - is centred on determining if a manufactured product (eg a vaccine) is quality-assured, safe and effective, according to WHO.

The Strategic Advisory Group of Experts on Immunization (SAGE) of the WHO met on Tuesday to make its recommendations on Covaxin on EUL, among other issues.

Bharat Biotech gave a presentation on the Vaccine's safety and efficacy data of clinical trials (phase 1-3 trial results and post-marketing) and Risk management plans and other implementation considerations, according to the SAGE draft agenda.

SAGE is authorised with advising WHO on overall global policies and strategies, ranging from vaccines and technology, research and development, to delivery of immunization and its linkages with other health interventions.

According to the agenda, Hanna Nohynek, a member of SAGE, is expected to present a draft recommendation for the vaccine and the session will make its recommendations.

Last month, Bharat Biotech said it submitted all the data to the WHO for Emergency Use Listing (EUL) of its Covaxin vaccine and is awaiting feedback from the UN Public Health Agency.

"COVAXIN clinical trial data was fully compiled and available in June 2021. All Data was submitted for Emergency Use Listing (EUL) Application to World Health Organization in early July. We have responded to any clarifications sought by WHO and are awaiting further feedback," Bharat Biotech had tweeted.

As a responsible manufacturer with past approvals for its other vaccines, the company said it would not find it appropriate to speculate or comment on the approval process and its timelines, it further said. "We are continuing to work diligently on obtaining WHO EUL at the earliest," it added.

Bharat Biotech has submitted its Phase 3 clinical trials data that demonstrated 77.8% efficacy to the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO).

Covaxin was developed by Bharat Biotech in association with the Indian Council of Medical Research and the National Institute of Virology. Covaxin contains a whole virion inactivated SARS-CoV-2 vaccine, which is produced in Vero cells.

(With inputs from agencies)

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