Tuesday, 19 October 2021

Final Decision on Covaxin by WHO in next week

Final Decision on Covaxin by WHO in next week

WHO and an independent set of experts are scheduling to meet next week to carry out the risk and 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.

The health agency said.

Experts are currently reviewing this information, and if it addresses all questions raised, the WHO assessment will be finalizing next week,

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

SAGE of the WHO met on Tuesday to recommend Covaxin on EUL, among other issues.

Final Decision on Covaxin by WHO in next week 1unsplash image

Read More: WHO delay Approval to Covaxin for Emergency use

According to the SAGE draft agenda, Bharat Biotech presented the vaccine's safety and efficacy data of clinical trials (phase 1-3 trial results and post-marketing), risk management plans, and other implementation considerations.

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

According to the plan, Hanna Nohynek, a member of SAGE, is expected to present a draft recommendation for a 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.

Bharat Biotech had tweeted.

"COVAXIN clinical trial data was fully put together and available in June 2021. All Data were submitted for (EUL) Emergency Use Listing Applications to WHO these year early in July. We have responded to any clarifications ask by WHO and are awaiting further feedback,"

As a responsible manufacturer with past approval for its other vaccine, the company said it would not find it appropriates to speculate on the approval process and timelines, it further said.

It added.

"We are continuing to work constantly on obtaining WHO EUL at the earliest as possible,"

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

Bharat Biotech developed Covaxin 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 producing in Vero cells.

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