Covaxin approval: WHO panel’s four-day meeting begins today


Covaxin approval: WHO panel’s four-day meeting begins today

Covaxin approval: WHO panel’s four-day meeting begins today

Covaxin approval: WHO panel’s four-day meeting begins today: India’s indigenous Covid-19 vaccine, Covaxin, is in line to receive WHO’s emergency use listing authorisation in October, according to the world body’s document detailing the assessment status of pending vaccine applications. The document mentions the status of Covaxin’s assessment by the WHO as “ongoing” and the decision date as “October 2021”.

The decision on Covaxin’s WHO EUL could be expected sooner than later with the global health body’s Strategic Advisory Group of Experts on Immunisation (SAGE), which decides on such applications, meeting for four days starting Monday.

WHO chief scientist Soumya Swaminathan today said, “There is a lot of interest in vaccine policy and authorisation process. All vaccine dossiers submitted to the WHO go through both SAGE — which is meeting on October 4 to 7 for policy guidance and technical advisory group, which is also meeting this month for EUL or pre qualification.”

The SAGE develops evidence-based policy recommendations for the best use of vaccines against Covid-19.

It continuously reviews the available evidence on the progress of candidate vaccines, guides vaccine introduction for optimal impact, prepares policy advice on the accelerated use of vaccines (pre-licensure and post-licensure) and recommendations for early allocation of vaccines when vaccine supply is still limited.

So far, the WHO has included six vaccines in its EUL. These are Pfizer, Johnson and Johnson, SII-AstraZeneca, Moderna, Sinopharm and Sinovac.

Covaxin approval: WHO panel’s four-day meeting begins today

Bharat Biotech, the makers of Covaxin, meanwhile said as responsible manufacturers with past approvals to other vaccines, the firm is working with the WHO to obtain EUL at the earliest. Biotech said it did not consider it appropriate to comment on the pending regulatory approval and its timelines.

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