Final decision on granting clearance to Covaxin next week: WHO

Hyderabad: Officials from the World Health Organisation (WHO) and an independent group of experts will meet next week to carry out a risk/benefit assessment and take a final decision on whether to grant ‘Emergency Use Listing’ to Hyderabad-based Bharat Biotech’s Covaxin as a safe and effective vaccine against the COVID-19 virus.

“Covaxin manufacturer, Bharat Biotech, has been submitting data to WHO on a rolling basis & submitted additional info at WHO’s request on 27 September. WHO experts are currently reviewing this info & if it addresses all questions raised, WHO assessment will be finalized next week,” the WHO said in a series of tweets on Tuesday.

The ‘Emergency Use Listing’ process by the WHO and the Technical Advisory Group of independent experts is centred on determining if a manufactured product is quality-assured, safe and effective.

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Covaxin was developed in India, and will in all likelihood be cleared by the World Health Organisation after the United Nations (UN) agency’s meeting. The development comes about a week after the ’emergency use authorisation’ (EUA) for Covaxin was delayed because more technical queries were sought from Bharat Biotech.

As of now, Covaxin is not considered and accepted as a vaccine by most countries around the world due to a lack of EUA. The Hyderabad-based drug manufacturer had stated that it has submitted all data required for the clearance. According to the company, phase-3 clinical trials of Covaxin had shown an efficacy rate of 77.8 percent.

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