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.

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.