HYDERABAD: The World Health Organisation (WHO) will be taking a final call on Bharat Biotech’s Emergency Use Listing (EUL) application for India’s first indigenously developed Covid-19 vaccine Covaxin next week, the global health body said on Tuesday evening.
“WHO & 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 Covaxin,” WHO tweeted after a meeting of its Strategic Advisory Group of Experts (SAGE) to discuss the Covaxin EUL application.
Covaxin manufacturer, Bharat Biotech, has been submitting data to WHO on a rolling basis & submitted additional inf… https://t.co/6qZJlo4Ptd
— World Health Organization (WHO) (@WHO) 1633444570000
“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,” WHO said.
WHO also pointed out that the EUL process carried out by WHO and the technical advisory group of independent experts is centred on determining if a manufactured product, like a vaccine, is quality-assured, safe and effective.
On September 29, WHO had updated the decision date for Covaxin EUL to October 2021 in its latest EUL guidance document for Covid-19 vaccines from the “yet to be confirmed” status.