The World Health Organization (WHO) has sought additional data to decide on much-awaited Emergency Use Listing (EUL) to Covid vaccine Covaxin. The Technical Advisory Group of WHO has sought additional clarification from vaccine manufacturer Bharat Biotech to decide on granting EUL approval to Covaxin said a source.
The WHO’s Technical Advisory Group in a meeting on Tuesday agreed to conduct the final risk assessment after receiving additional data from the manufacturer.
Hyderabad-based Bharat Biotech is expected to submit the data by this weekend. The Technical Advisory Group may meet for the final risk-benefit assessment on November 3. The company also submitted additional info at WHO’s request on September 27.
The Technical Advisory Group for Emergency Use Listing (TAG-EUL) provides recommendations to WHO on whether a Covid 19 vaccine can be listed for emergency use under the EUL procedure.
Bharat Biotech, the Hyderabad-based pharmaceutical company which developed Covaxin, has now been waiting for months for the specialized United Nations (UN) agency to provide a formal nod to its Covid-19 vaccine. It had submitted the Expression of Interest (EOI) for the emergency use approval as far back as April 19, but WHO has said it needs more data from the company before showing the green light.
Last week, a top official of the global health body said the process of thoroughly evaluating a vaccine for use and recommending it sometimes takes a long time but it has to be ensured that the right advice is given to the world “even if it takes another week or two.”
Dr. Mike Ryan, the executive director of the WHO Health Emergencies Programme, said that the UN agency is “very clear” that it wants all countries to recognize vaccines that have been given a EUL by the WHO advisory process. “But it is also very important that WHO when it makes a recommendation like that, is making that globally,” Ryan added.
(With IANS inputs)