Guwahati: The World Health Organisation (WHO) technical advisory group will meet on October 26 to consider EUL (Emergency use listing) for Bharat Biotech’s Covaxin, Soumya Swaminathan, Chief Scientist at WHO, said on Sunday. She said WHO has been working closely with Bharat Biotech to complete the dossier.
On Thursday, foreign secretary Harsh Vardhan Shringla expressed hope that the WHO will soon give approval to Hyderabad-based Bharat Biotech’s Covid vaccine Covaxin.
“It is not the administrative or political process, rather it is a technical process of WHO. Technical Committee will evaluate the submissions made by Bharat Biotech which created Covaxin. I am sure the approval of Covaxin from WHO will come at the soonest possible,” he had said.
The WHO and an independent group of experts were scheduled to meet earlier this month to carry out the risk/benefit assessment and come to a final decision whether to grant Emergency Use Listing to Covaxin. However, the meet was extended.
Covaxin manufacturer, Bharat Biotech, has been submitting data to WHO on a rolling basis and submitted additional info at the UN Public Health Agency’s request on September 27.
Experts are currently reviewing this information and if it addresses all questions raised, WHO assessment will be finalized next week, the health agency said on October 5.
The Emergency Use Listing process – done by WHO and the Technical Advisory Group of independent experts – is centred on determining if a vaccine is quality-assured, safe and effective, according to WHO.
While WHO is yet to authorise the vaccine for emergency use, India’s expert panel has recommended granting emergency use authorization (EUA) to Covaxin for vaccination of children.
Bharat Biotech has submitted data from clinical trials in the 2-18 years age group for Covaxin to Central Drugs Standard Control Organization (CDSCO).
“The data has been thoroughly reviewed by the CDSCO and SEC and have provided their positive recommendations,” the vaccine maker said in the statement.
