Covaxin Approval: The World Health Organization (WHO) Technical Advisory Group will meet on October 26 to review Bharat Biotech’s EUL (Emergency Use List) for Covaxin, Soumya Swaminathan said Sunday, chief scientist at WHO. She said the WHO was working closely with Bharat Biotech to complete the case.
On Thursday, Foreign Minister Harsh Vardhan Shringla expressed hope that the WHO would soon approve the Covid Covaxin vaccine from Hyderabad-based Bharat Biotech.
âThis is not the administrative or political process, rather it is a WHO technical process. The technical committee will assess the submissions made by Bharat Biotech who created Covaxin. I am sure that the approval of Covaxin from l ‘WHO will come as soon as possible “He had said.
WHO and a group of independent experts were due to meet earlier this month to conduct the risk / benefit assessment and make the final decision whether or not to grant the emergency use list to Covaxin. However, the meeting was extended.
The manufacturer of Covaxin, Bharat Biotech, has submitted data to the WHO on an ongoing basis and submitted additional information at the request of the United Nations Public Health Agency on September 27.
Experts are currently reviewing this information and if it answers all the questions raised, the WHO assessment will be finalized next week, the health agency said on October 5.
The emergency use listing process – carried out by the WHO and the Technical Advisory Group of Independent Experts – focuses on determining the quality, safety and efficacy of a vaccine, according to the WHO.
While the WHO has yet to clear the vaccine for emergency use, the Indian expert group has recommended granting Emergency Use Clearance (EUA) to Covaxin for childhood immunization.
Bharat Biotech has submitted clinical trial data in the 2 to 18 year age group for Covaxin to the Central Drugs Standard Control Organization (CDSCO).
âThe data has been carefully reviewed by CDSCO and the SEC and provided their positive recommendations,â the vaccine maker said in the release.
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