Covaxin, developed by the Hyderabad-based pharma company Bharat Biotech, is continuing to face hurdles to get approval from the World Health Organization (WHO) for emergency use. In its latest report, WHO said that additional clarifications are needed before recommending Covaxin for emergency use.
In an official statement, WHO said, “The Technical Advisory Group for Emergency Use Listing (TAG-EUL) is an independent advisory group that provides recommendations to WHO on whether a Covid 19 vaccine can be listed for emergency use under the Emergency Use Listing (EUL) procedure.”
“The TAG met today (October 26, 2021) and decided that additional clarifications from the manufacturer are needed to conduct a final EUL risk-benefit assessment for global use of the vaccine,” the statement further read.
WHO stated that it is expecting these additional clarifications from Bharat Biotech by the end of this month. “The TAG expects to receive these clarifications from the manufacturer by the end of this week, and aims to reconvene for the final risk-benefit assessment on Wednesday, November 3,” stated WHO.
Covaxin is currently approved in 14 countries. Bharat Biotech stated to WHO that 70 million doses have been distributed overseas. As per WHO, a thorough evaluation is made to ensure vaccines are safe before it is recommended for emergency use.
As of now, Pfizer-BioNTech, Johnson & Johnson-Janssen, AstraZeneca – SK Bio – Serum Institute of India, Moderna, and Sinopharm are approved by WHO for emergency use.