A top official of the World Health Organization (WHO) said on Thursday that India is regularly and very expeditiously submitting data to the Technical Committee on Biotech Covaxin. Which is expected to get the final approval of WHO next week. He emphasized that this UN body believes in the Indian industry manufacturing high quality vaccines. Hyderabad-based Bharat Biotech, which developed the vaccine, submitted a letter of interest to the World Health Organization on April 19 for emergency use listing (EUL) of the vaccine.
The Technical Advisory Group of the United Nations Health Agency met on Tuesday, which has sought additional clarification from Bharat Biotech on the final risk-benefit assessment for the emergency use listing of the vaccine. Dr Mariangela Simao, Assistant Director General for Access to Medicines and Health Products at WHO, told a press conference in Geneva that Bharat Biotech is submitting data regularly and very rapidly and they last submitted a batch of data on October 18. She was responding to a question on the delay in granting emergency use listing to Covaxin. It is noteworthy that the Chinese vaccines Sinofam and Sinovac were approved only due to lack of data.
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Simao said they had sought additional clarifications from Bharat Biotech when the Technical Advisory Group met on October 26 to discuss the EUL. The next meeting of the Technical Advisory Group for risk-benefit assessment of the Covaxin EUL will be held on November 2. WHO is in touch with Bharat Biotech and is conducting daily calls and meetings to clarify the need for additional data to be submitted to the technical expert group. It is important to mention that WHO’s process in issuing EUL is very transparent.
