India is submitting data on the biotech Covaxin “regularly and very expeditiously” to the Technical Committee on Thursday. A top World Health Organization (WHO) official said on Thursday. Which it expects to approve by the WHO next week. Final approval will be given.
He point up that this UN body believes in the Indian industry manufacturing high-quality vaccines. Hyderabad-based Bharat Biotech, which developed Covaxin, on April 19 submitted a letter of interest to the World Health Organization for emergency use listing (EUL) of the vaccine.
‘Bharat Biotech is giving data fast’
The Technical Advisory Group of the United Nations Health Agency. Which met on Tuesday, has sought additional clarification from Bharat Biotech on the final risk-benefit assessment for the emergency use listing of Covaxin. Dr. Mariangela Simao, Assistant Director-General for Access to Medicines and Health Products at the WHO, said in Geneva. ‘Bharat Biotech is submitting data regularly and very rapidly. And they last handed over the lot of data on October 18’. She was responding to a question on delay in providing emergency use listing to
Chinese vaccines approved without data
Explain that the Chinese vaccines Sinofam and Sinovac approve only due to a lack of data. Simao said he had sought additional Explaination 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 the risk-benefit assessment of the Covaxin EUL will take place on November 2. He said the WHO is in touch with Bharat Biotech. And is run daily calls and meetings to clarify the need for additional data to submit to the technical expert group. He said that it is important to mention that the process of WHO is very transparent in issuing EUL.
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