WHO’s statement on the approval of Covaxin: Giving the example of Coveshield, the health agency said – we trust India’s vaccine industry

Whether or not Covaxin will get approval from WHO can be decided in the final meeting of the Technical Advisory Group to be held on 2 October. Maryangela Simao, ADG of Medicine and Health Products at WHO, said during a press conference in Geneva that we have confidence in India’s vaccine industry.

Bharat Biotech is rapidly and continuously providing us data. The company has given the last installment of its data till October 18. Hyderabad-based company Bharat Biotech Company had applied for approval to WHO on 19 April.

What is the Technical Advisory Committee of WHO?
When a vaccine company made in different countries goes to the WHO for emergency approval, the health organization constitutes a technical advisory committee. The task of this committee is to examine the data of trials of all phases of the vaccine and recommend approval to WHO if the data is found correct. WHO has also formed a technical committee for Covaxin.

Asked to submit final data
WHO hopes that the committee can give approval by next week. WHO’s ADG Simao said that our Technical Advisory Group has asked the company to submit data for the Final Risk Benefit Assessment.

Questions raised on approval of China’s 2 vaccines
Covaxin is getting delayed in getting emergency approval, while China’s Sinovac and Sinoform got approval in less than 40 days. According to reports, both the companies were not asked to submit more data. Giving clarification on this, Simao gave the example of Coveshield of Serum Institute of India and said that earlier another Indian company had sought approval and they got approval in just 30 days. He said that WHO is in touch with Bharat Biotech. We will complete his investigation soon.

meeting on 2nd November
Simao said that Bharat Biotech was asked to provide further clarification in the technical committee meeting held on October 26. On November 2, there will be a meeting regarding the Advisory Group Final Risk Benefit Assessment.