Covaxin approval: An AIIMS Professor on Wednesday said that though it is difficult to predict time-frame, Bharat Biotech’s Covaxin will surely get the WHO’s approval. 

“It is difficult to predict how soon we will get the approval but we will get it definitely. When Bharat Biotech and Centre will provide the data, WHO will give its approval. So, we have to wait till then,” said Dr Rai, Professor of Centre for Community Medicine (CCM) in AIIMS Delhi, while speaking to ANI.  

The World Health Organisation (WHO) has sought additional clarifications for emergency use listing of Bharat Biotech’s Covid-19 vaccine Covaxin. 

“Additional data means there is a certain procedure. They (WHO) want data related to efficacy, data related to effectiveness, data related to safety,” the professor said.

Rai further said that there is a committee for approval of all vaccines and new drugs. “WHO has approved only a few vaccines till now. So, the approval of vaccines is under process,” he said.

The AIIMS professor further said that WHO follows a certain procedure for the approval of vaccines. “There are prescribed procedures and it is a good thing that everything is being scrutinised thoroughly,” he added.

The WHO has said that additional clarifications are needed to conduct a final Emergency Use Listing (EUL) risk-benefit assessment for global use of Covaxin.

“The Technical Advisory Group for Emergency Use Listing (TAG-EUL) expects the clarification from Bharat Biotech by end of this week and thus will reconvene for the final risk-benefit assessment on Wednesday, November 3,” WHO said.

“The 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 EUL procedure,” it added.

Bharat Biotech had on April 19 submitted its EOI (Expression of Interest) to WHO EUL.

 

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