Covaxin will get WHO nod, but time frame difficult to predict: AIIMS Pro

Dr Rai said, “It is difficult to predict how soon we will get approval but we will definitely get it. When India Biotech and Center provide the data, WHO will approve it. So, we will have to wait till then.” ” Professor, Center for Community Medicine (CCM) at AIIMS Delhi talking to ANI.

The World Health Organization (WHO) has sought additional clarification for the list of emergency uses of Bharat Biotech’s Covid-19 vaccine Covaxin.

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

Rai further said that there is a committee for approval of all vaccines and new drugs. He said, “WHO has approved only a few vaccines so far. Therefore, the approval of the vaccines is in process.”

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

The WHO has stated that additional clarification is needed to conduct a Final Emergency Use List (EUL) risk-benefit assessment for global use of Covaxin.

The WHO said, “The Technical Advisory Group for Emergency Use List (TAG-EUL) expects clarification from Bharat Biotech by the end of this week and as such will convene again for a final risk-benefit assessment on Wednesday, November 3. “

“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 process,” it added.

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