Reacting to World Health Organisation (WHO) seeking additional clarifications for emergency use listing of Bharat Biotech's Covid-19 vaccine Covaxin, Professor of Centre for Community Medicine (CCM) in All India Institute of Medical Sciences (AIIMS) Delhi on Wednesday said that though it is difficult to predict time-frame, Covaxin will surely get the WHO's approval.
Speaking to ANI, Dr Rai said, "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."
"Additional data means there is a certain procedure. They want data related to efficacy, data related to effectiveness, data related to safety," he added.
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 stated.
Dr Rai 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.
WHO has said that additional clarifications from manufacturer are needed to conduct a final Emergency Use Listing (EUL) risk-benefit assessment for global use of India-made 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.
On April 19, Bharat Biotech submitted its EOI (Expression of Interest) to WHO EUL.
Till date, Pfizer-BioNTech, AstraZeneca-SK Bio/Serum Institute of India, Johnson and Johnson-Janssen, Moderna, and Sinopharm vaccines have been approved by WHO for emergency use.
( With inputs from ANI )
Disclaimer: This post has been auto-published from an agency feed without any modifications to the text and has not been reviewed by an editor