WHO approval for Covaxin: Bharat Biotech's crucial pre-submission meeting today
New Delhi, June 23: India's homegrown Covid-19 vaccine Covaxin's manufacturers will attend a pre-submission meeting with World Health Organization on Wednesday. This is seen as a step that will push the vaccine producer closer to WHO emergency use listing (EUL).
As per WHO guidelines, Emergency Use Listing (EUL) is a procedure to streamline the process by which new or unlicensed products can be used during public health emergencies.
According to WHO, pre-submission meetings provide an opportunity for advice and guidance before submission of a medicines dossier, as well as an opportunity for the applicant to meet WHO medicine assessors who will be involved in assessing their product.
"The pre-submission meeting does not include a detailed review of data or full study reports.However, an essential aspect of the meeting is the submission (at least two weeks in advance of the pre-submission meeting) of a completed QOS-PD (Quality overall summary product dossiers)," WHO said, explaining the process of pre-submission meeting.
The Bharat Biotech International Limited (BBIL) has conveyed to the Centre that it has already submitted 90 per cent of documents to WHO for obtaining EUL for Covaxin.