Bharat Biotech Expression of Interest for Covaxin gets WHO nod

New Delhi: In a major boost for Hyderabad-based Bharat Biotech, the World Health Organisation has accepted its Expression of Interest (EoI) for coronavirus vaccine, Covaxin, and scheduled a pre-submission meeting on June 23, a step that will take the vaccine manufacturer closer to a WHO emergency use listing (EUL). Though the meeting will not be a detailed review on the product, the Covid-19 vaccine maker will have an opportunity to submit a summary on the overall quality of the jab, as per the WHO.

The information was provided on the WHO website in the Status of Covid-19 Vaccines within WHO EUL-PQ evaluation process document.

Last month, Bharat Biotech had said that it expects approval for Covaxin from the WHO for emergency use listing during July-September.

According to the guidelines of the global health body, 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.