In a major boost for Bharat Biotech, the World Health Organisation (WHO) has accepted its Expression of Interest (EoI) for COVID-19 vaccine Covaxin and scheduled a pre-submission meeting on June 23, a step that will take the vaccine maker closer to a WHO’s emergency use listing (EUL).
Though the meeting will not be a detailed review of the product, the vaccine maker will have an opportunity to submit a summary on the overall quality of the jab, according to the WHO.
The information was provided on the WHO website in the ‘Status of COVID-19 Vaccines’ within the WHO EUL-PQ evaluation process document.
Bharat Biotech had said last month that it expects approval for its COVID-19 vaccine Covaxin from the WHO for emergency use listing during July-September.
As per WHO guidelines, EUL is a procedure to streamline the process, where 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.
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“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 the pre-submission meeting.
Sources had earlier indicated that Bharat Biotech International Limited (BBIL) has conveyed to the government that it has already submitted 90 percent of documents to WHO for obtaining EUL for Covaxin.
The remaining documents are expected to be submitted by June, the city-based vaccine maker had told the central government during a discussion last month on obtaining the WHO’s authorisation for EUL for Covaxin.
