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Bharat Biotech’s Pre-Submission Meeting for Covaxin Emergency Use Approval with WHO on June 23

Bharat Biotech’s Pre-Submission Meeting for Covaxin Emergency Use Approval with WHO on June 23

The logo of Covaxin on Bharat Biotech’s website. Photo: Jernej Furman/Flickr CC BY 2.0

Hyderabad: The World Health Organisation (WHO) has accepted Bharat Biotech’s Expression of Interest (EoI) for COVID-19 vaccine Covaxin and scheduled a pre-submission meeting on June 23.

Though the meeting will not be a detailed review on the product, the vaccine maker will have an opportunity to submit a summary on 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 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 (EUL) during July-September.

As per WHO guidelines, EUL is a procedure to streamline the process by which new or unlicensed products can be used during public health emergencies.

Also read: US FDA Denies Emergency Use Approval to Bharat Biotech’s Covaxin

According to the 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.

Sources had earlier indicated that Bharat Biotech International Limited (BBIL) has conveyed to the Centre that it has already submitted 90% of documents to the 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.

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