On June 23, Bharat Biotech held a pre-submission meeting with WHO for Covaxin 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. Bharat Biotech earlier conveyed to the Centre that it has already submitted 90 per cent of documents to WHO for obtaining Covaxin EUL.

Source: dnaIndia

In a major boost for Bharat Biotech, the World Health Organisation 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 emergency use listing (EUL).

According to the WHO, the vaccine maker will have the opportunity to submit a summary of the overall quality of the vaccine, even though the meeting will not be a detailed review of the product.

The data was published on the WHO website in the document Status of Covid-19 Vaccines, which is part of the WHO EUL-PQ evaluation process.

Covaxin EUL Approval soon

Bharat Biotech said last month that it expects the World Health Organization to approve its Covid-19 vaccine Covaxin for emergency use listing between July and September.

EUL is a procedure that, according to WHO guidelines, streamlines the process of allowing new or unlicensed products to be used during public health emergencies.

According to WHO, pre-submission meetings give applicants the opportunity to get advice and guidance before submitting a medicines dossier, as well as meet WHO medicine assessors who will be evaluating 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 the pre-submission meeting.

According to sources, Bharat Biotech International Limited (BBIL) has informed the Centre that it has already submitted 90% of the documents to WHO in order to obtain an EUL for Covaxin.

The remaining documents are expected to be submitted by June, according to the city-based vaccine maker, who told the Central government during a meeting last month about obtaining the WHO’s approval for EUL for vaccines.

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