WHO accepts Bharat Biotech's EoI for Covaxin, pre-submission meeting on 23 June

A health worker inoculates a woman with a dose of Covaxin during a vaccination drive in Hyderabad. (AFP) — A health worker inoculates a woman with a dose of Covaxin during a vaccination drive in Hyderabad. (AFP)

2 min read . Updated: 18 Jun 2021, 03:59 PM IST Livemint, Edited By Staff Writer

The details were provided on the WHO website in the Status of Covid-19 Vaccines within WHO EUL-PQ evaluation process document

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 23 June, 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.

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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.

Sources had earlier indicated that 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.

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 theWHO's authorisation for EUL for Covaxin.

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