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Bharat Biotech’s pre-submission meeting for Covaxin EUL with WHO on June 23

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.

By: PTI | Hyderabad |
June 18, 2021 3:51:58 pm
covaxin efficacy, covaxin efficacy data, covaxin bharat biotech, covaxin emergency authorisation, Covid-19 vaccines, India news, indian express newsAccording to senior officials of Bharat Biotech, the results from the phase 3 trial of the vaccine will be made available in an international scientific journal “very soon”. (File)

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).

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 the WHO EUL-PQ evaluation process document.

Bharat Biotech had said last month that it expects approval for its Covid-19 vaccineCovaxinfrom the World Health Organisation for emergency use listing 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.

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 the 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 forCovaxin.

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