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WHO's approval for Covaxin: Bharat Biotech's pre-submission meeting today. Why it is important?

Last week, WHO has accepted the Bharat Biotech's Expression of Interest (EoI) for its Covid-19 vaccine Covaxin (MINT_PRINT)Premium
Last week, WHO has accepted the Bharat Biotech's Expression of Interest (EoI) for its Covid-19 vaccine Covaxin (MINT_PRINT)

  • As per WHO guidelines, Emergency Use Listing (EUL) is a procedure to streamline the process by which new or unlicensed products can be used during public health emergencies
  • Covaxin manufacturer Bharat Biotech last month had submitted 90% of the documentation needed for WHO’s EUL, the company said

Covaxin Covid vaccine manufacturer Bharat Biotech is likely to attend a pre-submission meeting with World Health Organisation (WHO) later today, a step that will take the vaccine maker closer to a WHO emergency use listing (EUL).

Last week, WHO has accepted the Hyderabad-based firm's Expression of Interest (EoI) for its Covid-19 vaccine Covaxin.

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 Hyderabad-based Bharat Biotech last month had submitted 90% of the documentation needed for WHO’s Emergency Use Listing, the company said. It had further said that the rest of the documents would be submitted this month.

Why the meeting is important?

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. Hence, it is speculated that countries may allow travellers inoculated only by the Covid vaccines which have WHO approval.

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.

WHO's approval for Covaxin: Govt says milestone will be achieved soon

As the country looks forward to WHO's approval for Bharat Biotech's Covid vaccine Covaxin, the Centre earlier this month said that 'the milestone will be achieved soon' and 'the process of data sharing is going on.'

Speaking on the topic at a press conference, Dr. VK Paul, Member (Health) Niti Aayog, had said that government is close working with Bharat Biotech and WHO.

He had said, "We have been working with Bharat Biotech and WHO, data sharing is on, we are keen that this milestone is achieved soon. We are pursuing it."

(With inputs from agencies)

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