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Bharat Biotech to hold Covaxin pre-submission meeting with WHO on June 23

The Hyderabad-based Bharat Biotech last month had submitted 90% of the documentation needed for WHO’s Emergency Use Listing.
 

Bharat Biotech to hold Covaxin pre-submission meeting with WHO on June 23-dnm
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New Delhi, First Published Jun 17, 2021, 11:46 AM IST
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Hyderabad-based vaccine manufacturer Bharat Biotech will hold its pre-submission meeting with the World Health Organization (WHO) next Wednesday, i.e. on June 23 regarding the approval of Covaxin, its India-made Covid-19 vaccine, reported news agency ANI after reviewing a WHO document.

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

The External Affairs Ministry is coordinating with Bharat Biotech to secure WHO recognition for the Covid-19 vaccine.

Covaxin is among three vaccines currently being administered in India against the COVID-19 pandemic.

It is also speculated that countries may allow travellers inoculated only by the vaccines which have WHO approval.

Earlier this month, 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."

Meanwhile, last week, the US Food and Drug Administration (FDA) has also rejected Bharat Biotech’s proposal for an emergency use authorization (EUA) of Covaxin. The US FDA further asked the company to launch an additional trial so that the company can file for a Biologics Licence Application (BLA), i.e. a full approval. Following this, the US partner of Bharat Biotech Ocugen had said the company will now be seeking a full approval of Covaxin.

The pharmaceutical company has been facing hurdles in getting Covaxin approved in some foreign countries since it lacks Phase-3 trial data, which is essential for a WHO nod to export the vaccine and make it a part of the much-coveted coronavirus "vaccine passport".

NOTE: Asianet News humbly requests everyone to wear masks, sanitize, maintain social distancing and get vaccinated as soon as eligible. Together we can and will break the chain #ANCares #IndiaFightsCorona

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