Bharat Biotech will hold its Covaxin pre-submission meeting for WHO's approval

Jun 17 2021 03:17 PM
Bharat Biotech will hold its Covaxin pre-submission meeting for WHO's approval

Hyderabad-based vaccine manufacturer Bharat Biotech will hold its pre-submission meeting with the World Health Organization (WHO) on June 23 regarding the approval of Covaxin, after reviewing a WHO document.

Bharat Biotech last month said the WHO approval was expected in the July-September quarter. The WHO had then said the application was submitted in April 19 and more information was needed. A pre-submission meeting was scheduled in May-June, the U.N. agency had said. Notably, it is the External Affairs Ministry who 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.

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.

 

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