Bharat Biotech submits documents for Covaxin’s ‘emergency use listing’ to WHO

Hyderabad, July 13: The Hyderabad-based Bharat Biotech on Monday informed that  it submitted all documents for the Emergency Use Listing (EUL) of its Covid-19 vaccine contender ‘Covaxin’ to the WHO World Health Organization. With that submission the organisation has commenced the Vaccine review process.

 

 

Bharat Biotech chairman and managing director Krishna Ella on Monday said that all documents required for the EUL were submitted to the WHO on July 9. “The review process has now commenced with the expectation that we will receive EUL from the WHO at the earliest,” he reportedly said.

 

The Hyderabad-based pharmaceutical company had earlier said in May that the application for EUL was submitted to the WHO in Geneva and all regulatory approvals are expected anytime between July and September.

 

 

On June 30, the vaccine manufacturer had informed that it was working closely with the WHO for the inclusion of Covaxin in its EUL. It has said, “Approval from WHO is not expected to be a long-drawn process as the cell line and majority of our facilities have already been audited and approved by WHO for our other vaccines in the past. We are a step closer to the final decision on Covaxin's global acceptance, as the rolling data is slated to begin in July 2021.”

 

Bharat Biotech had claimed that with 10 scientific publications in 12 months, ‘Covaxin’ is one of the very few Covid-19 vaccines that have extensive data published in peer-reviewed journals across the world.

 

The indigenous vaccine showed 63.6 percent efficacy against the Delta variant of COVID-19, which has spread in many other countries. Covaxin demonstrated 93.4 percent efficacy against severe symptomatic Covid-19 and 63.6 percent against asymptomatic Covid-19. The trial was conducted on 25,800 subjects, and the data submitted to the Subject Expert Committee (SEC) showed the vaccine was “well-tolerated.”

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