'Submitted all documents to WHO for Emergency Use Listing of Covaxin as of July 9': Bharat Biotech

By | Written by Karan Manral, New Delhi
Jul 12, 2021 09:55 PM IST

In a statement uploaded on Bharat Biotech's Twitter account, managing director Dr Krishna Ella said he expects to receive WHO's Emergency Use Listing for Covaxin 'at the earliest.'

Hyderabad-based Bharat Biotech, the firm behind India's only home-made shot against the coronavirus disease (Covid-19), said on Monday it has submitted all documents required for Emergency Use Listing (EUL) of the vaccine, Covaxin, to the World Health Organization (WHO) as of July 9.

Bharat Biotech's Covaxin (Sanchit Khanna/HT PHOTO)
Bharat Biotech's Covaxin (Sanchit Khanna/HT PHOTO)

"All documents required for EUL of Covaxin has been submitted to WHO as of July 9th. The review process has now commenced with the expectation that we will receive EUL from WHO at the earliest," Dr Krishna Ella, chairman and managing director of Bharat Biotech, said in a statement which was shared through the vaccine maker's Twitter account.

The statement comes days after Suchitra Ella, Bharat Biotech's co-founder and joint managing director, said approval from the world health body is not expected to be a "long-drawn process."

Also Read | 'Not a long-drawn process': Bharat Biotech expecting WHO approval soon

The pre-submission meeting between the two sides took place in June in Singapore. According to the WHO site, the health body will go through Covaxin's data, and publish an anticipated date by when the approval is likely to come. If approved by the WHO, the vaccine, which has thus far received emergency use authorisation (EUA) in 16 countries, is likely to be cleared for use by several other countries.

Also Read | WHO approval to Covaxin likely in 4-6 weeks, says chief scientist

Covaxin, which was developed in association with the Indian Council of Medical Research (ICMR), was found to be nearly 78% effective against symptomatic Covid-19 cases in final phase 3 analysis, according to Bharat Biotech. As per the data, the vaccine is 63% effective against asymptomatic cases, while the corresponding figures for the Delta variant and severe Covid-19 cases are 65% and 93% respectively.

Also Read | Bharat Biotech says completed final analysis for Covaxin, claims 77.8% efficacy

Drugs Controller General of India (DCGI) announced EUA for Covaxin and the Oxford University-AstraZeneca shot, being manufactured by Pune-based Serum Institute of India (SII) as Covishield, in January. The nationwide vaccination drive commenced on January 16 and since then, these have been the two most prominently used vaccines. A third, Russia's Sputnik-V, received EUA in April, while US pharamceutical firm Moderna's mRNA technology-based shot was approved for import late last month, becoming India's fourth anti-Covid jab.

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