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Bharat Biotech Dossier Under Review For Emergency Use Listing of Covaxin, Says WHO

Empty vials of Covaxin COVID-19 vaccine lie on a table at the venue of a vaccination drive. (AP Photo)

Empty vials of Covaxin COVID-19 vaccine lie on a table at the venue of a vaccination drive. (AP Photo)

Hyderabad-based pharmaceutical firm has announced last week that all documents required for Covid-19 vaccine Covaxin in EUL was submitted to WHO and the review process is ongoing.

World Health Organisation (WHO) officials had a meeting with the Bharat Biotech and its dossier for Emergency Use Listing (EUL) of Covaxin is under review by technical experts for consideration, Dr Poonam Khetrapal Singh, Regional Director, WHO South-East Asia said on Monday.

Dr Singh also said that India has been offered 7.5 million doses of Moderna vaccine through WHO’s COVAX program, ANI reported.

“Pfizer, AstraZeneca, Moderna, Johnson and Johnson, Sinovac and Sinopharm have been granted EUL by the WHO. For Covaxin, an expression of interest for EUL has been made to WHO by Bharat Biotech. WHO has already conducted a pre-submission meeting with the company following which a dossier has been submitted by Bharat Biotech to WHO in early July. The dossier is currently under review by the technical experts for consideration of EUL," the Regional Director of WHO said.

Hyderabad-based pharmaceutical firm has announced last week that all documents required for Covid-19 vaccine Covaxin in EUL was submitted to WHO and the review process is ongoing. It had added that the firm is expected to receive authorisation at the earliest.

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WHO chief scientist Soumya Swaminathan had said that a decision regarding Covaxin’s emergency use listing would be announced within four to six weeks. “There is a process to be followed for EUL and pre-qualification of vaccines under which a company has to complete phase 3 trials and submit the whole data to the regulatory department of WHO which is examined by an expert advisory group,” Swaminathan said.

Covaxin is among the three vaccines used in India against Covid-19 in mass vaccination programme.

Dr Poonam Khetrapal Singh said that Delta variant has spread to over 100 countries and the way in which its spreading is likely to soon become the most dominant COVID strain globally.

“Among all variants of concern, Delta spreads most rapidly. The rapid spread means more cases, leading to more pressure on health systems and more deaths," she said. She also said that globally, Covid cases and fatalities were again on the rise.

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first published:July 20, 2021, 08:11 IST