‘Continuing to work diligently’: Bharat Biotech responds to WHO on Covaxin EUL

Hyderabad-based pharma company Bharat Biotech today said it has responded to all clarifications sought by the World Health Organisation (WHO) on their Emergency Use Listing (EUL) Application for the Made in India COVID-19 vaccine -- Covaxin. The pharma firm, popularly known for vaccine manufacturing, said it has provided the global health watchdog with all the details and is awaiting Emergency Use Listing approval.

Data of clinical trials was fully compiled and available in June this year. The final data for the Emergency Use Listing (EUL) application was submitted to the WHO in early July. The Emergency Use Listing application provides advice before the submission of the final dossier.

“As a responsible manufacturer with several WHO prequalified vaccines, we do not find it appropriate to speculate or comment on the approval process and its timelines. However, we are continuing to work diligently on obtaining WHO EUL at the earliest,” Bharat Biotech’s announcement on the matter read. It added that the WHO and Bharat Biotech are working in tandem to obtain EUL at the earliest.

Earlier this month, Union Health Minister Mansukh Mandaviya had also met WHO Chief Scientist Dr Soumya Swaminathan to discuss the approval of Covaxin, news agency ANI had reported. WHO Assistant Director General for vaccines, Marianne Simao, also said the Geneva-based health agency’s assessment of Covaxin was quite advanced and officials hoped for a decision in September. WHO has approved Pfizer-BioNTech, AstraZeneca, Moderna, Sinopharm and Johnson and Johnson COVID-19 vaccines.

Edited by Mehak Agarwal; with agency inputs

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