New Delhi : Bharat Biotech on Friday said it has submitted all the data to the World Health Organisation (WHO) for Emergency Use Listing (EUL) of its COVID-19 vaccine Covaxin and is awaiting feedback from the UN Public Health Agency.
In a series of tweets, Bharat Biotech said that Covaxin clinical trial was fully compiled and available in June 2021.
“#COVAXIN clinical trial data was fully compiled and available in June 2021. All Data was submitted for Emergency Use Listing (EUL) Application to World Health Organization in early July. We have responded to any clarifications sought by #WHO and are awaiting further feedback,” Bharat Biotech tweeted.
As a responsible manufacturer with past approvals for its other vaccines, the company said it would not find it appropriate to speculate or comment on the approval process and its timelines, it further said.
“We are continuing to work diligently on obtaining WHO EUL at the earliest,” it added. Earlier on Monday, the sources said that the World Health Organisation’s (WHO) approval for Covaxin, is expected this week.
Bharat Biotech has submitted its Phase 3 clinical trials data that demonstrated 77.8 per cent efficacy to the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO).
Earlier in June, a pre-submission meeting for WHO Emergency Use Listing Procedure (EUL), which provides advice before the submission of the final dossier, was also held.
Union Health Minister Mansukh Mandaviya had also earlier met WHO Chief Scientist Dr Soumya Swaminathan and held discussions over the approval of Bharat Biotech’s Covid-19 vaccine Covaxin.
Covaxin was developed by Hyderabad-based Bharat Biotech in association with the Indian Council of Medical Research and the National Institute of Virology. Covaxin, which has been developed in collaboration with the Indian Council of Medical Research (ICMR), contains a whole virion inactivated SARS-CoV-2 vaccine, which is produced in Vero cells.
The vaccine is stable at 2 degrees Celsius to 8 degrees Celsius (refrigerated) and is shipped in a ready-to-use liquid formulation that permits distribution using existing vaccine supply chain channels.
The WHO has approved COVID-19 vaccines by Pfizer-BioNTech, AstraZeneca, Johnson and Johnson, Moderna and Sinopharm.