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World Health Organisation's (WHO) approval for the emergency use authorisation (EUA) to COVID-19 vaccine Covaxin, developed by the Hyderabad-based Bharat Biotech, faces more delay, reported news agency ANI quoting sources.
“World Health Organization (WHO) has asked for more data from Bharat Biotech for its COVID19 vaccine Covaxin. The Emergency Use Authorisation (EUA) for the vaccine will be delayed by a few more days," it said.
“As a responsible manufacturer with past approvals for our other vaccines, we do not find it appropriate to speculate or comment on the regulatory approval process and its timelines. We are diligently working with the WHO to obtain EUL at the earliest," Bharat Biotech said in a statement.
Earlier, WHO's nod for Covaxin was expected by 5 October, ANI had earlier stated.
Meanwhile, Bharat Biotech last 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.
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).
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 so far approved Covid vaccines developed by Pfizer-BioNTech, US pharma majors Johnson & Johnson, Moderna, China's Sinopharm and Oxford-AstraZeneca for emergency use.
With agency inputs
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