WHO emergency use authorisation to Covaxin delayed till October 5
Sep 18, 2021
New Delhi [India], September 18 : World Health Organisation's (WHO) approval for the emergency use authorisation (EUA) to COVID-19 vaccine Covaxin, developed by the Hyderabad-based Bharat Biotech, is likely to be delayed till October 5.
As per WHO, the Strategic Advisory Group of Experts on Immunization (SAGE) will be meeting on October 5 to granting EUA to Covaxin.
Hanna Nohynek, SAGE member will be introducing session objective setting, an update on regulatory decisions and an overview of Working Group deliverables.
The session will recommend EUA based on the clinical data on Covaxin from phase 1, 2, 3 trial and post-marketing studies on safety, immunogenicity, efficacy and effectiveness.
It will update on global, regional and country-level plans for vaccine safety monitoring.
The assessment of the SAGE working group on the available pieces of evidence will determine EUA.
Meanwhile, 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.
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.
