New Delhi: The World Health Organisation’s (WHO) approval for the emergency use authorisation (EUA) to Bharat Biotech’s COVID-19 vaccine Covaxin is likely to be delayed till October 5. According to WHO, the Strategic Advisory Group of Experts on Immunization (SAGE) will be meeting on October 5 to grant EUA to Covaxin.
A member of SAGE, Hanna Nohynek is going to introduce session objective setting, an update on regulatory decisions and an overview of Working Group deliverables. This session will be based on the data extracted by the clinical trials phase 1, 2, 3 and post-marketing studies on safety, immunogenicity, efficacy and effectiveness on Covaxin.
The SAGE working group assessment on the available pieces of evidence will determine EUA.
Meanwhile, Bharat Biotech on Friday (September 17, 2021) said that it has submitted all the data to the WHO for Emergency Use Listing (EUL) of its COVID-19 vaccine Covaxin and is awaiting feedback from the UN Public Health Agency.
Bharat Biotech, in a series of tweets, 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.
The Hyderabad-based company acted as a responsible manufacturer and said it would not find it appropriate to speculate or comment on the approval process and its timelines.
"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 percent efficacy to the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO).
Covaxin was developed by Bharat Biotech in association with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV). Covaxin 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 ANI inputs)