The World Health Organization’s (WHO) Emergency Use Authority (EUA) approval for Covaxin, a COVID-19 vaccine developed by Hyderabad-based Bharat Biotech, is likely to be delayed till October 5.
According to the WHO, a meeting of the Strategic Advisory Group of Experts on Immunization (SAGE) will take place on 5 October to give the EUA to Covaxin.
Hanna Nohynek, SAGE member session will present objective setting, an update on regulatory decisions and an overview of the working group’s deliverables.
Will recommend EUA based on clinical data on Covaxin from Phase 1, 2, 3 trials of Session 1, 2, 3 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 SAGE Working Group’s evaluation of the available pieces of evidence will determine the EUA.
Meanwhile, Bharat Biotech on Friday said it has submitted all data for the Emergency Use List (EUL) of its COVID-19 vaccine Covaxin to the World Health Organization (WHO) and is awaiting a response from the United Nations Public Health Agency. Used to be.
In a series of tweets, Bharat Biotech said that the Covaxin clinical trial was fully compiled and available in June 2021.
“The #COVAXIN clinical trial data was fully compiled and available in June 2021. All data were submitted for emergency use list (EUL) application to the World Health Organization in early July. We requested #WHO Have responded to any clarifications made and awaits further response,” Bharat Biotech tweeted.
#COVAXIN® Clinical trial data was compiled in its entirety and was available in June 2021. All data for emergency use list (EUL) application was submitted to the World Health Organization in early July. (1/3) pic.twitter.com/r4CnROpUfP
— bharatbiotech (@bharatbiotech) September 17, 2021
As a responsible manufacturer with no previous approvals for its other vaccines, the company said it would not be appropriate to speculate or comment on the approval process and its timeline, it added.
“We are continuing to work diligently to achieve the WHO EUL as soon as possible,” it added.
Bharat Biotech has submitted its Phase 3 clinical trial data which has demonstrated 77.8 percent efficacy to the Subject Expert Committee (SEC) of Central Drugs Standard Control Organization (CDSCO).
Covaxin was developed by Hyderabad-based Bharat Biotech in collaboration with the Indian Council of Medical Research and the National Institute of Virology. Covaxin, developed in collaboration with the Indian Council of Medical Research (ICMR), contains a complete virion inactivated SARS-CoV-2 vaccine, manufactured in Vero cells.
The vaccine is stable at 2 °C to 8 °C (refrigerated) and is shipped in a ready-to-use liquid formulation that allows for distribution using existing vaccine supply chain channels.
The WHO has so far approved COVID vaccines for emergency use developed by Pfizer-BioNtech, US pharma major Johnson & Johnson, Moderna, China’s Sinopharm and Oxford-AstraZeneca.
(Except for the title, this story has not been edited by NB staff and is published from a syndicated feed.)