WHO (World Health Organisation's) approval for the emergency use authorization EUA to COVID-19 vaccines Covaxin, developed by the Hyderabad-based firm Bharat Biotech, will face more delay, reported by ANI.
it said.
"WHO (World Health Organization) 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,"
Bharat Biotech said in a statement.
"As a responsible manufacturer in past approvals for our other vaccines, we do not find it proper to speculate or comment on the regulatory approval procedure and its timeframe. We are intensity working with the WHO to obtain EUL at the earliest as possible,"
ANI stated.
Earlier, WHO's nod for Covaxin was expecting by 5 October,
Last Friday, Bharat Biotech said it has submitted all the data to the WHO (World Health Organisation) for EUL (Emergency Use Listing) of COVID-19 vaccine Covaxin and is waiting for feedback from the UN Public Health organization/agency.
In a tweet, Bharat Biotech said that Covaxin clinical trial was fully compiled and available in June 2021.
#COVAXIN® clinical trial data was fully Compiled & available in June 2021. All Data submitted for Emergency Use Listing (EUL) Application to World Health Organization in early July. (1/3) pic.twitter.com/r4CnROpUfP
— BharatBiotech (@BharatBiotech) September 17, 2021
Twitter image : @BharatBiotech
Read More : Covaxin to get WHO approval this week as per reports
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 developing by Hyderabad-based Bharat Biotech associated with the Indian Council of Medical Research and the National Institute of Virology. Covaxin, growing with the Indian Council of Medical Research (ICMR), contains a whole virion-inactivated SARS-CoV-2 vaccine produced in Vero cells.
The vaccine is stable at 2 degrees Celsius to 8 degrees Celsius (refrigerated) and is shipping in a ready-to-use liquid formulation that permits distribution using existing vaccine supply chain channels.
WHO has approved Covid vaccines developed by Pfizer-BioNTech, US pharma majors Johnson & Johnson, Moderna, China's Sinopharm, and Oxford-AstraZeneca for emergency use.
