New Delhi: The World Health Organization’s (WHO) approval for Bharat Biotech’s COVID-19 vaccine Covaxin’s emergency use authorization (EUA) is likely to be delayed until October 5. The WHO Strategic Advisory Group of Experts on Immunization (SAGE) will meet on October 5 to grant Covaxin EUA.
Hanna Nohynek, a SAGE member, will present session objectives, an update on regulatory decisions, and an overview of Working Group deliverables. This session will be based on data from clinical trials phase 1, 2, 3, and post-marketing studies on Covaxin’s safety, immunogenicity, efficacy, and effectiveness.
The EUA will be determined by the SAGE working group’s assessment of the available evidence.
Meanwhile, Bharat Biotech announced on Friday (September 17, 2021) that it has submitted all data to the WHO for Emergency Use Listing (EUL) of its COVID-19 vaccine Covaxin and is waiting for a response from the UN Public Health Agency.
Bharat Biotech stated in a series of tweets that the Covaxin clinical trial was completed and would be available in June 2021.
“The clinical trial data for #COVAXIN was fully compiled and will be available in June 2021. In early July, all data was submitted to the World Health Organization for an Emergency Use Listing (EUL) application. We have responded to any clarifications requested by the #WHO and are awaiting additional feedback “Bharat Biotech posted a tweet.
The Hyderabad-based company acted responsibly and stated that it would not be appropriate to speculate or comment on the approval process and its timelines.
“We are continuing to work diligently to obtain WHO EUL as soon as possible,” it added.
Bharat Biotech has submitted Phase 3 clinical trial data demonstrating 77.8 percent efficacy to the Central Drugs Standard Control Organization’s Subject Expert Committee (SEC) (CDSCO).
Bharat Biotech collaborated with the Indian Council of Medical Research (ICMR) and the National Institute of Virology to develop Covaxin (NIV). Covaxin contains a whole virion-inactivated SARS-CoV-2 vaccine made in Vero cells.
The vaccine is stable at temperatures ranging from 2 to 8 degrees Celsius (refrigerated) and is shipped in a ready-to-use liquid formulation that allows distribution through existing vaccine supply chain channels.
So far, the WHO has approved Covid vaccines developed by Pfizer-BioNTech, Johnson & Johnson, Moderna, Sinopharm in China, and Oxford-AstraZeneca for emergency use.