Emergency Use Listing

Emergency Use Listing

Subject: Science and Technology

Context: The World Health Organisation (WHO) may decide on giving an emergency authorisation for Covaxin in September, said S Jaishankar, Minister of External Affairs

Concept:

• COVAXIN is an inactivated vaccine, created from a strain of the infectious SARS-CoV-2 virus that has shown promise in preclinical studies demonstrating extensive safety and effective immune responses.
• COVAXIN has been developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV).
• The SARS-CoV-2 strain was isolated in NIV, Pune and transferred to Bharat Biotech. The indigenous, inactivated vaccine will be developed and manufactured by Bharat Biotech’s BSL-3 (Bio-Safety Level 3) High Containment facility located in Genome Valley, Hyderabad, India.
• Bharat Biotech’s track record in developing Vero cell culture platform technologies has been proven in several vaccines for polio, rabies, rotavirus, Japanese Encephalitis, Chikungunya and Zika.

Emergency Use Listing

• Emergency Use Listing (EUL) is the procedure to streamline the process by which new or unlicensed products can be used during public health emergencies.
• The EUL replaces the Emergency Use Assessment and Listing (EUAL)procedure, which was used during the West Africa Ebola outbreak of 2014-2016.
• The WHO established its emergency use listing (EUL) process to help poorer countries without their own regulatory resources quickly approve medicines new diseases like Covid-19, which otherwise could lead to delays.