IVI and Ukraine

Ongoing Collaboration

COVID vaccine Clinical and Operational Alliance (COCOA)

Ukraine has been one of the participating countries in a global Phase 3 clinical trial of SK bioscience’s COVID-19 vaccine candidates. The trials are being conducted by COVID vaccine Clinical and Operational Alliance (COCOA) in partnership with IVI and funded by the Coalition for Epidemic Preparedness Innovations (CEPI). The aim of this consortium is to make the vaccine available worldwide with WHO prequalification (PQ) / WHO Emergency Use Listing (EUL). 

As part of the COVID Vaccine Clinical and Operational Alliance (COCOA) consortium, IVI led a global Phase III pivotal trial of SKYCovione™, SK bioscience’s COVID-19 vaccine and Korea’s first homegrown vaccine licensed by the Korean Ministry of Food and Drug Safety. The trial demonstrated the vaccine’s strong immunogenicity and safety profiles in more than 4,000 adults.

The clinical trials were conducted in Philippines, Thailand, Viet Nam, New Zealand, Ukraine, and Korea in an effort to accelerate the development of much-needed “Wave 2” vaccines.  Study sites in Korea were overseen by SK bioscience, while IVI coordinated the trial across five other countries.

Based on clinical results, SKYCovione™ was added to the WHO Emergency Use Listing in 2023, receiving full marketing authorization from the United Kingdom’s Medicines and Healthcare Products Regulatory Agency. 

Funding for this Phase III study has been provided by the Coalition for Epidemic Preparedness Innovations (CEPI). Additionally, IVI, SK, and the Korea National Institute of Health (KNIH) under the Korea Disease Control and Prevention Agency (KDCA) signed an agreement to jointly conduct antibody testing for the global Phase III trials.