YUBIO Receives Approval for Phase 1 and 2 Clinical Trials of COVID-19 Vaccine Booster

[Asia Economy Reporter Chunhee Lee] UbioLogics announced on the 8th that it has received approval from the Ministry of Food and Drug Safety for the clinical trial plan (IND) for the Phase 1/2 booster shot clinical trial of its COVID-19 vaccine under development, "Yukobac-19".

This booster shot clinical trial will be conducted on 200 adults aged 19 and older at locations including Eunpyeong St. Mary's Hospital in Seoul. The trial will evaluate safety, tolerability, and immunogenicity. It is a clinical study to assess the cross-immunogenicity against the original virus and recently circulating variants when Yukobac-19 is administered as a booster to individuals who have completed primary vaccination with various vaccines, aiming to confirm its potential as a booster vaccine.

Yukobac-19 is currently undergoing Phase 3 clinical trials in Congo and the Philippines. Vaccinations are expected to be completed by early next month, with interim results on immunogenicity and safety during the main study period to be reported within the first half of the year. The company plans to commercialize the vaccine through approval and export product licensing in these countries and pursue listing on the World Health Organization (WHO) Emergency Use Listing (EUL).