YUBIologics Completes Overseas Phase 3 Vaccination of COVID-19 Vaccine 'Yukoback-19'

Over 2,500 People Each in Democratic Republic of Congo and Philippines Complete Two-Dose Vaccination

[Asia Economy Reporter Myunghwan Lee] UbioLogics announced on the 10th that it has completed the administration of the overseas comparative Phase 3 clinical trial of its COVID-19 vaccine under development, 'Ucovac-19.'

This Phase 3 clinical trial was conducted simultaneously in the Democratic Republic of the Congo and the Philippines. In each country, 2,500 to 3,000 adults aged 19 to 75 were vaccinated to compare the immunogenicity and safety of the Ucovac-19 vaccine against a control vaccine. UbioLogics explained that additional monitoring will be conducted thereafter.

UbioLogics plans to secure interim results for the primary endpoints of the Phase 3 trial within the first quarter of this year and to apply for approval in each country during the second quarter.

In the case of the Democratic Republic of the Congo, the Phase 3 trial is being conducted independently by the company targeting the African market. The Philippine trial is being conducted with government support (Ministry of Health and Welfare New Drug Development Project Group) aiming for export approval. UbioLogics had already applied for export approval targeting the Philippines in October last year.

UbioLogics emphasized that through the Phase 1/2 clinical trials of Ucovac-19, the safety and efficacy of the vaccine platform technology were confirmed. The results were published in the international journal BMC Medicine.

An UbioLogics official stated, "If approval for the maternal vaccine is obtained through this Phase 3 trial, we plan to continuously develop vaccines to respond to the persistently recurring and endemic COVID-19 by conducting additional clinical trials for booster vaccines, variant vaccines, and mixed vaccines."