Taiwan-based UBI Asia plans to reapply for Emergency Use Authorization (EUA) for its COVID-19 vaccine. UBI said that this time it has strong data on the effectiveness of a third dose of the vaccine on their clinical trial subjects.
UBI’s first application for an EUA was denied in mid-August when the level of antibodies, or geometric mean titers (GMTs), was low in people who received two doses of its vaccine. In order to be granted an EUA by Taiwan’s FDA, a vaccine has to have GMTs at least equal to two-thirds of the level found in those who were given the AstraZeneca vaccine in Taiwan.
UBI stated that a third dose was given to 50 people, aged between 18 and 64, eight to ten months after being administered the second dose in the Phase 1 trial. It said the third dose increased antibodies 37 fold to more than 4,000 GMTs against the COVID-19 virus and almost 2,400 GMTs against the Delta variant. UBI said that after its third dose, its Delta variant GMTs are much higher than those for BioNTech, Moderna and the Taiwanese Medigen vaccines.
UBI said that it will submit a new Phase 2 clinical trial plan to the FDA which will give all trial participants a third dose of the vaccine. It will also send its new data so the FDA can reevaluate whether the vaccine is qualified for an EUA.