Taiwan-based United Biomedical Inc. (UBI) Asia is planning to reapply for emergency use authorization (EUA) for its COVID-19 vaccine based on what it described as very strong data after giving clinical trial subjects a third dose of the vaccine.
The company’s application for an EUA was rejected on Aug. 16 based on the low level of antibodies its UB-612 vaccine generated in people who received two doses.
In a statement issued Monday, however, the company said a third dose given to 50 people who participated in its Phase 1 trial 8-10 months after they received a second dose showed a substantial increase in protective antibodies, measured in geometric mean titers (GMTs).
It said it will present the new data to the Taiwan Food and Drug Administration to have its EUA application reviewed again.
According to the company, the third dose increased antibodies 37-fold to 4,018 GMTs against the original COVID-19 “wild-type virus” and reached 2,358 GMTs against the Delta variant of the virus.
It said the Delta variant GMTs were considerably higher than those for the Pfizer-BioNTech (1,321), Moderna (1,268) and domestically produced and EUA approved Medigen (395) vaccines after a third dose, based on data submitted to the World Health Organization.
For a vaccine to be granted an EUA by the Taiwan FDA, it had to have GMTs at least equal to two-thirds the level found in recipients of the AstraZeneca vaccine commonly given in Taiwan.
The UBI Asia vaccine fell short of the 125 GMTs necessary to meet the threshold, and its EUA application was therefore rejected.
The Medigen vaccine had antibodies 3.4 times the amount found in the AstraZeneca vaccine.
In its statement, UBI Asia said it would also submit a modified version of its Phase 2 clinical trial plan so that all Phase 2 trial participants could get a third dose of the vaccine.
The Taiwan FDA had not responded to the new developments as of late Monday night.
Taiwan’s EUA standards were based on antibodies generated because local vaccine makers did not conduct large-scale Phase 3 trials to get real-life efficacy data to determine whether the vaccine offers protection against a particular virus.
The Taiwan FDA decided to test antibody concentrations against people who have been immunized with the AZ vaccine because there is no uniform, globally accepted method for measuring GMTs or how high the GMT level should be to indicate protection.
Taiwan’s government ordered 5 million doses each of the Medigen and UBI Asia vaccines.
A first dose of the Medigen vaccine has been administered to more than 600,000 people, though demand has been tepid because of uncertainty over its effectiveness.