United Biomedical seeks appeal after EUA denied

United Biomedical Asia has urged the government to give its COVID-19 vaccine candidate, UB-612, a second chance after its application for emergency use authorization (EUA) was denied last week, Taipei Times reported.

According to company founder Wang Chang-yi, the FDA only considers the virus neutralizing antibodies but the reaction of T-cells should also be part of the equation.

She added that the FDA should compare the effectiveness of UB-612 and the AstraZeneca vaccine against the Delta variant of the virus, given that the variant is the most contagious.

Last week, the FDA said that a majority of experts had voted not to grant the company an EUA. To be granted the authorization a vaccine must have a seroconversion rate of more than 50%, with GMTs at least equal to two-thirds of the level found in recipients of the AstraZeneca vaccine.

The interim results of the company’s Phase II clinical trials show that participants in the 19 to 64 age group had a seroconversion rate of 95.65%. At the time, the company said that the GMT level was 102.3, while the GMT level of the AstraZeneca vaccine was 187.9, according to the FDA.

United Biomedical said it plans to soon appeal the FDA’s decision.