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United Biomedical seeks appeal after EUA denied

Source: Taipei Times

United Biomedical Inc Asia (聯亞生技) on Sunday 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.

Company founder Wang Chang-yi (王長怡) said that the Food and Drug Administration’s (FDA) standards for granting an EUA were hastily devised and outdated.

In assessing the effectiveness of a vaccine candidate, the FDA only considers the virus neutralizing antibodies — expressed as geometric mean titers (GMTs) — but the reaction of T-cells should also be part of the equation, Wang said.

The FDA should compare the effectiveness of the UB-612 vaccine and the AstraZeneca vaccine against the Delta variant of SARS-CoV-2, given that the variant is the most contagious, she said.

“It would be deeply regrettable to deny people access to such a good vaccine because of hastily devised EUA standards,” Wang said.

Despite the setback, the firm remains committed to seeking international approval for its COVID-19 vaccine candidate, she said.

United Biomedical said that it would soon appeal the FDA’s decision not to grant an EUA for the UB-612 vaccine.

The FDA respects the company’s right to appeal, it said, adding that it would review the application and decide whether another meeting of experts would be necessary.

On Monday last week, the FDA said that a majority of the experts had on Sunday voted not to grant the company an EUA.

To be granted an EUA, a vaccine must have a seroconversion rate of more than 50 percent, with GMTs at least equal to two-thirds of the level found in recipients of the AstraZeneca vaccine.

The FDA decided to test the antibody concentrations against people who had been inoculated with the AstraZeneca vaccine, because there is no globally recognized method for measuring GMTs or an accepted standard for what GMT level indicates effective protection.

The interim results of the company’s phase 2 clinical trials, released in late June, show that participants in the 19 to 64 age group had a seroconversion rate of 95.65 percent, meaning that 95.65 percent of participants produced neutralizing antibodies.

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.

The comany had said that it would continue its phase 2 clinical trials in Taiwan and that its parent company, United Biomedical Inc, would re-evaluate the benefits of conducting phase 3 clinical trials.

At Sunday’s news conference, Wang did not say whether the company was proceeding with its plan to begin phase 2/3 efficacy trials in India, which were expected to have 11,000 participants.

The company would conduct phase 3 clinical trials in India for its “next-generation” COVID-19 vaccine, named “UB-613,” she said, without elaborating.

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