Taiwan-based United Biomedical Inc. (UBI) Asia called on the government Sunday to give its COVID-19 vaccine candidate UB-612 a second chance, after its request for emergency use authorization (EUA) was denied last week.
UBI founder Chang Yi Wang (???) said Taiwan’s Food and Drug Administration’s (FDA) standards for granting EUA were hastily devised and outdated.
In assessing the effectiveness of a vaccine candidate, the FDA takes into consideration only the virus neutralizing antibodies –expressed as geometric mean titers (GMTs) — but the reaction of T cells should also be part of the equation, Wang argued.
She urged the FDA to compare the effectiveness of her company’s UB-612 vaccine against the COVID-19 Delta variant with that of the AstraZeneca vaccine, given that Delta is now the most transmittable and contagious variant.
“It would be deeply regrettable to deny people access to such a good vaccine because of hastily devised EUA standards,” Wang said.
Despite the setbacks in Taiwan, however, UBI remains committed to seeking international approval for its COVID-19 vaccine candidate, she said.
UBI Asia, meanwhile said it will soon appeal the FDA’s decision to not grant EUA for the vaccine candidate.
In response, the FDA said it respected the right of UBI Asia to file an appeal, and said it would review the application and decide whether another meeting of experts is necessary.
On Aug. 16, the FDA said that a majority of experts had voted on Aug. 15 not to grant EUA for UBI Asia’s vaccine, as it did not meet the approval standards.
For a vaccine to be granted an EUA by the Taiwan FDA, it has to have a seroconversion rate of over 50 percent and GMTs at least equal to two-thirds the level found in recipients of the AZ vaccine.
The Taiwan FDA decided to test the antibody concentrations against people who had been immunized with the AZ vaccine because there is no uniform, globally accepted method of measuring GMTs or how high the GMT level should be to indicate protection.
According to the interim results of UBI Asia’s Phase 2 clinical trials released in late June, participants in the 19-64 age group had a seroconversion rate of 95.65 percent, meaning 95.65 percent of them produced neutralizing antibodies.
At the time, the company said the GMTs were 102.3. According to Taiwan FDA, the AZ vaccine’s GMTs were 187.9.
UBI Asia had said it would continue its Phase 2 clinical trials in Taiwan and that its parent company UBI would re-evaluate the benefits of conducting Phase 3 clinical trials.
At Sunday’s press 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.
She said, however, that the company plans to conduct Phase 3 clinical trials in India for its “next generation” COVID-19 vaccine, named “UB-613,” but she did not elaborate.
Source: Focus Taiwan News Channel