An expert review report released by the Food and Drug Administration (FDA) Monday raised doubts as to whether the vaccine developed by Taiwan-based United Biomedical Inc. (UBI) Asia offers sufficient protection against COVID-19 variants.
According to the report, a panel of 22 experts at a review meeting held on Aug. 15, which denied a request from UBI for emergency use authorization (EUA) for its vaccine candidate UB-612, suggested the company should conduct a third phase of clinical trials to determine the jab’s efficacy.
At the meeting, 17 of the 21 experts, not counting the chairman, voted against UBI Asia’s request for EUA as the vaccine candidate failed to meet approval standards, while the remaining four asked the company to submit more documents for another review.
For a vaccine to be granted an EUA by the Taiwan FDA, it has to have a seroconversion rate over 50 percent and virus neutralizing antibodies — expressed as geometric mean titers (GMTs) — at least equal to two-thirds the level found in recipients of the AstraZeneca vaccine, which has been administered in the country.
UBI has claimed its vaccine candidate is expected to protect those inoculated against the Delta variant, which is now the most transmittable and contagious variant worldwide.
According to the report, however, the GMTs of UBI’s vaccine candidate declined at a moderate pace when faced with virus variants and based on the limited information available it is hard to say people who receive the vaccine will be protected against the Delta and Alpha variants.
In addition, the report cited some experts on the panel as saying UBI’s vaccine did not even appear to be effective against the original COVID-19 virus.
However, some others on the expert panel said peptides inside the vaccine still have the potential to create protection against virus variants, suggesting UBI should conduct a third phase clinical trial, adding it also remains to be seen how the vaccine creates a response to T-cells.
On Aug. 22, UBI founder Chang Yi Wang (???) said Taiwan’s FDA standards for granting EUA were hastily designed and outdated, adding that it would be deeply regrettable to deny people access to such a good vaccine because of hastily devised EUA standards.
Despite the denial of the EUA in Taiwan, UBI remains committed to seeking international approval for its COVID-19 vaccine candidate, according to Wang.
Wang said the company plans to conduct Phase 3 clinical trials in India for its “next generation” COVID-19 vaccine, named “UB-613.”
The FDA decided to test antibody concentrations against people who have been immunized with the AstraZeneca vaccine because there is no uniform, globally accepted method of measuring GMTs or how high the GMT level should be to indicate protection.
Source: Focus Taiwan News Channel