Domestic vaccine developer United Biomedical bombarded the FDA with fierce criticism last Sunday, after its request for emergency use authorization was denied. Speaking at press briefing, the company’s chairwoman said the FDA’s review standards were, quote, “out of date” and incomprehensive. On Monday, we spoke to experts who came down on both sides of the issue.

Wang Chang-yi
United Biomedical CEO
The UB-612 vaccine was not granted authorization for emergency use. United Biomedical deeply regrets this outcome.

United Biomedical CEO Wang Chang-yi 王長怡 presided at a press conference on Sunday, after her firm’s request for an EUA was denied. She criticized the FDA’s EUA standards, saying they don’t factor in all reactions that contribute to immunity.

Wang Chang-yi
United Biomedical CEO
The government adopted an immunobridging approach that centers on a single point in time. This standard of review looks only at a single, partial aspect of immunity. It does not comprehensively evaluate the immunity stimulated by the vaccine.

Wang said it was “outdated” to use the original COVID virus as benchmark for EUA review. But physician Huang Li-min disagreed.

Huang Li-min
NTU Children’s Hospital superintendent
Is your vaccine comparable to the AstraZeneca vaccine? If you want to compare two vaccines, you can just choose one point of comparison. Any valid point of comparison will do. From a methodological standpoint, it is not necessary to use the latest virus strain. After all, if you adopted that logic, if delta were to be replaced as dominant strain, wouldn’t you have to run another comparison? You’d have to keep comparing and comparing, you’d have to do it so many times. Right now, the lambda strain is emerging. Should we be running these comparisons based on the lambda strain?

Chao Ming-wei
Toxicologist
It cannot be denied that immunobridging is one-size-fits-all. That is to say, it does miss some things. For instance, as mentioned before, it doesn’t factor in T cell activity, or the memory and responses of T cells. But immunobridging is currently the world’s simplest way of drawing direct connections between different vaccine brands.

Huang argued that the original COVID virus was a valid point of comparison. But toxicologist Chao Ming-wei 招名威 agreed with United Biomedical, saying that the FDA didn’t factor in its vaccine’s effect on T cells.

Voice of Wu Hsiu-mei
FDA director
These standards were the outcome of discussions by our panel of experts. If they have other ideas of their own, they can propose them.

The FDA said its EUA standards were determined by experts. But United Biomedical appears set on pressing its case, meaning that the dispute is far from over.