With great hope, the minutes of the high-end vaccine emergency user license (EUA) review meeting has finally been released. Although it is not as transparent, complete and real-time as the US FDA public meeting, and it is not word-by-word draft, the text will inevitably be chosen and deleted, but the traces of the dual track of expert consensus and official leadership can still be seen.
The responsibility of the local vaccine review meeting is to make a judgment on whether the overall benefits and risks outweigh the disadvantages based on the information provided by the manufacturer, so as to make the basis for the decision-making of the administrative authorities. What are the opinions expressed by the expert committee members during the review meeting?
First of all, Taiwan’s food and drug department has specially tailored a unique set of EUA review standards for local vaccines, in order to bridge the protection power with immunity data, claiming that “immunity bridging” is an international trend, and experts have consistent questions about this. Among the 21 experts in A~U, 9 made relevant statements on this, of which only one (Expert I) briefly echoed the "international trend towards receiving immune bridging", while the other 8 did not agree. Six experts (E, G, H, N, P, R) pointed out that the titer of neutralizing antibodies cannot be used alone as a vaccine protection indicator; Expert D suggested that it is appropriate to apply for an internationally recognized biomarker; Expert T also pointed out that due to the lack of internationally recognized immune response and clinical protection indicator (CoP), although neutralizing antibodies and AZ vaccines produced by high-end vaccines are comparable, the clinical protection of AZ vaccines cannot be directly reflected in high-end vaccines. Not only is the scientific effectiveness of
not only not recognized by the committee members, but most committee members do not agree with this point. Up to 12 (more than half) of experts (D, E, I, K, L, M, N, O, Q, R, S, T) mentioned that the Phase 3 clinical trial should be conducted, or suggestions on how the Phase 3 trial will be conducted, or what data is expected. Expert D also hopes that the vaccine will obtain international certification in the future; Expert E questioned the manufacturer's failure to explain how to estimate the number of subjects in the Paraguay trial; Expert N said that it was subject to conditional approval, but the manufacturer still had to promise to carry out the third phase clinical trial; Expert Q pointed out directly: "This is only a phase two trial, and there is still a lot of uncertainty in efficacy and safety, so it can only be approved under the premise of "there is an emergency public health need". The disease management department has explained at today's meeting that Taiwan has such an urgent need, so it agrees to pass the conditional", and said that the additional conditions include providing clinical trial results from other places (such as Paraguay). In addition to bluntly stating that it lacks scientific effectiveness to the EUA review standards, the common shortcomings raised by the most experts include: the failure to provide human T cell immunity data (this is one of the two immunity data required by the US FDA); the protection of Beta and Delta variant viruses is highly unoptimistic; it is not yet confirmed whether it will have some rare side effects like other vaccines; in terms of quality, the ability and quality insurance of mass production (50L process) are still insufficient. As for whether the third dose is needed, how effective it is for pregnant women, adolescents, etc., and how long the antibody titer can last, there is also a lack of data.
is among the 20 members, only 3 passes, and 15 passes with conditions. Many members mentioned that it was because the official endorsement of Taiwan meets the EUA conditions, and that the manufacturer proposed to go overseas (Paraguay) to conduct the third phase clinical trial, and was willing to pass the conditions. However, has the manufacturer provided any legal or written information for the third phase test proved that it was sure that it would conduct the third phase test? More importantly, does the situation on the island meet the legal requirements for application?
Article 48-2 of the current "Pharmaceutical Law" on the island regulates the production or import of specific drugs by the administrative authority by project approval. There are two conditions: one is to prevent, diagnose and treat life-threatening or severely disabled diseases, and there is no appropriate medicine or appropriate alternative therapy on the island; the other is to meet the needs of emergency public health matters. In the meeting minutes, the disease control department pointed out that the global vaccine supply was very tight, and the total vaccine arrival was only 8.9026 million doses, saying that "the supply of vaccines from Taiwan is still needed, and there is indeed emergency public health demand on the island."However, what everyone still remembers is that the Tsai administration used "card" drama to donate vaccines from private sources, and has been delayed again and again. Nantou, Yunlin, Hualien, and , Taitung 4 ruling Kuomintang counties and cities jointly commissioned qualified drug dealers to formally submit an application to purchase 5 million doses of BNT vaccines. The epidemic commander Chen Shizhong also publicly stated at a press conference on July 14 that the total amount of vaccines is enough, but it is just a matter of time (arrival). Since the commander has publicly stated that the vaccine is enough, and the epidemic has been controlled at that time and micro-unlocking measures have been put on the road, it is obvious that before the high-end EUA review meeting, it was known that the two major EUA conditions did not exist at all.
Since EUA lacks scientific foundation and practical emergency conditions, is this approval effective? No country or region in the world dares to take vaccine approval as a joke. The construction of self-produced vaccines must comply with scientific and international norms. Since there are more mature drugs available and the number is enough, experts have also shown that antibody titers cannot be used for immune bridging, indicating that the third phase of the test is needed to provide protection and safety data. Without any conditions, high-end vaccines have not only been approved, but also entered the public registration system and started to accept appointments. Moreover, the system not only did not clearly inform the public of clearly what differentiated this vaccine was from other vaccines before the public chose, but even acted so bold that it was set as a default option for the public, which was like a blatant improper trick. With such a one-stop process, relevant officials may not be able to escape legal responsibility, and the people on the island are even more pitiful to the innocent paid white rats. (The author is a concurrent professor at public Yangming Jiaotong University)
