Isn't the world only the United States and Taiwan's vaccine in Europe?

The original text was published on 2021/9/23 " Multidimensional News "

The Taiwan-made "high-end vaccine" publicly stated on September 22 that it was approved by the European Medicines Agency (EMA) and will conduct Phase III clinical trials in Europe. It is expected that no more than four cases will be received between October and November. Thousands of people are targeting AstraZeneca's vaccine by means of "immuno-bridging", hoping to obtain international certification. In the face of the new entry regulations in the United States, and the possibility of free entry for high-end vaccines is slim, Taiwan's Minister of Health and Welfare Chen Shizhong declared that "the world is not only the United States", which may have given some inspiration to enterprises. After all, the world is indeed not only the United States. And the EU.

Fight for dominance of clinical trials to avoid burial in Colombia

Regardless of the more than 700,000 people in Taiwan who have been injected with high-end vaccines, the EU's license will undoubtedly allow high-end vaccines to start what they perceive as the "second" clinical phase III trial. The first clinical phase III trial of a high-end vaccine was conducted in Paraguay in mid-July, in cooperation with the Medical School of Universidad Nacional de Asunción. .

Colombia's drug administration unit recently announced that the World Health Organization (WHO) will conduct Phase III clinical trials of a high-end vaccine and the U.S.'s Inovio Pharmaceuticals vaccine in its territory, and the number of cases is expected to reach 40,000. The news of this Phase III clinical trial was so advanced that it exceeded the cognition of high-end vaccines, leaving the company in a daze. It would be too passive to allow yourself to occupy a position in the clinical phase III trial, when all the data is in the hands of the WHO.

In this context, the high-end vaccine, which originally stated that it is "difficult to conduct clinical phase III", has to speed up the pace of clinical phase III trials, so that it can also conduct clinical phase III in which it can control itself, so as to avoid WHO's After the Colombian experimental data came out, the result was that he turned his eyes and couldn't speak.

Stealing peaches for plums: stealing “non-inferiority experiments” with “immune bridges”

The immune bridging touted by Taiwan's official and high-end vaccines refers to the use of immunogenicity (neutralizing antibody titer) instead of efficacy indicators to measure whether the immunogenicity results induced by the vaccine are consistent with the approved emergency use authorization (EUA). The vaccines are equivalent, and the target designated by Taiwan officials is the AZ vaccine, which does not perform well in this data. The high-end vaccine has passed the test and has become the vaccine that has obtained EUA in Taiwan.

In order to boost morale, high-end vaccines claimed that after the meeting of the "ICMRA International Alliance of Drug Regulatory Agencies" in June, the drug regulatory agencies in Japan, South Korea and France approved the vaccines of companies such as Daiichi Sankyo, SK Pharmaceuticals and Valneva. Is it true that phase III clinical trials are conducted in the form of immune bridging?

If you look closely at the "Nihon Keizai Shimbun"'s report in mid-July about Daiichi Sankyo's vaccine clinical phase III trial, in fact, the report did not mention the mechanism of immune bridging at all, but clearly stated that the company Thousands of people (the exact number is unknown) will be accepted and conducted in the form of "non-inferiority trials".

There are two main logics for the experimental verification of new drug research and development. The most common one is "superiority trials". The goal is to replace it in the market; the logic of the "non-inferiority experiment" is to confirm that the efficacy of the new drug is not lower than that of the control group, so that clinical drugs can have one more choice. ) approved experimental methods. For vaccines, the truly meaningful "efficacy" is reflected in the data of "protective power". After all, vaccination is to avoid severe disease or even death after infection.

The Daiichi Sankyo vaccine using mRNA technology has a great appetite, and its "non-inferiority experiment" directly targets the BNT vaccine and Moderna vaccine using the same technology. The protective power data of the two are 95% and 94%, it can be said that the real art master is bold. The "immune bridging" of high-end vaccines is only the "neutralizing antibody titer" of the standard AZ vaccine.

"The world is not only the United States" Is the experiment not only clinical phase III?

The high-end vaccine went to sea this time, verbally saying that it hopes to obtain the EU's drug certificate in order to gain international recognition, but experts in Taiwan are not optimistic about the fairy tale ending.

Su Yiren, the former director of disease control in Taiwan, said that these are not formal clinical phase III trials, and at most they can only obtain EUA, not a complete drug certificate. Scientifically speaking, no matter how many countries have conducted immune bridging experiments, there is no way to obtain real-world protection data. Such vaccines are still unclear in actual effect. Even if they are certified, they will not be a complete drug certificate. When the new crown epidemic subsides and the EUA is revoked, it cannot continue to be used.

Su Yiren also said that if a high-end vaccine with protein sub-units is used, it may be a bit theoretical to compare Novavax with the same technology, but the comparison object for high-end vaccine selection is the AZ vaccine using adenovirus technology. , such a comparison is meaningless.

The U.S. FDA has already closed the door for EUA issuance. Even in the face of its own property, all walks of life are generally optimistic that Novavax, which will get the last EUA ticket and has obtained considerable protection data through clinical phase III trials, is still It is prudent and cautious. How can high-end vaccines be easily bypassed by the side door? But "the world is not only the United States", since the FDA does not work, then go to the door of the EMA! However, what is the EMA's attitude towards non-EU vaccines that have not yet completed clinical phase III trials? Let's take a look at Russia's Sputnik-V.