Is Arcturus Therapeutics' replicon vaccine "KOSTAIVE" safe?

- from interviews with the presidents of Meiji Seika Pharma and Arcturus Therapeutics

President of Meiji Seika Pharma

From an interview with the president of Meiji Seika Pharma, the company supplying the replicon vaccine “KOSTAIVE” in Japan.

Question

Isn’t it also necessary to have empathetic communication with people who feel anxious?

Answer

No, it’s important to clearly convey that you should get vaccinated. If we say, “Whether or not to get vaccinated is up to the individual,” no one will take the risk and get vaccinated. We should say, “You should get vaccinated, but there is a certain percentage of severe side effects,” and then have people think it over for themselves.

We can say that vaccines are not something to be taken at the risk of severe side effects. This is not the words of a president of a company that has failed to eliminate risks or disclose all risks.

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President of Arcturus Therapeutics

On the other hand, the president of Arcturus Therapeutics, a US company, stated as follows in an interview regarding concerns about their self amplicon vaccine “KOSTAIVE.”

We would like to collect data for many years and publish the long-term effectiveness and safety in literature.

His words made it clear that the long-term safety of “KOSTAIVE” has not been established. What else can we call this but human experimentation?

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Meiji Seika Pharma, the supplier of the replicon vaccine "KOSTAIVE" of Arcturus has sent warning letters suggesting a legal action for defamation to an influencer, a journalist, an expert and a politician who have expressed concerns about this vaccine.

Despite this situation, they have continuously sent letters of inquiry to Meiji Seika Pharma, seeking answers to their concerns about the vaccine. However, no responses have been provided to date.

The scientific arguments are likely to be eliminated from the public view and brought before the courts. However, the subject matter of the trial would be the defamation, meaning that the specific scientific arguments may not be addressed.

Meiji Seika Pharma Co., Ltd. has begun threatening to sue Japanese citizens.

As of now (February 2025), there have been no reports of a lawsuit being filed by Meiji Seika Pharma. Some believe their threats have failed, but it is necessary to keep a close eye to this issue.

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This might be an indirect form of the suppression of speech by the pharmaceutical companies. The vaccines are procured with the government funds (that is, our tax), the specific contract details and the technical information thereof are kept secret, and thus they have mutual interests. Therefore, it becomes in their direct interest to silence the public concerns about the vaccines.

If such measures were permitted, public discussions about risks of pharmaceuticals would no longer be possible, while discussions on safety of pharmaceuticals based on the insufficient and complexity data could continue freely and without restriction. Also, this would mean that the risks of pharmaceuticals is only discussed in closed circles among a select few experts with potential conflicts of interest.

This disparity clearly violates the principle of fairness and is completely unwelcome from the public health perspective.

Technological progress includes not only the development of new technologies as extensions of existing ones but also the elimination of technologies that pose disadvantages to society. Suppressing discussions about technologies of concern is tantamount to unfairly depriving society of the opportunity for technological progress.

In the case of new pharmaceuticals, the technologies involved are so cutting-edge that even the developers cannot fully understand them. Moreover, the existing laws have not kept pace with those technological advances, meaning that safety is not always sufficiently and legally guaranteed.

There is no one in the world who has fully covered all the issues related to mRNA vaccine technology, including its mechanism of action, at an individual level. Even now, new discoveries are being reported worldwide, demonstrating that mRNA vaccine technology is an extremely advanced field.

As part of the evidence supporting this, the president of Arcturus Therapeutics stated in an interview regarding concerns about their self amplicon vaccine "KOSTAIVE", "We would like to collect data for many years and publish the long-term effectiveness and safety in literature."

As this testimony clearly indicates, long-term safety falls outside the scope of the existing laws and cannot be guaranteed. Furthermore, conflicts of interest are unlikely to be eliminated from the future publications.

The existing laws permit the use of short-term and limited data from eight common laboratory albino mice (i.e., BALB/c mice, which are not even humanized mice; hACE2 mice), as long as the mRNA vaccine belongs to the same platform.

https://www.mhlw.go.jp/content/10906000/001266060.pdf

Consumers are not the only ones expressing concerns about replicon vaccines. Recently, authors who claim to be current employees of Meiji Seika Pharma published a book titled “We Don’t Want to Sell,” in which they voiced the same concerns as the consumers.

The burden of proving the safety of a product typically rests with the manufacturer side, and this responsibility should not be shifted to the consumers. In this connection, the vaccines not widely available for experimental purposes, particularly to test for their harmfulness.

If manufacturers fail to fulfill their responsibilities, consumers will be exposed to unnecessary risks. Meanwhile, the assurance that a vaccine is not provided for experimental purposes is extremely important from the perspective of public trust.

Meiji Seika Pharma should address consumer concerns not by using legal measures to eliminate individuals who are perceived as obstacles, but by providing long-term, proper experimental results conducted by independent third parties with no conflicts of interest.

I believe this is the best way to resolve the issue that has grown significantly both domestically and internationally. It represents a healthy industry where no one is harmed, and it is a reassuring conclusion that all consumers want.

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The exclusive purchase of pharmaceutical products from private pharmaceutical companies using public funds, such as taxes, violates the principles of a free market and fairness, significantly disrupting economic order.

Dependency-based pharmaceutical companies, which maintain a mutually dependent relationship with politics, can make well-forecasted and proactive development investments using abundant public funds. At the same time, these companies are able to establish subsidiaries, acquire other companies or startups, and provide substantial funding to universities and research institutions.

As a result, technical standards are shaped around these companies, and the competitiveness of non-dependency-based companies diminishes relative to theirs, making them further vulnerable to acquisition.

The domination of the market by such companies will lead to a highly directed market, stifling the creation of new ideas and technologies. Furthermore, these influences will ripple across other industries through sectors connected to these companies. This, in turn, will widely and significantly hinder technological development.

On the other hand, politics will deepen its ties with these companies, gradually prioritizing the interests of both parties. This structure is highly distorted, raising serious concerns from the perspective of fairness.

Having confronted technology and the progress of science for many years through my profession and its philosophy, I have never encountered such a dysfunctional industry.

If we isolate the relationship between the government and dependency-based pharmaceutical companies, their relationship can only be described as “communistic.”

Such a society is extremely unhealthy, and we should not tolerate a society that tolerates this.

https://x.com/Patent_SUN/status/1883295164355248172