Healthcare Collapse (91)Is the Approval of Meiji HD's "KOSTAIVE" Compensation for Cleaning up the Kaketsuken Scandal?

Masahiro Kami, M.D., Ph.D.

President, Medical Governance Research Institute, Tokyo, Japan

The COVID-19 vaccine KOSTAIVE, developed by Meiji Seika Pharma, a subsidiary of Meiji Holdings (Meiji HD), is drawing public attention. Social media is overflowing with rumors such as false claims that "shedding from vaccinated individuals can infect others around them." Shedding refers to the idea that after KOSTAIVE proliferates in the recipient’s body, some of it is released into the environment and can harm people nearby. There is no scientific evidence supporting this.

Meiji is reportedly suing anti-vaccine groups led the spread of these rumors for defamation. On October 8, CEO Daikichiro Kobayashi explained in a press conference, that "Medical institutions that have introduced KOSTAIVE have been receiving slander and threats. This is causing disruptions in the flow of vaccine administration."

On October 16, the company placed full-page advertisements in several national newspapers, stating, "There have been a series of posts with claims and rumors without any scientific basis." The situation is quite out of the usual.

In various countries across the world, discourse about vaccine safety hasn’t been productive. There are two conflicting positions. One argues that medical accidents where a vaccine causes death to the recipient are unacceptable, insofar as vaccines are administered to healthy individuals. The other maintains that the occurrence of certain adverse reactions toward a vaccine, including death, are costs necessary in order to save much more lives. These differing viewpoints are rooted in fundamentally different value systems. Consensus through dialogue is difficult.

The Country Where Vaccines Are Trusted Least in the World

However, there is no country in the world where the safety of COVID-19 vaccines has been as loudly debated and scrutinized as Japan. A unique feature of Japan is that even major newspapers — those considered top-tier in the country — often give significant attention to the side effects of COVID-19 vaccines. Numerous articles have been published, such as "Replicon Vaccine, World’s First Practical Use as a COVID-19 Vaccine — What About Its Efficacy and Safety?" (Mainichi Shimbun, October 3).

Some online media and weekly magazines even feature extreme and inflammatory claims. "Pharmaceutical Company Insider Blows Whistle: 'We Don't Want to Sell Out Our Truth' — The Terrors of the Replicon COVID Vaccine, Only Approved in Japan" (Shukan Gendai, September 29) is a typical example.

Why are such articles so widespread? Most probably because they sell well. Many Japanese people are doubtful of the safety of vaccines. They want to hear vaccines being criticized. That is why the media eagerly covers this issue.

This situation arises because Japanese people do not trust vaccines. Though it may sound surprising, this is a well-known “fact” worldwide. In September 2020, a research team from the University of London conducted a survey on vaccine confidence levels across 149 countries. The results, published in The Lancet, revealed that Japan was rated as "one of the countries with the lowest levels of confidence in vaccines in the world." Confidence in vaccine safety was at only 8.9%, one of the lowest ranking alongside France and just above Mongolia (8.1%). As a result, in Japan, articles critical of vaccines have a persuasive effect and attract a large audience.

The Inextricable Link Between Vaccines and the Military

What should be done? More historical context needs to be discussed. Vaccine development in Japan has long been monopolized by a few domestic manufacturers through a "convoy system" led by the Ministry of Health, Labour, and Welfare. This history dates back to the prewar period.

Before the war, vaccine development was spearheaded by the Home Ministry's National Institute of Contagious Diseases (Denken), as well as the Imperial Army's military doctors. This included the notorious Unit 731 of the Kwantung Army, infamous for its human experiments.

The Home Ministry was responsible for maintaining public order by preventing the spread of infectious diseases. In 1897, it enacted the Infectious Disease Prevention Law, which forced the quarantine of individuals diagnosed with one of eight infectious diseases, such as cholera. This task was carried out by the Public Health Police, part of the Police Affairs Bureau of the Home Ministry (now the National Police Agency).

The public health administration system grew out of this structure. In 1938, in order to focus on promoting “healthy citizens, healthy soldiers” policy — in other words, military conscription— the Ministry of Health was separated from the Home Ministry, but the inherent value system, geared toward "controlling the populace for national interest" remained unchanged. The priority was not in respecting the rights of patients, but was instead in excluding infected individuals from society, a pattern that continued even after WWII with numerous human rights violations toward patients suffering from diseases like Hansen's and AIDS.

The Home Ministry, in collaboration with the Denken, also put effort into vaccine development. In 1910, it passed the vaccination law, and by 1938, it began BCG vaccinations. In an era before antibiotics, the development of vaccines for disease prevention was critical.

The Imperial Army placed significant emphasis on vaccines to protect soldiers from infectious diseases. This is not something unique to Japan. Even today, vaccine development in the U.S. is led by institutions such as the Walter Reed Army Institute of Research and the U.S. Naval Medical Research Center, while the Centers for Disease Control and Prevention (CDC) is the postwar offspring of the Office of Malaria Control in War Areas (MCWA) of the U.S. Military.

Today, the global vaccine market is dominated by a handful of multinational corporations: Merck (USA), Pfizer (USA), GSK (UK), and Sanofi (France). All of these countries were members of the victorious Allied powers in WWII, and still possess large military forces. It is no secret that vaccine research and development advances rapidly in countries with strong military forces.

Before WWII, Japan, led by the Home Ministry and the Imperial Army, was leading the world in vaccine development. From the Epidemic Research Institute came researchers such as Kitazato Shibasaburo, Shiga Kiyoshi, and Noguchi Hideyo, whom all were candidates for the Nobel Prize.

However, the defeat in the War drastically changed the landscape for Japanese vaccine development. The Epidemic Research Institute was disbanded by the General Headquarters of the Allied Powers (GHQ). Its current successors are the University of Tokyo's Institute of Medical Science and the National Institute of Infectious Diseases.

With the Imperial Army no longer in existence, military hospitals were taken over by the Ministry of Health and Welfare. The National Center for Global Health and Medicine in Toyama was originally a military hospital, as was the National Cancer Center in Tsukiji, which was formerly a naval hospital.

As such, the organizations involved in vaccine development were restructured post-war under GHQ leadership. However, changes in name did not lead to changes in its structural reality: Many of the individuals involved were granted indemnity, returning to leadership positions in pharmaceutical companies and research institutions that inherited the legacy of the pre-1945 “military-industrial complex”. What makes the military-industrial complex what it is, is its prioritization of national goals over the health of the people; that system hardly changed.

The KM Biologics Heritage

I believe that historical factors like these have influenced the approval of the Replicon vaccine. What I find particularly noteworthy is that Meiji Holdings has a subsidiary called KM Biologics. Its predecessor was the Experimental Medicine Research Institute, which was responsible for the development and manufacturing of vaccines and antisera in the pre-WWII era. The Experimental Medicine Research Institute was established at Kumamoto Medical University based on a proposal by Toyoichi Ohtawara, a former Denken (Japan's National Institute of Infectious Diseases) researcher who had become a professor at the university in 1924. After the war, it was reorganized into the Chemical and Serotherapy Research Institute (Kaketsuken). KM Biologics was established in 2018, taking over Kaketsuken’s pharmaceutical manufacturing and sales operations.

The national interest in terms of the development of a COVID-19 vaccine, from a national security perspective, is that Japan possesses domestically produced vaccines. Stakeholders prioritized this above all else in the approval of the Replicon vaccine, downplaying safety evaluations against global standards.

Because they are administered to healthy individuals, vaccines must maintain a high level of safety. The landscape has changed from back in 2020 when the approvals of the Pfizer and Moderna vaccines were debated. Now, with the coronavirus having weakened in virulence and other vaccines available, there is no reason to approve the KOSTAIVE vaccine under "provisional" approval.

So far, Meiji has only published results from two clinical trials involving 828 and 927 participants, respectively. These trial sizes are much too small to properly evaluate the safety of the vaccine. With Meiji conducting large-scale clinical trials in Southeast Asia, it would have been reasonable to wait for those results to come in before determining its approval.

I believe that there is much potential in KOSTAIVE. The fact that the mRNA of the injected coronavirus replicates itself in the body, which means that even small amounts of the vaccine can have long-lasting effects, is highly valuable for pandemic preparedness in the future. The potential benefits however, do not justify overlooking the proper verification of KOSTAIVE’s safety. 

The healthcare sector does not want the KOSTAIVE vaccine

Both the Ministry of Health, Labour and Welfare (MHLW) and Meiji are likely aware that the healthcare sector has no need for the KOSTAIVE vaccine. Given this situation, what Meiji should have done is complete large-scale clinical trials and publish the results in top medical journals. The Replicon vaccine is promising. After undergoing rigorous peer review, the results would probably be published in a prestigious journal like the New England Journal of Medicine. This is how companies like Pfizer and Moderna have earned the trust of the global medical community, which is why their vaccines were widely administered around the world.

However, the MHLW did not require Meiji to take these steps. Instead, it incorporated the vaccine into the official national vaccination program. As a result, Meiji was guaranteed substantial profits. This is because the government would buy up the vaccines regardless of actual usage in the healthcare sector.

This winter, the MHLW secured about 32.24 million doses of COVID-19 vaccines. Of these, about 4.27 million doses are KOSTAIVE. Although the MHLW has not disclosed the purchase price, it can be reasonably estimated at 10,000 yen per dose. In this case, Meiji stands to make more than 40 billion yen in sales with KOSTAIVE. Since the COVID-19 vaccine is part of the official vaccination program, this situation will likely continue for the foreseeable future.

Meiji HD’s sales for FY 2023 were 1.1054 trillion yen, with an operating profit of 84.3 billion yen. For its pharmaceutical business alone, sales were 206.1 billion yen, with a profit of 22.7 billion yen. The profits from KOSTAIVE are significant for Meiji.

This is unfair. There is no rational reason to pour massive amounts of taxpayer money into a vaccine that is expected to be used only rarely. Why would the MHLW do this? I believe it is because the MHLW was trying to repay a favor that Meiji had done for them in the past.

The Kaketsuken Scandal — Looming in the Background?

As previously mentioned, KM Biologics was established as a body that would inherit the business of Kaketsuken. What germinated this transfer was the systemic corruption at Kaketsuken revealed in 2015.

When Kaketsuken was found to have been manufacturing blood products through methods unauthorized by government, the then Minister of Health, Labour and Welfare, Yasuhisa Shiozaki, demanded uncompromising punishment. However, since Kaketsuken held a semi-monopoly on certain vaccines, the ministry could not afford to let the company go into bankruptcy. The ministry reached out to large domestic companies to bail out Kaketsuken, but was met with refusals. It was Meiji that eventually —and ultimately— took the lead in taking over the business.

The MHLW’s response during this period was appalling. In spite of Kaketsuken’s persistent and malicious cover-up for over 40 years, the ministry showed no intention to properly address the matter, and worked instead to protect Kaketsuken.

Symbolic of this failure was the fact that the “Working group to discuss the future of the blood product and vaccine manufacturing industry”—the working group formed to address this particular case—did not include the Health Insurance Bureau, the branch of the MLHW responsible for setting medical fees.

If the government had indeed intended to properly address Kaketsuken’s corruption, it would have been necessary to demand Kaketsuken to return the money it received from medical institutions for purchasing its pharmaceutical products. The ministry would have most likely had to step in to mediate this process — one too complicated for individual medical institutions to handle on their own. The appropriate department to handle that matter would be the Health Insurance Bureau. According to a former MHLW official, “The exclusion of the Health Insurance Bureau means that the MHLW had no intention of making Kaketsuken return the money from the very beginning.”

If similar corruption were exposed in medical institutions, the MHLW would likely demand the return of medical fees retroactively. Many medical institutions have gone bankrupt or been sold off in the past this way. There is a clear double standard in use.

Of course, the MHLW may have its reasons: “The vested interests of the ‘military-industrial complex,’ which have existed since before WWII, cannot be easily rinsed away. Reforms would involve intense "pain." Regardless of what the Minister may say, the only option is to kick the can.” In this way, vested interests were preserved.

This, perhaps, is what led to the special approval of KOSTAIVE. If that is the case, Japan’s vaccine development capabilities will continue its decline, and public distrust will only grow for as long as such practices continue. A fundamental review is necessary now.

Originally published in Foresight, Nov 5th, 2024