The Shadow of Vaccines Revealed by the Costaive Controversy: Lessons for the Future on Establishing Safety Evaluations

Masahiro Kami, M.D., Ph.D. President, Medical Governance Research Institute, Tokyo, Japan

The new coronavirus vaccine "Costaive," developed by Meiji Seika Pharma (a subsidiary of Meiji Holdings), has garnered significant public attention. Social media is flooded with misinformation, including claims that vaccinated individuals can infect others through 'shedding'.

Meiji has initiated defamation lawsuits against anti-vaccine groups that have led the spread of these falsehoods. Additionally, on October 16th, Meiji published a full-page advertisement in national newspapers stating, "Posts without scientific basis and spreading misinformation are on the rise," highlighting the bizarre circumstances.

Why has it come to this? It's because the Japanese public does not trust vaccines. In September 2020, a research team from the University of London published findings in "The Lancet" that surveyed vaccine confidence across 149 countries. Japan was rated as the country with the least trust in vaccines globally, with a confidence level of only 8.9%, comparable to France and just above Mongolia at 8.1%.

In Japan, where vaccines are distrusted, articles against vaccines are welcomed by readers, encouraging journalists to sensationalize the dangers of vaccines. Most journalists are aware of the problem but feel powerless to stop, as newspapers and publishers need to generate sales. This cycle of vaccine disinformation is likely to continue.

What can be done? More discussion on the historical background is needed. Vaccine development in Japan has been monopolized by a few domestic manufacturers through a convoy system managed by the Ministry of Health, Labour and Welfare, a practice that dates back to pre-war times.

Before the war, vaccine development was predominantly led by the Infectious Disease Research Institute (now part of the University of Tokyo's Medical Science Research Institute and the National Institute of Infectious Diseases) and military doctors from the Imperial Army, including the infamous Army Epidemic Prevention and Water Purification Department (Unit 731). It's fair to say that a "military-industrial complex" was in charge.

Post-war, the basic structure remained unchanged. Many involved were exempted from prosecution and returned to executive positions within the pharmaceutical companies and research institutions, continuing the legacy of the "military-industrial complex."

KM Biologics, a subsidiary of Meiji HD, originated as the Institute of Chemical and Serum Therapy. Established in 1947, it was based on an experimental medical research institute at Kumamoto Medical University, which was involved in vaccine and antiserum development under the advocacy of Toyokazu Otawara, a professor at Kumamoto Medical University, who had worked at the Infectious Disease Research Institute until his appointment at Kumamoto in 1947.

The authoritarian nature of the pre-war "military-industrial complex" is well-documented, and its influence persists to this day. The approval of the replicon vaccine ignored public safety in favor of stakeholders' interests, exemplified by a disregard for safety since vaccines are administered to healthy individuals, necessitating high safety standards. Unlike the situation in 2020 when the Pfizer and Moderna vaccines were being debated, there is no need to grant an "emergency license" to Costaive now, given the availability of other vaccines and the mild nature of the current coronavirus strains.

To date, Meiji has only published results from two clinical trials involving 828 and 927 individuals, respectively—far too small to adequately assess vaccine safety. Meiji is conducting larger trials in Southeast Asia, and approval could wait until those results are available.

I highly regard the potential of Costaive. The self-replicating mRNA of the injected coronavirus suggests that a small amount of the vaccine could provide long-lasting effects, which is valuable for future pandemic preparedness. However, the potential of Costaive and the verification of its safety are separate issues.

Medical professionals in Japan, recognized by both the Ministry of Health and Meiji, are not demanding Costaive. Even if its safety and efficacy are promoted, few doctors or citizens would choose it over Pfizer or Moderna products. When patients ask me which vaccine to take, I advise against using the replicon vaccine at this stage due to its limited application experience.

What Meiji should do now is complete the large-scale trials and publish the results in a leading medical journal. Replicon vaccines are promising, and if they undergo rigorous peer review, publications like the New England Journal of Medicine will likely feature them. This is how Pfizer and Moderna gained the trust of the global medical community and why their vaccines are widely administered.

However, the Ministry of Health and Meiji have skipped these steps, presumably for financial reasons. This brings us to the issue of incorporating Costaive into the legal vaccination framework, ensuring Meiji profits substantially. Regardless of its actual use in medical settings, the government will continue purchasing the vaccine. This winter, the Ministry secured 32.24 million doses of coronavirus vaccines, 4.27 million of which are Costaive. While the purchasing price has not been disclosed, it's reasonable to assume a cost of about 10,000 yen per dose, resulting in over 40 billion yen in revenue for Meiji. With Costaive legally integrated into the vaccination schedule, this situation is expected to persist.

In fiscal year 2023, Meiji HD reported sales of 1 trillion 105.4 billion yen, with an operating profit of 84.3 billion yen. The pharmaceutical division alone posted sales of 206.1 billion yen and an operating profit of 22.7 billion yen. The significance of Costaive's profits to Meiji HD is clear.

This is not fair. There is no rational reason to pour vast amounts of taxpayer money into a vaccine that is unlikely to be widely used. Why would the Ministry of Health do this? I believe it's because the Ministry is repaying a debt to Meiji HD.

This repayment is linked to the scandalous takeover of Kaketsuken by Meiji following organizational misconduct exposed in 2015. At the time, then-Minister of Health Yasuhisa Shiozaki demanded severe penalties, but because Kaketsuken had nearly monopolized the sale of certain vaccines, the Ministry could not allow it to fail. After all major domestic companies refused to take over, Meiji, along with Kumamoto Prefectural Government and local businesses, inherited the business.

The Ministry's response was excessive. For about 40 years, Kaketsuken continued its egregious cover-ups with the Ministry's support, never intending to handle the situation appropriately from the start. This is evidenced by the absence of the Insurance Bureau, which handles medical fees, from the working group convened to discuss responses to the blood product and vaccine manufacturing scandal. This indicates there was no intention to make Kaketsuken repay the funds.

If similar misconduct were exposed in medical institutions, the Ministry would demand reimbursement of medical fees retroactively, leading many institutions to bankruptcy or sale. This represents a complete double standard.

Of course, the Ministry has its reasons. The privileges of the pre-war "military-industrial complex" are not easily settled, and reform involves intense "pain." No matter what former Minister Shiozaki says, they cannot accomplish it. This leads to the perpetuation of the privilege system and the special approval of Costaive.

Can this kind of favoritism continue? Over time, Japan's vaccine development capabilities have declined, and Japanese vaccines have lost the trust of the public. More serious "work" is needed.

Originally published in Iyakukeizai in November 1, 2024