Japanese Researchers Call for Withdrawal of mRNA Vaccines
- Simian Practicalist
- Sep 4
- 4 min read
A Japanese study by J. Ueda et al titled “Regulatory and Safety Assessment of COVID-19 mRNA-LNP Genetic Vaccines in Japan: Evidence for Revocation of Approval and Market Withdrawal” posted on 26 August 2025 reviews the “deficiencies” in the approval and regulatory processes leading up to the vaccine rollout, and subsequent issues and their mismanagement.
Anyone who has been half-following this topic will unlikely find anything new in this paper, but it is a well-written piece that reviews the history mostly in Japan (which is similar to much of the world) and from the Japanese perspective.
The paper is 45 pages long, with the main text at about 23 pages. The remaining are tables and references. Despite the length, it is not a difficult read. Some of the information is tabulated for convenience; for example, Table 1 is a summary of relevant statutory provisions regarding the regulation and approval of vaccines.
A few key points are reproduced below, not intended as a summary.
The mRNA “vaccines” are not even vaccines in the conventional sense. The authors explicitly refer to these as “genetic vaccines” that should be classified as “gene therapy products”. Yet, these were approved without adequate trials or communication in packaging.
Genetic vaccines should properly be classified as gene therapy products based on their mechanism of action (Table 4), yet they were reviewed under the same regulatory framework as conventional vaccines despite not being pharmacologically or structurally equivalent. Consequently, several key elements typically evaluated in non-clinical safety studies—such as biodistribution, pharmacokinetics, organ-specific toxicity, placental transfer, fetal toxicity, and immunogenicity—were not assessed.
Approximately 103.46 million people (79.5% of the Japanese population) received their second dose. However, case fatality rates do not favor the vaccinated.
The case fatality rates across all age groups were 0.12% (unvaccinated), 0.41% (single dose), and 0.58% (two doses), respectively, showing a trend of increasing case fatality rates with increasing doses of genetic vaccines. This trend is more pronounced in specific age groups.
The statistics for new cases also do not favor the vaccinated.
For example, in the 65-69 age group, unvaccinated individuals had 66.5 new positive cases, compared to 265.5 cases among those who received two doses and 169.5 cases among those who received three doses.
New cases within 14 days of vaccine administration were not classified as “vaccinated”, thus inflating the efficacy. Simultaneously, the obvious temporal clustering of deaths within days of administration suggests a serious safety issue.
The lack of a framework allows these genetic vaccines to remain available and to continue to cause problems.
[A]lthough over 2,000 post-vaccination deaths have been reported by physicians in Japan, autopsies have been performed in only approximately 10% of cases. Consequently, nearly 99% of these reports have been classified as “causality indeterminable.”
The authors mention the much-repeated fact that repeated exposure to the spike protein is “associated with elevated IgG4 responses, which may modulate immune reactivity”.
Supporting these concerns, mortality rates for specific cancers—including ovarian cancer, leukemia, lip/oral cavity/pharyngeal cancer, and pancreatic cancer—have shown a notable increase in Japan since the initiation of genetic vaccine administration.
The authors are also concerned about the development of the self-amplifying RNA (saRNA) vaccines when the current mRNA vaccines are associated with so many health problems.
Indeed, according to a document published by Meiji Seika Pharma Co., Ltd. in May 2025, multiple adverse events were reported within just a few months after initiating the administration of this formulation, including four fatalities.
As already mentioned, the regulatory misclassification of these genetic vaccines and the consequent lack of standards cause problems. This includes the technique of how the RNA is structured.
On the other hand, genetic recombination experiments conducted at research institutions such as universities and companies require strict risk management from a biosafety perspective to avoid infection risks and unexpected recombination risks. As part of this approach, measures are implemented to minimize risks, such as dividing genes within viral vectors across multiple plasmids. In contrast, the saRNA vaccine approved in Japan incorporates both the mRNA replication enzyme (replicase) and the antigen gene on a single vector, suggesting that biosafety safeguards may be insufficient for pharmaceutical products intended for human use.
As adverse events such as myocarditis were reported, the Ministry of Health, Labour and Welfare (MHLW) became even less transparent.
Until the end of 2021, the MHLW routinely published cumulative data on post-vaccination deaths officially certified under the government relief program. Starting in 2022, these cumulative updates ceased, compelling researchers to reconstruct the data manually from individual review committee minutes and annual reports. This interruption in transparent data dissemination appears to reflect a broader institutional tendency where information potentially deemed politically or administratively sensitive is selectively disclosed or withheld.
There are other issues, such as members of the study group tasked with investigating adverse reactions receiving funding from pharmaceutical companies, which is an obvious conflict of interest and violates multiple Japanese statutes.
In short, the authors point out the inadequacy of the relevant authorities in not only approving these genetic vaccines but also failing to deal with post-implementation issues in a transparent manner—such as increasing new cases, excess deaths, the discovery of DNA contamination levels—and call for their withdrawal.
Genetic vaccines have already caused extensive harm worldwide following administration. Furthermore, given the absence of scientific evidence demonstrating efficacy in preventing the infection or severe disease, these formulations should be recognized as “not found to have the efficacy or effects indicated in the application” (PMD Act, Article 14, paragraph (2), item (iii), (a)) or “found to have no value as a pharmaceutical or quasi-pharmaceutical product as they have harmful effects which outweigh their efficacy or effects” (PMD Act, Article 14, paragraph (2), item (iii), (b)). Accordingly, the approval of these formulations should be revoked pursuant to Article 74-2, paragraph (1) of the PMD Act, on the grounds that they have come to fall under one or more of the conditions specified in Article 14, paragraph (2), item (iii), subitems (a) through (c) of the same Act.
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