Chapter 3
METHODOLOGY
In this research, a qualitative method was employed through critical analysis, entailing the examination of data such as texts, images, or observations to acquire profound insights and understandings of a particular phenomenon or issue. Critical analysis in qualitative research involves questioning assumptions, scrutinizing power dynamics, and considering multiple perspectives. Researchers employed this method to uncover underlying meanings, ideologies, or social structures that might have influenced the phenomenon under study. Theories regarding the implementation of COVID immunization vary depending on different factors such as public health policies, vaccine availability, and societal attitudes. Some theories focus on the diffusion of innovations, examining how new vaccines spread through populations and communities. Others may emphasize behavioral theories, exploring factors that influence individual decisions to get vaccinated, such as perceived risks and benefits, social norms, and access to healthcare. In this study, health communication theories were utilized, considering how messages about vaccination are crafted and disseminated to the public. Overall, theories regarding the implementation of COVID immunization provide frameworks for understanding and addressing the complex dynamics involved in vaccination campaigns.
REVIEW OF RELATED LITERATURE
Dr. Masanori Fukushima, a respected Professor Emeritus at Kyoto University, made critical remarks at a Vaccine Evaluation Committee meeting in Japan on November 25, 2022. His career highlights include directing the Clinical Research Information Center and currently leading the Medical Innovation Promotion Center at the Kobe Medical Industry City Promotion Organization. He's known for his contributions to clinical research and public health, actively engaging in discussions about vaccines and public health policy (Fukushima, 2022).
The remarks by Masanori Fukushima, Professor Emeritus of Kyoto University, during this meeting, provide valuable insights into the perceived risks associated with the COVID-19 genetic vaccine. Robust immunohistopathological evidence indicates that the COVID-19 genetic vaccine is widely distributed in the body and may affect tissues far from the terminally differentiated injection site. Fukushima's statements, as presented in various sources, highlight concerns about the widespread distribution of the vaccine in the body and its potential impact on tissues beyond the injection site (Polykretis et al., 2023).
Figure 1. Number of additional vaccinations
Fukushima, a highly regarded medical scientist in Japan, criticizes the decision-making process regarding the COVID-19 vaccine and expresses frustration at what he sees as a disregard for scientific and medical principles (Zhou et al., 2020). He emphasizes the importance of a robust immunohistopathological approach in understanding the vaccine's effects and advocates for the dissolution of the evaluation committee, calling for a comprehensive investigation (Tomey, 2022).
The professor raises significant points related to vaccine safety, citing a paper that underscores the global implications of vaccine damage. He draws attention to adverse outcomes and questions the legitimacy of public health agencies in addressing these concerns. Fukushima points to specific issues such as cardiovascular problems in children post-vaccination and contends that the vaccine may have contributed to numerous deaths, potentially beyond official figures.
The critique extends to the vaccine's impact on various physiological systems, including the cardiovascular system, autoimmune responses, increased susceptibility to infections, and potential effects on the brain. Fukushima challenges the narrative around the safety of lipid nanoparticles, emphasizing their role in cellular transformation and their potential to breach the blood-brain barrier. The professor also discusses the suppression of natural immunity in vaccinated individuals, linking it to breakthrough infections and transmission dynamics. He refers to data from the Ministry of Health, Labor and Welfare to support his claims and urges individuals to report adverse reactions promptly (Ministry of Health, Labor and Welfare, 2022).
Fukushima's remarks at the Vaccine Evaluation Committee meeting contribute to the growing body of literature expressing concerns about the safety and efficacy of the COVID-19 genetic vaccine. His statements underscore the need for a thorough examination of potential adverse effects and a reevaluation of vaccination strategies. The professor's perspectives, rooted in scientific and medical expertise, add a critical dimension to the ongoing discourse surrounding COVID-19 vaccines.
The Japanese government's COVID-19 vaccination strategy has come under scrutiny, particularly regarding the basis for vaccine quantity calculations, data interpretation, and safety communication. The Board of Audit has emphasized the necessity of a transparent and objective foundation for decisions, highlighting concerns about the procurement of 880 million vaccine doses. The Board specifically noted insufficient documentation from the Ministry of Health, Labor and Welfare in describing the basis for quantities secured in each contract with pharmaceutical companies (Board of Audit, 2020).
Furthermore, the Board expressed apprehensions about potential economic inefficiencies due to overestimating required vaccine quantities, citing the risk of cancellation fees and disposal costs. With Japan's population exceeding 120 million, discrepancies between initial vaccination targets and actual budget utilization have been criticized as haphazard, lacking clear justification (Board of Audit, 2020).
Concerns about data interpretation have also arisen, with revelations about vaccination efficacy leading to discussions on the reliability of vaccination data. The New Coronavirus Infectious Disease Countermeasures Advisory Board presented data showing higher infection rates among individuals who received two vaccine doses. Changes in categorizing vaccination history, including the controversial inclusion of "vaccination history unknown" as "unvaccinated," have fueled concerns about data manipulation (Ministry of Health, Labour and Welfare, 2023).
The Ministry of Health, Labor and Welfare's communication about vaccine safety has faced criticism, particularly regarding a pamphlet comparing myocarditis/pericarditis cases between vaccinated individuals and those with a new coronavirus infection. Despite over 300 approved relief cases under the Immunization Law, concerns persist about the government's proactive promotion of vaccination despite reported health damages (Ministry of Health, Labour and Welfare, 2023).
Controversies surrounding excess deaths and a potential link to vaccination have been highlighted by journalist Shigemitsu Fujie and Director Wakita of the National Institute of Infectious Diseases. While Director Wakita clarified the absence of scientific evidence supporting excess deaths due to vaccination, concerns persist, and the issue remains contentious.
Figure 2. Excess deaths/month
In response to safety concerns, Representative Yanagase and other political figures have called for a reevaluation of vaccination policies. Questions in the Diet reflect concerns about the government's handling of health hazards related to vaccination and the potential impact on excess mortality (Ministry of Health, Labour and Welfare, 2023).
The establishment of the Bipartisan WCH Parliamentarians' League underscores Japan's involvement in international debates on the WHO's "Pandemic Convention" and "International Health Regulations." Questions about the democratic process in deciding on these regulations highlight the global impact of vaccination policies and the need for comprehensive discussions (Ministry of Health, Labour and Welfare, 2023).
In summary, Japan's COVID-19 vaccination strategy faces challenges in quantity planning, data interpretation, and safety communication. Criticisms range from economic considerations to data reliability and potential health risks. Ongoing debates in parliamentary sessions and international forums highlight the complexity of balancing public health, individual rights, and global health governance in the face of a pandemic.
A Critical analysis approach aids in deciphering nuanced perceptions and interpretations surrounding COVID-19 vaccination. The global spread of SARS-CoV-2 prompted the World Health Organization (WHO) to declare a pandemic, marking a significant public health challenge. Despite the declaration of the end of the public health emergency in May 2023, the ongoing threat of severe symptomatic damage persists. This paper critically examines the robust immunohistopathological evidence suggesting widespread distribution of COVID-19 genetic vaccines beyond the injection site, affecting terminally differentiated tissues such as the heart and brain.
In a paper titled "Autoimmune inflammatory reactions triggered by the COVID-19 genetic vaccine in terminally differentiated tissues" by Polykretis, P., Donzelli, A., Lindsay, J. C., Wiseman, D., et al., a content claim is made. Robust immunohistopathological evidence indicates that the COVID-19 genetic vaccine can be widely distributed in the body, affecting tissues far from the terminally differentiated injection site, such as the heart and brain. This can lead to in situ production of the spike protein, triggering a strong autoimmune inflammatory response.
The World Health Organization (WHO) declared a global pandemic due to the spread of SARS-CoV-2. Although the WHO Director-General declared the end of the public health emergency on May 5, 2023, it was emphasized that the disease remains a global threat (Pezzullo ,2023). Recent histopathological evidence suggests that genetic vaccines against SARS-CoV-2 may distribute beyond the injection site and involve terminally differentiated tissues susceptible to severe symptomatic damage. Young people and those with natural immunity have a lower infection fatality rate, and the latter have greater protection against reinfection and severe COVID-19 infection provided by natural immunity (Chemaitelly, 2022) .
Doctors and scientists advocating for genetic vaccines may be overlooking important immunological mechanisms and underestimating potential autoimmune effects. Recognizing that all cells synthesizing viral proteins are perceived as threats by the immune system and are killed, it becomes crucial to determine the precise biodistribution of genetic vaccines within the organism. Some authors have highlighted the need for accurate pharmacokinetic and pharmacodynamic evaluation. However, according to the European Medicines Agency (EMA) policy, pharmacokinetic studies are generally not mandatory for vaccines, despite being a fundamental part of the safety assessment of medicinal products (Zhou et al., 2020). A biodistribution study conducted by Pfizer in rats and submitted to drug regulatory authorities was published for the first time by Japan's Pharmaceuticals and Medical Devices Agency (PMDA), showing that mRNA-containing lipid nanoparticles (LNPs) mainly accumulate in the liver, exceeding the injection site. Over 48 hours, distribution from the injection site to most tissues occurred, with most tissues showing low levels of radioactivity. Additional evidence suggests genetic vaccines can persist in the blood, with vaccine-associated synthetic mRNA remaining detectable for at least 2 weeks after injection.
Exosomes containing the spike protein were detected in the blood 14 days after vaccination, increased after the booster vaccination, and persisted for 4 months. Exosomes, protecting the mRNA cargo from degradation, can travel through the vasculature, lymphatic system, and nerve fibers, reaching major organs like the heart, liver, and brain.
Exosome transport of genetic material also plays a role in reproductive tissues, where sperm-mediated gene transfer (SMGT) has been demonstrated. In vitro data suggesting vaccine-derived genetic material can be reverse transcribed into DNA in human liver cell lines raises concerns about possible reactions to host tissues, including reproductive tissues. The possibility of these sequences being passed on to offspring should be thoroughly investigated.
Histological evidence from biopsies and autopsies shows that the vaccine-derived spike protein is synthesized in terminally differentiated tissues. Neurological diseases, including chronic inflammatory demyelinating polyneuropathy (CIDP) and multiple sclerosis (MS), have been directly attributed to mRNA-based COVID-19 vaccination. The mediation machinery supporting translation of the spike protein within affected neural tissue and the mechanism of p53 overexpression due to spike protein toxicity in neurons have been revealed. The presence of free spike protein in the blood can cause dysregulation of the renin-angiotensin system through ACE2 binding, leading to endothelium-platelet interactions and adversely affecting the cardiovascular system
Biodistribution Challenges and Immunological Mechanisms:
Young individuals and those with natural immunity exhibit lower infection fatality rates, emphasizing the importance of understanding the immunological nuances of genetic vaccines. However, the current focus on genetic vaccines may overlook potential autoimmune effects. The paper highlights the need for precise biodistribution studies to determine the reach of genetic vaccines within the organism. Pharmacokinetic studies, not mandatory for vaccines per European Medicines Agency (EMA) policy, are deemed crucial for safety assessments. (Polykretis, et al. 2023)
Biodistribution Evidence and Persistence:
The study cites Pfizer's biodistribution study, revealing mRNA-containing lipid nanoparticles' accumulation in the liver and distribution to various tissues. Evidence of genetic vaccine persistence in the blood, with vaccine-associated synthetic mRNA detectable for at least two weeks post-injection, raises concerns about long-term effects. Exosomes containing the spike protein, detected in the blood even four months post-vaccination, highlight potential routes of transport to major organs like the heart, liver, and brain. (Polykretis, et al. 2023)
Reproductive Tissue Implications:
The paper emphasizes the role of exosome transport in reproductive tissues, raising concerns about sperm-mediated gene transfer (SMGT) in the testis. In vitro data suggesting reverse transcription of vaccine-derived genetic material into DNA in human liver cell lines necessitates comprehensive investigations into possible reactions to host tissues and potential transmission to offspring. (Polykretis, et al. 2023)
Histological Evidence and Neurological Implications:
Histopathological evidence from biopsies and autopsies indicates the synthesis of vaccine-derived spike protein in terminally differentiated tissues. Neurological diseases, including chronic inflammatory demyelinating polyneuropathy (CIDP) and multiple sclerosis (MS), have been directly attributed to mRNA-based COVID-19 vaccination. The paper highlights the mediation machinery supporting translation of the spike protein in affected neural tissues and reveals the mechanism of p53 overexpression due to spike protein toxicity in neurons. (Polykretis, et al. 2023)
Cardiovascular System Concerns:
The presence of free spike protein in the blood raises concerns about dysregulation of the renin-angiotensin system through ACE2 binding, potentially affecting endothelium-platelet interactions and posing a danger to the cardiovascular system.
This comprehensive analysis underscores the need for a nuanced understanding of the immunological mechanisms and potential risks associated with COVID-19 genetic vaccines.
The evidence presented calls for further research, emphasizing the importance of accurate biodistribution studies, pharmacokinetic assessments, and a thorough investigation into the long-term effects, especially concerning reproductive tissues and the cardiovascular system. (Polykretis, et al. 2023)
In conclusion, Dr. Masanori Fukushima, a respected medical scientist, has expressed significant concerns about the safety and efficacy of the COVID-19 genetic vaccine. The analysis, supported by Polykretis et al., emphasizes the potential widespread distribution of the vaccine in the body, triggering autoimmune responses in tissues such as the heart and brain. Fukushima's critique aligns with broader challenges in Japan's vaccination strategy, including issues with quantity planning, data interpretation, and safety communication.
The paper underscores the need for precise biodistribution studies, pharmacokinetic assessments, and thorough investigations into long-term effects, especially regarding reproductive tissues and the cardiovascular system. The Critical analysis approach used in this analysis helps decipher nuanced perceptions surrounding COVID-19 vaccination, emphasizing the ongoing importance of research to inform vaccination strategies and policy decisions.