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FOR IMMEDIATE RELEASE
Orthomolecular Medicine News Service, June 3, 2024

Considerations about the Children's Immunization Program

by Jorge R Miranda-Massari, PharmD*,1,3 and Michael J. González, DSc, NMD, PhD2,3,4

Introduction

To make a careful decision on how to address the issue of vaccines so that we protect the health of our children, details of the immune system response and the physiological challenge it produces in the young individual must be considered and calibrated in detail. The criteria used to generate the recommended vaccine guidelines vary from one country to another according to the evidence considered of their need to protect from certain conditions according to the perceived risks, the effectiveness of the product and its safety.

One of the most important criteria regarding the need for protection from infection is the functioning of the immune system. Individuals with balanced and active immune systems have a lower risk of contracting infections, and when they do contract them, they have lower severity and shorter duration of symptoms, as well as a lower risk of complications.

For the proper functioning of the immune system, it is essential to have good nutrition. A diet where refined, processed and low nutritional density foods are very common will cause micronutrient insufficiencies, which decreases the cellular immune system (white blood cells and lymphocytes) and the humoral immune system (antibodies). In fact, it has been reported in studies from the US Federal government (CDC) that there is a high rate of people with various insufficiencies of micronutrients that support the immune system [12]. There is available evidence indicating that supplementation with micronutrients with immune system supporting roles can modulate and reduce the risk of infections [3]. Nutrition and supplementation are relevant because it allows for an appropriate and balanced immune defense. A population with an appropriate immunological defense reduces the risks of infection and complications, which has an impact on defining the need for a vaccine, since this decision must be a balance of risk and benefit.

Discussion

The following three factors are key to understanding the problem with the current vaccination schedule.

1-Immune exhaustion

Traditional vaccines work by using an attenuated or inactive virus in a medium that, when injected, causes inflammation to attract various types of white cells of the innate immune system, which trap, break down and process its proteins. Dendritic cells induce the responses of the acquired system (lymphocytes). A type of T lymphocytes processes the information from the viral protein and presents it to B lymphocytes so that they produce antibodies. The antibody production process is stimulated by the vaccine and leads to information processing, the assembly of amino acid molecules forming peptides catalyzed by enzymes, a process that consumes cellular energy. It is important to recognize the complexity of the process and the resources it requires, since the more vaccines are administered and the more frequently they are given, the more molecular and energetic resources are required for the immune system to produce functional or neutralizing antibodies.

When frequent stimuli challenge the body to push the capacity of antibody production to the limit in terms of enzymes, available amino acids and other cofactors, and metabolic energy, this can cause a variety of imbalances that include, among others, immune exhaustion. This exhaustion refers to a dysfunction of T lymphocytes in which they lose the ability to bind to and neutralize viruses, in addition to a decreased ability to generate functional antibodies. .

By 1962 the government vaccination program for children and adolescents required 5 doses (OPV, Smallpox, DTP), by 1983 this had been increased to 24 doses. In 1986, President Ronald Reagan passed a law (National Vaccine Harm to Children Act) to grant vaccine manufacturers immunity from lawsuits over deaths or injuries resulting from vaccines. This law created a compensation fund from which around 5 billion has been paid for damages from vaccines, which is estimated to be a fraction of the true current damages [5,6]. After 1986 there was rapid growth in the number of vaccines recommended as necessary. For 2018, 72 doses were already recommended. Which is a challenge to the immune system, especially in children.

2-Immune system confusion

Various adverse reactions are involved with vaccines. These adverse reactions to vaccines can be considered as a result of the interaction between the susceptibility of the vaccinated subject and various components of the vaccine. Among the mechanisms involved in these reactions is molecular imitation. Imitation or molecular mimicry refers to a significant similarity between certain pathogenic elements contained in the vaccine and specific human proteins. This similarity can lead to immune cross-reactivity, in which the immune system's reaction toward pathogenic antigens can damage similar human proteins, essentially causing autoimmune diseases [15].

3-Antibody-dependent Enhancement (ADE)

Antibodies may occasionally have diminished or contrary actions. They may lose the ability to bind and neutralize viruses and, in rare cases, may actually increase the ability of a virus to enter cells and cause worsening of the disease through a mechanism called antibody-dependent enhancement (ADE). ADE has been observed in Dengue, SARS, MERS, and other human respiratory virus infections [10,17]. Data from studies of respiratory viruses such as SARS-CoV-2 suggest that antibodies against SARS-CoV-2 may exacerbate the severity of infection through the ADE mechanism [8]. The constant production of non-neutralizing antibodies reduces the ability to generate other antibodies, allowing greater infection of variants or other infectious organisms.

Appropriate informed consent

Responsibility for the maintenance and promotion of health in a society is shared between governments, communities, institutions and the individual. Institutions must take great care in managing the resources of the country and communities in terms of sanitation, pollution control, food safety and others. However, each individual must make the decisions regarding their health and body, because each individual will live with the consequences. All evidence of risks and benefits must be presented to have truly informed consent. Informed consent should include information about the potential benefits and risks of vaccines. It should also include information on important aspects of lifestyle that protect against contagious infections including strengthening the immune system and the opportunity to refuse the vaccine for religious, philosophical and medical reasons. The state must protect the human rights of its citizens and protection from discriminatory actions must be provided.

The proposed benefits of vaccines are:

  1. Disease prevention: Vaccines are a tool to prevent infectious diseases.
  2. Disease eradication: Vaccines have proven to be essential in the eradication of diseases.
  3. Herd Immunity: Mass vaccination creates herd immunity, which reduces the spread of disease and protects individuals who cannot be vaccinated due to underlying medical conditions.
  4. Reduction in hospitalizations and medical costs: Disease prevention through vaccination reduces the burden of disease on society, which in turn reduces the need for hospitalizations and the associated cost of healthcare.

The known risks of vaccines are:

  1. Side effects: As with any medication, vaccines can have adverse side effects. There are mild side effects that go away quickly, such as fever, pain at the injection site, or general malaise. However, more serious reactions can occur.
  2. Allergies: Some people may have allergies to vaccine components, such as egg, gelatin or latex. It is important to inform your health care professional of any known allergies before receiving a vaccine.
  3. Risk of disease: There is a small risk of developing the disease being vaccinated. Most vaccines are designed to be inactivated or weakened so as not to cause full-blown disease.
  4. Serious adverse reactions: Some vaccines can have serious adverse reactions, such as seizures or severe allergic reactions.

We must evaluate individually with the help of a trusted health professional who helps evaluate the benefits of vaccination against the risks. In general, to evaluate the risks and benefits of vaccines, the expected benefits of the vaccine, such as disease prevention, effectiveness, and the importance of preventing the disease in question, must be considered. Possible side effects should also be analyzed, evaluating their frequency and severity. It is essential to consult reliable sources, including competent and trustworthy health professionals always considering the personal situation of each individual. Furthermore, it should be noted that risk-benefit assessment is an ongoing process that is constantly updated.

Immunization against SARS-Cov-2

All vaccines introduced before 2020 were attenuated or deactivated microorganisms that were integrated into a preparation. When this preparation was applied to the human body, it produced a stimulation of the immune cells and finally resulted in the production of neutralizing antibodies against the microorganism used. It is relevant to note that this traditional method integrates a standard amount of protein and used all the microorganism's proteins, which produces a predictable and complete immune reaction. On the other hand, the new vaccines recommended by the CDC and authorized by the FDA for immunization against SARS-Cov-2 for 2020, are substantially different from traditional vaccines since, instead of containing proteins from the microorganism in question, they contain mRNA with the instruction to produce the virus's spike protein (Protein S). It is important to clarify that the evidence in the literature clearly and unequivocally indicates that the S protein is the most harmful and toxic element of the SARS-Cov-2 virus [4].

This change in methodology design is very important, because instead of delivering a known amount of protein, mRNA is injected with the instruction for the tissues in the body of the inoculated person to produce protein S.

The problem with the production of protein S is that we do not know the quantity, intensity and for how long this toxic substance will be produced. This has the potential to cause many adverse effects [4,7].

Another aspect related to the new inoculations of mRNA technology is that the definition of the term "vaccine" was changed. The original term referred to products that contained all the proteins of the infectious agent. The gene products, however, have also been called "vaccines" to create trust in the public. This product is a genetic manipulation technique to force tissues to produce protein S to stimulate the production of antibodies. The protein S is the toxic element that induces clots, inflammation and damage to the mitochondria. That is why they affect nerves and cardiac tissues, because they require the most energy. This S protein also changes its structural conformity frequently, due to the high mutation rate of the SAR-Cov2 virus. For this reason, inoculations quickly lose their ability to neutralize the virus.

Consequently, it has been observed that the effectiveness of inoculations decreases rapidly, which is why new inoculations have to be carried out frequently. Having people with one vaccine and several boosters who continue to get sick, it was decided to change the definition of a fully vaccinated individual. In this way they could justify that people vaccinated with one or more boosters were hospitalized or died from COVID, saying that they were not fully vaccinated.

VAERS

The Vaccine Adverse Event Reporting System is a US program to monitor vaccine safety, created by the US Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA). . The records of adverse effects including deaths following immunization with mRNA products in three years is much greater than the total number of adverse effects recorded for all vaccines since 1990 (34 years ago). Examining VAERS data during the first year of mRNA inoculations finds that one year of COVID inoculations compared to 30 years of all other vaccines combined the number of adverse events and disabling events are comparable. However, there are more deaths, hospitalizations, and life-threatening events [14].

Safety reports of serious individual cases and serious adverse events after vaccines were 51,498 and 271,444 respectively. Hypertension was the most common comorbidity (22%). It was detected that the odds of acute myocardial infarction increased by 10 times. Those who had suffered a myocardial infarction (MI) were 5.7 times more likely to suffer an MI after immunization. Additionally, patients who had atrial fibrillation (AF), acute kidney injury (AKI), cardiovascular accident (CVA), or pulmonary embolism (PE) had 7.02 times, 39.09 times, 6.03 times, or 3.97 times more likely to suffer each adverse effect after immunization respectively, [2]. In one study, 21% of BNT162b2 recipients reported adverse events related to inoculation, a rate that is significantly higher than that of the placebo group (5%) [11].

Other vaccines

Gardasil is a vaccine against human papillomavirus (HPV). It is promoted to prevent the proliferation of certain strains of HPV and reduce the risk of certain types of cancer.

There are several types of HPV vaccines according to the number of strains used. Studies with various types of vaccines have found considerable adverse effects [9]. Compared with 2,871 women who received aluminum placebo, the group of 2,881 women injected with the bivalent HPV vaccine had more deaths at follow-up (14 vs. 3, p = 0.012). Compared with 7,078 girls who received the quadrivalent HPV vaccine, 7,071 girls who received the 9-valent dose had more severe systemic adverse events (3.3 vs. 2.6%, p = 0.01).

An analysis of Danish girls and young women reported adverse effects on HPV vaccines and found a high proportion of these reports included symptoms of cognitive disorder (78%), abdominal pain (77%), dysuria (60%), and sleep disorder ( 60%) [16]. Of 40,735 VAERS reports after HPV vaccination, we identified 29 POTS reports that fully met diagnostic criteria. Of them, 27 (93.1%) were female and the average age was 14 years (range 12-32). The median time from vaccination to symptom onset was 43 days (range 0-407); the majority (18, 75.0%) had onset between 0 and 90 days. Frequently reported concomitant symptoms included headache (22, 75.9%) and dizziness (21, 72.4%). Twenty (68.9%) reports documented a history of pre-existing medical conditions, of which chronic fatigue (5, 17.2%), asthma (4, 13.8%), and chronic headache (3, 10.3% ) [1].

Conclusion

Our recommendation is that before defining the vaccination regimen for each child, the specific aspects of their medical history be evaluated and taken into consideration and that the vaccines be applied individually and separately (not together). It is recommended that you wait a period of at least three months between one vaccine and another to reduce the possibility of adverse effects. We do not recommend COVID inoculation for children, pregnant or lactating women.


Footnotes:

1. School of Pharmacy, Medical Sciences Campus, UPR
2. School of Public Health, Medical Sciences Campus, UPR
3. Naturopathic Sciences Program, EDP University
4. Central University of the Caribbean, School of Chiropractic

*Corresponding author jorge.miranda2@upr.edu


References:

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2. Choi JY, Lee Y, Park NG, Kim MS, Rhie SJ. Serious Safety Signals and Prediction Features Following COVID-19 mRNA Vaccines Using the Vaccine Adverse Event Reporting System. Pharmaceuticals. 2024; 17(3):356. https://pubmed.ncbi.nlm.nih.gov/38543142/

3. Gombart AF, Pierre A, Maggini S. A Review of Micronutrients and the Immune System-Working in Harmony to Reduce the Risk of Infection. Nutrients. 2020;12(1):236. https://pubmed.ncbi.nlm.nih.gov/31963293/

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5. HRSA(a) (Health Resources & Services Administration). https://www.hrsa.gov/vaccine-compensation/about. Accedido 11 de febrero de 2024.

6. HRSA(b). Accedido 12 de febrero de 2024. https://www.hrsa.gov/sites/default/files/hrsa/vicp/vicp-stats-01-01-24.pdf

7. Lesgards JF, Cerdan D, Perronne C, Sabatier JM, Azalbert X, Rodgers EA, McCullough PA. Toxicity of SARS-CoV-2 Spike Protein from the Virus and Produced from COVID-19 mRNA or Adenoviral DNA Vaccine. Arch Microbiol & Immunol 2023;7(3):121-138. https://www.fortunejournals.com/articles/toxicity-of-sarscov2-spike-protein-from-the-virus-and-produced-from-covid19-mrna-or-adenoviral-dna-vaccines.html

8. Lee WS, Wheatley AK, Kent SJ, DeKosky BJ. Antibody-dependent enhancement and SARS-CoV-2 vaccines and therapies. Nat Microbiol. 2020 Oct;5(10):1185-1191. https://pubmed.ncbi.nlm.nih.gov/32908214/

9. Martínez-Lavín M, Amezcua-Guerra L. Serious adverse events after HPV vaccination: a critical review of randomized trials and post-marketing case series. Clin Rheumatol. 2017 Oct;36(10):2169-2178. doi: 10.1007/s10067-017-3768-5. Epub 2017 Jul 20. Erratum in: Clin Rheumatol. 2017 Jul 29;: PMID: 28730271. https://pubmed.ncbi.nlm.nih.gov/28730271/

10. Okuya K, Hattori T, Saito T, Takadate Y, Sasaki M, Furuyama W, Marzi A, Ohiro Y, Konno S, Hattori T, Takada A. Multiple Routes of Antibody-Dependent Enhancement of SARS-CoV-2 Infection. Microbiol Spectr. 2022 Apr 27;10(2):e0155321. https://pubmed.ncbi.nlm.nih.gov/35319248/

11. Polack, F.P.; Thomas, S.J.; Kitchin, N.; Absalon, J.; Gurtman, A.; Lockhart, S.; Perez, J.L.; Pérez Marc, G.; Moreira, E.D.; Zerbini, C.; et al. Safety and Efficacy of the BNT162b2 MRNA COVID-19 Vaccine. N. Engl. J. Med. 2020, 383, 2603-2615. https://pubmed.ncbi.nlm.nih.gov/33301246/

12. Reider CA, Chung RY, Devarshi PP, Grant RW, Hazels Mitmesser S. Inadequacy of Immune Health Nutrients: Intakes in US Adults, the 2005-2016 NHANES. Nutrients. 2020 Jun 10;12(6):1735. https://pubmed.ncbi.nlm.nih.gov/32531972/

13. Greene J, New data is out on COVID vaccine injury claims. What's to make of it? Reuters. Accedido 12 de febrero de 2024. https://www.reuters.com/legal/litigation/new-data-is-out-covid-vaccine-injury-claims-whats-make-it-2022-10-12/

14. Saxon, S. 2022. The Covid-19 and Beyond. Invitation to Destiny, LLC.

15. Segal Y, Shoenfeld Y. Vaccine-induced autoimmunity: the role of molecular mimicry and immune cross-reaction. Cell Mol Immunol. 2018 Jun;15(6):586-594. https://pubmed.ncbi.nlm.nih.gov/29503439/

16. Ward D, Thorsen NM, Frisch M, Valentiner-Branth P, Mølbak K, Hviid A. A cluster analysis of serious adverse event reports after human papillomavirus (HPV) vaccination in Danish girls and young women, September 2009 to August 2017. Euro Surveill. 2019 May;24(19):1800380. https://pubmed.ncbi.nlm.nih.gov/31088598/

17, Wen J, Cheng Y, Ling R, Dai Y, Huang B, Huang W, Zhang S, Jiang Y. Antibody-dependent enhancement of coronavirus. Int J Infect Dis. 2020 Nov;100:483-489. https://pubmed.ncbi.nlm.nih.gov/32920233/


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