The Serious Lack of Studies On The “Safety” of The Childhood Immunization Schedule

“Further limitations are that concomitant administration of BNT162b2 with other vaccines was not assessed, and cell-mediated responses to immunization are not yet available.”

-Limitation of the recent Pfizer vaccine “safety” study for 5-11 year olds admitting that the safety of this vaccine used along with other vaccines was not addressed.

https://www.nejm.org/doi/full/10.1056/NEJMoa2116298

In 1962, if children received any vaccines at all, at most they encountered three different vaccines (5 doses total): for Polio, Smallpox, and DTP. Over the decades, more vaccines hit the market and this small number of experimental injections increased dramatically. By 1983, kids received at least 24 doses and by 2018, this had more than tripled up to 76 doses. New vaccines are hitting the market regularly and with the promise of the dangerous mRNA technology, more “vaccines” are being explored for “viruses” which have yet to receive one.

With this ever-expanding and massive increase in the amounts of toxic ingredients (such as aluminum, formaldehyde, aborted fetal cells, antibiotics, etc) being injected directly into our children’s bloodstream, surely this practice has been thoroughly and extensively studied in order to determine that the cumulative effects are indeed safe? These corporations hell-bent on the aquirement of the almighty dollar must have taken the time to make sure that not only are their products safe for single use but also in conjunction with others, correct? If you thought so, you would be horribly wrong.

Due to the growing concerns of parents and stakeholders about the lack of safety studies on the childhood immunization schedule, in 2013 the Institute of Medicine compiled a report on the current evidence available. Previous reports had found a casual relationship between vaccines and different adverse events:

The Institute of Medicine (IOM) Reports and NVIC Statements

“IOM published a series of reports on evidence for adverse effects of vaccines between 1991 and 2013 confirming that:

  1. Vaccines can and do carry risks for complications that can be greater for some individuals than others and may lead to chronic brain and immune system damage or death. IOM committees published reports in 1991, 1994a, 1994b, and 2012 and found that the following health problems are causally related to vaccination:
  • Acute encephalopathy (brain inflammation)
  • Chronic Nervous System Dysfunction (brain damage)
  • Anaphylaxis (whole-body allergic reaction)
  • Febrile Seizures (convulsions with fever)
  • Guillain-Barre Syndrome (peripheral nerve inflammation)
  • Brachial Neuritis (arm nerve inflammation)
  • Deltoid Bursitis (shoulder inflammation)
  • Acute & Chronic Arthritis (joint inflammation)
  • Syncope (sudden loss of consciousness/fainting)
  • Hypotonic/Hyporesponsive Episodes (shock and “unusual shock-like state)
  • Protracted, Inconsolable Crying and Screaming
  • Vaccine Strain Infection (smallpox, live polio, measles, varicella zoster vaccines)
  • Death (smallpox, live polio, measles vaccines)”

https://www.nvic.org/nvic-archives/institutemedicine.aspx

What they found when reviewing the literature in 2013 was that there was not enough evidence to determine whether the childhood immunization schedule was or was not associated with the numerous adverse events and outcomes seen in children today such as:

  • Asthma
  • Atopy
  • Allergy
  • Autoimmunity
  • Autism
  • Learning disorders
  • Communication disorders
  • Developmental disorders
  • Intellectual disability
  • Attention deficit disorder
  • Disruptive behavior disorder
  • Tics and Tourette’s syndrome
  • Seizures
  • Febrile seizures
  • Epilepsy

In other words, there were no studies showing that the vaccine schedule was safe. NONE. Do not ask as they will not be able to tell you one way or the other.

Two different sources highlight the discoveries made by the IOM back in 2013. This first paper discusses the lack of studies comparing the safety of vaccine scheduling. It admits that this is a new area of research, meaning that the vaccine schedule, up to that time, had not been properly investigated for safety. It laid out guidelines on how to possibly study the immunization schedule and admitted that the evidence accumulated so far was fragmentary and inconclusive, requiring much needed studies in the future to determine safety (as is seemingly always the case):

Appendix D Study Designs for the Safety Evaluation of Different Childhood Immunization Schedules

“To date, there have been few comparative studies evaluating the safety of different vaccine schedules. A few of the existing studies have shown that there are cases in which the risk of adverse events can depend on the vaccination schedule used. Hence, it is both a feasible and an important area of study. As a relatively new field of investigation, the big question is what types of study designs will be most fruitful for evaluating different childhood vaccine schedules.”

“Most postmarketing studies evaluate the general question as to whether or not a vaccine causes an adverse event. Very few postmarketing studies have evaluated whether the risk of adverse events depends on the scheduling of the vaccines. For example, few postmarketing studies have evaluated whether the risk of adverse events depends on the age at which a vaccine is given, on the relative timing of two different vaccines, or on a combined cumulative effect generated by the timing of dozens of different vaccines. These are all different components of the vaccine schedule, and any one of these could potentially be related to the number and severity of adverse events. When evaluating the safety of different vaccine schedules, it is hence important to study the whole range of issues, from the timing of a single vaccine to summary metrics based on the timing of dozens of vaccines.”

“Some vaccines have been shown to cause an acute adverse event within a few weeks after vaccination. Examples include intussusception 3 to 7 days after vaccination with rotavirus vaccine (RotaShield) (Kramarz et al., 2001Murphy et al., 2001) and febrile seizure 7 to 10 days after vaccination with MMR and the measles, mumps, rubella, and varicella (MMRV) vaccine (Klein et al., 2010). There are also several such examples of less severe adverse events like fever and rash. The adverse event may be serious enough to warrant the withdrawal of the vaccine from the market, as with the rotavirus vaccine, or it may be mild enough to keep using the vaccine, as with MMR. A midlevel alternative option is to revise the vaccination schedule to minimize the number of adverse events or to contraindicate the vaccine in a certain age group.”

“In the CDC-recommended vaccine schedule, many different vaccines are given on the same day. It is plausible that two vaccines, if given separately from each other, do not increase the risk of adverse events, but if they are given on the same day, there is a vaccine-vaccine interaction effect, leading to increased risk. It could also be that one or both of the vaccines, when given separately, lead to a modest excess risk of the adverse event but, when given together, lead to a much higher excess risk.”

“While not a common concern, it has occasionally been suggested that the order in which vaccines are given may influence the risk of adverse events. Here, we are not thinking of vaccines given a couple of minutes apart at the same health care visit but of vaccines given a few days, weeks, or months apart. For example, in a study of DTP and the measles vaccine in a low-income African country, Aaby et al. (2004) hypothesized that “DTP as the last vaccine received may be associated with slightly increased mortality.” Veirum et al. (2005) suggested that “it might be examined whether provision of BCG [bacille Calmette-Guérin] or measles vaccine shortly after the last dose of DTP could secure specific protection and prevent the negative immune stimulation associated with having received DTP,” and that “different sequences of vaccinations” might have to be considered.”

“It is conceivable that it is neither the timing of individual vaccines nor the interaction between vaccines that is responsible for adverse events but, rather, some more general component of the vaccine schedule, such as the total number of vaccines given or the cumulative amount of immune-stimulating content, immunogenic adjuvants, or preservatives in all vaccines received.”

“At the other extreme, it would be unethical to do a randomized trial where children in one arm are completely unvaccinated, since the scientist will then knowingly put some of the children at increased risk for vaccine-preventable diseases, some of which may result in death.”

“The comparative safety evaluation of different vaccine schedules is a complex and multifaceted task, and all aspects of the vaccine schedule are currently understudied with regards to potential adverse events.”

https://www.ncbi.nlm.nih.gov/books/NBK206950/#_NBK206950_pubdet_

It’s always left to “future studies.”

This second source on the IOM 2013 findings provided an excellent summary of the the report. It pointed out that most studies only focused on individual vaccines and few had ever looked at schedules on the whole. No study had ever compared unvaccinated against the vaccinated in order to compare health outcomes. The research conducted was never of the mindset of looking at the vaccine schedules and there was considerable uncertainty as to whether all health outcomes and safety concerns had been addressed:

Review of Scientific Findings

CONCLUSIONS

“The committee conducted a review directed by conventional electronic searches of the peer-reviewed literature, findings from searches conducted by committee members, committee member expertise, committee discussions, and information from public presentations at open committee meetings.

The committee’s review confirmed that research on immunization safety has mostly developed around studies examining potential associations between individual vaccines and single outcomes. Few studies have attempted more global assessments of entire sequence of immunizations or variations in the overall immunization schedule and categories of health outcomes, and none has squarely examined the issue of health outcomes and stakeholder concerns in quite the way that the committee was asked to do in its statement of task. None has compared entirely unimmunized populations with those fully immunized for the health outcomes of concern to stakeholders.

Queries of experts who addressed the committee in open session did not point toward a body of evidence that had been overlooked but, rather, pointed toward the fact that the research conducted to date has generally not been conceived with the overall immunization schedule in mind.

The available evidence is reassuring, but it is also fragmentary and inconclusive on many issues. Nevertheless, the committee found in its literature review useful perspectives on how to define exposures and outcomes and how conventional study designs might be expanded and adapted to more clearly address the question of health outcomes after immunization with the overall immunization schedule.

A challenge to the committee in its review of the scientific literature was uncertainty as to whether studies published in the scientific literature have addressed all health outcomes and safety concerns. The field needs valid and accepted metrics of the entire schedule (the “exposure”) and clearer definitions of the health outcomes linked to stakeholder concerns (the “outcomes”) in research that is sufficiently funded to ensure the collection of a large quantity of high-quality data.”

https://www.ncbi.nlm.nih.gov/books/NBK206940/#_NBK206940_pubdet_

Following the guidelines laid out in the 2013 IOM report, in April 2016, the CDC released a 64-page report on studying the safety of the childhood immunization schedule utilizing their own Vaccine Safety Datalink. This had been determined by the IOM to be the best way to study the safety of the childhood immunization schedule as a whole. Thus, the CDC reiterated what the IOM said and presented its own take on the guidelines on how to possibly study the vaccine schedule instead of actually doing studies on the vaccine schedule. Like the IOM, the CDC admitted that the field of vaccine schedule research is in its infancy even though the schedule itself had been developed over decades. They outlined how this could be studied if it is deemed necessary. They admitted to no universal definition of short-term versus long-term adverse events and that those considered “unvaccinated” could also include partially vaccinated children. In the end, they determined it is feasible to use the VSD to study the safety of the vaccine scedule:

White Paper on Studying the Safety of
the Childhood Immunization Schedule:
For the Vaccine Safety Datalink

Summary

This White Paper provides a comprehensive assessment for how the VSD could be used to study the safety of the recommended childhood immunization schedule. Guided by subject matter expert engagement, the document outlines a 4 staged approach for identifying exposure groups of undervaccinated children, presents a list of 20 prioritized outcomes, and describes various study designs and statistical methods that could be used to analyze the safety of the schedule. VSD investigators will be able to use this document as a guide when designing and conducting studies of the safety of the childhood immunization schedule, if such studies are judged to be necessary.”

“On June 27, 2014, the study team met with VSD staff and external experts on drug and vaccine safety methodology. Several important methodological recommendations were developed
from the meeting. First, investigations into the safety of the vaccine schedule should plan for multi-part studies. Initial studies can be used to identify possible associations between outcomes and various vaccine schedules. This will then lead to follow-up studies to verify the observed associations and identify which aspects of the schedule(s) are responsible for them. Second, because vaccine schedule research is a field in its infancy, initial studies of vaccine schedule safety should focus on designs and methods with well-known properties – such as the cohort and case-control methods – until the various sources of bias in schedule safety research are better understood. Examples of these potential sources of bias include unmeasured confounding, health care seeking bias, reverse causality, selection bias and misclassification of exposures and outcomes.”

“Many more vaccines are recommended before 24 months of age than at any other age,22,23 and parents appear particularly concerned about the safety of vaccines given to young children.11-14

1.2 IOM Report on the Childhood
Immunization Schedule and Safety

In response to this public concern, the Institute of Medicine (IOM) in 2012 convened a committee to examine scientific evidence and stakeholder concerns regarding the safety of the recommended childhood immunization schedule, and to identify study designs and methods that could be used to rigorously examine this issue.

The IOM committee concluded that while the accumulation of available evidence indicated that the current U.S. immunization schedule was safe, few published investigations had specifically evaluated the safety of the childhood schedule as a whole. The committee concluded that new observational studies of the safety of the schedule were warranted, and stated that the Vaccine Safety Datalink (VSD) project represented one of the best resources in the nation for conducting such studies.”

Focus on Long-term Outcomes

While there is not a uniform definition of what constitutes a short- versus long-term adverse event, short-term adverse events are typically thought to occur in the hours, days, or weeks following vaccination. For example, VSD studies of vaccine safety will generally evaluate adverse events in the 1-2, 1-7, 1-14, or 1-42 days following vaccination. Long-term outcomes can be thought of as occurring in the months to years following vaccination.”

• Completely undervaccinated (zero vaccines)
• Published alternative schedules (ex: The Vaccine Book by Dr. Robert Sears28.
• Limiting the number of vaccines given per visit (“shot-limiting”)30
• Delaying start to vaccination
• Vaccine series not received
• Vaccine doses not received
• Age of receipt of each vaccine dose
• Spacing of vaccines
• Order of vaccines
• Cumulative exposure to vaccine antigens
• Cumulative exposure to other vaccines ingredients (ex: aluminum)

Completely unvaccinated (zero vaccines)

In the VSD, identifying children with no
vaccination records is straightforward. A previous VSD study estimated that approximately 1% of children had no vaccine records before age 24 months. However, children who appear completely unvaccinated in VSD data are likely a mix of the truly unvaccinated and children whose vaccination status is misclassified. The misclassification can be due to children receiving vaccines outside of the MCO or missing electronic vaccine records. Additional utilization and health
plan criteria could be applied to increase the likelihood that completely unvaccinated children were receiving regular care within the managed care organization (MCO).”

“Due to the potential information biases when comparing fully vaccinated children to undervaccinated children who lack an ICD-9-CM code for vaccine refusal, there may be many safety questions of interest that require additional data collection to overcome information biases. Cohort studies have limited utility for these situations.”

“In this White Paper, we provided a comprehensive assessment for how the VSD could be used to study the safety of the recommended childhood immunization schedule. Guided by subject matter expert engagement, we outlined a 4 staged approach for identifying exposure groups of undervaccinated children, developed a list of 20 prioritized outcomes, and described various study designs and statistical methods that could be used to assess the safety of the schedule.

It is important to re-emphasize that defining patterns of undervaccination and alternative immunization schedules is complex. There are numerous reasons why children may be undervaccinated in the VSD data, including parental choice, missing vaccine data, barriers to care, gaps in insurance, or receiving their vaccines outside of the MCO. For these reasons, there are numerous different patterns of undervaccination in the VSD, and the potential for misclassification of vaccination data among undervaccinated children is relatively high. While it is possible to identify groups of undervaccinated children in which misclassification would be minimized– such as those with an ICD-9 code for vaccine refusal – these groups are small in number and would therefore lead to low statistical power in studies of uncommon outcomes. To address the potential for misclassification, we recommend primary data collection, but this requires additional resources and could significantly increase the timeline of a study. We also described a data driven approach for identifying patterns of undervaccination, but this would likely result in exposure groups that are not as clinically meaningful as groups of children on known alternative schedules. All of these factors need to be carefully considered when designing future studies of the safety of the schedule.”

“This White Paper has some notable limitations. First, we only engaged 5 subject matter experts to help develop the content. However, it is important to stress, however, that our SMEs were highly regarded experts in the fields of vaccine science and applied statistical methods, and it is unclear if our findings would have changed had we engaged a larger group of subject matter experts. Second, we did not engage any parents or parental groups throughout the process. While parental input could have affected our results, the White Paper was heavily informed by the 2012 IOM report which incorporated a rigorous public stakeholder engagement process. Lastly, the IOM report questioned the VSD’s representativeness, and we did not explore this potential limitation of the VSD in the White Paper.

Despite the limitations described above, it appears feasible to study the safety of the childhood immunization schedule within the VSD. This finding is consistent with the IOM report conclusion that the VSD represented one of the nation’s best resources for studies of this nature. We believe that VSD investigators can use this document when designing and conducting studies of the safety of the childhood immunization schedule.”

https://www.google.com/url?sa=t&source=web&rct=j&url=https://www.cdc.gov/vaccinesafety/pdf/whitepapersafety_web.pdf&ved=2ahUKEwis_8H-38nyAhWGGs0KHXnlD0cQFnoECCEQAQ&usg=AOvVaw0lFnspxj1A62HQHQ2vgSje

Because the vaccines deemed “safe” must be continuously monitored to ensure they are, in fact, safe.

In December 2020, a slideshow released by the CDC updated where things currently stand regarding the study of the vaccine schedule since the 2013 IOM report and their own 2016 White Paper. They highlight that any study would be considered unethical if it involved unvaccinated children as this would “needlessly endanger children’s lives.” This has become the go-to excuse for not performing beneficial studies which would actually show health comparisons between vaccinated vs. unvaccinated. Instead, they compare vaccinated to partially vaccinated (or undervaccinted as defined here) children. They claim that while it is feasible to study the vaccine schedule, these types of studies would be complex. They claim studies have been done relating to the immunization schedule and that more are planned:

Studying the safety of the childhood immunization schedule in the Vaccine Safety Datalink

“However, the committee concludes that it is not ethical to implement any study requiring that some children receive fewer vaccines than recommended as part of the childhood immunization schedule because this would needlessly endanger children’s lives.”

“Undervaccination is broadly defined as children who are either behind on their immunizations or on an immunization schedule that differs from the recommended schedule of the Advisory Committee on Immunization Practices.”

“While it appears feasible to study the safety of the recommended immunization schedule in settings such as the VSD, these studies will be inherently complex, and as with all observational studies, will need to carefully address issues of confounding and bias.

VSD investigators will be able to use this document as a guide when designing and conducting studies of the safety of childhood immunization schedule, if such studies are judged to be necessary.

Assessment of undervaccination in the VSD

Objectives: To examine patterns and trends of undervaccination in children aged 2 to 24 months and to compare health care utilization rates between undervaccinated and age-appropriately vaccinated children.

Findings:
– Among 323,247 children born between 2004 and 2008, 48.7% were undervaccinated for at least 1 day before age 24 months.
– Compared to children who were age-appropriately vaccinated, undervaccinated children had lower outpatient visit rates and increased
inpatient admission rates
Children who were undervaccinated because of parental choice had lower
rates of outpatient visits and emergency department encounters

Conclusion: Undervaccinated children appear to have different health care
utilization patterns compared with age-appropriately vaccinated children”

Summary

* The Institute of Medicine identified the CDC’s Vaccine Safety Datalink (VSD) system as one of the best resources for research regarding the safety of the childhood immunization schedule
* Observational studies of the immunization schedule pose numerous methodological challenges and require careful planning to control for potential sources of bias
*To date, the VSD has completed many studies related to the immunization schedule
* Additional VSD studies of the immunization schedule are ongoing and planned to address the priorities outlined in the VSD White Paper”

https://www.google.com/url?sa=t&source=web&rct=j&url=https://www.hrsa.gov/sites/default/files/hrsa/advisory-committees/vaccines/meetings/2020/cdc-safety-child-immunization-schedule.pdf&ved=2ahUKEwiHh9aA7cnyAhVbV80KHfkUDnEQFnoECCUQAQ&usg=AOvVaw207X1tPLRCsjo4urceKHEM

In May 2021, an update to the 2014 Agency for Healthcare Research and Quality (AHRQ) report on the topic of vaccine safety was released. It built upon the IOM report and showed that there is still insufficient evidence to verify whether there is an increased risk of adverse events in vaccinated children. In the limitations section, the researchers admit that they may have missed studies on adverse events due to the challenging nature of assessing harms versus effectiveness. Search filters addressing harms are not very successful. The report did not address any new vaccines such as those in use for “Covid-19” nor did it include studies outside the US as well as non-english studies within the US even though they admit these may have provided relevant information. They admit that the study methods varied widely and that drawing conclusions about the safety of the immunization schedule taken as a whole, multiple vaccines together, and/or certain adjuvants and preservatives was not possible from this report’s findings:

Safety of Vaccines Used for Routine Immunization in the United States: An Update

“Regarding vaccines recommended for children and adolescents (KQ2), we found either no new evidence of increased risk for key adverse events with varied SoE or insufficient evidence, including for newer vaccines such as 9-valent human papillomavirus vaccine and meningococcal B vaccine. The prior 2014 report noted signals for rare adverse events—such as anaphylaxis, idiopathic thrombocytopenic purpura, and febrile seizures—with some childhood vaccines.”

“Conclusion. Across this large body of research, we found no new evidence of increased risk since the prior 2014 report for key adverse events following administration of vaccines that are routinely recommended. Signals from the prior report remain unchanged for rare adverse events, which include anaphylaxis in adults and children, and febrile seizures and idiopathic thrombocytopenic purpura in children. There is no evidence of increased risk of adverse events for vaccines currently recommended in pregnant women. There remains insufficient evidence to draw conclusions about some rare potential adverse events.”

https://effectivehealthcare.ahrq.gov/products/safety-vaccines/research

From the study itself:

Limitations of the Review

“While our literature search procedures were extensive, some unpublished trial results may not have been identified. As noted above, we were able to mitigate this possibility by searching trial databases directly and reference mining relevant publications, including ACIP recommendations. We also may have missed studies due to the challenging nature of assessing harms as contrasted with assessing effectiveness, since many publications focus on the clinical effectiveness of an intervention with either no, sparse, incomplete, or non-systematic assessment and/or reporting of safety data. While search filters exist for effectiveness studies, filters to address harms are not as successful in identifying relevant studies. Thus, as noted above, we intentionally screened the full text of all vaccine intervention studies to minimize missing safety data. We also note that the current review builds on the prior 2014 report, which itself built upon the 2011 Institute of Medicine (IOM) report. The prior 2014 report did not search for or include studies on vaccines that were covered in the IOM report and published prior to 2011. In the current report, only for vaccines for which there were new indications or for new vaccines did we perform targeted searches for research published prior to 2014.”

“This report reviews currently recommended vaccines for routine use, and does not include new vaccines in development or under emergency use authorization, such as vaccines for the 2019 coronavirus disease (COVID-19) pandemic. We also excluded studies of vaccines not currently in use in the United States. For example, while HPV2 and HPV4 are no longer in use in the United States, studies of the safety of these vaccines (still in use in other countries) would likely inform discussions of the safety of HPV9. We acknowledge that studies of other widely used vaccines could be useful but were required to limit the scope to a focus on the United States. We also excluded non-English language studies. Although we were considering only vaccines approved for use in the United States, it is possible relevant epidemiological studies have been published in non-English journals.”

“While we did identify sub-group analyses within studies that met our inclusion criteria, there may be additional reports of studies that assessed specific risk factors but that would not have been included if there were no appropriate comparator (e.g., a study comparing HPV9 in men and women, where all participants receive the vaccine). Despite the large number of studies included, indirect analyses across studies to assess the effect of participant or administration variables were possible only for selected characteristics and selected outcomes. This was because studies varied widely in the strategy used to assess the safety of the vaccines and used different datasets (e.g., some used mining datasets that included data for many different vaccines). In addition, some studies reported adverse events of interest at a system or group level (e.g., rate of all cardiovascular events), but others did not. For studies that did not report system-level rates of system-level adverse events, we had to instead choose the most common adverse event within the relevant system (e.g., unstable angina) to use available data to the extent possible. This resulted in some estimates that are based on combined systems and event-level rates, but in caseswhere such analyses indicated more events in the vaccinated group, we also performed sensitivity analyses to assess the robustness of the findings and reviewed the nature of the events.

As was the case for the prior Agency for Healthcare Research and Quality 2014 report and the IOM report, the current report focused on the association of specific vaccines with particular adverse events. One of our inclusion criteria was that studies must include both an intervention vaccine and a comparator (either placebo, no vaccine, or the comparator vaccine closest to what the new vaccine is replacing). Because of this approach, drawing conclusions about the safety of the immunization schedule taken as a whole, multiple vaccines together, and/or certain adjuvants and preservatives is not generally possible from this report’s findings.”

Limitations of the Evidence Base

“An important limitation common to systematic reviews in general is the quality of the original studies included. We critically appraised included studies in detail. Studies that reported timing and severity and defined adverse events using standard, precise definitions were rated higher than those that did not.

Limitations of studies vary according to their design. Controlled trials often have insufficient sample sizes to identify very rare adverse events as discussed above, and may not follow participants long enough to identify long-term sequelae. Even in studies with generous follow-up times, the timing of events is not always optimally reported. Except where explicitly noted in the text, controlled trials of vaccines tend to be conducted in healthy patients. Thus, persons who may be more susceptible to adverse events may be excluded from trials yet eligible to receive a vaccine after it is licensed.”

“Studies using passive surveillance such as the Vaccine Adverse Event Reporting System (VAERS) are crucial in identifying signals regarding adverse events post-licensure. By definition, they do not consider the rates of such events in non-vaccinated populations, and thus are not designed to assess a statistical association between a vaccine and an adverse event; thus, these studies were excluded from this project. VAERS data might contain important adverse event signals that are not identified in this report and that warrant future research.”

“Most vaccine interventions were tested either against placebo, against the closest comparator (e.g., MenACWY-TT versus MenACWY-CRM), or against the vaccine the newer formulation was replacing (e.g., HPV9 versus HPV4). In clinical practice, vaccines are often not given in isolation, particularly for children. A number of studies we identified were either clinical trials of a group of vaccines typically given together (e.g., MenACWY and Tdap and HPV9 versus Tdap and HPV9 alone; such studies would be included) or observational studies of children receiving routine vaccines, with a focus on one new vaccine (e.g., rotavirus and routine vaccines versus routine vaccines alone). While such studies better reflect the usual routine vaccination practices, they can be more challenging to analyze.”

“In terms of vaccines for children, our report shows that vaccines are generally very safe, continuing to show high SoE for no increased risk of autism following MMR across two studies and now moderate SoE for no increased risk of intussusception following rotavirus vaccine, although some studies still suggest increased risk particularly after the first dose. Some studies did find an increased risk of febrile seizures with MMR-V, and healthcare providers may wish to ensure that families are aware of this risk when balancing it against the benefit of giving one injection instead of two injections. Two studies that enrolled at-risk infants—one of DTaP in extremely low birth weight infants, and one of rotavirus vaccine in premature infants—reported an increased risk of certain adverse events such as evaluation for sepsis, need for respiratory support, and need for intubations after DTaP administration to extremely low birth weight infants, and bradycardia and apnea among premature infants receiving rotavirus vaccine. This population tends to be more medically fragile and may particularly benefit from vaccination, so potential risks of vaccination should be communicated to parents to inform decision making.”

Click to access cer-244-safety-vaccines.pdf

Healthy and healthier.

If it isn’t yet clear by now, it should be obvious that the study of the safety of the childhood immunization schedule is either entirely lacking or completely nonexistent. This is absolutely outrageous given that vaccines have been injected into children in ever-increasing amounts since 1962. This lack of definitive studies shows that the “safety” of this schedule is based on assumption and not evidence. It is blind faith bolstered by a successful pharmaceutical propaganda campaign but not science.

There has been plenty of smoke surrounding the use of vaccines and the potentially dangerous schedule as seen by the increasing rates of autism, diabetes, autoimmune diseases, childhood cancers, neurological and neurodegenerative conditions, etc. seen in rising numbers since their introduction. These conditions were all considered rare before but in today’s society, they are accepted as a part of life and just the luck of the draw. Genetics is to blame rather than the unstudied effects of the toxic injections.

Why is it that this vaccine schedule remains, after decades, a critically understudied field in its infancy? Why is there insufficient evidence to draw any conclusions? Why is it considered unethical to truly compare disease outcomes in the unvaccinated versus the vaccinated children when there are numerous unvaccinated children of parents willing to prove the dangers of this vaccine schedule? What is found when the vaccinated are compared to the unvaccinated?

Sadly, there are only a few instances of studies done comparing the vaccinated against the unvaccinated. When these studies are done, the researchers can either not find publishing in the pharmaceutically-controlled mainstream journals or if they do get published, they see their hard work retracted due to severe backlash despite disagreement from the authors. Here is a quick breakdown of the findings of three recent comparison studies.

From 2017:

Pilot comparative study on the health of vaccinated and unvaccinated 6- to 12- year old U.S. children

“The vaccinated were less likely than the unvaccinated to have been diagnosed with chickenpox and pertussis, but more likely to have been diagnosed with pneumonia, otitis media, allergies and NDD. After adjustment, vaccination, male gender, and preterm birth remained significantly associated with NDD. However, in a final adjusted model with interaction, vaccination but not preterm birth remained associated with NDD, while the interaction of preterm birth and vaccination was associated with a 6.6-fold increased odds of NDD (95% CI: 2.8, 15.5). In conclusion, vaccinated homeschool children were found to have a higher rate of allergies and NDD than unvaccinated homeschool children. While vaccination remained significantly associated with NDD after controlling for other factors, preterm birth coupled with vaccination was associated with an apparent synergistic increase in the odds of NDD. Further research involving larger, independent samples and stronger research designs is needed to verify and understand these unexpected findings in order to optimize the impact of vaccines on children’s health.”

https://archive.fo/PwUrN

From 2020:

Analysis of health outcomes in vaccinated and unvaccinated children: Developmental delays, asthma, ear infections and gastrointestinal disorders

“Vaccination before 1 year of age was associated with increased odds of developmental delays (OR = 2.18, 95% CI 1.47–3.24), asthma (OR = 4.49, 95% CI 2.04–9.88) and ear infections (OR = 2.13, 95% CI 1.63–2.78). In a quartile analysis, subjects were grouped by number of vaccine doses received in the first year of life. Higher odds ratios were observed in Quartiles 3 and 4 (where more vaccine doses were received) for all four health conditions considered, as compared to Quartile 1. In a temporal analysis, developmental delays showed a linear increase as the age cut-offs increased from 6 to 12 to 18 to 24 months of age (ORs = 1.95, 2.18, 2.92 and 3.51, respectively). Slightly higher ORs were also observed for all four health conditions when time permitted for a diagnosis was extended from ⩾ 3 years of age to ⩾ 5 years of age.”

“In this study, based on a convenience sample of children born into one of three distinct pediatric medical practices, higher ORs were observed within the vaccinated versus unvaccinated group for developmental delays, asthma and ear infections. No association was found for gastrointestinal disorders in the primary analysis, but a significant relationship was detected in the third and fourth quartiles (where more vaccine doses were administered), at the 6-month cut-off in the temporal analysis, and when time permitted for a diagnosis was extended from children ⩾ 3 years of age to children ⩾ 5 years of age. Similar results have been observed in earlier studies by Mawson et al.3 and Delong.20

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7268563/

Also from 2020:

Relative Incidence of Office Visits and Cumulative Rates of Billed Diagnoses Along the Axis of Vaccination

“Remarkably, zero of the 561 unvaccinated patients in the study had attention deficit hyperactivity disorder (ADHD) compared to 5.3% of the (partially and fully) vaccinated. The implications of these results for the net public health effects of whole population vaccination and with respect for informed consent on human health are compelling. Our results give agency to calls for research conducted by individuals who are independent of any funding sources related to the vaccine industry. While the low rates of developmental disorders prevented sufficiently powered hypothesis testing, it is notable that the overall rate of autism spectrum disorder (0.361%) in the cohort is one-fifth that of the US national rate (1.851%). The practice-wide rate of ADHD was roughly half of the national rate. The data indicate that unvaccinated children in the practice are not unhealthier than the vaccinated and indeed the overall results may indicate that the unvaccinated pediatric patients in this practice are healthier overall than the vaccinated.”

“We could detect no widespread negative health effects in the unvaccinated other than the rare but significant vaccine-targeted diagnosis. We can conclude that the unvaccinated children in this practice are not, overall, less healthy than the vaccinated and that indeed the vaccinated children appear to be significantly less healthy than the unvaccinated.

We concur with Mawson et al., 2017 [9], who reported: “Further research involving larger, independent samples is needed to verify and understand these unexpected findings in order to optimize the impact of vaccines on children’s health.”

We also concur with Hooker and Miller 2020 [14], who wrote: “Further study is necessary to understand the full spectrum of health effects associated with childhood vaccination.”

https://www.mdpi.com/1660-4601/17/22/8674/htm

In Summary:

  • A 2013 review by the Institute of Medicine Committee (IOM) found that there had been few comparative studies evaluating the safety of different vaccine schedules
  • A few of the existing studies have shown that there are cases in which the risk of adverse events can depend on the vaccination schedule used
  • The study of the safety of childhood vaccine schedules was said to be a relatively new field of investigation
  • The big question is what types of study designs will be most fruitful for evaluating different childhood vaccine schedules
  • Very few postmarketing studies have evaluated whether:
    1. The risk of adverse events depends on the scheduling of the vaccines
    2. The risk of adverse events depends on the age at which a vaccine is given
    3. The relative timing of two different vaccines can cause adverse events,
    4. A combined cumulative effect generated by the timing of dozens of different vaccines causes the adverse events
  • These are all different components of the vaccine schedule, and any one of these could potentially be related to the number and severity of adverse events
  • Some vaccines have been shown to cause an acute adverse event within a few weeks after vaccination such as:
    • Intussusception 3 to 7 days after vaccination with rotavirus vaccine (RotaShield)
    • Febrile seizure 7 to 10 days after vaccination with MMR and the measles, mumps, rubella, and varicella (MMRV) vaccine
  • There are also several such examples of less severe adverse events like fever and rash
  • The adverse event may be serious enough to warrant the withdrawal of the vaccine from the market, as with the rotavirus vaccine, or it may be mild enough to keep using the vaccine, as with MMR
  • It is plausible that two vaccines, if given separately from each other, do not increase the risk of adverse events, but if they are given on the same day, there is a vaccine-vaccine interaction effect, leading to increased risk
  • It could also be that one or both of the vaccines, when given separately, lead to a modest excess risk of the adverse event but, when given together, lead to a much higher excess risk
  • it has been suggested that the order in which vaccines are given may influence the risk of adverse events
  • in a study of DTP and the measles vaccine in a low-income African country, Aaby et al. (2004) hypothesized that “DTP as the last vaccine received may be associated with slightly increased mortality.” 
  • Veirum et al. (2005) suggested that “it might be examined whether provision of BCG [bacille Calmette-Guérin] or measles vaccine shortly after the last dose of DTP could secure specific protection and prevent the negative immune stimulation associated with having received DTP,” and that “different sequences of vaccinations” might have to be considered”
  • It is conceivable that the total number of vaccines given or the cumulative amount of immune-stimulating content, immunogenic adjuvants, or preservatives in all vaccines received can cause adverse events
  • It is considered unethical to do a randomized trial where children in one arm are completely unvaccinated (this is the go-to excuse for why we have no vaccinated vs unvaccinated studies even though there are many unvaccinated kids they could use)
  • All aspects of the vaccine schedule are currently understudied with regards to potential adverse events
  • A separate review of the IOM report in 2013 confirmed that research on immunization safety has mostly developed around studies examining potential associations between individual vaccines and single outcomes
  • Few studies have attempted more global assessments of entire sequence of immunizations or variations in the overall immunization schedule and categories of health outcomes
  • None has compared entirely unimmunized populations with those fully immunized for the health outcomes of concern
  • The evidence pointed toward the fact that the research conducted to date has generally not been conceived with the overall immunization schedule in mind
  • While they claim the available evidence is reassuring, it is also fragmentary and inconclusive on many issues
  • A challenge to the committee in its review of the scientific literature was uncertainty as to whether studies published in the scientific literature have addressed all health outcomes and safety concerns
  • In 2016, the CDC released a White Paper whicj provided a comprehensive assessment for how the VSD could be used to study the safety of the recommended childhood immunization schedule (in other words, they have not studied the safety of childhood immunization using this method)
  • It described various study designs and statistical methods that could be used to analyze the safety of the schedule
  • VSD investigators will be able to use this document as a guide when designing and conducting studies of the safety of the childhood immunization schedule, if such studies are judged to be necessary (why are these studies not considered necessary?)
  • Two recommendations were made:
    1. Investigations into the safety of the vaccine schedule should plan for multi-part studies
    2. Because vaccine schedule research is a field in its infancy, initial studies of vaccine schedule safety should focus on designs and methods with well-known properties – such as the cohort and case-control methods – until the various sources of bias in schedule safety research are better understood
  • Many more vaccines are recommended before 24 months of age than at any other age and parents are concerned about their safety
  • In 2012, the IOM reviewed the scientific literature and tried to identify study designs and methods that could be used to rigorously examine this issue
  • The IOM committee concluded that while the accumulation of available evidence indicated that the current U.S. immunization schedule was safe, few published investigations had specifically evaluated the safety of the childhood schedule as a whole (how was it deemed safe if it was not studied?)
  • The committee concluded that new observational studies of the safety of the schedule were warranted, and stated that the Vaccine Safety Datalink (VSD) project represented one of the best resources in the nation for conducting such studies
  • There is not a uniform definition of what constitutes a short- versus long-term adverse event:
    1. Short-term adverse events are typically thought to occur in the hours, days, or weeks following vaccination
    2. Long-term outcomes can be thought of as occurring in the months to years following vaccination
  • Children who appear completely unvaccinated in VSD data are likely a mix of the truly unvaccinated and children whose vaccination status is misclassified
  • Due to the potential information biases when comparing fully vaccinated children to undervaccinated (note “under” not “un”vaccinated – big difference) children who lack an ICD-9-CM code for vaccine refusal, there may be many safety questions of interest that require additional data collection to overcome information biases
  • In this White Paper, they provided a comprehensive assessment for how the VSD could be used to study the safety of the recommended childhood immunization schedule (i.e. remains unused)
  • It is important to re-emphasize that defining patterns of undervaccination and alternative immunization schedules is complex
  • There are numerous reasons why children may be undervaccinated in the VSD data, including:
    • Parental choice
    • Missing vaccine data
    • Barriers to care
    • Gaps in insurance
    • Receiving their vaccines outside of the MCO
  • For these reasons, there are numerous different patterns of undervaccination in the VSD, and the potential for misclassification of vaccination data among undervaccinated children is relatively high
  • This White Paper has some notable limitations:
    1. They only engaged 5 subject matter experts to help develop the content
    2. They did not engage any parents or parental groups throughout the process
  • It appeared feasible to study the safety of the childhood immunization schedule within the VSD
  • This finding was consistent with the IOM report conclusion that the VSD represented one of the nation’s best resources for studies of this nature
  • A December 2020 update by the CDC looked at the 2013 IOM report, the 2016 VSD White Paper, and what studies had been done afterwards
  • The committee concludes that it is not ethical to implement any study requiring that some children receive fewer vaccines than recommended as part of the childhood immunization schedule because this would needlessly endanger children’s lives
  • Undervaccination is broadly defined as children who are either behind on their immunizations or on an immunization schedule that differs from the recommended schedule of the Advisory Committee on Immunization Practices
  • While it appears feasible to study the safety of the recommended immunization schedule in settings such as the VSD, these studies will be inherently complex
  • Their objective was to examine patterns and trends of undervaccination in children aged 2 to 24 months and to compare health care utilization rates between undervaccinated and age-appropriately vaccinated children
  • Children who were undervaccinated because of parental choice had lower rates of outpatient visits and emergency department encounters
  • They concluded undervaccinated children appear to have different health care utilization patterns compared with age-appropriately vaccinated children
  • The CDC claims to date, the VSD has completed many studies related to the immunization schedule (yet none showing that the schedule itself, as recommended by the CDC, is safe)
  • Additional VSD studies of the immunization schedule are ongoing and planned to address the priorities outlined in the VSD White Paper
  • In May 2021, the Agency for Healthcare Research and Quality updated its own publication from 2014 based on the IOM report addressing vaccine safety
  • Regarding vaccines recommended for children and adolescents (KQ2), they found either no new evidence of increased risk for key adverse events with varied SoE or insufficient evidence
  • The prior 2014 report noted signals for rare adverse events—such as anaphylaxis, idiopathic thrombocytopenic purpura, and febrile seizures—with some childhood vaccines
  • There remained insufficient evidence to draw conclusions about some rare potential adverse events
  • The researchers noted they may have missed studies due to the challenging nature of assessing harms as contrasted with assessing effectiveness, since many publications focus on the clinical effectiveness of an intervention with either no, sparse, incomplete, or non-systematic assessment and/or reporting of safety data
  • While search filters exist for effectiveness studies, filters to address harms are not as successful in identifying relevant studies
  • The report reviewed currently recommended vaccines for routine use, and did not include new vaccines in development or under emergency use authorization, such as vaccines for “Covid-19”
  • They slso excluded studies of vaccines not currently in use in the United States
  • The researchers acknowledged that studies of other widely used vaccines could have been useful but they were required to limit the scope to a focus on the United States
  • They also excluded non-English language studies even though it was possible relevant epidemiological studies have been published in non-English journals
  • Studies varied widely in the strategy used to assess the safety of the vaccines and used different datasets (e.g., some used mining datasets that included data for many different vaccines)
  • Some studies reported adverse events of interest at a system or group level (e.g., rate of all cardiovascular events), but others did not
  • One of the inclusion criteria was that studies must include both an intervention vaccine and a comparator (either placebo, no vaccine, or the comparator vaccine closest to what the new vaccine is replacing)
  • Because of this approach, drawing conclusions about the safety of the immunization schedule taken as a whole, multiple vaccines together, and/or certain adjuvants and preservatives was not generally possible from this report’s findings
  • An important limitation common to systematic reviews in general is the quality of the original studies included
  • Limitations of studies vary according to their design
  • Controlled trials often have insufficient sample sizes to identify very rare adverse events as discussed above, and may not follow participants long enough to identify long-term sequelae
  • Persons who may be more susceptible to adverse events may be excluded from trials yet eligible to receive a vaccine after it is licensed
  • Studies utilizing the Vaccine Adverse Event Reporting System (VAERS) do not consider the rates of such events in non-vaccinated populations, and thus are not designed to assess a statistical association between a vaccine and an adverse event
  • These studies were excluded from this project
  • VAERS data might contain important adverse event signals that are not identified in this report and that warrant future research
  • Most vaccine interventions were tested either against placebo, against the closest comparator (e.g., MenACWY-TT versus MenACWY-CRM), or against the vaccine the newer formulation was replacing (e.g., HPV9 versus HPV4)
  • Studies looking at groups of vaccines commonly given together or adding one new vaccine better reflect the usual routine vaccination practices, they were more challenging to analyze
  • Some studies still suggest increased risk on intussusception particularly after the first dose of the “rotavirus” vaccine
  • Some studies did find an increased risk of febrile seizures with MMR-V, and healthcare providers may wish to ensure that families are aware of this risk when balancing it against the benefit of giving one injection instead of two injections
  • Two studies that enrolled at-risk infants—one of DTaP in extremely low birth weight infants, and one of “rotavirus” vaccine in premature infants—reported an increased risk of certain adverse events such as evaluation for sepsis, need for respiratory support, and need for intubations after DTaP administration to extremely low birth weight infants, and bradycardia and apnea among premature infants receiving “rotavirus” vaccine
  • A 2017 study found the vaccinated were less likely than the unvaccinated to have been diagnosed with chickenpox and pertussis, but more likely to have been diagnosed with pneumonia, otitis media, allergies and neural developmental delays
  • Vaccination, but not preterm birth, remained associated with NDD, while the interaction of preterm birth and vaccination was associated with a 6.6-fold increased odds of NDD (95% CI: 2.8, 15.5)
  • Vaccinated homeschool children were found to have a higher rate of allergies and NDD than unvaccinated homeschool children
  • A 2020 study found vaccination before 1 year of age was associated with increased odds of developmental delays (OR = 2.18, 95% CI 1.47–3.24), asthma (OR = 4.49, 95% CI 2.04–9.88) and ear infections (OR = 2.13, 95% CI 1.63–2.78)
  • In a quartile analysis, subjects were grouped by number of vaccine doses received in the first year of life and higher odds ratios were observed in Quartiles 3 and 4 (where more vaccine doses were received) for all four health conditions considered, as compared to Quartile 1
  • In a temporal analysis, developmental delays showed a linear increase as the age cut-offs increased from 6 to 12 to 18 to 24 months of age (ORs = 1.95, 2.18, 2.92 and 3.51, respectively)
  • Slightly higher ORs were also observed for all four health conditions when time permitted for a diagnosis was extended from ⩾ 3 years of age to ⩾ 5 years of age
  • A different 2020 study found zero of the 561 unvaccinated patients in the study had attention deficit hyperactivity disorder (ADHD) compared to 5.3% of the (partially and fully) vaccinated
  • The results give agency to calls for research conducted by individuals who are independent of any funding sources related to the vaccine industry
  • It was notable that the overall rate of autism spectrum disorder (0.361%) in the cohort is one-fifth that of the US national rate (1.851%)
  • The practice-wide rate of ADHD was roughly half of the national rate
  • The data indicate that unvaccinated children in the practice are not unhealthier than the vaccinated and indeed the overall results may indicate that the unvaccinated pediatric patients in this practice are healthier overall than the vaccinated
  • The researchers could detect no widespread negative health effects in the unvaccinated other than the rare but significant vaccine-targeted diagnosis

People need to understand that what is going on in the scientific world today is more akin to religion. This has been coined Scientism.

“Unlike the use of the scientific method as only one mode of reaching knowledge, scientism claims that science alone can render truth about the world and reality.”

https://www.pbs.org/faithandreason/gengloss/sciism-body.html

“The belief that the assumptions, methods of research, etc., of the physical and biological sciences are equally appropriate and essential to all other disciplines, including the humanities and the social sciences.

Scientific or pseudoscientific language.”

https://www.dictionary.com/browse/scientism

The cult of science has rejected the scientific method. The evidence that should be available is non-existent. Decisions are made based on assumptions, hypotheses, and theories with nothing to back them up. It is the equivalent of blind faith.

The promise of future evidence that will prove the guesswork correct is dangled in front of the ignorant like a carrot hanging by a string in the face of a hungry rabbit. They will reach for this promise only to have it continually yanked away. All the while, the believers subject themselves and their children as human Guinea pigs to the longest unproven “scientific” experiment in history. They are gambling that science will prove their blind faith in these corrupt criminal institutions correct in the future while ignoring the very real evidence as to the dangers inherent in this objectionable practice.

In the face of this substantial lack in evidence for the safety of the childhood immunization schedule, one must ask oneself: is this blind faith worth the risk to a child?

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