Children | Informed Consent | Can a Child Answer These Questions?

SB 866 Hearing on Thursday, May 5, and AB 2098 Hearing on Monday, May 9, 2022!

Informed Consent | mRNA | Can Children Understand These Questions?

Parents continue to remain concerned about the increasing pressure to pass laws allowing children to make their own medical decisions when it comes to the topic of vaccination.  To put the ‘bottom line upfront’  - specifically as it relates to the mRNA ‘vaccines’ - any decision that entails injecting a therapeutic, designed by the manufactures to force one’s body to create the synthetic S1 Spike protein, is complex and the technology used to do so is even more complex.  The results, both known and unknown, in terms of a risk/benefit calculus, are not readily understood by a child.

In a newsletter from Physicians for Informed Consent https://physiciansforinformedconsent.org/physicians-for-informed-consent-opposes-that-minors-obtain-vaccination-without-parental-knowledge-or-consent/ an educational nonprofit organization focused on science and statistics, you can find an opposition letter to California Senate Bill 866 (SB 866). Their newsletter and call to action along with the following list of questions in this article should be considered as the interdependencies between the issues - can a child answer these questions - and the impact of these bills if passed — are important factors. Lets look at some of the issues.

A look at some of the terms – Vaccine or Information Therapy

Does a child understand that the medical intervention they are being told is just a ‘vaccine’ - understand how the term is being used?  Would they know that the manufactures use the term ‘vaccines’ and other terms such as ‘information therapy’ and ‘gene therapy technologies’ - as if they are synonymous with the mRNA COVID-19 ‘vaccines’ countermeasures or injections?  They are not.

Children would likely not understand the nuanced differences. In short, calling an mRNA COVID-19 injection a vaccine omits a critical detail – namely – that these information therapies are coding our cells to produce - specifically, to use a technology, designed in a lab, that codes our cells to produce a synthetic S1 Spike Protein. 

Of note, for the current COVID mRNA injections in question, the manufactures documented that they are designed to ‘cause disease’ in the body, first – as in these products act like code [information therapy] telling the body to develop the S1 spike protein which is – again - by the manufacture’s definition - the ‘pathogen’.  For additional reference, per European standards, it is clear that – the mRNA ‘vaccine’ is a genetic set of instructions that forces the body to produce S1 Spike, which ‘…causes disease…’ (reference below):

 “...The BioNTech/Pfizer vaccine is based on messenger RNA (mRNA) technology. This allows cells to manufacture harmless fragments of viral proteins that the human body uses to build an immune response to prevent or fight subsequent, natural infection. When a person is given the vaccine, their cells will read the genetic instructions and produce fragments of the ‘spike protein', a protein on the outer surface of the virus which it uses to enter the body's cells, to replicate, and cause disease. The person's immune system will then treat this protein as foreign and produce natural defences — antibodies and T cells — against it.” https://ec.europa.eu/commission/presscorner/detail/en/ip_20_2466  First safe and effective vaccine against COVID-19 (europa.eu)

Of grave concern, would a child be following the rapid changes and opinions about the safety of repeated injections to include the boosters?  Would a child be able to follow - and understand - the most recent data dump from Pfizer and determine risk without a parent’s input? Just one example of the latest here: Pfizer dump .

Would a child know that as recently as January 11, 2022 the European Medicines Agency reversed course and acknowledged that ‘…repeated boosters could weaken the immune system…?” https://www.bloomberg.com/news/articles/2022-01-11/repeat-booster-shots-risk-overloading-immune-system-ema-says .  Would a child understand any of this data and understand that they could be making a permanent decision that they cannot undue?

Related to the topic of children and decision making, another question is relevant to this topic.  Would a child understand that when the FDA provided the 'approval' for Pfizer /COMIRNATY, they stipulated that there were serious safety signals already coming in from the Vaccine Adverse Events Reporting System (VAERS).  To address these safety signals, the FDA added that the manufacture must run 12 more clinical trials.... even though they gave the approval for COMIRNATY. 

Note the dates for completion.  Would a child understand that there will likely be more contraindications documented from these additional clinical trials and would a school nurse or physician consider this information relevant to a discussion with a child? The additional clinical trials are listed for reference below August 23, 2021 Approval Letter - Comirnaty (fda.gov)

1. Deferred pediatric Study C4591001 to evaluate the safety and effectiveness of COMIRNATY in children 12 years through 15 years of age. Final Protocol Submission: October 7, 2020 Study Completion: May 31, 2023 Final Report Submission: October 31, 2023  

2. Deferred pediatric Study C4591007 to evaluate the safety and effectiveness of COMIRNATY in infants and children 6 months to <12 years of age. Final Protocol Submission: February 8, 2021 Study Completion: November 30, 2023 Final Report Submission: May 31, 2024. 

3.  Deferred pediatric Study C4591023 to evaluate the safety and effectiveness of COMIRNATY in infants <6 months of age. Final Protocol Submission: January 31, 2022 Study Completion: July 31, 2024 Final Report Submission: October 31, 2024

4.  Study C4591009, entitled “A Non-Interventional Post-Approval Safety Study of the Pfizer-BioNTech COVID-19 mRNA Vaccine in the United States,” to evaluate the occurrence of myocarditis and pericarditis following administration of COMIRNATY. We acknowledge the timetable you submitted on August 21, 2021, which states that you will conduct this study according to the following schedule: Final Protocol Submission: August 31, 2021 Monitoring Report Submission: October 31, 2022 Interim Report Submission: October 31, 2023 Study Completion: June 30, 2025 Final Report Submission: October 31, 2025

5.  Study C4591021, entitled “Post Conditional Approval Active Surveillance Study Among Individuals in Europe Receiving the Pfizer-BioNTech Coronavirus Page 7 – STN BL 125742/0 – Elisa Harkins Disease 2019 (COVID-19) Vaccine,” to evaluate the occurrence of myocarditis and pericarditis following administration of COMIRNATY. We acknowledge the timetable you submitted on August 21, 2021, which states that you will conduct this study according to the following schedule: Final Protocol Submission: August 11, 2021 Progress Report Submission: September 30, 2021 Interim Report 1 Submission: March 31, 2022 Interim Report 2 Submission: September 30, 2022 Interim Report 3 Submission: March 31, 2023 Interim Report 4 Submission: September 30, 2023 Interim Report 5 Submission: March 31, 2024 Study Completion: March 31, 2024 Final Report Submission: September 30, 2024  

6.  Study C4591021 substudy to describe the natural history of myocarditis and pericarditis following administration of COMIRNATY. We acknowledge the timetable you submitted on August 21, 2021, which states that you will conduct this study according to the following schedule: Final Protocol Submission: January 31, 2022 Study Completion: March 31, 2024 Final Report Submission: September 30, 2024. 

7. Study C4591036, a prospective cohort study with at least 5 years of follow-up for potential long-term sequelae of myocarditis after vaccination (in collaboration with Pediatric Heart Network). We acknowledge the timetable you submitted on August 21, 2021, which states that you will conduct this study according to the following schedule: Final Protocol Submission: November 30, 2021 Study Completion: December 31, 2026 Page 8 – STN BL 125742/0 – Elisa Harkins Final Report Submission: May 31, 2027

8.  Study C4591007 substudy to prospectively assess the incidence of subclinical myocarditis following administration of the second dose of COMIRNATY in a subset of participants 5 through 15 years of age. We acknowledge the timetable you submitted on August 21, 2021, which states that you will conduct this assessment according to the following schedule: Final Protocol Submission: September 30, 2021 Study Completion: November 30, 2023 Final Report Submission: May 31, 2024. 

9. Study C4591031 substudy to prospectively assess the incidence of subclinical myocarditis following administration of a third dose of COMIRNATY in a subset of participants 16 to 30 years of age. We acknowledge the timetable you submitted on August 21, 2021, which states that you will conduct this study according to the following schedule: Final Protocol Submission: November 30, 2021 Study Completion: June 30, 2022 Final Report Submission: December 31, 2022

10. Study C4591022, entitled “Pfizer-BioNTech COVID-19 Vaccine Exposure during Pregnancy: A Non-Interventional Post-Approval Safety Study of Pregnancy and Infant Outcomes in the Organization of Teratology Information Specialists (OTIS)/MotherToBaby Pregnancy Registry.” Final Protocol Submission: July 1, 2021 Page 10 – STN BL 125742/0 – Elisa Harkins Study Completion: June 30, 2025 Final Report Submission: December 31, 2025 

 11. Study C4591007 substudy to evaluate the immunogenicity and safety of lower dose levels of COMIRNATY in individuals 12 through <30 years of age. Final Protocol Submission: September 30, 2021 Study Completion: November 30, 2023 Final Report Submission: May 31, 2024 

12. Study C4591012, entitled “Post-emergency Use Authorization Active Safety Surveillance Study Among Individuals in the Veteran’s Affairs Health System Receiving Pfizer-BioNTech Coronavirus Disease 2019 (COVID-19) Vaccine.” Final Protocol Submission: January 29, 2021 Study Completion: une 30, 2023 Final Report Submission: December 31, 2023 

 13.Study C4591014, entitled “Pfizer-BioNTech COVID-19 BNT162b2 Vaccine Effectiveness Study - Kaiser Permanente Southern California.” Final Protocol Submission: March 22, 2021 Study Completion: December 31, 2022 Final Report Submission: June 30, 2023 

When examining the topic of informed consent - ethics also comes to mind. Take for instance the misuse of the term "effectiveness" and the precedents being set to mandate a ‘symptom’ prevention medical intervention and a possible mandate of a vaccine that was not initially tested for its ability to prevent disease or transmission. https://childrenshealthdefense.org/defender/virginia-pfizer-moderna-vaccines-wont-prevent-disease-or-transmission/  . Just two years later and we are now facing those mandates, in part based on a flawed understand of the initial clinical trial results and again would ask – would a child be able to understand and follow all these changes? Is it ethical to assume that a child would understand this issue?

I have several questions but one ethical question stands alone.  

(1)       Is it ethical to assume that a child, as young as eleven, could reason, understand, interpret complex data - and provide fully informed consent surrounding a decision to get a vaccine or gene therapy technology (information therapy or other product) without a parent’s knowledge? 

D.C Bill B23-0171 and the Eleven-Year-Old

By way of background, and to the issue of children, their complex decision-making capabilities and vaccines, a Washington, D.C Bill B23-0171 was passed allowing children 11 years old and older to consent to vaccines without their parents’ permission. https://www.washingtonpost.com/local/dc-politics/dc-vaccine-minors/2020/10/20/7378801e-12e4-11eb-ba42-ec6a580836ed_story.html.   

What Can Children Understand | Some Questions

With the DC Bill B23-0171, a doctor could determine that a minor is "capable of meeting the informed consent standard” and therefore a child, as young as eleven could ask for government-recommended inoculations, like the novel gene therapy technology in the form of an mRNA injection, even when their parents object to it for ethical, moral, or religious reasons. 

Per the FDA, the use of the word ‘understandable’ is central to the meaning of informed consent standard.  

"Understandable" means the information presented to potential subjects is in a language and at a level the subjects can comprehend (including an explanation of scientific and medical terms). In ensuring that information is understandable, it should be noted that more than one-third of U.S. adults, 77 million people, have basic or below basic health literacy. 10   https://www.fda.gov/regulatory-information/search-fda-guidance-documents/informed-consent#genrequirments   

Can a child answer these questions?

I consider the following questions, and ask parents if their eleven-year-old child is capable of understanding some of the following questions, if any at all – even if presented in age-appropriate, understandable language. Further, how much of the complex data that surrounds this topic would be lost if these questions are paired down?

(1)       Do young children (an eleven-year-old) have the critical thinking skills needed to understand the concepts of informed consent or pharmaceutical developer’s indemnification protections when making a decision on their own, without a parent or guardian, about taking a vaccine? 

 (2)       Do they know about, and are they privy to the safety claims as they are reported by the Centers for Disease Control and Prevention (CDC), or the federally mandated use of the early warning system VAERS, or other health agency?  

(3)       Are children able to understand that a vaccine may not have been tested for its mutagenicity, carcinogenicity or reactogenic properties?  Would they even understand what these three words mean? 

(4)       Does an eleven-year-old understand or comprehend the risks to themselves from the disease that a vaccine purports to confer ‘immunity’? How does an eleven-year-old define ‘immunity’?

(5)       Does an eleven-year-old understand any stated risks of possible adverse events from a vaccine that would be listed on a vaccine insert, both known and unknown.  Are their statistical analysis skills able to discern the difference between the Relative Risk Reduction (RRR) and the Absolute Risk Reduction (ARR) used in the mRNA clinical trials and would they know how to use these metrics to determine personal risk?  

 (6)       In the case of a clinical trial, where no safety studies have yet to be completed, does a child know the meaning of, or have an understanding of the term post marketing surveillance?  

 (7)       Will there be situations whereby many children would not understand any of the terms already cited in combination with concepts of a manufactures ‘indemnification’ protections?

 (8)        Is it reasonable to assume that a child would be able to research and understand, on their own, that the CDC reported that with regard to the Sars-CoV-2 virus - “most children have mild symptoms or have no symptoms at all?” https://www.cdc.gov/coronavirus/2019-ncov/daily-life-coping/children/symptoms.html 

(9)       Would a child as young as eleven understand that such decisions would violate their parent’s substantive due process rights to make medical decisions for their children?  

(10)  In the case of the Washington, D.C Bill B23-0171, https://lims.dccouncil.us/Legislation/B23-0171 physicians across the United States are raising serious concerns.  Would a child understand their concerns and/or the details of Bill B23-0171 that would require insurance companies, vaccine providers and schools to conceal, from the parent, the fact that the child has been vaccinated. Recall, this bill stipulates those doctors would need to provide an insurance bill directly to the child’s school, without the parent’s knowledge if the child’s parent has a religious exemption on file.  Of significant concern, if the child develops potential side effects, has a severe adverse reaction and parents seek medical care for their child; the evaluating physician may not get the necessary information needed to recognize a reaction.  This puts physicians at risk of not being able to practice, using all the available medical history they need.  This bill adversely impacts the duties and responsibilities of physicians and presents grave ethical questions for physicians, parents and legislators alike. 

(11)  If a child, as young as eleven cannot understand, much less answer, any of the above questions does this meet the ‘informed consent’ requirement?   

(12) What questions are being asked of a child – do we know?

Informed consent includes the decision-making capacity to make a decision. Decisions must be made based on broad range of data and with the understanding that risk and consequence may arise from such a decision.

The answers to these questions will likely show that many, many children would not be able to develop a fully informed decision.  Would you?

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