RFK and Children's Health Defense Intends to Sue FDA: Warns Risks Far Outweigh Benefits for mRNA Eme

Numerous inconsistencies, controversies, and mass confusion relative to all things COVID-19 have prevailed thanks to mainstream broadcast, print, and social media's fear-soaked 24/7 narratives, bought and paid for by pharmaceutical companies and public-health authorities including the NIH, CDC, HHS, and FDA. Still, many of us continued to believe that an abundance of caution would be the norm rather than the exception when it came to experimentally injecting our children against a disease they are provably at zero risk from getting or giving to others.

After 19 months, there is still not a single confirmed case of a child transmitting and infecting an adult with COVID-19. Nor is there a single recorded hospitalization and/or death of a child from COVID-19 alone. In COVID-associated deaths, COVID-19 was merely detected, but other co-morbid illnesses played the far larger role in every case. Furthermore, in the 5-11 age cohort, there are zero COVID-associated deaths.

As such, eventually every healthcare official, provider, and researcher will have to explain his/her justification and advocacy for this child-endangerment policy when there is no discernible benefit that accrues to children by inoculating them with any of the mRNA gene therapies.

It begs the question: Why do it at all? Especially when the adverse event signals for the mRNA experimental injections in adults are exponentially greater than all other vaccines combined. And for children, the rate of adverse reactions, such as Mycarditis and Pericarditis, are unacceptable. CDC Director Rochelle Jenkins estimates seven children will have to suffer Mycarditis to save one child's life. Most of us would find the notion of a single child as a sacrificial lamb abhorrent, let alone seven.

The majority of children are believed to have natural immunity from contact and successful recovery from COVID-19, further discrediting the irrational medical policy of vaccinating children against a disease they already have full spectrum immunity against.

Increasing numbers of healthcare providers, scientists, patient and children advocates – including world-class epidemiologists, virologists, infectious disease experts, microbiologists, cardiologists, etc., around the globe – are finally standing against the crumbling narratives from a shrinking number of public-health officials, large health systems, mainstream and medical media conglomerates, teachers unions and associations, myriad NGOs, and industries' corporate leaders, all of whom benefit financially from their collective advocacy and adherence to global COVID policies.

Childrens Health Defense (CHD), founded by Robert Kennedy Jr, intends to hold U.S. Health agencies, more specifically the FDA, for the policy to experimentally inject children (5-11) with mRNA gene therapy that has insufficient safety and efficacy testing in this age cohort.

And for any reader who presumes to dismiss CHD's action as politically right, you know nothing. Robert Kennedy, Jr., besides being a Kennedy, was the darling of liberals for decades thanks to his tireless efforts as an environmental lawyer, doing far more than most to clean up our air and water.

In an October 25, 2021 letter signed by Robert F. Kennedy, Jr., CHD chairman and chief legal counsel, and Dr. Meryl Nass, member of the CHD Scientific Advisory Committee the organization put the FDA on notice of its intention to bring suit against its “reckless” Emergency Use Authorization for children 5-11 of Pfizer's BioNTech mRNA gene therapy, including ingredient modifications that have not been specifically tested for this cohort. Portions and excerpts from the notification letter below provides an essential overview of what is at stake, along with supplemental commentary.

Excerpts from the Children's Health Defense Notification Letter

Dear Chairman Monto, VRBPAC Members, and FDA Staff:

We have actively followed your work to evaluate, authorize and approve mRNA injections for the American public and particularly children.

We are aware that you authorized Pfizer’s BioNTech SARS-CoV-2 mRNA injections for children aged 5-11 at your meeting on Oct. 26., 2021. Your authorization will expose over 20 million children in the U.S., and millions more around the world, to potential COVID-19 injections of an Emergency Use Authorization (EUA) product.

We are writing to put you on notice that granting EUA status to this pediatric EUA mRNA injection, Children’s Health Defense (CHD) is taking legal action against you and other Vaccines and Related Biological Products Advisory Committee (VRBPAC) voting members, as well as the FDA.

CHD will seek to hold you accountable for recklessly endangering this population with a product that has little efficacy but which may put them, without warning, at risk of many adverse health consequences, including heart damage, stroke and other thrombotic events and reproductive harms.

We briefly outline why such authorization would be reckless:

1) The risks demonstrably outweigh the benefits of COVID mRNA injections for young children. Deaths and hospitalizations are rare and have been inflated inaccurately.

2) Nearly half of all children have natural immunity to COVID, according to the Centers for Disease Control and Prevention (CDC). There is no ethical justification for superfluous vaccination that will put children at elevated risk of mRNA injection harm.

[Editor's Note: 180 million Americans have been infected with SARS-CoV-2, acquiring immunity naturally that is considered full spectrum, durable, and long-term. Studies show that vaccinating people who are COVID-recovered destroys neutralizing antibodies necessary for combating infection and disease from future variants. This is confirmed by the Red Cross's refusal to accept donated plasma from anyone who has been vaccinated with any of the three COVID injections because it cannot be used for Convalescence Plasma or Monoclonal Antibodies, both proven successful treatments for COVID19.]

3) Some children likely will die or be permanently injured from these mRNA injections based on the authorization for children 12-16.

4) The clinical trials for the pediatric mRNA injection were too small to detect safety signals for a population in the millions.

5) There are no long-term safety data for COVID mRNA injections of young children, making this an experiment rather than appropriate medical prevention.

[Editor's Note: In the past six months, during various FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) and Advisory Committee Immunizations Practices (ACIP) review meetings, it was revealed that the information being presented to the review boards in support of approving additional vaccinations as boosters for adults, or for vaccinating younger age cohorts, was based on just several studies with fewer than 1,000 adult participants, using data collected thru April 2021. A sample of approximately 1,000 children 12-19 surveilled for fewer than three months from May thru July 2021, was also included but unpersuasive. The concern is that the studies' sample sizes do not begin to assess real world circumstances and are therefore alarmingly deficient in predicting meaningful safety and efficacy for adults, let alone children.

At this stage of global medical experimentation, the cumulative data is unable to adequately reflect the long-term impact of adverse reactions from injecting children, therefore unable to confidently assess the inherent risk-benefit ratio required for such a blanket emergency use medical policy. Nor is the all-important comparative risk-benefit ratio associated with vaccinating compared with contracting COVID-19 and recovering, in young cohorts 5-11 or 12-19, covered in the review process for approving this dangerous policy.

FDA's VRBPAC, and ACIP did recommend denying Pfizer's EUA adult booster application, yet recommended approval for its EUA application for two half doses for children 5-11, using much of the same data even though the application for the two half doses includes altering the ingredients with no accompanying testing whatsoever. It is important to note that CDC Director Rochelle Walensky ignored the FDA review board's denial and approved it, regardless.

Couple this glaring departure from required safety protocols with the omission of more current data as of October 2021, it is incomprehensible that approval was granted on such flimsy safety evidence, especially considering no requisite “emergency” exists for children by any definition. The data can only be described as thoroughly deficient in capturing the extent of the accelerated waning efficacy of Pfizer's injections as of October 2021. Nor did these presentations for review include the growing safety concerns flowing from increased numbers of serious adverse reactions and deaths, as of October 21, 2001. Each meeting can be viewed via the following links.

Vaccines and Related Biological Product Advisory Committee (VRBPAC) October 26, 2021 https://www.youtube.com/watch?v=laaL0_xKmmA

Vaccines and Related Biological Product Advisory Committee (VRBPAC) September 17, 2021


Advisory Committee Immunological Practices (ACIP) June 23, 2021


6) Unethical coercive pressure will be applied to children and their parents, as has occurred with older children and adults. To grant authorization is to abet this unethical coercion that violates the Nuremberg Code’s first principle.

[Editor's Note: The Nuremberg code and the Helsinki and United Nations Human Rights treaties all refer to the laws that unambiguously govern experimental medical research. 1) Fully informed “knowing” consent is required in writing from each participant as a result of complete, comprehensive disclosure of all the potential risks to the participant. Withholding known risks or potential harms from participants by researchers is a crime; 2) Participation is voluntary and cannot be compelled for any reason; 3) Withdrawal from the experimental medical research is optional at any time and there can be no penalty for withdrawal.]

8) There is no available care for children injured by COVID shots. The science and medicine have not yet developed, and most families will be unable to cover the costs of potential catastrophic injuries.

[Editor's Note: CHD previously published another letter that read in part: “Doctors for COVID Ethics, an EU-based international alliance of hundreds of concerned doctors and scientists, said COVID vaccines are not only “unnecessary and ineffective,” but also “dangerous for children and adolescents.”

Three of the group’s founding signatories – Dr. Michael Palmer (Canada), Dr. Sucharit Bhakdi, (Germany) and Stefan Hockertz, Ph.D. (Germany) – assembled in one document powerful expert evidence that highlights the Pfizer vaccine’s “catastrophically bad” safety profile in both adults and adolescents.

In an open letter to the EU’s Medicines and Healthcare Products Regulatory Agency, more than 40 doctors, medics and scientists in the U.K. said children are more vulnerable to the potential long-term effects of COVID vaccines.

Vaccinating kids for COVID is “irresponsible, unethical and unnecessary,” they said.

The letter warned against vaccinating people under 18 because evidence shows the virus poses almost no risk to healthy children. The risk of death from COVID in healthy children is 1 in 1.25 million, the authors wrote.

COVID vaccines, however, are linked to strokes due to cerebral venous thromboses in people under 40 – a finding that “led to the suspension of the Oxford-AstraZeneca children’s trial,” the authors said.

The doctors wrote: “Children have a lifetime ahead of them, and their immunological and neurological systems are still in development, making them potentially more vulnerable to adverse effects than adults.”

According to the latest available data for 12- to 17-year-olds, between Dec. 14, 2020 and July 16, 2021, VAERS received a total of 14,494 reports of adverse events related to COVID vaccines, including 871 rated as serious and 17 deaths.]

9) VRBPAC members should not participate in an exercise disguising a foregone conclusion. The president’s purchase of 65 million pediatric doses, the CDC guidance for COVID “vaccine” delivery, the American Academy of Pediatrics’s promotion of COVID mRNA injections for children all call into question whether this committee’s deliberations mean anything.

If the administration is unprepared to wait for your advice, let alone heed it, you should signify your disapproval on behalf of the country the FDA is meant to protect.

10) First, do no harm. You are physicians who owe a duty to patients and medical ethics. If you authorize these shots, given all you know, will you be upholding your oath? If not, is it possible that your acts could later be seen as reason to remove your medical licenses?

11) The liability-free nature of your deliberations may not stand the test of time. In the fullness of time, your decisions may not have the liability protection that they currently enjoy. Under the PREP Act of 2005, all actors advancing an EUA agenda for medical countermeasures enjoy liability protection, absent willful misconduct.

Nonetheless, if at a later point these shots are deemed non-therapeutic gene products that you knowingly and recklessly authorized, and which were then distributed to children as a direct result of your decision, it is possible that liability could later attach.

12) There is no COVID emergency for children of this age. There are safer drugs that could be used prophylactically and therapeutically for COVID in children.

13) There is extensive and compelling medical evidence for this assertion – and the choice to eschew use of these drugs in favor of a demonstrably dangerous mRNA injection is arbitrary and capricious.

Pediatric mRNA injections cannot be justified as necessary for herd immunity, when herd immunity itself is impossible to achieve with current mRNA injections.

MRNA injecting children to protect adults is also unethical:

(a) Given the rapid waning of protection and the inability of current mRNA injections to prevent transmission of SARS-CoV-2, admitted by CDC Director Walensky, it is not possible to achieve herd immunity with vaccination.

In fact, the U.K.’s head of the Oxford Vaccine Group, Professor Sir Andrew Pollard, told Parliament that herd immunity due to vaccination was a myth, and “not a possibility.”

(b) While protecting the elderly has sometimes been used as the justification for vaccinating children (for example, against influenza) it is unethical to have one group take on risk to protect another group. It is even more problematic when the group being asked to assume the risk, children, cannot give informed consent.

When the magnitude of the risk is significant (of myocarditis, for example) but has not been quantified, and the long-term risks of vaccination are unknown, demanding children shoulder this risk for others is ethically untenable.

3) We know nothing about the long-term risk of mRNA injections in children. The myocarditis risk immediately after vaccination in older children is considerable, potentially life-threatening, and increased exponentially with decreasing age.

a) The risk might be very high. The pediatric clinical trials are too small to quantify the risk from myocarditis and quantify the risk of most other adverse events.

FDA acknowledged, in its approval letter to BioNTech, c/o Pfizer on August 23, that it was unable to assess the “known serious risks of myocarditis.”

“We have determined that an analysis of spontaneous post-marketing adverse events reported under section 505(k)(1) of the FDCA will not be sufficient to assess known serious risks of myocarditis and pericarditis and identify an unexpected serious risk of subclinical myocarditis.

“Furthermore, the pharmacovigilance system that FDA is required to maintain under section 505(k)(3) of the FDCA is not sufficient to assess these serious risks.

“Therefore, based on appropriate scientific data, we have determined that you are required to conduct the following studies … .”

FDA told BioNTech-Pfizer that since FDA was unable to assess the myocarditis risk, it expected BioNTech-Pfizer to do so. FDA wants Pfizer’s final reports on myocarditis to be submitted in 2024 and 2025.

Do you think it is okay to vaccinate tens or hundreds of millions of the world’s children before BioNTech-Pfizer tells us to what extent their mRNA injections damage children's hearts?

[Editor's Note: There is significantly more evidence sited in this portion of CHD's notification letter to the FDA, including relevant need-to-know analysis of Vaccine Adverse Reactions Reporting System (VAERS) as it relates to children. Early treatments and their abject suppression is addressed in compelling rationale, especially as it relates to underpinning any justification for experimenting on children with mRNA gene therapy as a vaccine under a guise of emergency use. CHD's notification letter points out conflicts of interest on the part of many individuals responsible for review of the new mRNA gene therapies, including the presenters of relevant data under consideration. Space constrains, so please see the entire document online. degraw.substack.com/p/lawsuit-against-fda-for-recklessly]

10) Early treatment works, but to acknowledge this would prevent EUAs from being issued for COVID mRNA injections and on-patent drugs like Regeneron's monoclonal antibodies, Remdesivir and Molnupiravir.

(a) The statute under which Emergency Use Authorizations (EUA) are defined requires that there exist no alternative approved, adequate and available product in order for an EUA to be issued. Had effective drugs not been deliberately suppressed, no EUAs could have been issued.

[Editor's Note: During both the September 17 and October 26, 2021, VRBPAC meetings, nine of the 12 members reviewing the application(s) and voting declared direct conflicts of interest flowing from financial relationships with Pfizer. CDC has had to redefine “pandemic,” “vaccine,” “herd immunity,” and other such traditional elements of medical science to accommodate this single COVID-19 event and the policies that have flowed from these redefinitions.]

(b) If children and adults were treated early with proven drug combinations, very few would progress to the inflammatory and thrombotic stage of COVID-19. While this statement may appear controversial, forest plots of the compiled literature on chloroquine and ivermectin for COVID are very compelling, with average efficacy against the different endpoints of 64% to over 80%.

(c) The Nebraska Attorney General on October 15 issued an extraordinary 48-page opinion regarding these two drugs, giving safe harbor to medical practitioners and pharmacists who prescribe and dispense them with informed consent.

We expect to see more opinions like it as the states protect the public from the harmful acts of health professionals.

(d) The probable efficacy of chloroquine drugs for coronaviruses was demonstrated in experiments published by the CDC in 2005 and by Dr. Fauci‘s National Institute of Allergy and Infectious Diseases in 2014.

This prior knowledge, obtained by CDC and National Institutes of Health regarding these drugs’ efficacy at standard doses and their safety at standard doses, while agency officials suppressed their use during the pandemic, is clear evidence of willful misconduct and nullifies liability protection for these federal officials.

11) Spike protein, the putative antigen induced by all three COVID mRNA injections, is a toxin. It is produced and enters the circulation, has predictable negative consequences to vascular endothelium, activates platelets and crosses the blood-brain barrier. It would be expected to trigger the destruction of cells that produce it and present it on their surfaces.

Products that induce the production of spike protein should only be used after careful consideration of the individual recipient’s risks and benefits.

They should not be employed in mass mRNA injection programs where there is no learned practitioner to weigh appropriate use, nor in individuals with a very low risk of serious COVID disease.

[Editor's Note: There have been few threats to rival this global experimentation on our children by injecting them en masse with gene therapies masquerading as vaccines, especially based on severely limited studies on safety. Children's risk of COVID-19 is essentially zero, yet the know risk of adverse reactions from the mRNA injections to date is substantial, but for long-term adverse reactions, completely unknown. Proceeding with this reckless health policy under these circumstances is child endangerment, compelling parents, providers, et al to research all the available data on the risks of the injections, the risks of COVID-19 in the various younger age cohorts, and compare the risks to the stated benefits. Stop presuming children can shield adults' outcomes by imposing health policies that risk putting children in harms way. Start assuming responsibility for your own risks and leave them kids alone!]

Read the full CHD notification letter, along with links to all claims and statistical resources, at RCReader.com/y/chd.

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