In their 11/4 piece entitled, “COVID19 Vaccine And The Health Of Our Children”, a number of local medical providers asserted that it is “challenging” for individuals “to navigate the amount of information available” about the covid vaccine for children ages 5-11. We agree it is challenging to navigate these decisions, especially when there are concerning issues that were not acknowledged in the piece, and we offer them here for the consideration of providers in the local medical community as well as parents.

These are direct statements made by FDA scientists during the Oct. 26, FDA Panel Meeting on Pfizer’s covid vaccine for children ages 5-11:

“We’re never going to learn about how safe the vaccine is unless we start giving it, and that’s just the way it goes. That’s how we found out about rare complications of other vaccines…..” (Dr. E. Rubin)

“We’re getting down to a very small percent of otherwise healthy 5-11 year-old children who might derive some benefit, and we simply don’t know what the side effects are going to be.” (Dr. C. Meissner)

“I am just worried that if we say yes, then the states are going to mandate administration of this vaccine for children to go to school, and I do not agree with that. I think that would be an error at this time.” (Dr. C. Meissner)

“It just seemed to me that in some ways we’re vaccinating children to protect the adults when it should be the other way around. If 30 million children already have some form of immunity, they’ve made their contribution to herd immunity……” (Dr. J. Hildreth)

“I think the idea of doing an emergency use authorization, two doses for everybody without any flexibility around this, I think is just not going to go over very well and I don’t think it’s going to the give the healthcare community the options and parents the options to choose what is best for their children…Many have already had Covid infections and have some immunity because of it…I don’t see the need for ‘emergency use’ of this vaccine across the entire age group and would have preferred a more nuanced approach.” (Dr. M. Kurilla)

Additional concerns were recently voiced in an October 28, 2021, Washington Times opinion commentary titled, “Applying the Brakes on ‘Warp Speed’ COVID-19 Vaccinations for Children,” written by Dr. Larry Kwak, Dr. Steven Rosen and Dr. Idit Shachar, in which they stated:

“As physician-researchers who have pioneered the invention of vaccines and other experimental drugs for over 30 years (against cancer), we feel compelled to highlight the need for caution and honest public debate about potential long-term consequences of the available COVID-19 vaccines. Operation Warp Speed successfully enabled rapid deployment of vaccines under Emergency Use Authorization, but we believe there are urgent reasons to apply the brakes on mass vaccine mandates for children. Disturbing short-term complications from COVID-19 vaccines in adults, including myocarditis, blood clots in the brain and neurological disorders, warrant us to pause. But we must be transparent that the real threat to children is the unknown long-term, complications.”

Similar concerns are being echoed around the world by many scientists and doctors, such as Dr. Martin Kulldorf (Harvard Medical School), Dr. Jay Battacharya (Stanford Medical School), Dr. Peter McCullough (formerly Texas A&M), Dr. Harvey Risch (Yale) and Dr. Vinay Prasad (U.C.S.F.). Dr. Matthew Memoli, a top doctor within the NIH under Dr. Anthony Fauci, has come forward with concerns against mandates and vaccinating low-risk populations such as children. The committee that evaluates vaccines in the UK declined to recommend vaccination for even 12-15 year-olds. More than 13,000 doctors have signed the Global Covid Summit Declaration acknowledging covid policy and protocol concerns, specifically declaring that children should not be mandatorily vaccinated, and naturally immune persons should not be subject to any restrictions or vaccine mandates. There are also over 860,000 infectious disease epidemiologists and public health scientists who have signed the Great Barrington Declaration expressing their “grave concerns about the damaging physical and mental health impacts of prevailing COVID-19 policies….”

We specifically note the following issues relating to scientific integrity, bioethics and data analysis and interpretation around the recent Emergency Use Authorization (EUA) of the experimental covid vaccine for children 5-11 that have also been raised by prominent doctors and scientists:

• The clinical trial to assess benefit versus risk had a sample size too small to detect even serious side effects already observed in older age groups, or to identify additional side effects.

• FDA focused on myocarditis and pericarditis, and did not evaluate potential risk of a range of various serious adverse events that have been observed in vaccinated people, including neurological issues, Bell’s palsy, thrombosis, thrombocytopenia, heart attacks, Guillain-Barre Syndrome, or other risks determined by the FDA.

• No long-term safety data has been collected. Despite our local providers’ optimism, we have no direct evidence to definitively conclude that issues related to puberty, fertility, cardiovascular, neurology, autoimmunity, cancer or other long-term health conditions won’t arise.

• Even short-term safety data is severely limited because the majority of children enrolled were only followed for 17 days, and a smaller subset for two months. If, as has been done in prior trials, the control group is unblinded, how will long term risks be ascertained?

• Children with prior covid infection were not included in sufficient numbers, thus impacts of the vaccine were not able to be adequately assessed in this population. CDC estimates that about 40% of children already have natural immunity. We do not know how children who have been infected, many asymptomatically, will react to the vaccine.

• There were no severe covid cases or hospitalizations in the vaccinated or placebo group; there was no direct evidence, therefore, that the vaccine was effective in preventing severe covid. Efficacy had to be “inferred” through a process called immunobridging to assess the “likelihood” of a vaccine’s beneficial effect. More concerningly, a vaccine ingredient for this age group has been changed from a phosphate buffered saline solution to tromethamine (TRIS). According to the FDA, the use of immunobridging to assess efficacy must be done using the same vaccine.

• There is now a large body of accumulating evidence that the spike protein itself causes the entire cascade of events which result in the harm associated with covid. The vaccines have the “recipe” to tell your cells how to make the spike protein and this could be the basis of the various observed adverse events following vaccination, including myocarditis. This warrants further investigation prior to rolling out the experimental vaccine to a population with a near-zero risk of severe covid or related complications.

• There are serious questions and even legal challenges as to whether the statutory criteria for issuing authorization under EUA for the 5-11 age group have been met.

• It is now widely acknowledged, by CDC director, Dr. Rochelle Walensky and others, that the Pfizer vaccine does not prevent infection or transmission. It may not even reduce spread, as was found in a research study performed by Harvard Center for Population and Development Studies, entitled, “Increases in COVID-19 are unrelated to levels of vaccination across 69 countries and 2497 counties in the United States.” This correlation hits very close to home as Vermont, among the most vaccinated US states, is currently experiencing peak case transmission. A study published in The Lancet determined that “fully vaccinated individuals with breakthrough infections have peak viral load similar to unvaccinated cases and can efficiently transmit infection in household settings, including to fully vaccinated contacts…”

Given the statements at the FDA meeting by government scientists, prominent doctors and scientists around the world expressing dissent, and the specific details surrounding the EUA, there clearly remain some very serious outstanding questions on the decision to mass vaccinate children.

What gives us further pause are stories like that of 12-year old Maddie de Garay of Cincinnati, Ohio who volunteered for the Pfizer trials in her age group. According to her parents she was a healthy, active child. Unfortunately, Maddie had a severe reaction to the experimental Pfizer injection during the initial period of the trial and is now wheelchair bound and has a feeding tube. De Garay’s mother said neither Pfizer, the FDA or CDC have contacted her about her daughter’s condition, and Maddie’s adverse event was excluded from the data Pfizer reported about its clinical trial.

There is also the story of Kyle Warner, elite mountain biker, who received the Pfizer experimental injection in June 2021 and has suffered debilitating symptoms post-vaccine. He has been diagnosed with pericarditis and POTS (Postural Orthostatic Tachycardia Syndrome), and has not been able to return to a normal life, much less competitive mountain biking. Kyle, Maddie and many others spoke on November 2 in Washington DC at US Senator Ron Johnson’s hearing regarding the high levels of vaccine injury and the call for awareness of this unfortunate reality.

While Maddie and Kyle’s experiences are anecdotal, they are part of a narrative borne out on a large scale by the Health and Human Services’s Vaccine Adverse Events Reporting System (VAERS) data. The medical community often meets VAERS reports with a level of skepticism and disbelief, but it is important to note that this is the only public government surveillance system for vaccine adverse events reporting and healthcare providers are required by law (42 U.S. Code § 300aa-25) to report any potential vaccine adverse event. Reports of injuries in the VAERS following covid vaccinations have been numerous: 856,917 adverse events, and 18,078 deaths, through October, 29, 2021. Many of the deaths reported occurred 0-4 days after vaccine administration. These numbers may in fact be significantly underreported — the Lazarus Report performed by Harvard Pilgrim Healthcare and presented to Health and Human Services determined that “[f]ewer than 1% of vaccine adverse events are reported.” While underreported, a recent report found that 67

percent of the claims in the system were made by health service providers, an indication of reliability.

A CALL TO ACTION

We call on local healthcare providers to acknowledge our concerns and to provide the following safeguards:

• Promote open community dialogue on the risks and benefits of vaccination.

• Ensure that true informed consent is obtained regarding the facts that this vaccine was fast-tracked under Emergency Use Authorization and that Pfizer is not liable for any injuries caused by its product. Ensure that parents are receiving unbiased information on known and unknown risks to help support their ability to make the best informed decision for their children. Refrain from claiming that these are 100% safe and effective, when there is no existing data to support this claim. Ensure that experimental vaccine inserts and paperwork are made available to parents.

• Practice an individual approach versus a collective-one size fits all. Providers should assess each child’s overall situation, health history and actual risk before recommending an experimental vaccine. Consider appropriate antibody testing to determine need for vaccine. Natural immunity is the gold standard, and research is showing it provides durable, robust protection.

• Acknowledge the conflicting research and differing opinions regarding solutions and the use of covid vaccines within the larger scientific community. Cultivate an informed, independent, unbiased decision after assessing all of the available research, not mere adherence to official government pronouncements.

• Transparent and timely adverse event reporting. We request that hospitals and providers report on the incidence of adverse events weekly. Healthcare providers should have established written procedures on what is required for submitting to VAERS. How does our local medical community plan to adequately track, monitor, and report out adverse events for the pediatric covid vaccine? Does it pledge to believe parents, and move quickly to halt vaccinations if a certain threshold of safety signals are met?

• Respect a parent’s right to refuse covid vaccination for their child, with no impact on their access to healthcare or any part of society. Do not participate in discrimination or coercion to meet arbitrary vaccination goals in a short period of time. Stand firmly against mandates for community events, school, sports or any other extracurricular activities.

• Consider well-researched and clinically documented early outpatient treatment protocols that are being successfully utilized nationally and globally.

The following four people are credited with writing this commentary. They are Allison Cassavechia, Newark, Alison Despathy, Danville, Anat Grosfeld, Kirby and Sandy Reider MD, Lyndonville, and Jennifer Stella. Other who endorse the message are Jennifer Stella, Karen Bufka, Mary Hauser, Krissy Pozatek, David Edry, Josh Lawrie, Sharon Reihmer, Mary Jo O’Neill, Luke O’Neill, Janah Pellerin, Amber Sprouse, Katrina Diller, Diane Tetrault, Hanna Jenkins, Kate Scarlott, Moriah Vance, Jeni Broughan and Rich Broughan.

Numerous studies and resources have been utilized to formulate this response

Global Covid Summit (doctorsandscientistsdeclaration.org)

(PDF) Analysis of COVID-19 vaccine death reports from the Vaccine Adverse Events Reporting System (VAERS) Database Interim: Results and Analysis (researchgate.net)

Senator Johnson Expert Panel on Federal Vaccine Mandates and Vaccine Injuries - YouTube

Emergency Use Authorization of Pfizer’s Vaccine for Children Illegal & Unethical, Nov. 4th Letter to U.S. Representatives—Siri & Glimstad Letter

Thousands of Physicians and Scientists Reach Consensus on Vaccinating Children and Natural Immunity - Global Covid Summit

Risk Factors for COVID-19 Mortality among Privately Insured Patients - A Claims Data Analysis - A FAIR Health White Paper.pdf

Increases in COVID-19 are unrelated to levels of vaccination across 68 countries and 2947 counties in the United States (nih.gov)

FDA Authorizes Pfizer-BioNTech COVID-19 Vaccine for Emergency Use in Children 5 through 11 Years of Age | FDA

Pfizer-BioNTech COVID-19 Vaccine EUA LOA reissued October 29 2021 (fda.gov)

Vaccines and Related Biological Products Advisory Committee October 26, 2021 Meeting Announcement - 10/26/2021 - 10/26/2021 | FDA

(PDF) The Safety of COVID-19 Vaccinations - Should We Rethink the Policy? (newly and independently peer-reviewed version) (researchgate.net)

Why are we vaccinating children against COVID-19? - ScienceDirect

Thrombosis with Thrombocytopenia Syndrome - Hematology.org

Thrombosis and Thrombocytopenia after ChAdOx1 nCoV-19 Vaccination | NEJM

One-year sustained cellular and humoral immunities of COVID-19 convalescents | Clinical Infectious Diseases | Oxford Academic (oup.com)

Community transmission and viral load kinetics of the SARS-CoV-2 delta (B.1.617.2) variant in vaccinated and unvaccinated individuals in the UK: a prospective, longitudinal, cohort study - The Lancet Infectious Diseases

One of Fauci’s Top Scientists Opposes Mandates, Is Unvaccinated | MSN

Vaccines and Related Biological Products Advisory Committee June 10, 2021 Meeting Presentation- COVID19- Considerations on Data to Support Licensure and EUA of Pediatric Vaccines (fda.gov)

Applying brakes on ‘Warp Speed’ COVID-19 vaccinations for children - Washington Times

FDA panel: Benefits of COVID-19 vaccine for ages 5-11 outweigh risks | AAP News | American Academy of Pediatrics

F.D.A. Panel Recommends Vaccine for Children 5 to 11 - The New York Times (nytimes.com) FDA meeting on Pfizer’s Covid vaccines for kids ages 5 to 11 — 10/26/2021 - YouTube

Überantibodies From Recovered COVID-19 Patients Could Spur New Therapeutics and Vaccines | Allergy and Clinical Immunology | JAMA | JAMA Network

Multifaceted highly targeted sequential multidrug treatment of early ambulatory high-risk SARS CoV-2 infection (COVID-19) (imrpress.com)

Pathophysiological Basis and Rationale for Early Outpatient Treatment of SARS-CoV-2 (COVID-19) Infection (nih.gov)

Electronic Support for Public Health–Vaccine Adverse Event Reporting System (ESP:VAERS) (ahrq.gov)

Geert Vanden Bossche & Peter McCullough Webinar: Presentation by Geert Vanden Bossche - YouTube

Peter McCullough, MD testifies to Texas Senate HHS Committee - YouTube

Dr. Peter McCullough Sounds Alarm & Demolishes “Safe & Effective” Vaccine Slogan In Powerful Speech (bitchute.com)

Great Barrington Declaration (gbdeclaration.org)

How the coronavirus infects cells — and why Delta is so dangerous (nature.com)

The SARS-CoV-2 spike protein alters barrier function in 2D static and 3D microfluidic in-vitro models of the human blood–brain barrier - ScienceDirect

SARS-CoV-2 spike protein S1 induces fibrin(ogen) resistant to fibrinolysis: Implications for microclot formation in COVID-19 | medRxiv

Welcome (openvaers.com)

https://www.gov.uk/government/publications/jcvi-statement-september-2021-covid-19- vaccination-of-children-aged-12-to-15-years/jcvi-statement-on-covid-19-vaccination-of children-aged-12-to-15-years-3-september-2021

1
0
1
0
0

(0) comments

Welcome to the discussion.

Keep it Clean. Please avoid obscene, vulgar, lewd, racist or sexually-oriented language.
PLEASE TURN OFF YOUR CAPS LOCK.
Don't Threaten. Threats of harming another person will not be tolerated.
Be Truthful. Don't knowingly lie about anyone or anything.
Be Nice. No racism, sexism or any sort of -ism that is degrading to another person.
Be Proactive. Use the 'Report' link on each comment to let us know of abusive posts.
Share with Us. We'd love to hear eyewitness accounts, the history behind an article.