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By Paul Elias Alexander, MSc, MHSc, PhD

We can potentially kill thousands of our children, if not more, if we move forward with these ‘safety untested’ COVID-19 injections! There is real potential risk and we have never ever done this whereby we are seeking to inject a substance that has not even gone through the minimal safety level testing. Why would I make this stark statement and why would regulators such as the USA’s FDA and Canada’s Health Canada be considering this when they know that the requisite safety testing has not been done?

With the type of available evidence that has existed for well over one year now regarding vanishingly low risk in children, our argument is therefore taking on urgency, given recent reporting that Pfizer‘s COVID vaccine could be rolled out to babies as young as six months in the US this coming winter (2021) under plans being drawn up by the pharmaceutical company. Pfizer has recently announced that it plans to go to the FDA to get authorization for vaccination of 5-to-12-year-old children based on a study they claim to have completed. We consider this absolutely reckless, dangerous based on lack of safety data and poor research methodology, and without any scientific basis whatsoever. This safety point is critical and places our children in sheer danger. 

Are children at risk for COVID-19 that would warrant a vaccine? What does the evidence show? 

The infection mortality rate (IFR) is roughly similar (or likely lower once all infection data is collected) to seasonal influenza. Stanford’s John P.A. Ioannidis identified 36 studies (43 estimates) along with an additional 7 preliminary national estimates (50 pieces of data) and concluded that among people <70 years old across the world, infection fatality rates ranged from 0.00% to 0.57% with a median of 0.05% across the different global locations (with a corrected median of 0.04%). Survival for those under 70 years is 99.5% (Ioannidis update). Moreover, with a focus on children, “The estimated IFR is close to zero for children and young adults.” The global data is unequivocal that “deaths from COVID are incredibly rare” in children. While anyone is at risk of being infected, “there is more than a thousand-fold difference in the risk of death between the old and the young”. The CDC reported that children accounted for 0.05% of all COVID-involved deaths since the beginning of the emergency in February/March 2020, but have not been declarative on whether these children died ‘with’ COVID or ‘of’ COVID. 

The published evidence is conclusive that the risk of severe illness or death from COVID-19 in children is almost nil (statistical zero) and this evidence has accumulated for well over a year now. In fact, we knew this for over 15 months. It is clear that children are at very low risk of spreading the infection to other children, of spreading to adults as seen in household transmission studies, or of taking it home or becoming ill, or dying, and this is settled scientific global evidence. This implies that any mass injection/inoculation or even clinical trials on children with such near-zero risk of spread and illness/death is contraindicated, unethical, and potentially associated with significant harm. Injection (vaccine) studies have failed to ‘exclude’ harms for our children or proven their necessity and as such we do not know what will happen if children take the injections. The injections in children offer no opportunity for benefit and only opportunity for harms based on the risk-benefit calculation that dramatically skews risk towards harms for them. We don’t just inject our children simply because Dr. Fauci (NIAID), Walensky (CDC), or Collins (NIH) tell us to!     In my opinion, they have been routinely flat-out wrong in their statements and positions on most things COVID-19. Moreover, they have failed to prosecute their case that these injections are a necessity for our children. The necessity must be shown in terms of risk and the injection must be proven safe. Neither of these ‘must haves’ have been met. 

The risk-benefit discussion for children with these COVID-19 injections is a very different one than that for adults. Furthermore, the accumulated evidence of adverse effects and deaths (in CDC’s VAERS database for vaccine injuries) temporally linked to the injection (requiring validation) with biological plausibility (Bradford Hill criteria for causality), remains a very serious cause for concern. The fact is that this is a completely novel and experimental injection therapy with no medium- or long-term safety data (or even definitive effectiveness data). We are very concerned that if we move forward with the vaccination of our children without the proper safety testing, then we will present them with potentially catastrophic risk, including deaths in some. We make this claim based on what has transpired thus far in adults who have been vaccinated (and young persons). 

Thus far, no convincing information has been given by the CDC to determine if US children deaths were causal or incidental COVID deaths since the inception of the pandemic February 2020. Dr. Marty Makary of Johns Hopkins’ recent Wall Street Journal op-ed was titled “The Flimsy Evidence Behind the CDC’s Push to Vaccinate Children. The agency overcounts COVID hospitalizations and deaths and won’t consider if one shot is sufficient.” A recent article by David Zweig in the Atlantic suggests a 50% error rate in reporting. More specifically, a team of Johns Hopkins researchers recently reported that when they looked at a group of about 48,000 children in the US infected with the virus, they found no (zero) COVID deaths among the healthy kids. Dr. Makary indicated that his team “worked with the non-profit FAIR Health to analyze approximately 48,000 children under 18 diagnosed with COVID in health-insurance data from April to August 2020…after studying comprehensive data on thousands of children, the team “found a mortality rate of zero among children without a pre-existing medical condition such as leukemia.” Rather than acknowledge this scientific reality, Makary says the CDC continues to use “flimsy evidence” to push the COVID vaccine upon children”.

With this background, we knew of the very low risk to children in the first place, but we wanted scientific documentation of why this low risk existed, to help support our argument against these injections in our children. What, if any, was the underlying biology or molecular explanation for such negligible risk? Is there one? The evidence presented below (including on the risk of the injection itself) may help explain why children are not candidates for the COVID-vaccines (here and here) and may well be (are) immune and can be considered “fully vaccinated.” The evidence also surrounds the potential risk of the spike protein to the vaccinee. 

The key arguments are:

1) The ACE 2 receptor plays a key role in fluid balance and blood pressure control (in terms of excretion and retention of salt). However, the virus uses the ACE 2 receptor to gain entry to the host cell, and the ACE 2 receptor has limited (less) expression and presence in the nasal epithelium in young children (potentially in upper respiratory airways); this partly explains why children are less likely to be infected in the first place, or to spread it to other children or adults, or to even get severely ill; the biological molecular apparatus is simply not there in the nasopharynx of children as reported eloquently by Patel and Bunyavanich. By bypassing this natural protection (limited nasal ACE 2 receptors in young children) and entering the shoulder deltoid, this could release vaccine, its mRNA and LNP content (e.g. PEG), and generated spike into the circulation that could then damage the endothelial lining of the blood vessels (vasculature) and cause severe allergic reactions (e.g. here, here, here, here, here). 

2) Recent research (August 2021) by Loske deepens our understanding of this natural type biological/molecular protection even further by showing that pre-activated antiviral innate immunity in the upper airways of children works to control early SARS-CoV-2 infection. The study provides evidence that “the airway immune cells of children are primed for virus sensing, resulting in a stronger early innate antiviral response to SARS-CoV-2 infection than in adults”. 

3) When one is vaccinated or gets infected naturally, this drives the formation, tissue distribution, and clonal evolution of B cells, which is key to encoding humoral immune memory. There is recent research evidence by Yang published in Science (May 2021) that blood examined from children retrieved prior to the COVID-19 pandemic have memory B cells that can bind to SARS-CoV-2, suggestive of the potent role of early childhood exposure to common cold coronaviruses (coronaviruses). This is supported by Mateus et al. who reported on T cell memory to prior coronaviruses that cause the common cold (cross-reactivity/cross-protection). Yang et al.’s research underscores the importance of early childhood B cell clonal expansions and cross-reactivity/cross-protection, in subsequent exposures and responses to novel pathogens e.g. SARS-COV-2.  This may well help explain why children are not candidates for the COVID vaccines and may (are) already be immune and can be considered ‘vaccinated’. “Giving them a dangerous vaccine has virtually no benefit but significant downsides (like death)”.

4) Building the case against COVID-19 vaccination in children even further, ongoing research and discussion suggests that children are less likely to suffer widespread infection throughout the body and that their immune systems appear capable of eradicating SARS-CoV-2 before it can reproduce in high numbers. Weisberg and Farber et al. suggest (and building on research work by Kumar and Farber) that the reason children can more easily neutralize the virus is that their T cells are relatively naïve. They argue that since children’s T cells are mostly untrained, they can thus immunologically respond more rapidly and nimbly to novel viruses.

5) We would also draw attention to the transmission research in the Journal of Infection by Galow (April 2021) that examined household transmission rates in children and adults. They reported that there was “no transmission from an index-person < 18 years (child) to a household contact < 18 years (child) (0/7), but 26 transmissions from adult index-cases to household contacts < 18 years (child) (26/71, SAR 0=37)”. These findings add to the stable existing evidence that children are not spreading to children but rather adults are spreading to children. The findings are in line with overall accumulated evidence that children are less at risk of developing severe illness courses and also are far less susceptible and likely to spread and drive SARS-CoV-2 (references 1, 2, 3, 4).

6) Risk: There is an emerging discussion that with approximately 570 COVID injection deaths registered in VAERS in children, and the CDC reporting approximately 350 deaths in children since the inception of the emergency (Feb/March 2020), then the vaccine is killing more children than the virus/disease itself (Steve Kirsh, personal communication, September 2,  2021). We argue it is beyond a theoretical risk that children can be harmed by these suboptimally- and safety-untested injections. We have the severe morbidity and mortality accumulated in the CDC’s very own VAERS vaccine adverse event database, with 15,000 deaths (and 700,000 adverse reports) in the 1-5 day period post injection (80% linked to the injection). This is not my data. It is logged in the CDC’s very own database and vetted by the CDC. Alarmingly, VAERS is known to capture only approximately 1% of the burden but let us handicap the debate and say that VAERS captures 10%. Then we are potentially looking at 150,000 deaths thus far due to the injections. 

I am not only prognosticating; I am warning parents and the public, and I do so because the vaccine developers have failed in producing optimal methods and reporting and have not performed the proper safety testing. The FDA should have never granted FDA based on the ‘thin’ data and suboptimal methods by the vaccine developers. Again, I support vaccines once properly developed with the proper safety testing that excludes harms. The goal is to inform the public and parents urgently so that they understand the risks involved when they are making a decision based on a drug or vaccine providing no benefit and they are bringing no risk to the table. The threshold must be set very high to even consider these. I argue that these injections were never needed in children in the first place. 

Dr. Patrick Whelan has summarized the stunning research evidence that, if it bears out, can present our children with catastrophe from these injections. Whelan affirms that the spike protein itself is a lethal toxin and is devastating to the vasculature (endothelial layer), having the potential to cause “microvascular injury to the brain, heart, liver, and kidneys in a way that does not currently appear to be assessed in safety trials of these potential drugs”. For example, Dr. Whelan points to research by Nuovo et al. showing “that in 13/13 brains from patients with fatal COVID-19, pseudovirions (spike, envelope, and membrane proteins) without viral RNA are present in the endothelia of cerebral microvessels. Furthermore, tail vein injection of the full length S1 spike subunit in mice led to neurologic signs (increased thirst, stressed behavior) not evident in those injected with the S2 subunit. The S1 subunit localizes to the endothelia of micro-vessels in the mouse brain, and is a potent neurotoxin. So, the spike S1 subunit of SARS-CoV-2 alone is capable of being endocytosed by ACE2 positive endothelia in both human and mouse brain, with a concomitant pauci-cellular microencephalitis that may be the basis for the neurologic complications of COVID-19. The Pfizer/BioNTech vaccine (BNT162b2) is composed of an mRNA that produces a membrane-anchored full-length spike protein. The mouse studies suggest that an untruncated form of the S1 protein like this may cause a microvasculopathy in tissues that express much ACE2 receptor”. 

What can be concluded? Pulling these emerging research findings together strengthens the case that children are not candidates for the COVID vaccines and are to be considered already “fully and completely COVID vaccinated.” Furthermore, as lucidly outlined by Whelan, it is potentially disastrous to children if we move forward with vaccines without proper study of the possible harms to them. We do not have all of the answers yet for the vaccine developers have failed to conduct the proper safety studies and for the duration that would unravel any harms. Yet, as Whelan points out, “it appears that the viral spike protein that is the target of the major SARS-CoV-2 vaccines is also one of the key agents causing the damage to distant organs that may include the brain, heart, lung, and kidney. Before any of these vaccines are approved for widespread use in humans, it is important to assess in vaccinated subjects the effects of vaccination on the heart (perhaps using cardiac MRI, as Puntmann et al. did). Vaccinated patients could also be tested for distant tissue damage in deltoid area skin biopsies, as employed by Magro et al….it would be vastly worse if hundreds of millions of people were to suffer long-lasting or even permanent damage to their brain or heart microvasculature as a result of failing to appreciate in the short-term an unintended effect of full-length spike protein-based vaccines on these other organs”.

No vaccine developer, nor the FDA, Health Canada, or similar national regulators have ensured that the proper safety testing has been done to ‘exclude harms’ to our children. As such, we state that under no condition must children get these injections. None! We find this very reckless and dangerous by these regulators who are to ensure that no unsafe drug, medical device, or vaccine is to be brought to the market. They have failed thus far! We ask these regulators to please slow down and demand safety testing, no matter how long it takes. We ask them to conduct proper risk-benefit analyses and they will see that the injections are contraindicated in children. Particular carefulness is needed with regard to the potential widespread injection of children before there is any real data on the safety or effectiveness of these injections.

We make this clarion call principally based on the injections having never been needed in children in the first place given the risk-benefit calculation, and, critically, on the lack of safety data to inform decision-making. These injections are just not needed in our children and can be devastatingly unsafe! We presented above a reasonably plausible and strong biological and molecular explanation of why children should not, and in fact, ‘must not’ be administered these COVID-19 injections. 

In closing, there is very little risk and no data, evidence, or science to justify any of the COVID-19 injections in children. Under no circumstance should we expose the risk of the injections to children, and to consider putting risk on children so as to protect adults is perverse, reckless, and very dangerous. There is no safety data. The focus rather has to be on early treatment and testing (sero antibody or T cell) to establish who is a credible candidate for these injections if properly ethically informed and consented, for it is very dangerous to layer inoculation on top of existing COVID recovered, naturally acquired immunity (no benefit and only potential harm/adverse effects) (here, here, here, here, here, and here). We must establish who is COVID recovered, which is natural immunity, as this is a critical piece of the puzzle before any injection. Additionally, if public health agency leaders Fauci, Walensky, and Collins continue to demand our children be vaccinated, then they must remove liability protection for all who benefit from it. 

What does all of this mean? I am calling for a pause at least on the administration of these vaccines in toto until we can figure out the safety issues. We are calling for a definite ‘no go’ on administration of any of these injections in children. We think that given the lack of safety data that could inform decision-making, then it is very dangerous and reckless to move to vaccinate our children, especially given their very low risk of acquiring the pathogen and spreading it or getting seriously ill once infected. Global data and science are settled on this. If Dr. Fauci of the NIAID, Dr. Walensky of the CDC, and Dr. Collins of the NIH do not want (offer) to remove liability protection, and if the vaccine developers do not offer to do this, then parents must take this cue that the injection is potentially dangerous and that they (Fauci, Walensky, Collins) know it (at least suspect this), that they know that children may die from these injections (that harms were not ‘excluded’ based on the existing studies), and thus you must refuse to allow any such injection of their children. If these public health leaders do not remove liability protection, then there is a problem. If they think and know the injections are safe, removing liability protection should be no issue for them to do. No liability means no trust! If one child is harmed or dies from these injections, these public health leaders and vaccine companies must be held to account legally for the pain and suffering to the child and families.