Paul Elias Alexander, PhD; Parvez Dara, MD, MBA; Howard Tenenbaum, DDS, PhD

We raise the specter of harm from the vaccines in children and adolescents. We are scientists and prognosticators who believe in the science of pre-existing vaccines that have undergone rigorous pretesting prior to human exposure. We have very serious concerns about these COVID-19 vaccines especially given escalating adverse effects being reported in the CDC’s VAERS vaccine adverse event database, the European vaccine adverse event reporting database, and the evidence in the general media. The reports of several thousand deaths post vaccine that appear temporally linked to the vaccines are very alarming. We are raising the alarm and call for urgent examination. 

We also raise these risk concerns for pregnant women who must only be administered safe drugs or vaccines. We never ever administer an untested biological substance to a pregnant woman. There could be no exception to this and we are very concerned by the administration of these vaccines to pregnant women. They are very concerning risks to these COVID-19 vaccines and we are referring to not just immediate risks, but the long-term ones that would emerge in years to come e.g. autoimmune disorders etc. We just do not have the required long-term safety data for the vaccines and this worries us immensely. The reality is that we strongly support vaccines that are ‘properly’ developed, and we are not anti-vaxxers. 

We have always argued for a ‘focused’ approach that is stratified based on age-risk targeting, recognizing that COVID-19 operates based on age and risk. A ‘one-size-fits-all’ approach is suboptimal and does not work. We continue to fail to strongly protect the high-risk among us (elderly, elderly with co-morbid conditions etc.) while restricting the ‘well’ and ‘low-risk’ healthy persons in our populations with policies that have had devastating societal consequences beyond what could have been caused by the pathogen on its own.  Outcomes once infected, has less to do with the virus itself and more to do with one’s baseline risk. Age, obesity, diabetes etc. are the key risk factors. Obesity particularly emerged as a super loaded factor. 

We have harmed our children for decades to come by these unscientific, illogical, irrational, ridiculous, and absurd school closures policies and it is the very poor children (minority, African-American, Latino, South Asian/South East Asian) who have fared worst of all. Working women have fared worst of all also, especially minority women. They were least able to afford the lockdowns and school closures that the ‘lap-top’ class could. Shame on all of our governments and their unsound, academically sloppy so called ‘medical advisors’ who exhibited a depth of cognitive dissonance to any science or evidence that misaligned with their specious edicts and policies. Shame on our government agencies such as the CDC, FDA, and NIH who have been wrong on virtually everything COVID-19 related. Shame on Dr. Anthony Fauci for his nonsensical, often inaccurate statements and flip-flops that left the nation so very confused. They have all failed! 

Before focusing on the vaccine safety concerns, we call into question the true effectiveness of the vaccines and the reported estimates of effect. In the Phase I/II trial analyses, the efficiency of the mRNA vaccines were reported as 95%. The implications were derived from a Relative Risk Reduction (RRR). If the real numbers are used to determine the Absolute Risk Reduction (ARR), then the results are a paltry 0.8%. Had the ARR been published, then a different picture would have emerged as to the effectiveness, and why one would accept a vaccine with such low indications of benefit, and while as we are now learning, potential harms? 

This was terribly deceitful by the CDC, NIH, Dr. Anthony Fauci etc. and pharmaceuticals, as well as all who touted the RRR of 95% knowing it is not reflective of the effectiveness in a meaningful manner, and which could optimally inform the public. It is the ARR that is meaningful for the public for their decision-making. 

Shame also on all of the medical establishment cartel, the academic scientists, and regulators such as the FDA and agencies like the NIH who have prevented the use of early treatment for high-risk patients. They know these drugs work yet have let hundreds of thousands (at least 80%) die needlessly. People have died being denied access to safe, effective, cheap, and available therapeutics. We knew that if you start treatment early, you could save the patient. You could stop hospitalization and death by as much as an 85% reduction in risk. But the medical community settled into a group think of therapeutic nihilism. Doctors should have stood up and be brave, and exercised their clinical discretion and judgement. They should have used an empirical approach as they usually do. They should have trusted their clinical judgement and treat their patients who were scared and needed help, not just to send them home to ‘wait-and-see’ and ‘worsen in place’, and only come see me again (or go to the emergency room) when you cannot breathe properly or have seizures etc. It is often too late by then, and way more complex to treat. This was a massive blunder and will go down as one of the greatest public health disasters in history, along with the catastrophic failures of lockdowns and school closures and mask mandates, and with the potentially unsafe vaccines we will now discuss. 

Now to the vaccine safety concerns. SARS-CoV-2 virus has a glycosylated spike protein (spicule) that sits on the ball of the virus and it is this protein that the virus uses to bind to the ACE 2 receptor on the surface of our respiratory epithelial cells or similar cells. This docking or binding that enlists the help of receptor binding domains and cleavage serine protease enzymes (and a furin cleavage site) allows for the virus to fuse its outer membrane with the host cell’s outer membrane, then gaining entry of the virus’s mRNA genetic material into the cells’ interior. From there, the mRNA uses the host cells’ metabolic machinery e.g. ribosomes etc. to produce a multitude of the spike proteins. As part of building an immune response to the virus, we are injecting the mRNA code to build the spike protein (mRNA delivery platform) or the DNA code also to build the spike protein (adenovirus vector delivery platform). This is the core theory behind the COVID-19 vaccines and how immunity will be developed (development of neutralizing antibodies). 

However, we have learnt that COVID-19 is as much a vascular illness as it is a respiratory illness and we are seeing that many of the catastrophic symptoms have one thing in common, this being impairment and damage to blood circulation. Researchers discovered that the SARS-CoV-2 virus infects the endothelial cells that line the inside of blood vessels. “The concept that’s emerging is that this is not a respiratory illness alone, this is a respiratory illness to start with, but it is actually a vascular illness that kills people through its involvement of the vasculature”. It has been shown that SARS-CoV-2 can directly infect engineered human blood vessel organoids in vitro (in the laboratory). 

Moreover, we are now witnessing thousands of cases of adverse effects e.g. bleeding disorders, blood clotting, and deaths, that are occurring immediately after vaccination and this close temporal relationship has led us to believe that the vaccine’s content is precipitating this. The adverse effects are being logged into the CDC’s VAERS database as well as the European adverse event database,  as mentioned, and we have learnt that the reporting which is voluntary, captures roughly 1% of the events, at least in the VAERS database. This elevated under-reporting gives much concern that we are still not getting the true picture of morbidity and mortality due to the vaccines. 

With this knowledge at hand and known widely via the scientific literature, we are calling for a pause at least in the administration of these vaccines until the safety issues are clarified. In this regard and especially concerning the children and young adults, we are calling for a moratorium against vaccinating them currently. There is no safety data nor evidence of support in the need to vaccinate children. Our main concern remains that the safety analysis for these vaccines have not been done and the required time to follow-up for this vaccine to ascertain its safety was limited to a median of 2 months in the initial trials. This is public knowledge. 

The emerging data from a recent Norwegian report concluded that “the Pfizer-BioNTech covid-19 vaccine is “likely” to have been responsible for at least 10 deaths of frail elderly people in nursing homes in Norway”. This reported evidence caused us grave concern on the functionality of the vaccine. Similarly, Shimazawa has reported on the potential adverse events in Japanese women who received COVID-19 vaccine ‘tozinameran’ (BNT162b2, Pfizer-BioNTech). “Reports of cerebral venous sinus thrombosis and intracranial hemorrhage (ICH) following the administration of coronavirus vaccines have raised concerns regarding their safety…in Japan, 10 fatal cases (five men and women) have been reported to date. Four of the five women died of ICH and the other died of aspiration pneumonia, whereas all five men died of causes other than stroke”. 

In December 2020, Dr. J. Patrick Whelan, a pediatric rheumatologist, warned the FDA that mRNA vaccines could cause microvascular injury to the brain, heart, liver and kidneys in ways NOT assessed in safety trials. Whelan stated: “Is it possible the spike protein itself causes the tissue damage associated with Covid-19? Nuovo et al (in press) have shown 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 micro-vessels. 

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 microvessels in the mouse brain and is a potent neurotoxin. So the spike S1 subunit of SARS-CoV-2 alone is capable of being endocytosed (engulfed) by ACE-2 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” Whelan further states “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”. If this is so, then we have to urgently assess the impact of these vaccines on the heart for this can be devastating if millions of vaccinated persons incur long-lasting permanent injury to their heart vasculature or brain. Whelan argues it would be terrible if we failed “to appreciate in the short-term an unintended effect of full-length spike protein-based vaccines on these other organs”. 

Whelan further reports that “ACE-2 receptor expression is highest in the microvasculature of the brain and subcutaneous fat, and to a lesser degree in the liver, kidney, and heart. They have further demonstrated that the coronavirus replicates almost exclusively in the septal capillary endothelial cells of the lungs and the nasopharynx, and that viral lysis and immune destruction of those cells releases viral capsid proteins (or pseudo-virions) that travel through the circulation and bind to ACE- 2 receptors in these other parts of the body leading to mannan-binding lectin complement pathway activation that not only damages the microvascular endothelium but also induces the production of many pro-inflammatory cytokines. Meinhardt et al. (Nature Neuroscience 2020, in press) show that the spike protein in brain endothelial cells is associated with formation of microthrombi (clots), and like Magro et al. do not find viral RNA in brain endothelium. In other words, viral proteins appear to cause tissue damage without actively replicating virus”. 

This implies that the spike, on its very own, could act like a pathogen, causing devastating morbidity and fatality. 

Suresh (2020) reported that “in addition to facilitating the membrane fusion and viral entry, the SARS-CoV-2 spike protein promotes cell growth signaling in human lung vascular cells, and patients who have died of COVID-19 have thickened pulmonary vascular walls, linking the spike protein to a fatal disease, pulmonary arterial hypertension (PAH)”.

Suzuki (2021) examined SARS-CoV-2 Spike protein’s capacity to elicit cell signaling in human host cells and the implications for possible consequences of COVID-19 vaccines. They cautioned that while the aim is for the vaccines to para “introduce the spike protein into our body to elicit virus-neutralizing antibodies…we note that human host cells sensitively respond to the spike protein to elicit cell signaling…it is important to be aware that the spike protein produced by the new COVID-19 vaccines may also affect the host cells”. 

Zhang (2020) examined SARS-CoV-2 binding to platelet ACE 2 and the role in enhancing thrombosis (blood clotting) in COVID-19. They used platelets from healthy volunteers, non-COVID-19 and COVID-19 patients, including wild-type and hACE2 transgenic mice. They reported a different function of SARS-CoV-2 “on platelet activation via binding of Spike to ACE 2”. They reported that SARS-CoV-2-induced platelet activation “may participate in thrombus formation and inflammatory responses in COVID-19 patients”.

Similarly, Lei et. al. (2021) also reported that pseudovirus contributed to inflammation and damage in both the arteries and lungs of mice exposed intratracheally. They “exposed healthy human endothelial cells to the same pseudovirus particles. Binding of these particles to endothelial ACE 2 receptors led to mitochondrial damage and fragmentation in those endothelial cells, leading to the characteristic pathological changes in the associated tissue”. This research raised the very serious prospect that the spike protein on its very own, without the rest of the virus and the genome, can cause endothelial damage “associated with COVID-19”.

With this type of adverse effects data and the research and warnings emerging from prominent scientists that SARS-CoV-2 has serious effects on the vasculature in multiple organs, including the brain vasculature, we strongly question why efforts by the vaccine developers and the CDC are focused around vaccinating the entire general US population, and particularly children and young people and those who had previously been infected with COVID-19. 

Additionally, we feel that prior infected persons should not be vaccinated as there is no benefit and there is potential for serious harm. They are effectively immune and it is not a case of ‘would’ their immunity be lasting, when we have evidence that immunity from natural exposure to respiratory virus is so durable and long-lasting that it can last for 100 years. “These studies reveal that survivors of the 1918 influenza pandemic possess highly functional, virus-neutralizing antibodies to this uniquely virulent virus, and that humans can sustain circulating B memory cells to viruses for many decades after exposure – well into the tenth decade of life”.

Moreover, given the emerging adverse events and deaths from the vaccines that are being reported, we call urgently for an independent data safety monitoring board for the CDC’s VAERS system to urgently review the thousands of hospitalizations and deaths after COVID-19 vaccination to assess what ‘definitively’ caused the deaths. Yet we question whether such an independent safety monitoring board can remain independent in this era of politicized medicine. 

Specifically, the biology seems to be coming together now and we are beginning to realize that the spike protein can potentially enter the plasma (blood stream) and systemically circulates and travels to the spleen, bone marrow, liver, adrenal glands, with elevated concentration in the ovaries, etc. It can potentially combine with the receptors on the platelets and the cells that line the blood vessels. It is showing the capacity to function as an endothelia pathogen. If this is proven true, this can cause blood platelets involved in clotting, to clump, which could create the blood clotting issues we have already seen associated with these vaccines. This could be catastrophic. It thus can potentially cause heart problems since it is part of the cardiovascular system. It appears that the spike protein is what is seemingly responsible for the pathology to the cardiovascular system. 

“Science has found that the spike protein itself, when it gets into the bloodstream, causes the damage to the cardiovascular system almost entirely on its own. In fact, when the purified spike protein is injected into the blood of experimental animals, they get all kinds of damage to the cardiovascular system and it can cross the blood-brain barrier and cause damage in the brain”. The incoming data is showing us the unanticipated disastrous side effects of the vaccine itself. 

Dr. Bryam Bridle out of the University of Guelph (Associate Professor of Viral Immunology) and who is a world-renowned virologist stated para “we made a big mistake, we did not realize it until now, we thought the spike protein was a great target antigen, but we never knew the spike protein itself was a potential toxin. By vaccinating people, we are inadvertently inoculating them with a toxin”.  

The assumption is we are injecting the COVID-19 vaccine into the shoulder muscle (deltoid) and up until now, we felt the vaccine would behave like traditional vaccines and they do not go anywhere else but reside in the injection site e.g. stay in our shoulder muscle. Some of the protein will travel to the local lymph nodes to activate the immune system.

That was the assumption, but an important piece to the puzzle has recently emerged from a request to the Japanese regulatory agency (freedom of information request). Based on this confidential report (PHARMACOKINETICS: ORGAN DISTRIBUTION CONTINUED pages 6 & 7), we now have information of the biodistribution in animals that shows that the mRNA lipid nanoparticles (and as such one would extrapolate the mRNA and resulting spike protein) does not stay in the shoulder muscle and this finding is very potentially catastrophic. Bridle stated “so is it likely that the vaccine will remain in the shoulder muscle? The short answer: no way! And that is very worrying. The spike protein gets into the blood, circulates systemically in the blood for several days after vaccination. It accumulates as soon as it enters the blood and accumulates in a number of tissues such as the spleen, bone marrow, liver, adrenal glands, and what is particularly worrying to me, it accumulates in fairly high concentrations the ovaries.

The animal data clearly shows that it accumulates in various organs in very elevated concentrations.  As mentioned, if the protein gets into the blood stream, it can potentially circulate in the blood systemically and potentially accumulate in tissues such as the spleen, bone marrow, liver, adrenal glands, and ovaries. What we speculated on is now borne out by this biodistribution data. The biodistribution data alarmingly shows that and suggests potentially then that the spike proteins in humans does not (and will not) stay in the injection site and can travel throughout the body. This is a major development. This requires urgent acute examination. 

This additional piece to the puzzle as to explaining why we are seeing these problematic adverse events and deaths post vaccination, in terms of whether the spike protein moves from the injection site, is also backed up by a very recent publication that reported on 13 young healthcare workers (in CID/Ogata et al.) who received the Moderna vaccine. Researchers found detectable levels of SARS-CoV-2 protein in 11 of the 13 participants one day after first vaccination. “Spike protein was detectable in three of 13 participants an average of 15 days after the first injection… for one individual (Participant #8), spike was detected at day 29”, circulating in the blood. While nascent, this warrants urgent clarification. 

To add to this, Dr. Hamid Merchant is also investigating the biodistribution to body tissues (for instance brain) beyond the injection site for a possible explanation of the rare fatal clots formed in the brain. “The biodistribution of ChaAdOx1 in mice confirmed the delivery of vaccine into the brain tissues. The vaccine may therefore spur the brain cells to produce CoViD spike proteins that may lead to an immune response against brain cells, or it may spark a spike protein-induced thrombosis. This may explain the peculiar incidences of the fatal CVST observed with viral vector-based CoViD-19 vaccines. It is anticipated that other vaccines using similar technology such as AstraZeneca/Oxford (Chimp adenoviral vector), J&J/Janssen (Human adenoviral vector 26), CanSinoBio (Human adenoviral vector 5), and Sputnik V (Human adenoviral vectors 26 and 5), may also lead to the same safety concerns”.

Avolio et al. (pre-print) reported that the SARS-CoV-2 spike protein disrupts the cooperative function of human cardiac pericytes – endothelial cells through CD147 receptor-mediated signalling. They investigated the effects of the recombinant, stabilised S protein on primary human cardiac pericytes (PCs) signalling and function and found that the recombinant S protein alone elicits functional alterations in cardiac PCs. They concluded that the “S protein may elicit vascular cell dysfunction, potentially amplifying, or perpetuating, the damage caused by the whole coronavirus. This mechanism may have clinical and therapeutic implication”. 

We were becoming aware some time now that the spike was a potential pathogen on its own and we were awaiting additional research data to inform us. We have presented the data above. Now we have clear cut evidence from the Japanese biodistribution regulatory data and the recent healthcare worker data that the vaccine gets into the blood circulation and travels systemically. Once in the blood stream, theoretically, the spike protein can bind to cells on our platelets and vascular endothelium that lines our blood vessels. Again, this can cause the platelets to clump and clot and this is why we have been seeing the many clotting disorders temporally associated with the vaccine administration. Again, we hypothesize this is why we have been seeing the bleeding disorders that have been reported and the heart problems. This means that the spike protein may even cross the blood brain barrier and cause neurological damage and clots in the brain. We are very concerned and this has to be acutely focused on urgently to ascertain the risk. 

We are thus calling on regulatory agencies for safety information that could tell us:

i) “which cells are actually involved in the production of the spike protein, seeing that Pfizer’s own study submitted to the Japanese authorities shows the deposition of vaccine nanoparticles in various tissues and organs; 

ii) whether the spike protein is gaining access to the circulatory system and, if so, for how long; 

iii) whether the spike protein crosses the blood-brain barrier; 

iv) whether the spike protein interferes with semen production or ovulation, 

v) whether the spike protein crosses the placenta and impacts a developing baby, or 

vi) whether the spike protein is excreted in the milk of lactating mothers”. 

“The same information is needed for the S1 subunit of the spike protein, which is the part that binds to ACE2 receptors; and which has also been detected in the plasma of individuals following mRNA-1273 (Moderna) vaccination (Ogata et al., 2021)”.

We worry greatly for our children and are also calling on all regulators like the FDA to prevent the administration of these vaccines to our children. There is no reason to vaccinate them for this disease, none, zero! This is so serious an issue for if the spike protein can get into the blood and if proven true that it operates as we are fearing, and based on some preliminary reporting, then we could also have a national blood spike protein contamination catastrophe due to blood donations. We do not want transfer of the spike in blood related transfusions, and blood transfusion regulators and agencies such as the AABB in the US must respond to this potential risk. 

What does all of this mean? What happens if these reports and the evidence we have presented prove true and the spike protein can and does behave pathogenically? Then we have made a catastrophic mistake with the spike protein as the key antigen for our immune system to target as it also may be functioning as a toxin and a pathogen, with a potential capability of a long-term disaster. The safety of the COVID-19 vaccines is in question. 

In closing, we must not allow our children to be vaccinated given all we know about their statistical zero risk of becoming infected, spreading the virus, or becoming seriously ill post-infection. There is no benefit from these vaccines and as presented, the potential can be catastrophic to our children. We knew that our children did not have the biology to acquire infection as adults do due to the limited expression of the ACE 2 receptor in their nasal epithelium. We also knew they were likely heavily protected due to cross-protection from exposure to prior ‘common cold’ coronaviruses. We thus argue that by vaccinating children who come with a ‘protective factor’ in the first place, then we would be bypassing this natural protective barrier (low expression of or absent ACE 2 receptors in their nasal epithelium) and injecting the potentially pathogenic spike protein directly into them where it could cause serious harm that we are now witnessing in adults (due to the virus itself and the vaccine’s spike protein). 

We know that the ACE 2 receptor is involved throughout the body in the renin-angiotensin (RAS) system of blood pressure and fluid balance and it is most certainly expressed at similar levels throughout the bodies of children. “ACE 2 is widely expressed, including, in the lungs, cardiovascular system, gut, kidneys, central nervous system, and adipose tissue”. While this must be verified, we must operate on this assumption that ACE 2 is expressed at similar levels in children systemically throughout the body as in adults. That it functions in a similar manner as in adults. 

We must therefore conclude, and based on the preliminary information presented above, that by bypassing this natural protection due to limited ACE 2 expression nasally (Patel, Bunyavanich) and based on injecting into the deltoid muscle, we would be potentially setting up our children for catastrophe. If this spike protein is deleterious on the platelet and vascular endothelium (as we fear it could be based on emerging and still to be clarified, yet potentially credible indications), and if it can travel systemically as is being now reported, then we could doom our children to devastating effects.  

What this means is that our children who have been largely spared from COVID-19 thus far in terms of infections and serious outcomes, may now become victim to severe outcomes in levels we have seen in adults across the last 15 months, due to a push to vaccinate them. How low is the risk? In Canada as an example, there have been approximately 260,000 confirmed SARS-CoV-2 infections in persons under 19 years of age. Of these, 0.48% (1 in 208) were hospitalized, and 0.06% were admitted to ICU. Reporting indicates that 0.004% died (1 in 23,600). We know that seasonal influenza is associated with more severe illness than COVID-19 for our children. In the US, CDC reporting suggests that approximately 0.04% of persons up to 17 years of age have died from COVID-19. 

Based on reporting, the Pfizer BioNTech’s study involved 2,260 children and adolescents who were 12-15 years of age. From these, 1,131 received the vaccine intervention. We argue that this is a very small number of adolescents and does not permit any optimal evaluation of rare but potentially serious side-effects, such as effects that may happen in only 1:5,000 adolescents. Moreover, the participants were followed-up for at most 2 months and this cannot allow the adequate duration of follow-up needed to assess safety of the vaccine. Thus, as we speak, we have no long-term safety data and do not know how this vaccine (or others) will behave long-term. 

We say ‘NO’. No vaccine. There is no data to support this, yet only potential for downsides. In terms of our children, it is beyond establishing whether the risk is real. This demand to stop any vaccination of our children is based on no risk and thus no benefit. As stated earlier, we call for an immediate pause to the vaccinations and immediate assessment of the risks (across the board), so as to confirm whether or not the adverse effects and deaths being reported are directly linked to the vaccines. We have very strong temporal associations but we need this validated. This will greatly allay the concerns that have emerged in the public due to the troubling adverse effect and death reports. 

As parents, whether American, Canadian, British, or any parent globally, we absolutely must question the fast-tracked and undiscerning, indiscriminate vaccination of our children and adolescents with a vaccine whereby the vitally important biodistribution, pharmacokinetic, and safety data on the SARS-CoV-2 spike protein, is absent. We do not have this information and it is imperative that this be collected and made known to all, given the preliminary information we have shared and the concerns that we have raised (e.g. the deposition of vaccine nanoparticles in various tissues and organs). 

To close, the CDC, NIH, Dr. Anthony Fauci of the NIAID, Dr. Rochelle Walensky who heads the CDC, the vaccine manufacturers and all involved, have failed to prosecute their case on why our children are to be vaccinated with these vaccines given their near absent risk and the many safety concerns that have emerged. To move forward would be reckless and very dangerous to our children and we raise serious concerns about the safety of these vaccines. We have presented our case above and ask your consideration of the facts. 

Note that views expressed in this opinion article are the writer’s personal views and not necessarily those of TrialSite, Inc.