Paul Elias Alexander, PhD; Howard Tenenbaum, DDS, PhD; Parvez Dara, MD, MBA
We write this brief clarion call to the FDA of the United States and the citizenry, in the hopes that we could call for a time-out as to the drive for an EUA of COVID-19 vaccines in children (up to 11 years old). We think this is a catastrophic mistake that will endanger the lives of our children particularly given that the proper safety data would not have been yet collected to determine the safety (short and long-term effects). We call for a hard stop in the process to grant this EUA given the US’s Food and Drug Administration (FDA) is moving fast to consider an EUA in this age group of children. There are reports that the meeting could consider ages as low as 2 years old. But the data is not developed or complete enough and especially lacking as to safety, with regards to these vaccines.
We do agree that the underlying body of evidence is not sufficiently mature enough to allow for an optimal adjudication of the benefits versus harms of this vaccine in children. We see absolutely no benefit of these vaccines (no COVID vaccine in children), even if there was data, because there is no risk to children. It is that simple a risk-management decision for parents. Why would to put a foreign substance into your child (a newly developed platform) that confers no benefit to them, none, and has possible severe harms? The threshold for granting an EUA has not been met in these children. This is not an ‘emergency’ for these children and with such low risk of bad outcomes, they can be allowed to develop much more-broad based and robust long-lasting ‘natural exposure’ immunity. It would be an abuse of the EUA process by the FDA to grant this.
We call for natural exposure immunity in children and they would be effectively immune potentially life-long 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”. So why risk a foreign substance that we do not know how it behaves safety wise and long-term? Why? You trust the government agencies to advise you? After what has transpired for COVID the last 1.5 years? Where they were flat wrong on every aspect of COVID from lockdowns, school closures, mask mandates, social distancing, and masking in general.
We thus petition the FDA openly here to stop this move to EUA (and pull it if they move prematurely) for we think it is very hasty and rash given the vanishingly small risk to children of severe sequela or death from COVID-19, and the alarming reports of harms of the COVID vaccines in adults and teens (see CDC’s VAERS vaccine adverse reporting system). These reports range from mild adverse effects to anaphylaxis, blood clotting, bleeding disorders, and up to death. We are not calling for a pause, we are calling for a hard stop. There is absolutely no sound justification to rush to grant an EUA for this age-group. No good reason.
“In what we can best be described as a monumental and very positive move, the German scientific vaccination commission (STIKO) has now moved to declare “no vaccination for healthy children against COVID-19, only severely pre-diseased children”. We are seeking more details to verify and are hoping that the FDA sees this and is swayed in this direction as this is the only optimal way forward”.
The health and well-being of our children remain our priority always. COVID has thankfully spared our children and has not been damaging as we see yearly with seasonal influenza. We know based on settled global data, that children are at exceedingly low risk (near zero and we will say statistical zero) of acquiring the SAR-CoV-2 infection in the first place (less expression of ACE 2 receptors in nasal epithelia and possible cross-protection from prior common cold coronaviruses), spreading it to other children, spreading it to adults, taking it home, of getting severely ill, or of dying from COVID disease.
We thus find that the aggressive push by Dr. Anthony Fauci, the NIH, and the CDC as well as television medical experts to vaccinate our children is very reckless, dangerous, and without the required exclusion of harm. We as parents and scientists find it reprehensible and very unsafe. They have failed to prosecute their case as to why children are to be offered this vaccination. “We are not referring to high-risk children with co-morbidities. An unwell child. Of course, a parent would be well placed to consider this vaccine (even untested for safety as it is) as it will make reasonable sense given the risk to the child of underlying conditions. We would be reckless ourselves to say ‘no vaccine’ in that instance. Children who have had problems with COVID-19 and any that may have died tragically, have had co-morbid conditions and were sick children. The data shows this. We are being emphatic that healthy ‘well’ children (vastly all children) must be exempt from these potentially unsafe vaccines”. We are for vaccination once properly developed, but there is no benefit with these vaccines and only the potential for downsides. There is even concern over recent statements by the CDC about rising teen hospitalizations among unvaccinated teens whereby the CDC apparently used duplicitous data and graphs that are contrary to its own data. Thus, CDC is using misleading statements to drive fear in parents to vaccinate their teens, when such young persons carry extremely low risks of COVID illness.
Furthermore, the existing vaccines are under EUA and this indicates that they are investigational and experimental, and as such have not met the stringent regulatory assessment (proper methods, appropriate duration of follow-up to allow safety assessment) that a vaccine must go through to attain full BLA regulatory approval. They have not undergone the appropriate animal testing and safety testing that is needed so as to exclude harm. We have looked for this data and cannot find any. We find this very concerning and to subject children to this type of risky vaccine is unacceptable and grossly reckless and irresponsible by all involved.
They have no liability as are indemnified and this is very unfair to the vaccinee (children) and parents for there is no risk by the vaccine developers and FDA etc. We have called on them to accept risk and to remove liability exemption from the table. They have thus far refused but we feel they must be held accountable and accept risk, people like Dr. Fauci, Dr. Collins of the NIH, Dr. Walensky of the CDC, the FDA, the CDC, and all of the vaccine development companies who subject children to these vaccines. If any children are harmed or die due to the vaccine, these people must have liability, seeing that if they say to vaccinate our children, then the vaccine must be safe. We question the benefits versus risks as well as all of the research methods questions that are worrisome and outstanding. Why not wait to 2022/2023 when data is supposed to be complete? At least two years of full data (not partial or interim) on safety. They talk about safety yet provide no safety results, and are rushing to vaccinate children. This makes no sense and is very dangerous should there be risks.
We have also 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 an 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. There is damage to the glycocalyx and endothelial layer and this is potentially dangerous. “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).
We are witnessing thousands of cases of adverse effects e.g. bleeding disorders, blood clotting, and deaths, that are occurring near immediately post 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 suggests elevated under-reporting.
We are calling for a stop in the administration of these vaccines in children (as part of a study or any EUA) until the safety issues are clarified yet we see no reason to vaccinate children. We are calling for a full moratorium against vaccinating them. 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 and this is very concerning.
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.
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.
Dr. Bryam Bridle, a world-renowned virologist stated, “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.” “It was a grave mistake to believe the spike protein would not escape into the blood circulation, according to Bridle. “Now, we have clear-cut evidence that the vaccines that make the cells in our deltoid muscles manufacture this protein — that the vaccine itself, plus the protein — gets into blood circulation,” he said. Bridle said the scientific community para “has discovered the spike protein, on its own, is almost entirely responsible for the damage to the cardiovascular system, if it gets into circulation”.
Recent FOIA animal data from Japan shows that it (lipid nanoparticles/mRNA/spike) 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 for clarification. Is the FDA cognizant of this data as they push to vaccinate our children? We urgently need Moderna, Pfzier, J & J, and AstraZeneca to provide the biodistribution data and study of the sequela when mRNA undergoes translation in distant cells and tissues. The case has indeed been built that the lipid nanoparticles and thus the constituent mRNA and resulting spike that is translated, is likely ending up in distant tissue it usually would not end up in. With possible catastrophic outcomes of clotting, bleeding, and immune system attack (NK lymphocytes etc.).
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 the 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), a spike was detected at day 29”, circulating in the blood. While nascent, this warrants urgent clarification.
With this emerging knowledge that no doubt needs clarification, if any of it is true, then we have a potential disaster in the making for our children. Why? Why has the FDA disregarded the emerging evidence of the spike being potentially deleterious especially to the endothelium of the vasculature?
We raise a hypothesis that children have limited ACE 2 receptors in their nasal epithelia and this confers protection from serious illness and we have seen that they are largely immune from COVID sequelae. But by vaccinating into the deltoid muscle (shoulder), and knowing now that the spike and vaccine (lipid nanoparticles) are finding their way to distant parts of the systemic circulation including crossing the blood-brain barrier, then the implications could be very serious in terms of blood clots and bleeding, etc. We would be essentially causing disease at levels seen in adults and not normally seen in children, to now emerge in children due to the vaccination push. We would be bypassing a natural protective barrier (limited ACE 2 in nasal epithelia) with potentially severe life-threatening consequences, if this bares out. This makes no sense and is highly dangerous.
Doctors have begun to raise concerns for they see across the world, a sort of recklessness and derangement with regards to the vaccination of children. How come Dr. Fauci does not know this about the spike protein? Or the troubling biodistribution data? Or has not considered this risk? Why not? Is something other than science at play here? Where is the safety data that the FDA is considering? Is there any collection of safety data by the vaccine manufacturers? We are raising very troubling questions. As such, given all that we have raised, we call for a hard stop and no issuance of an EUA by the FDA for children up to 11 years old. They must not be subjected to these vaccines. There are just too many unknowns and their baseline risk is low and the possible vaccine harms are potentially very high.
I end by calling on POTUS Trump to stand up now and say NO to vaccinating our children. I call on POTUS Biden to do the same. I call on the Prime Minister of Canada, UK, Australia, India, France, Italy etc. and all global leaders to do the same. I call on Caribbean governments, South American, African, European, and Asian governments to do the same. All global governments to not subject our children to these potentially harmful vaccines. There is no justification to vaccinating our children with these vaccines. There is no benefit and only possible downsides that could leave them with 70 to 80 years of disability or even death. COVID has spared them, say thank God and leave them alone!
Note that views expressed in this opinion article are the writer’s personal views and not necessarily those of TrialSite.