Paul Elias Alexander, MSc, MHSc, PhD, Howard Tenenbaum, DDS, PhD, Parvez Dara, MD, MBA
Op-Ed articles published on TrialSite reflect the opinion of the author and do not necessarily represent the views of the publisher
We have written about this topic of no COVID-19 vaccination for children several times, raising our strong objections against vaccinating America’s children with the current COVID-19 vaccines, and our work was previously published in the American Institute of Economic Research (references 1, 2). Our core thesis for this op-ed offering encompasses a resounding “NO” against vaccination of children for COVID-19. There is zero science to support this, and there is potential serious harm. It is as simple as that. The benefits do not outweigh the harms, and the CDC and Dr. Fauci, and all who are pushing vaccinating our children with this set of COVID-19 vaccines are being very reckless, unscientific, specious, and dangerous with regard to our children. We call on them to reverse course. We argue that it is very dangerous and reckless to push to vaccinate low-risk children with untested vaccines for safety that could leave children with decades of severe disability if something goes wrong.
We make our argument now and we make it based on ‘No liability incurred by the CDC, NIH, FDA, and vaccine developers translates into no trust by parents’. Parents want to trust what is being done in this regard but how could they at this time when there is no basis for the vaccine? We ask the CDC in general, NIH, FDA, Dr. Fauci, the CDC’s new Director Walensky, and vaccine developers, to show us the evidence, show us and the public the data they are looking at, the science they are looking at, to warrant vaccinating our children. We can see none, we found none. If such exists, we certainly want to see it, if they would like to share it. These so-called ‘medical experts’ make statements and take positions often with no evidence or science to support what they are saying. In this case, we say no more. We want to see the evidence before we vaccinate our children.
Mask Mandate for Children
Firstly, let me/us be as clear as we can. All face masks must be removed from all children immediately unless you are a high-risk child and this is needed. Other than that, all other children, in the US, in Canada, Britain, France etc., all, must immediately rip up the masks and go on with life freely. Throw them away, they are not needed for our children. Nor is social distancing and definitely not in school. It is ridiculous. The CDC and the television medical experts, these talking head senseless and highly illogical people in these Task Forces like Fauci and Birx, have become (and became) contemptible with the drivel they spewed at the public 24/7 about these masks that are ineffective (the do not work and never worked, they just cannot as used) and very harmful. These experts in the CDC, NIH, FDA etc. costed jobs, businesses, and even lives with their corrupted pandemic response—denying early treatment when it existed. Especially the lives of our African-American and minority young people and children who could have least afforded the specious, unscientific, and unsound lockdown edicts.
Many good people and children lost their lives in desperation due to the crushing harms and devastation from the lockdowns and school closures that continue even today due to the CDC and the AFT teachers’ union collusion. Our statements on masks pertain to adults too but our focus here is on our children today, and urgently. These CDC, NIH, and similar agency and medical experts and advisors are all clueless, disgraceful, hysterical, illogical, irrational, specious, and patently absurd. Pure nonsense has been showcased with these masks mandates that they know do not work. After 20 minutes, they are garbage with the moisture they accrue. These CDC and NIH etc. experts reveal a depth of academic sloppiness and cognitive dissonance to any real science or anything that does not line up with their twisted unsound politicized narratives.
We always knew this. They the CDC, have never followed the science on masks as the science says it is junk and useless but do not tell “CDC 365” this (as described below). The surgical and cloth masks are and were all junk.We knew the science, reported it repeatedly, and spoke to it. How insane are these CDC experts? How embarrassing that they are the marque agency, and I am hoping the CDC can return to its former days of glory for at present, it is a non-scientific, pseudoscientific clubhouse for inept political representatives. The CDC does not do science, it does politics. The CDC is like the furniture store where with payment options, you do not pay for one year; you may think you are buying furniture, but they are really selling you ‘money’. You may think you are reading a scientific report from CDC when in fact, it is a political report.
Questions for Our Leaders
We open this op-ed with seven urgent questions for Dr. Fauci, Dr. Walensky (CDC’s Director), the NIH’s Dr. Collins, and the FDA, as well as the vaccine developers:
1) Would Dr. Fauci and Dr. Walensky as well as Dr. Collins of the NIH sign paperwork placing liability on themselves (their agencies) should any child be harmed or die from these vaccines?
2) Since the risk of Covid-19 infection is less than 1% and the Pfizer vaccine reduces the risk of infection by only 0.7% (absolute risk reduction), why are we vaccinating children with a non-FDA approved vaccine that is currently on EUA when their survival rate from Covid-19 is 99.997% according to the CDC? Near zero risk of severe illness or death. So, what is the benefit?
3) We have not seen any clinical trial data for children 12-15? Can we see it, can the public see it? What is the Absolute Risk Reduction measure, NOT the relative risk reduction?
4). How can the vaccine recipients (children) legally provide Informed Consent? Informed consent is not just ‘hey you, roll up your sleeves’…
5.) How do you plan to inform vaccine recipients about the Antibody-Dependent Enhancement risk (ADE) and similar risks, for if not properly informed of these “non-theoretical and ‘real’ compelling” risks, it violates medical ethics standards?
6.) Since studies show that those who have recovered from Covid-19 are at a greater risk of a severe vaccine reaction if they took the vaccine, do you plan to conduct antibody testing first of our children, to see if they have already been infected with Covid-19?
7). Are you aware that the vaccines cannot prevent infection or stop the spread according to Pfizer’s clinical trial data, and Topol/Doshi (New York Times)….it is and was only set up for mild COVID…nothing else….no transmission, no infection, no severe illness, no hospitalization, no death…so if children can get immunity harmlessly and naturally, and are at such low risk of spreading it or getting ill or dying, what is the benefit? It cannot be to drive herd immunity numbers for if you consider cross protection from common cold coronavirus and immunity from prior COVID infection that is cleared, then you do not need children for this…so why place our children at such unnecessary risk?
If our children are to take a vaccine that is not needed to be based on their risk (a child’s) of becoming infected and spreading the infection or becoming severely ill (and this is clear, stable global science), and a vaccine with questionable efficacy and very real potential harms based on emerging CDC VAERS adverse reporting database reports and anecdotal reports, then the CDC, NIH, FDA, and vaccine developers must take on the risk and consequent liability if our children are harmed.
Must be Held Accountable
We are vehement, that if any child dies or is harmed by these vaccines, then the CDC, NIH, FDA, Dr. Fauci, etc. must be held accountable. The CDC, NIH, FDA, and vaccine developers must be willing to immediately take on the risk if they stand by these vaccines for this is the safety of our children we are talking about. They must be willing to be accountable and put skin in the game. This is a very different situation than that for adults. No liability by the CDC, NIH, FDA, and vaccine developers equals no trust from parents and the public when it comes to our children. As a risk management question, we see no benefit from this vaccine and only potential downsides.
We consider vaccinating children for COVID-19 as dangerous and reckless, as reckless as the recent administering of this set of vaccines that lacks proper safety data, in pregnant women as per CDC’s guidance. We have read the enabling study and it raises many questions particularly the key one being the optimal time duration of study conduct was not done. How do you assess harms for a drug or medical device or vaccine when you are running studies for roughly 4 months? How? It is not possible. Safety signals (especially rare) cannot emerge during this time nor the optimal sample size for study (or event numbers). Where is the correct comparative group to assess the impact of vaccination on pregnant, vaccinated, positive women? Moreover, the initial decision for EUA for the vaccines was based on very small event numbers e.g. one key study had 170 events (162 placeboes and 8 in the intervention arm). This is incredible that such small event numbers enabled EUA for vaccinating hundreds of millions/billions of persons.
Many Questions Raised, With Little Answers
The vaccine trials have raised many methodological questions and we are concerned given the reports of over 3,000 participants’ data being omitted in one study as they were ‘suspected’ but not ‘confirmed’ positive. We find this incredible especially how there is no full accounting by the vaccine developers of why this was done, and when we back calculate and do our own crude modeling, we find the efficacy declines from the reported 95% to 19-20%.
But here is the core issue as we look at the risk for children and this obsession by Fauci and Walensky to vaccinate our children:
i) children do not acquire it readily e.g. studies show less ACE 2 receptors in nasal epithelia
ii) children do not readily spread infection to other children
iii) children do not spread it readily to adults, it is the other way around
iv) children do not readily take it home; arises mainly from home clusters and the adults there
v) children do not become severely ill
vi) children do not die from it
vii) MISC is very rare, very treatable, and almost all leave the hospital…could it be that masking and locking kids down have driven MISC? how come nations with no lockdowns do not report MISC? or strong children masking?
So, given all of this, what is the benefit of vaccinating kids? It cannot be that kids are needed to drive herd immunity threshold for it can only be that, if you disregard cross protection that exists from prior common cold coronavirus, and also that there is existing immunity from persons who had COVID infection and cleared it. So, once you include those portions in the math, there is no need for children to achieve herd immunity, that’s a bogus reason, Dr. Fauci.
Children & the Risk of Spreading Infection
Let us for a moment, look at the issue of masking of our children and when outdoors. This will help demonstrate the ludicrousness and harmfulness of the CDC and what it is advocating for in vaccinating our children. The CDC’s guidance raises serious questions if harms emerge and comports itself to ridicule as much as wearing mask outdoors if vaccinated. As we view the CDC guidance from an eagle-eye perspective, we come to a conclusion that the CDC is not talking science anymore. It is purely nonsensical and confusing. For example, regarding the risk of outdoor transmission, the CDC knows of the Chinese study that showed only one of 7,324 infection events following careful contact tracing was linked to outdoor transmission. They, the CDC, know that the Irish analysis showed that only one in 1,000 infections out of 232,000 infections were linked to outdoor transmission. They know that outdoors has ample ventilation and thus spread is virtually non-existent (CDC originally reported that less than 10% of infection occurs outdoors and one is near 20 times more likely to be infected indoors than outdoors; however CDC’s 10% figure was inaccurate and proper research shows this to be 0.1% and CDC has now backtracked due to their startling error on outdoor transmission).
There remains an absence of evidence supporting the notion that children even spread the COVID-19 virus in any meaningful way, but there is direct evidence showing that they simply do not spread this infection and disease! This has been shown in school settings and as published in other papers. Children typically, if infected, have asymptomatic illnesses. It is well-noted that asymptomatic cases are not the drivers of the pandemic; something particularly important in relation to children as they are generally asymptomatic. A study published in the journal Nature found no instances of asymptomatic spread from positive asymptomatic cases among all 1,174 close contacts of the cases, based on a base sample of 10 million persons. The World Health Organization (WHO) also made this claim that asymptomatic spread/transmission is rare. This issue of asymptomatic spread is the key issue being used to force vaccination in children. The science, however, remains contrary to this proposed policy mandate.
In terms of masking children, which we are vehemently against (in school or out of school), Ludvigsson evidenced the low risk in children by publishing this seminal paper in the New England Journal of Medicine out of Sweden on COVID-19 among children one to 16 years of age and their teachers in Sweden. From the nearly 2 million children that were followed in school in Sweden, it was reported that with no mask mandates, there were zero deaths from COVID and a few instances of transmission and minimal hospitalization.
Similarly, a high-quality robust study in the French Alps examined the spread of the COVID-19 virus via a cluster of COVID-19. They followed one infected child who visited three different schools and interacted with other children, teachers, and various adults. They reported no instance of secondary transmission despite close interactions (to any child or teacher). These data have been available to the CDC and other health experts for over a year. It is not ‘new’ evidence as the CDC seems to allude to. We have science on deck for near 14 months now and the CDC is clearly out of step with the science. Each turn we make. Why?
They, the CDC, also know of a high-quality review study by Madewell published in JAMA that sought to estimate the secondary attack rate of SARS-CoV-2 in households and determine factors that modify this parameter. The study was a meta-analysis of 54 studies with 77 758 participants. Secondary attack rates represented the spread to additional persons and researchers found a 25-fold increased risk within households between symptomatic positive infected index persons versus asymptomatic infected index persons. “Household secondary attack rates were increased from symptomatic index cases (18.0%; 95% CI, 14.2%-22.1%) than from asymptomatic index cases (0.7%; 95% CI, 0%-4.9%)”. This study showed just how rare asymptomatic spread was within a confined household environment.
The CDC also knows of a high-quality randomized controlled trial Danish Study published in the Annals of Internal Medicine sought to assess whether recommending surgical mask utilization outside of the home would help reduce the wearer’s risks of acquiring SARS-CoV-2 infection in a setting where masks were uncommon and not among recommended public health measures. The sample included a total of 3,030 participants who were assigned randomly to wear masks, and 2,994 who were told to not wear masks (i.e. the control arm). The authors concluded that there was no statistically or clinically significant impact of mask-use in regard to the rate of infection with SARS CoV-2.
As a result of the nonsense guidance by the CDC, Dr. Leana Wen (emergency physician and public health professor at George Washington University; former Baltimore City Health Commissioner) has just about had it with the nonsensical capricious CDC guidelines and is reportedly shocked’ by new CDC Mask Guidance and rightly so. “They went from this overly cautious, nonsensical approach to another nonsensical approach — but one that is dangerous, one that throws caution out the window”. We agree, what the CDC is putting out is utter nonsense and actually dangerous. Dr. Marty Makary (Johns Hopkins) has also weighed in stating that this is the “most political CDC in history”, where guidance is “based on discretion not science”. We argue, CDC guidance is based on whimsy and is as far removed from science as possible.
Even the Wall Street Journal (WSJ) is now saying to take off the mask when outside. The WSJ knows that the gig is up with the ineffective masks but also that it is insane to consider masking outdoors when it is properly ventilated and the risk of spread is near zero, if at all. It is insane, illogical, irrational, and pure nonsense that the CDC and Dr. Fauci are advising children and teenagers to wear masks at summer camp, but not if they are vaccinated. It defies logic what is coming out of the CDC at present as to scientific guidance.
Disastrous Public Policy
It is incredible that a marque public health agency like the CDC could be making such disastrous public policy statements and guidance when they are constantly flat wrong and constantly having to revere them or adjust them. What is going on at the CDC? We want the CDC to succeed and shine and be the ‘go to’ public health agency. But how could they, the CDC, provide guidance that masks are needed outdoors even ‘if vaccinated’. The totality of their argument remains meritless and absurd to date. It is nonsensical. We have argued that masks as currently used, the blue surgical and white cloth masks (or any cloth masks) are ineffective and essentially worthless. It is actually harmful and particularly for our children. We have raised this issue many times as to no benefit and possible harms of masking and it is catastrophic to our children, emotionally, socially, and health-wise. These masks do nothing and it is beyond being ‘neutral’, they are ineffective. It did nothing. Mask mandates have all failed. And now we refocus on the issue of vaccinating our children for COVID.
In this regard, the CDC knows (at least we would hope they do) that if fully vaccinated, if these vaccines do what they were purported to do by conferring sterilizing immunity (which we argue the vaccines fail to do), with the high titers of neutralizing antibodies, then you are effectively immune. You can toss your masks and you are liberated after your second shot. But do these vaccines really work as effectively as reported? Does the CDC know something that the public does not know, and hence the insistence on mask-wearing and distancing away from others, even if vaccinated? Ours is not merely a curiosity, but a legitimate question that remains without a scientific answer from the CDC. We are in full support of vaccines once developed properly with the proper safety testing.
We also find the current mechanisms being employed by the media and some people in shaming others for not being vaccinated is deplorable, while they take selfies and parade on the internet social media and denounce others. Why would you shame someone who is not vaccinated when you are fully vaccinated, if you are immune? If you are immune and, again, if you think you are, then why does it matter if someone else has not taken the vaccine, for they could be COVID recovered and have decided that they do not need the vaccine as they have robust and durable natural exposure immunity? They have this right to make a personal ‘informed’ decision. You are immune, so why be concerned with someone else’s vaccine status? Why infringe on others’ rights and freedoms and use public shaming as a venue to exploit your compliance.
Risk of Death?
But, what does the epidemiological data show as to the risk of death for children? Are children at such elevated risk to warrant vaccinating? Well, the most updated data by the American Academy of Pediatrics showed that “Children were 0.00%-0.19% of all COVID-19 deaths, and 10 [US] states reported zero child deaths. In states reporting, 0.00%-0.03% of all child COVID-19 cases resulted in death.” This is the data.
Based on reporting of CDC data, 266 children aged 0 to 17 years in the US have died of COVID-19 and we mourn each death and we cannot understand the pain for the grieving parents and family. But let us put this in perspective to yearly seasonal influenza. During the 2018-2019 influenza season, 477 children 0 to 17 died of the regular flu, and we did not mask the nation, did not close schools, and did not seek to mass vaccinate children, and did not push them to cower under their beds in fright. This is all so illogical and insane what they have done in terms of COVID-19! In 2019, 2,545 children died in traffic accidents, 776 died due to drowning often in their backyard pools by accident, and 2,156 died due to homicide. As a result, did we stop sending them to school? Did we pave over our swimming pools or ban the driving of cars? No, we have as a society accepted this level of risk and we have learned to live with it. Life goes on. We get up, dress, go to work or school, and we pray for each other daily that we get through the day and live to see another day and we make it home.
Esteemed Dr. Marty Makary out of Johns Hopkins weighed in with his expertise and appeared to suggest that children 12 to 15 years old should be vaccinated. We were surprised and disagree fully with Makary as the risk to these children which he also admitted, was essentially zero. Exceedingly rare. Then why would he advocate for vaccinations? This is confusing as we find no clear evidence, in fact none, that children are at any appreciable risk. He even stated that the ‘rare’ MISC inflammatory condition that is reported, typically ends with the children fully recovering. This is completely treatable also. Again, why would he recommend the vaccine when the risk is so low for severe outcomes and the children can develop natural robust immunity? The immunity conferred by this narrow ‘spike-specific’ immunity cannot provide the broad-based, robust, durable, comprehensive immunity that natural exposure immunity can.
This is basic immunology and the risk-management decisions for parents in our view suggests ‘no’ vaccines when there is no benefit and no potential for tremendous harms. There are adverse events and deaths being reported in the CDC’s own VAERS database due to the COVID-19 vaccines that the media medical cartel is not reporting. We find it is reckless and dangerous for CDC and Fauci and NIH to be advocating for these vaccines in children when they know there are no safety studies to rule out harms and what is planned cannot rule out harms.
At the same time, and we do applaud his bravery, Makary re-iterated that CDC has been ‘consistently late or wrong’ since the pandemic began and on most everything, and the latest CDC guidance on masks in summer camps and school reveals just how out of touch the CDC is with the science. We agree fully with Makary on this and advocate for a renaming of the CDC to ‘CDC 365’ given they are routinely at least nine months to one year behind the science! He claimed that we needed the updated guidance by Fauci 14 months ago. Overall, Makary says para CDC school guidelines are scientifically flawed and being used by Biden to stall reopening and appease teacher’s unions. We agree fully with this too! There is no sound, scientific, no good reason to keep schools closed, no sound reason to mask children in schools, and no sound scientific reason, none, no justification for children to wear masks indoors in school or in summer camps. It is illogical, irrational, hysterical, unscientific and actually absurd guidance by the CDC 365. As usual! What CDC and Dr. Fauci are advocating for in terms of children being vaccinated is dangerous and reckless in our opinion and has no basis, none!
Benefits Do Not Outweight Risks
We again argue that it is very dangerous and reckless to push to vaccinate low-risk children with untested vaccines for safety that could leave children with decades of severe disability if something goes wrong. We are for vaccines but they must be properly developed, and the emerging adverse effects and the lack of safety data raises serious concerns for these vaccines in children. The benefit just does not outweigh the risks and to claim that we need kids taking the jab to get to population-level herd immunity is absurd because you are not, Dr. Fauci and CDC and NIH, factoring in the natural immunity that already exists in the population, and you are not factoring in cross-protection from prior common cold coronaviruses etc. It is also very dangerous to mask our children. There is no basis for this, none! It defies basic common sense.
Thus, we cannot understand, once again, why public health agencies such as the CDC and Dr. Fauci, along with the nonsensical bureaucrats and technocrats would make such senseless statements and provide no basis for them, in that children require vaccination for prevention of COVID-19 when he and they know they are at little, vanishingly small risk! We have serious concerns about the safety of these vaccines for all persons (including questionable efficacy as it has been reported). Let us not pretend. Why? We applaud the tremendous feat under the Trump administration of seeking to bring vaccines in such a short period by cutting the regulatory red tape and circumventing and squeezing out the ‘dead’ time across the different phases of vaccine development. However, this does not obviate us from raising questions when there are troubling signs as to safety signals (rare or otherwise).
We are now seeing reports of the mRNA and adenovirus vector vaccines promoting blood clotting, blood disorders, various bleeding disorders, and that the spike protein on its own is potentially pathogenic. Besides the real documented adverse effects, there are also theoretical risks such as to the brain from lipid nanoparticles (LNPs) that will not manifest for years. Such that we may be mistakenly injecting people with a pathogenic protein. The AAPS has also stated that “blood Clotting Needs to Be Watched with All COVID Vaccines”.
No Liability Means No Trust
With this, the phrase we want the public to adopt is ‘no liability means no trust’ and by this, we mean that we want the FDA and Dr. Fauci, and the vaccine developers to remove the liability waiver from the vaccines for children. We waiver is one thing for adults but not for children given the low risk for infection and spread. The benefit does not outweigh the risk and if our children are being asked to take this untested vaccine, then the vaccine developers must have risk in the game. They must be willing to stand up for the vaccine and as such, be willing to attest to its safety by removing the liability waiver. This will give parents the confidence they need for as it stands, they have none. No liability means no trust in the vaccine. It is that simple. If the vaccine developers and all linked to the vaccine have no liability, then we can have no trust in it. Furthermore, the criteria for emergency use authorization (EUA) in children is not met and thus no EUA is warranted for children.
Building on this, Dr. Patrick Whelan (UCLA pediatrician) (Regulations.gov) shares our grave concerns especially regarding the nascent evidence about the pathogenicity of the spike protein the vaccine is injecting. In December 2020, Whelan warned the FDA that mRNA vaccines could cause microvascular injury to the brain, heart, liver, and kidneys in ways NOT assessed in safety trials. He stated, “I am concerned about the possibility that the new vaccines aimed at creating immunity against the SARS-CoV-2 spike protein (including the mRNA vaccines of Moderna and Pfizer–BioNTech) have the potential to cause microvascular injury to the brain, heart, liver, and kidneys in a way that is not currently being assessed in safety trials of these drugs”. Yes, we are concerned the vaccine developers have been less than forthcoming, and the government and their medical experts are being evasive with their statements. And we are now going to play with the safety and lives of our children? We say NO. No liability equals no trust.
An Uninformed Public
The public is not properly informed about the risks and the safety data is not there. It is just not there and we are being asked to trust? Trust who, the CDC? When on one day the CDC says you do not carry COVID virus if vaccinated then the next day having to retract it? When on one day they advise all pregnant women to get the COVID vaccine and then the next day say only if they are eligible to get it? The CDC has lost its credibility. No liability equals no trust. And what about ‘informed consent’? It is not simply “hey you, roll up your sleeve’.
Alarmingly, additional evidence is emerging that COVID-19 is less of a respiratory disease and more of a vascular disease with the ensuing ill effects all generally having vascular underpinnings. But we are arguing that the spike itself may be ‘potentially’ pathogenic and if it has a role in the damaging of vascular cells (damaging/impairing vascular endothelial cells via downregulating the ACE 2 receptor), then by injecting mRNA code to build the spike protein to derive an immune response, or injecting the complete spike itself, then we may be naively or unwittingly injecting the very deleterious spike protein that will wreak havoc on vaccinated persons. Potentially, but there is a real theoretical risk and some may argue, it is already unfolding based on the nascent reports of blood clots and bleeding disorders. The spike protein may emerge as one of the more damaging ingredients in COVID disease and we are giving it to people deliberately, unknowingly.
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 pseudovirions) 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 the 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”.
Whelan as a pediatrician, has gone even further and must be applauded for his bravery by stating openly that “before any of these vaccines are approved for widespread use in children, it is important to assess in vaccinated subjects the effects of vaccination on the heart…vaccinated patients could also be tested for distant tissue damage in deltoid area skin biopsies…important as it is to quickly arrest the spread of the virus by immunizing the population, it would be worse if hundreds of millions of children were to suffer long-lasting 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”.
As we consider the implications of the spike itself being potentially pathogenic (and this has to be further validated), we have argued prior against children vaccination for COVID and that the science is clear and settled that children do not transmit COVID-19 virus and that the concept of asymptomatic spread has been questioned severely, particularly for children. Children rarely get infected and biologically, it seems, based on nascent findings, they may be unable to due to less expression of the Angiotensin-Converting Enzyme 2 receptor (ACE 2) in their nasal epithelium (references 1, 2).
The accumulated evidence suggests that children have been less impacted than adults in terms of severity and frequency, accounting for <2% of the cases. Children (as opposed to other respiratory illnesses) do not appear to be a major vector of viral transmission, with most pediatric cases described inside familial clusters. There has been no documentation of child-to-child or child-to-adult transmission and this has remained the trend across the last 15 months of the pandemic and reported pediatric data. This was demonstrated elegantly in a study performed in the French Alps. The pediatric literature is settled science on this.
NO Vaccination of Children for COVID-19
This brings us to our core thesis, this being NO vaccination of children for COVID-19. The reality is that our stance on children getting COVID vaccines is similar to our stance on why children must not be forced to wear masks, and especially children as young as two years old. There is no science or data to support this, vaccine or masks. Whatsoever. Israel has now released data showing that all age group infections have declined substantially, while not vaccinating children under 16. Why? Could it be a clear example that children are not the drivers but rather adults are and that by protecting adults using vaccines, children are automatically protected? The Israeli data seem to provide clear evidence why vaccines are not needed in US children.
We have been arguing this and we ask, why would we do this to children then? Why would CDC and Dr. Fauci take such steps when they know that the safety testing will not be suitable and that our children will be at risk to these vaccines if they are not tested properly? We may be setting vaccinated persons up for a disaster, naïvely, and as such, could we be doing the same to our children? We call for an immediate stop! We must not expose our children to ‘unnecessary’ harm. We must not expose them to a substance that has not been tested on children (or plan to be adequately) in the way it should be and for as long as necessary. We cannot circumvent ‘time’ with elevated sample size or any other tactic. This is a nonsensical methodology. These vaccines must be studied for the appropriate length of time. We must not expose children to a vaccine that based on their risk is absolutely not needed. Moreover, they can become infected naturally, if their immunity is needed.
As such, we are asking for a pause on vaccinating all persons with these vaccines until we understand what is emerging and safety is fully declared. Yet beyond that, we find it so very repugnant and dangerous an idea to submit children to these untested vaccine platforms, that once again we realized that we had to take a stand against testing and/or provision of any of the current vaccines for SARS-CoV-2 in children. Moreover, our view is that the risks of the vaccine far outweigh the benefits of persons under the age of 50, and we even argue up to 70 years of age. There should be no coercion or threat of reprisal if one does not want to be vaccinated and we call for a mass suspension of the vaccination in the US and maybe worldwide to assess the serious safety concerns we have. We are calling for proper ‘informed consent’ for all who decide to take the vaccine. We are being threatened when we raise this issue of safety and we are trying to inform the public.
We find it disturbing that the media has never pressed Dr. Fauci on overtly erroneous assertions and other major self-contradictory statements and continues to let him express an opinion without a deeper probing. We have great respect for his career and his bench work, but he is highly inaccurate and out of step with the science on most things COVID-19, the immunology, and the vaccinology, and I/we do not pretend to be any level of expert. Given what is at stake here now, this being the safety of our children, we felt we should take a stand and demand more. If this goes wrong as we think the potential is certainly there and based on what we are seeing with the adult administration of the vaccine, then our children may be left with a lifetime of morbidity, disability, and far worse, death. We demand that Dr. Fauci layout the childhood vaccination evidence for the scientific community (and the public, the parents) to evaluate.
Runinng Behind, and in the Wrong Direction
That said, we are being declarative in our position that our public health agencies like CDC, NIH, and FDA are running 9 to 12 months behind contemporary data and science and are routinely wrong. Dr. Fauci and CDC are wrong on the vaccination of children science as they were on all of the catastrophically destructive societal lockdown, school closure, and mask/mask mandate policies they advocated and implemented. We believe that the currently promulgated policies by the CDC and Dr. Fauci concerned with vaccinating pregnant women is both reckless and perhaps dangerous, since no long-term data exist on the mother or the fetus and the potential ill effects from mRNA and adenovirus vector vaccines. We believe they are wrong as it relates to our children as well, with these sub-optimally developed vaccines that are largely long-term safety untested and being administered as ‘investigational’ under the Emergency Use Authorization (EUA) without the time-tested and honored Biological License Application.
For example, in the Daily Herald article, whereby Dr. Fauci advocates for kids as young as first-grade to be vaccinated by September 2021, he was quoted stating when asked about vaccinating by September 2021, “I would think by the time we get to school opening, we likely will be able to get people who come into the first grade.” We find this by Fauci to be incredibly dangerous and without any merit. Is Dr. Fauci thinking clearly? We believe that the very low circulating virus especially among children prevents a proper study from being undertaken conclusively and would require a large “n” to get meaningful results. The study will also not be conducted for the proper duration to collect the safety data.
The article expressly admitted it will not be possible to do this by stating, “Since children rarely are hospitalized due to COVID-19, the vaccine’s ability to reduce severe cases would be hard to measure unless the trials enrolled an enormous number of children”. The potential harms to the children must always be considered for any intervention in children. This must not be construed as an anti-vaxxer stand, but a sane and logical argument that must be meted out with the requisite intellectual curiosity and scientifically proven evidence. We, therefore, call for no vaccine for our children in this illness and we only discuss this option after we have properly collected long-term safety data collected from children and including safety data from adults.
Current Vaccination Indications & Supporting Evidence
Currently, in the U.S., the vaccine is indicated only for those ages 16 and up. The article referred to several pediatricians and infectious disease experts opining that “vaccinating children is essential to helping the country, as a whole, reach herd immunity and decrease the threat of new variants”. This is a dangerous and inept statement. The global evidence is quite settled that children do not spread the infection or get severely ill if infected, and that they can become immune naturally with regular exposure that is natural and harmless. If children ‘numerically’ are needed to achieve population-level immunity, then why would they not be allowed to achieve immunity naturally, that confers robust protection e.g. T-cell immunity, for many years? Why expose them to an untested and potentially unsafe vaccine that could damage them lifelong? Moreover, we argue that their math is clearly wrong for they routinely discount the contribution made by prior exposure to coronaviruses (common cold) and thus the cross-protection they already have (T-cell immunity). They also discount in their math the vast amount of immunity that prior exposure and recovery from COVID-19 confers. Thus, the nation and states are potentially near or at herd immunity already.
Currently, we have no evidence that any variants are more lethal and the real issue with the variants is the mistake in making vaccines with a very narrow ‘spike-specific’ immunity. Selection pressures from the vaccine as well as from the natural immunity will cause mutations to continue to happen at a pace commensurate with the replicative ability of the virus. A broad natural immunity is more desirable as protection so long as there is minimal risk involved, as we believe is the case with children.
We are very concerned that the American Academy of Pediatrics has been pushing this childhood vaccination and “really advocating to try and make these trials happen with the same urgency that they happen for adults”. This is very troubling and we ask, do they read the science that is available and that has accumulated on the risk to children? Is the Academy of Pediatrics willing to take this safety risk with our children?
The article states that we are mistaken in thinking that children were immune from SARS-CoV-2. We never said this and we do not think anyone has meant this, for what we did state and still strongly believe is that the risk for children is very small, exceedingly rare in all aspects of this virus and illness (acquiring the infection, spreading it to other kids and to adults, and becoming seriously ill). “Children experience lower infection rates, accounting for less than 10 percent of cases in the United States”. If Dr. Fauci and the CDC think otherwise, again, we request such information to be made public. Stating that children spread the virus “to some extent” is grossly misleading. The CDC, Dr. Fauci, and the writer of this slanted inaccurate piece know that this should have been stated as ‘vanishingly small or exceedingly rare, if at all.’ These people know that evidence from Sweden with fully opened schools showed no significant evidence of spread and no deaths.
Key Drivers of SARS-CoV-2
In this regard, it is evident that neither children (nor asymptomatic adults) are the key drivers of SARS-CoV-2. In the rare cases where a child is infected with SARS-CoV-2, it is exceptionally rare for the child to get severely ill or die. And to reiterate, teachers are not at risk of transmission from children and schools are to be reopened immediately with no restrictions. Schools remain the safest place for children and teachers. They should have never remained closed and we knew this for 15 months now, and our children are being harmed by the unholy alliance between unions and government leaders in certain states. The New York Post recently reported of this relationship whereby the Teacher unions have a hand in the devising of CDC school re-open policy. “Emails show a call between Walensky and Weingarten — the former boss of New York City’s United Federation of Teachers — was arranged for Feb 7. The lobbying paid off. In at least two instances, language “suggestions” offered by the union were adopted nearly verbatim into the final text of the CDC document”. However, despite what the media and the CDC and unions are trying to tell the public, the pediatric literature suggests that this is now settled science as to low risk in children. This is not ‘new’ evidence, this has been settled for over one year now, and certainly since last fall 2020.
Dr. Sarah Lang stated para that the issue of children not being in school will be solved if they got immunized. We find this to be reprehensible for this is a blackmail of parents when the children are being denied schooling with no basis due to risk, but by both the Teacher’s unions and the respective state governments and the federal government. Exact words were “Our current chaos about children not being in schools is just terrible for children, and I think a lot of the concern would be assuaged if children were immunized”. We would ask Dr. Lang if she will like to state conclusively that the vaccines as currently devised are ‘safe’ and what is planned will be safe, knowing what is currently occurring in terms of the emerging adverse events and deaths due to the vaccine. Is she prepared to place our children at this unnecessary risk?
O’Leary also stated para that as young as 6-month-old infants can get vaccinated. He knows that the trials will not be powered to detect meaningful differences (a sample size of 3,000 will not allow for the statistical power) and that the duration will not allow for assessment of safety. What this expert has stated is very dangerous. “That’s enough to prove safety and benefit, experts said, in part, because the adult trials have already paved the way”. We find this statement to be incredibly flawed science and dangerous given there are now emerging adverse effects of the vaccines and also, Pfizer as an example, failed to include over 3,000 suspected but unconfirmed infections (with no explanation) and our own calculations showed that the efficacy for mild COVID would have dropped from 95% to 19% if this omitted data was included.
The article reported, “In the absence of a definitive immune correlate of protection, the trials would compare antibody levels in children with those found in adults and extrapolate that the efficacy should then be similar”. We argue that children are not adults and their biological response will differ and we must not extrapolate especially given the harms we see accumulating with these vaccines. Children are still in a growing phase when their brain, neural, vascular and other systems are developing and thus may be subject to developmental anomalies from these untested vaccines.
The article reported that “Pfizer’s and Moderna’s adolescent trials will focus on evaluating participants’ immune response by measuring antibodies”, and it is likely the trials with younger children will do the same. We ask the vaccine developers and Dr. Fauci, do they think this is an appropriate end-point? We do not, and feel that this does not tell us if the recipient will be protected from infection or from acquiring infection, or from getting seriously ill or dying from it. This in no way tells us if the recipient will be immune once vaccinated. This is what parents will want to know if they are going to make a risk management decision to give their child this vaccine. This again raises many questions as to how these trials will be run, what the end goal is, and why the vaccine is needed in our children in the first place.
The article reported, “In the absence of a definitive immune correlate of protection, the trials would compare antibody levels in children with those found in adults and extrapolate that the efficacy should then be similar”. We argue that children are not adults and their biological response will differ and we must not extrapolate especially given the harms we see accumulating with these vaccines.
It is unfortunate that we have arrived at this stage where untruths are elevated to a daily briefing.
And these daily briefings cause irrational fear, panic, and hysteria among the public. These briefings driven by the media cause unnecessary fear despite “a thousandfold difference in risk between old and young.” Such conflation of the risks between the young and the elderly population with comorbidities and at risk is wrong-headed and creates unnecessary fear for all. It is well known that there is a distinct stratified risk (strongly associated with increasing age and comorbidities).
We end by again stating that the recent push by the CDC, Dr. Anthony Fauci, and other television medical experts who suggest that we can only get to herd immunity by vaccinating our children is absurd and patently false. They continue to inaccurately discount cross protection immunity from prior coronaviruses and common colds. They are pushing a vaccine that is potentially unsafe to our children especially since we have no data on their safety.
Furthermore, data thus far suggest that the COVID ‘variants’ do not drive infection in children and harm them any more than the original strain. There is no basis for such a statement. For those who are trying to frighten parents by the illogical and absurd statements that a lethal strain may emerge among the variants, then we argue that you are using terms like ‘may’ and ‘could’ and ‘might.’ We can find no evidence to support such claims. It is simply rampant supposition and speculation and fear-mongering! Making such claims is not science, and decisions based on such claims are not evidence-based. We need to see the actual science and not just rampant speculation and supposition by often nonsensical media medical experts. We regard the retraction of the double-mask needs as a rampant abuse of the term “science-based.” Because it wasn’t as was the statement that Covid-19 is 10 times more lethal than the seasonal flu? A very prominent Professor out of Johns Hopkins, Dr. Marty Makary, gets it right now when he calls out these experts and agencies for their foolishness and fear mongering that is often inaccurate. He recently eviscerated CDC’s guidelines and called out Dr. Fauci for his inaccurate claims on herd immunity.
We advocate for the safety of all our children. Parents have a responsibility to ask for and get accurate information from the public sector that governs policy decisions. Parents, so armed, can make appropriate decisions for their children. It is better science to use a more ‘focused‘ protection and targeting that is based on age and known risk factors especially, regarding the children. We abide by the Hippocratic principle of “Primum Non Nocere.”
We conclude that our children must be exempt fully from any of the existing COVID-19 vaccines, and until proper studies are conducted with the proper safety data, and until it can be shown that the benefits far outweigh the risks in the need for the vaccine. There must be no vaccination of our children with these potentially unsafe, untested for safety vaccines. Period! No liability equals no trust and we close by again calling on the CDC, the NIH, the FDA, Dr. Fauci, and vaccine developers to remove the liability waiver. There is no benefit. None. In fact, we call on the CDC, the NIH, the FDA, Dr. Fauci, and vaccine developers to meet with us at any time, to their convenience, collectively or however, to discuss with us, debate with us, why our children should be vaccinated with these vaccines given their risk. We wish this open public discussion to your convenience.
Paul E. Alexander, PhD…email: [email protected]
Howard Tenenbaum, DDS, PhD…email: [email protected]
Parvez Dara, MBA, MD…email: [email protected]
i) Paul E Alexander MSc PhD, McMaster University Canada, University of Oxford, and University of Toronto
ii) Howard Tenenbaum DDS, Dip. Perio., PhD, FRCD(C) Centre for Advanced Dental Research and Care, Mount Sinai Hospital, and Faculties of Medicine and Dentistry, University of Toronto, Toronto, ON, Canada
iii) Parvez Dara MD, FACP, MBA, Consultant, Medical Hematologist and Oncologist
Note that views expressed in this opinion article are the writer’s and not necessarily those of TrialSite, Inc.