Monday, 28 August 2023

 

2 major papers directed to Pfizer & Moderna on why vaccinating our children would be deadly with the COVID mRNA technology gene based vaccine (AIER & Brownstone), me as senior author with colleagues

i)2.5 years ago-We Must Not Be Forced Into Vaccinating Our Children From COVID (Alexander, Tenenbaum, Dara) ii)2 years ago-Dear Pfizer: Leave the ​​Children Alone; yet they did not listen & kids died

‘There is no basis for vaccinating children from Covid-19 as indicated by Dr. Anthony Fauci, none (6 months to 11 years old). The children are at very low risk of illness, especially severe illness from Covid, and children do not spread the illness. 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.” 

A high-quality robust study in the French Alps examined the spread of 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. These data have been available to the CDC and other health experts for over a year. Ludvigsson published a seminal paper in the New England Journal of Medicine on Covid-19 among children 1 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. A study published in 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.

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 are denying scientific reality. They are spreading false information to the nation. The current data suggest that we are much nearer to herd immunity than they wish it to be. They continue to inaccurately discount cross protection immunity from prior coronaviruses and common colds. They have disregarded the fact that a large swath of the population was not captured in the case load, via laboratory confirmed cases. 

The estimates range that for every ONE confirmed case, there might be 6 or even 8 unidentified individuals who have had Covid. Many people have recovered from Covid and they are being disregarded in Dr. Fauci’s inaccurate statements on herd immunity e.g. his absurd statement that 90% must be vaccinated. Children can become infected as they do for usual pathogens they encounter in their daily lives, ‘naturally.’ Like the common cold or influenza, and alike for other infections. We already know that there is no emergency in children regarding Covid-19. And so why would Moderna Inc. seek to trial this vaccine on children with a death rate in this group of 0.003% (IFR 0.00003)? Moderna must show us why it is not dangerous to put this vaccine in children, and they have not.

We argue vehemently that if children are needed from a ‘numbers’ point of view for driving population level ‘herd’ immunity, then they must be allowed to get infected naturally and harmlessly as part of day-to-day living and we do it by opening schools and allowing them to live reasonably normal lives with sensible precautions e.g. enhanced sanitation, hygiene, and disinfectant. Children can and do get infected as they do for usual pathogens they encounter in their daily lives, ‘naturally.’ These pathogens include the common influenza virus and other influenza-like illnesses.  

Allow child-to-child daily interaction. Not only will that drive the adaptive immunity but it will give the children a more robust defense against any mutant variants of the virus itself. This will also allow our children’s immune systems to be taxed and tuned up daily, as opposed to the weakening we are subjecting it to with the year-long lockdowns and school closures. We do it while at the same time strongly protecting the elderly who are frail, the elderly in general, and those with comorbid conditions and obese individuals. We must use stringent protections of our nursing homes and other similar congregated settings (including the staff, who remain often the source of the infection). 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. 

History teaches us to pause and reflect upon our previous miscues and unforced blunders that had significant consequences. It behooves us to remember the increased incidence of narcolepsy in children in Scandinavian countries following the H1N1 influenza ASO3-adjuvanted vaccine used for the 2009 pandemic (Pandemrix influenzavaccination program).  Additionally, the harms caused by the dengue vaccine in children in the Philippines also come to mind that bore a burden on our society of humans. Sanofi Pasteur halted the vaccines in 2017 due to the very dangerous risk of plasma leakage akin to ebola. “It’s a complication called plasma leakage syndrome…he [Halstead] was so worried, he started writing editorials to scientific journals, even warned the Filipino government about the problem…I just say, no, you can’t give a vaccine to somebody – some perfectly normal, healthy person – and now put them at risk for the rest of their lives for plasma leakage syndrome. You can’t do that.” The tainted polio vaccine that sickened and fatally paralyzed children in 1955 in the United States is also worthy of review in this context. The harm that can accrue from a rapid deployment of mass vaccination to the children has not proven to be safe in all the cases. Perhaps this comment is worth noting: “In 1977, for example, a triple vaccination (against diphtheria, pertussis and tetanus) from a defective batch left several children blind, deaf and disabled forever.”

There are potentially real harms to these Covid vaccines and as an example, Canada has now suspended the AstraZeneca-Oxford vaccine for those under 55 based on risk. “Canada’s National Advisory Committee on Immunization (NACI) is recommending provinces pause the use of the AstraZeneca-Oxford COVID-19 vaccine on those under the age of 55 because of safety concerns” (blood clotting and thrombocytopenia). There is the real concern of “disease enhancement” whereby “in the past for a few viral vaccines where those immunized suffered increased severity or death when they later encountered the virus [in the wild] or were found to have an increased frequency of infection.” This is a concern for the Covid vaccines, in adults and certainly children given the past catastrophic experience with the dengue vaccine. Harms and adverse events (e.g. blood clots) are being reported in the CDC’s VAERS system as well as globally and we need urgent study of the temporal relationship of reported adverse events to administration of the vaccines. Currently, there have been approximately 1,900 vaccine-related deaths reported to VAERS as of March 15th 2021. It is still too early to tell how this will play out with these vaccines and reported harms and we remain cautiously optimistic yet cognizant that the trials have not run for the optimal duration of time to assess safety. Thus, our grave concern for our children being administered these yet proven safe vaccines. 

Moreover, one has to understand that all medications and drugs including vaccines may have some adverse effects on the human body. All drugs, including all interventions carry risk. It is therefore imperative that parents of children be informed about the potential risks of any such intervention employed on a child. “But,” says the CDC representative, “Individuals react differently to vaccines, and there is no way to absolutely predict the reaction of a specific individual to a particular vaccine. Anyone who takes a vaccine should be fully informed about both the benefits and the risks of vaccination.” The key is to have total transparency of benefits and risks of using the vaccine in children. We agree wholeheartedly that vaccines are important and potent weapons we have in reducing disease in the population as a whole. 

In comparison, we point out that with the Polio vaccine, from inception of the vaccine concept in 1931 (10 years after FDR was stricken with Polio), indications are that it took roughly 20 years before Jonas Salk used the vaccine to vaccinate his family and then the world. Over the years, vaccines have saved countless lives and will continue to do so. We believe that vaccines have a large and critically important role in protecting human lives, but these protections have been the result of a thorough and sometimes tedious ritual of testing along with long-term safety assessment over a period of years in order to be confident that any one new vaccine is both safe and effective. Unfortunately, we cannot apply these time-tested requisites to the current crop of new vaccines for Covid-19. But again, we reiterate that it’s one thing to let adults decide, after informed consent, to be vaccinated but it is another thing entirely to go about vaccinating our children without evidence for long-term safety, especially when their risks of either becoming ill, or suffering severe illness from SARS-CoV-2 are infinitesimally small.

The argument for a well-tested and safe vaccine requires time under study, and this prevents unnecessary harm to the children that we aim to protect. Ensuring their safety requires a thorough review of well-established data of use of such vaccines in children. Otherwise, we as their caretakers are subjecting them to potentially real harm under the banner of doing good!

What is needed is to allow children to mingle and to acquire infection naturally and harmlessly, in their schools, home, and their everyday environments. We remain skeptical about the safety of the currently administered vaccines, since the FDA issued an emergency use authorization (EUA) and did not apply the needed full regulatory BLA approval. This continues to concern us greatly, since the safety component has not been fully assessed and essentially means that all persons taking Covid vaccines at present are in a large Phase III trial. The efficacy and safety results will be known in 2-3 years and perhaps longer for the longer-term adverse effects that become known at a later date. Exposing children to an untested Emergency Use medication implies that there is a dire risk to the children without it. There are no data to support such a potential risk. No such data, no evidence whatsoever of this exists, and for the CDC or Dr. Fauci or any medical expert to imply otherwise is duplicitous. We know the new CDC Director is working in a highly politically charged environment with many moving parts, and we urge her to ensure that the American population, and particularly parents, are not misled by public health experts on vaccinating children. We trust that she will ensure this. 

This really is a question of risk management for parents and parents must seriously consider that Covid-19 is a far less dangerous illness for children than influenza. This is known by the medical community and parents are being deceived as to greater risk. Parents must be brave and be willing to assess this purely from a benefit versus risk position and ask themselves: ‘If my child has little if any risk, near zero risk of severe sequelae or death, and thus no benefit from the vaccine, yet there could be potential harms and as yet unknown harms from the vaccine (as already reported in adults who have received the vaccines), then why would I subject my child to such a vaccine?’ And in the presence of the potential risks, as well as the fact that a vaccine for Covid-19 is simply not indicated in children, why would a loving parent allow their child to be vaccinated with still-experimental vaccines? Why put a foreign substance into the body of your child when they have vanishingly low risk of spreading it or getting seriously ill if infected? Why? You must take a step back, we plead, and think this through carefully. 

Furthermore, it is nonsensical to suggest that the Covid ‘variants’ may drive infection in children and harm them and 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 speculation! 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 by often nonsensical media medical experts. We have heard Dr. Fauci make statements with no science or data to back his statements up. Remember the retraction of the double-maskidiocy? Remember when he said Covid is 10 times more lethal than the seasonal flu? Now they are talking about a third vaccine boostershot and it suggests that those in charge are flying by the seat of their pants and do not know what they are doing. 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

Focusing a bit more on the variants or mutations, of concern is the emerging indication (at this time we are prognosticating and conjecturing but we are indeed concerned) that the very narrowly focused ‘spike-specific’ antibody immunity provoked by the existing Covid vaccines is not broad enough, or comprehensive, durable, robust, and complete as ‘natural exposure immunity.’ There is debate that these vaccines are not as effective as they were reported to be and are not conferring the sterilizing type immunity with strong neutralizing antibodies, rendering the emerging variants as potentially noxious, capable of blowing past the vaccine-induced immunity. 

Vaccine developers may be faced with having to fix the spike protein (epitopes) immunity by swapping them out for the new variants as they emerge (else they will be ineffective), or, providing the host immune response with a much broader vaccine with multiple protein targets on the virus and not only the spike protein. Thus, we ask, is Dr. Fauci and the CDC etc. advising parents to take a vaccine that does not and will not provide the long-term safety assessment, and will be under ‘experimental’ emergency use by the FDA, and that will require multiple shots given the issue we just raised about the variants and the inability for the narrow immunity to confer protection? How many shots? How regular? Why not one ‘universal’ vaccine administered once, and only after the long-term safety data is available and assessed? Why not allow several years of adults having the current vaccine to assess the harms before we interfere with our low-risk children? Do you understand the issues involved and how unsettling all of this is and the lack of clarity by the public health experts and decision-makers, leaving parents in the dark as to what’s next? This makes no sense and is very frightening. 

Our purpose is to shed light on the risky nature of the proposed vaccine policy for children. Such a policy merits detailed investigation prior to implementation. Experts have proven to be less of experts and more of the fear mongering crowd. For fear of being exposed, these experts tend to blame others, especially those that offer valid critique of their failed methodologies and enacted policies. We therefore continue to urge that parents be fully informed in the decision-making process with their physician, prior to their children receiving the vaccine. Children, especially those who have not acquired the critical thought process, must not be used to experiment upon unless there is a valid consent form bearing the parent’s signature. We also reiterate that vaccines that have been tested thoroughly, such as the Mumps, Measles and Rubella vaccine, the Polio vaccine and others (to prevent vaccine preventable illnesses), are a must to avoid large-scale harm to children. But these vaccines have undergone the rigors of research and have a determinant safety record. The current Covid vaccines do not have such a detailed record of either safety or efficacy to warrant a large-scale vaccination of the children. The planned research suggests similar. 

We are in a dangerous situation here by advocating vaccination of our low-risk children and we must ask these experts for the evidence to support their often ridiculous specious statements. Look at how wrong they were on lockdowns. They have failed and continue to fail in protecting the elderly while destroying families and sacrificing our kids, especially low-income families. Incredibly, they now try to blame those who criticized and questioned the lockdowns for the failure of the very lockdowns they advocated and that were implemented. It makes no sense and the hubris of these experts defies logic. So you want to trust these same people when they just tell you nonchalantly that your child is to be vaccinated? And they do it with hollowness and no scientific basis whatsoever and we are to accept that speciousness? I say no! 

Our children are not for you to ‘experiment’ on. There is absolutely no data, no evidence, none,  to support the vaccination of our children in this matter. We are against it and find this unacceptable a proposition. Our children are far too precious to experiment with. And we make this clarion call to minority and African-American parents, to be careful and safeguard your children.

Faust stated para that “the FDA will assess the vaccines for children and consider them safe.” This is a forgone conclusion by Faust and we consider it absurd and reckless. It raises many questions for he does not know what the FDA will be assessing and what the trials will show. We urge the mothers and fathers to demand the science, demand the evidence before embarking on this journey.

We especially urge the minority parents and their children to seek as much information as possible and always make decisions with their physicians, regarding the risks and benefits of such a vaccine. 

Think carefully you mothers and fathers out there, you are well capable of informed decision-making. Demand the science, demand the evidence from these talking heads, often unscientific and unsound experts who till now have devastated societies with their nonsensical, baseless, damaging, destructive lockdownsschool closuresmask mandates, and other restrictions. Minority children (and minority women often with least bargaining power) have fared the worst in all of this pandemic lockdown insanity and may well fear the worst with these experimental unnecessary vaccines. To date, no argument, no information, no statements by Dr. Fauci, the CDC, or any of the television medical experts have made any sense on why children must be vaccinated. None. If there is a credible basis, if there is evidence, then bring the evidence and let us have a look at it, but until then, please leave our children alone! If we see evidence of the necessity, we will agree, but we have seen none and all we are hearing in this is fear mongering and falsehoods and the nation’s parents must not be lied to anymore! They want honesty, clarity, balanced information that could help them make informed decisions. 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) in the way it should be and for as long as necessary. 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. 

To close, we make this plea and urge those in the medical field to reiterate the need for a thorough examination of the science of efficacy, the potential risks to the children and the evidence that supports the need for such a medical intervention foisted on our children. Failing which, it would seem a violation of the Hippocratic Oath, “Above all do no harm.” We will address the insanity of vaccine passportsin a subsequent op-ed.’

AND

‘fizer plans to go to the FDA to get authorization for vaccination of 5 to 12 year old children based on a study they claim to have completed. The Biden administration is on board. 

This is absolutely reckless, dangerous based on lack of safety data and poor research methodology, and without any scientific basis.

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

The infection mortality rate (IFR) is roughly similar (or likely lower once all infection data are collected) to seasonal influenza. Stanford’s John P.A. Ioannidis identified 36 studies (43 estimates) along with an additional 7 preliminary national estimates (50 pieces of data) and concluded that among people <70 years old across the world, infection fatality rates ranged from 0.00% to 0.57% with a median of 0.05% across the different global locations (with a corrected median of 0.04%). Survival for those under 70 years is 99.5% (Ioannidis update). Moreover, with a focus on children, “The estimated IFR is close to zero for children and young adults.” The global data is unequivocal that “deaths from Covid are incredibly rare” in children.

The published evidence is conclusive that the risk of severe illness or death from Covid-19 in children is almost nil (statistical zero) and this evidence has accumulated for well over a year now; in fact we knew this for over 18 months. It is clear that children are at very low risk of spreading the infection to other children, of spreading to adults as seen in householdtransmission studies, or of taking it home or becoming ill, or dying, and this is settled scientific global evidence. Children are less at risk of developing severe illness courses, and also are far less susceptible and likely to spread and drive SARS-CoV-2 (references 1234). This implies that any mass injection/inoculation or even clinical trials on children with such near zero risk of spread and illness/death is contraindicated, unethical, and potentially associated with significant harm.

The risk-benefit discussion for children with these Covid-19 injections is a very different one than that for adults. The fact is that this is a completely novel and experimental injection therapy with no medium or long-term safety data (or even definitive effectiveness data). If we move forward with the vaccination of our children without the proper safety testing, then we will present them with potentially catastrophic risk, including deaths in some.

A team of Johns Hopkins researchers recently reported that when they looked at a group of about 48,000 children in the US infected with the virus, they found no (zero) Covid deaths among the healthy kids. Dr. Makary indicated that his team “worked with the non-profit FAIR Health to analyze approximately 48,000 children under 18 diagnosed with Covid in health-insurance data from April to August 2020…after studying comprehensive data on thousands of children, the team “found a mortality rate of zero among children without a pre-existing medical condition such as leukemia.”

With this background, we knew of the very low risk to children in the first place, but wanted scientific documentation (molecular/biological) of why this low risk existed, to help support our argument against these injections in our children. The evidence presented below (including on the risk of the injection itself) may help explain why children are not candidates for the Covid vaccines (here and here) and may well be (are) immune and can be considered “fully vaccinated.”

The key arguments are:

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

2) Recent research (August 2021) by Loskedeepens our understanding of this natural type biological/molecular protection even further by showing that pre-activated (primed) antiviral innate immunity in the upper airways of children work to control early SARS-CoV-2 infection…resulting in a stronger early innate antiviral response to SARS-CoV-2 infection than in adults.”

3) When one is vaccinated or gets infected naturally, this drives the formation, tissue distribution, and clonal evolution of B cells which is key to encoding humoral immune memory. There is recent research evidence by Yang published in Science (May 2021) that blood examined from children retrieved prior to Covid-19 pandemic have memory B cells that can bind to SARS-CoV-2, suggestive of the potent role of early childhood exposure to common cold coronaviruses (coronaviruses). This is supported by Mateus et al. who reported on T cell memory to prior coronaviruses that cause the common cold (cross-reactivity/cross-protection). 

4) Weisberg and Farber et al. suggest (and building on research work by Kumar and Faber) that the reason children can more easily neutralize the virus is that their T cells are relatively naïve. They argue that since children’s T cells are mostly untrained, they can thus immunologically respond more rapidly and nimbly to novel viruses.

5) Risk: There is an emerging discussion that with approximately 570 Covid injection deaths registered in VAERS in children, and the CDC reporting approximately 350 deaths in children since the inception of the emergency (Feb/March 2020), then the vaccine is killing more children than the virus/disease itself (Steve Kirsh, personal communication, September 2nd 2021).

6) A Yale University report (Yale and Albert Einstein College of Medicine report Sept. 18, 2020 in the journal Science Translational Medicine) indicates that children and adults display very diverse and different immune system responses to SARS-CoV-2 infection which helps understanding why they have far less illness or mortality from COVID. “Since the earliest days of the COVID-19 outbreak, scientists have observed that children infected with the virus tend to fare much better than adults…researchers reported that levels of two immune system molecules — interleukin 17A (IL-17A), which helps mobilize immune system response during early infection, and interferon gamma (INF-g), which combats viral replication — were strongly linked to the age of the patients. The younger the patient, the higher the levels of IL-17A and INF-g, the analysis showed…these two molecules are part of the innate immune system, a more primitive, non-specific type of response activated early after infection.”

7) Dowell et al. (2022) recently published and commented on antibody and cellular immunity in children (aged 3-11 years) and adults. Their findings confirm a biological basis for why SARS-CoV-2 infection is generally mild or asymptomatic in children. They reported that antibody responses against spike protein were elevated in children and seroconversion “boosted responses against seasonal Beta-coronaviruses through cross-recognition of the S2 domain. Neutralization of viral variants was comparable between children and adults. Spike-specific T cell responses were more than twice as high in children and were also detected in many seronegative children, indicating pre-existing cross-reactive responses to seasonal coronaviruses.” Very key in the findings were that children maintained and preserved “antibody and cellular responses 6 months after infection, whereas relative waning occurred in adults. Spike-specific responses were also broadly stable beyond 12 months. Therefore, children generate robust, cross-reactive and sustained immune responses to SARS-CoV-2 with focused specificity for the spike protein.”

What can be concluded? Pulling these emerging research findings together strengthens the case that children are not candidates for the Covid vaccines and are to be considered already “fully and completely Covid-vaccinated.” Furthermore, as lucidly outlined by Whelan, it is potentially disastrous to children if we move forward with vaccines without proper study of the possible harms to them. Vaccine developers failed to conduct the proper safety studies and for the duration that would unravel any harms. 

Regulators: please slow down and demand safety testing, no matter how long it takes. Conduct proper risk-benefit analyses and see that the injections are contraindicated in children. Particular care is needed with regard to the potential widespread injection of children before there are any real data on the safety or effectiveness of these injections.

There is very little risk and no data or evidence or science to justify any of the Covid-19 injections in children. Under no circumstance should we expose the risk of the injections to children, and to consider putting risk on children so as to protect adults is perverse and reckless and very dangerous. There is no safety data. The focus rather has to be on early treatment and testing (sero antibody or T cell) to establish who is a credible candidate for these injections if properly ethically informed and consented, for it is very dangerous to layer inoculation on top of existing Covid-recovered, naturally acquired immunity (no benefit and only potential harm/adverse effects) (hereherehereherehere, and here). 

We must establish who is Covid-recovered, which is natural immunity, as this is a critical piece of the puzzle before any injection. Additionally, if public health agency leaders Fauci, Walensky, and Collins continue to demand that our children be vaccinated, then they must remove liability protection for all who benefit from it.

What does all of this mean? A biological and molecular (as well as epidemiological) argument was presented that shows children are already ‘vaccinated.’ Pfizer and all Covid vaccine developers (including Walensky of the CDC, Fauci of NIAID, and Francis Collins of the NIH) must step away from our children and only discuss this if they remove liability protection from the table. 

If they have no risk on the table, then we cannot take this chance as parents. Something then is not entirely proper about these vaccines in our children. If children are at such low risk, then it should be a problem for these officials and vaccine developers to remove their protection. With such low risk in children and no opportunity for benefit and just costs in terms of possible harms, then these vaccines are a ‘no go’ for our children.’  

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