The acute focus in this writing is on the vaccination of children under 12 years of age with the Covid-19 vaccines as this raises very serious and urgent issues that must be confronted by societies in terms of possible unnecessary harms to our children. SARS-CoV-2 virus that leads to Covid-19 disease may be used interchangeably in this report. Why this focus? Because there is now a major effort to test the new mRNA-based vaccines against SARS CoV-2 virus in young children.
What is the rationale for this and what is the basis? Why would there be a push to vaccinate six-month-old babies? Vaccinate two-year-old infants? Vaccinate six-year-old children? Ten-year-old children? Via an experimental vaccine that delivers genetic code into your cells instructing it to produce a mock portion of the virus?
Before examining this issue directly, we wish to situate the illogicality and real concerns of vaccinating children within the devastating Covid-19 societal restrictions. We point out that lockdowns, school closures, and mask mandate policies have made no sense whatsoever (particularly the prolonged restrictions) and as a consequence of their implementation, societal devastation has occurred and is still occurring and the impact on children’s health and well-being has yet to be examined in toto. The crushing harms are amplified and thus even more dramatic on women and the poorer members of society.
We also know that masks can be potentially dangerous to children. In terms of children and Covid-19, we know children do not transmit Covid-19 virus and that the concept of asymptomatic spread has been questioned severely, particularly for children. Children, if infected, just do not spread Covid-19 to others readily, either to other children, other adults in their families or otherwise, nor to their teachers. This was demonstrated elegantly in a study performed in the French Alps. The pediatric literature is settled science on this.
Not only is there an absence of evidence supporting the notion that children spread Covid-19 virus in any meaningful way, but there is direct evidence showing that they simply do not spread this disease! This has been shown in school settings and as published in other papers. Children typically, if infected, have asymptomatic illness. It is well-noted that asymptomatic cases are not the drivers of the pandemic; something particularly important in relation to children as they’re generally asymptomatic.
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. They should have never remained closed and we knew this for one year now. The pediatric literature suggests that this is now settled science. Yet it seems that the ‘television’ medical experts and prominent US agency representatives, as well as government advisors and bureaucrats either do not read the science, do not understand the science, do not ‘get’ it, are blinded to it, or are just ignorant to the data and science. Most of what we have just stated we have known for one year now. This is not ‘new’ evidence, this has been settled for one year now, and certainly since last fall 2020.
We even know of the early ‘potent’ seminal study calling into question ‘asymptomatic’ spread in Covid-19 which was published in Nature and was not covered by the media or television medical experts, and which showed that in a sample of ten million, when all positive ‘asymptomatic’ cases were followed and all close contacts were traced (n=1,174), there were zero (0) no instances of asymptomatic spread. Kerkhove from the World Health Organization (WHO) stated “From the data we have, it still seems to be rare that an asymptomatic person actually transmits onward to a secondary individual.” We agree with this based on the sum total of evidence we have seen to date. At the same time, the Covid-19 responses and dictates by the medical experts have taken on a sense of absurdity and ridiculousness now and our reading of Dr. Fauci’s explanations of why masking and social distancing is still needed after vaccination borders on the absolute confusing if not ridiculous.
Just consider the confusing and some would say ‘reckless’ statements of Dr. Anthony Fauci when he first stated that it is para ‘common sense’ to wear double masks, to then soon after retract the double mask request. Dr. Fauci again caused tremendous angst and confusion when questioned in the Senate and in an exchange with Senator Rand Paul about mask wearing after being vaccinated or having had prior infection and cleared it and recovered. We know that there is no study, no evidence of significant reinfection after being vaccinated or having had prior ‘natural’ infection from Covid-19. None. “Reinfections appear to be very rare. Out of tens of millions of Covid-19 cases reported worldwide, there have been only fewer than five with properly documented reinfections. That’s a rate of 1.25 per 10 million infections based on crude analysis.” Also, no evidence of reinfection in the US from variants, yet Dr. Fauci still could not articulate why one must wear masks after recovering from Covid-19 or having been vaccinated, but he is calling for masks as protection.
In this light, a seminal study found that 95% of Covid survivors were protected from reinfection for at least 8 months, if not more. The team at the La Jolla Institute for Immunology led by Dr. Shane Crotty measured the levels of antibodies, memory B cells and two kinds of T cells in the blood of 188 Covid-19 patients. They “tracked a group of Covid-19 survivors for up to eight months after their infection, and found about 95 percent had strong levels of bespoke immune cells specially tailored to fight SARS-CoV-2,”…their findings suggest the vast majority of Covid-19 survivors have the immune cells needed to fight reinfection for at least eight months and potentially much longer, based on projections from the data gathered so far… “it certainly looks like there’s going to be immune memory for multiple years and it wouldn’t be surprising for there to be substantial immune memory for ten years.”
Senator Paul took the necessary step by telling Dr. Fauci in Senate testimony that the mask wearing after the vaccine is ‘just theater’ with no evidence of significant transmission and reinfection after vaccination or natural exposure infection. All this is to say that Dr. Fauci’s call for double masks or continued mask wearing then seemed illogical, unscientific, and absurd, as does his new position on vaccination of children under 12 years of age. The latter raises very serious questions.
As we focus specifically on the issue of children being vaccinated for Covid-19, whatever arguments there may be for consenting adults – children should not be carte blanche subjected to the same policies as adults without careful examination of the benefits versus the risks. Of course, zero risk is not attainable – with or without masks, vaccines, therapeutics, distancing or anything else medicine may develop or government agencies may impose.
Focusing on Covid-19 vaccination of children, we are against this and question the decision-makers as we feel this is entirely illogical based on all we know. The campaigns for Covid-19 vaccination have begun in earnest across the globe. Inexplicably, there has been a recent flurry of statements supporting the vaccination of children. Of course, this also means that the experimental vaccines must be tested in children prior to mass introduction and use! We consider this to be irrational given there are no data whatsoever that could be used to support the need for vaccination of children in this Covid-19 pandemic. And because of the absence of any supportive data, we suggest that the concept of testing this vaccine in children and/or simply starting to administer this vaccine to children is irresponsible at best.
We cannot fathom how it is possible to suggest, as has Dr. Fauci, that children require vaccination for prevention of Covid-19! This is so abhorrent an idea 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. And unless Dr. Fauci has access to data that we have not seen (or are we expected to just trust and judgements and opinions?), we are compelled to demand that this atrocity (for that’s what it is) not go forward. Is this the situation Dr. Fauci recently opined upon when he said para ‘often there is no data or evidence in Covid-19, so we must go on trust and judgements… his judgements’? We must remind Dr. Fauci that this is not science and that we and he must not make medical decisions or develop medical guidelines that are based on speculation, assumption, or supposition. These are much more serious decisions that require more than an ‘assumption.’
In trying to understand what underlies the decisions to promote vaccination of children we have some other thoughts that might explain what’s going on. Do we do it for the children? Sometimes the answer is yes. But the first rule of medicine is first do no harm (Primum non nocere). For nearly all children under 20 years of age the risks from getting Covid-19 are exceedingly small and for children the risk is basically near zero in this population— it is the closest to zero we can get to — the cost-benefit argument against using an essentially untested vaccine is heavily in favor of risk and virtually no benefit. The potential risk of unknown and serious side effects from the brand-new and barely tested vaccines are — in truth — completely unknown. That’s because it is almost unheard of for a vaccine to be released to the public this quickly. That doesn’t mean you shouldn’t get the vaccine.
We’re certainly not anti-vaxxers and certainly children should receive their measles, mumps, and rubella vaccines among others, as these have had a dramatic effect on morbidity and mortality for decades. For populations where the risk of death or serious illness from Covid-19 is substantial — middle-aged and older adults or individuals with other chronic medical vulnerabilities like serious respiratory, cardiac, or immunological problems — using a new and barely tested vaccine is not only reasonable, it may and can be the most prudent and responsible thing to do. Indeed, for a population of otherwise healthy children under 20 and then when we look at children under 12 — where the risk of death or even serious complications from Covid-19 is very low — in fact, exceedingly rare, the cost-benefit argument against using an essentially untested vaccine is off the charts and not in favour of the vaccine.
People might ask; haven’t these vaccines been proven safe and reliable? Haven’t they been developed by the world’s best scientists? The “miracle vaccines” against Covid-19 developed in the last year are true miracles — but not only because of their noteworthy scientific achievements. They have arrived well ahead of any previously imaginable vaccine that has been developed which en face looks rather miraculous. But in this case, the government was able to waive the normal testing rules and remove bureaucratic, regulatory, and associated hurdles (e.g. simultaneous development, manufacture, and logistics) with the government absorbing all the risk out of the gate. No doubt, the prior Trump administration deserves tremendous credit for the capacity to innovate nimbly in this emergency. Bear in mind however, that these vaccines received the “Emergency Use Authorization” (EUA) and not the time-tested Biologic License Application (BLA) where rigorous and thorough testing and analysis preceded the issuance of such a license.
For comparison, consider that the measles vaccine was also developed quite quickly — the science wasn’t that difficult. But it wasn’t released —even after the scientists hung up their lab coats — until teams of statisticians and painstaking researchers had nearly 20 years to test it. Fortunately, they didn’t find any problems with that one — and hopefully that will prove true of the Covid-19 vaccines as well. But the truth is, it is extremely premature to even guess what might be any longer time side effects of the current vaccines. And we must emphasize here that it isn’t that we don’t trust the science behind the vaccine development — it is simply impossible to predict what the longer-term (1-5 years as an example) effects of these new vaccines are at this point. The issues pertaining to longer-term sequelae that could be associated with the vaccines cannot be balanced off by including more and more people in short-term studies. We need ‘time’ to evaluate the vaccines’ safety.
This is a real cause for concern, in particular for our children. To compare, we point out that the Polio vaccine, from inception of the vaccine concept in 1931 (10 years after FDR was stricken with Polio), took 20 years before Jonah 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 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 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. 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.
Physicians are entrusted to above all else “Do No Harm.” We certainly demand the same at this juncture. In response to the pandemic emergency situation, we believe that those individuals, elderly over the age of 70 years, frail, with comorbid conditions identified as potential risks for infection, serious illness and where potential for loss of life is high, vaccination might prove beneficial. Under such circumstances, there is an acceptable trade-off. But when the “downside” of contracting Covid-19 becomes very, very small — as it is for children — taking even a “moderate” risk of serious side effects from a barely tested vaccine may be . . . the word that comes to mind is irresponsible. There is little if any benefit given the low risk in the first place, but the potential harm is real and very troubling.
Dealing with concerns of the general public at large, perhaps the best mechanism of action would be to tailor the needs of those at highest risk (prioritize them for vaccines) and then subsequent cohorts of lower age groups down to the 30-40-year-olds. Below that age group, the risk of serious illness is very low (approximately 0.01%) and balance of risk and benefit are outweighed on the side of caution. By then we are likely to have herd immunity (due to a combination of vaccine and natural infection), so the social argument for more vaccinations will likely be moot. We must keep in mind that the infection fatality rate (IFR) is close to zero for children (zero) and young adults.
Even in six months to one year we will have a little more experience with side effects, but the reality is it normally takes years — sometimes decades — to be reasonably sure a vaccine is safe enough to use on persons under 20. Yes, it takes that long and thus why risk our children now? Given the low risks of contracting it and spreading it or getting seriously ill. We feel that an informed parent, informed as to the very little if any benefit, yet more certain potential harm, would place more value on their child avoiding that more certain harm, and as such, will opt for no vaccine at this time.
The need to write this piece is related in large part to the fact that Moderna Inc. has recently announced that it is beginning a mRNA vaccine study on children 6 months to 11 years in the U.S. and Canada, in the latest effort to broaden the mass-vaccination campaign beyond adults. “This pediatric study will help us assess the potential safety and immunogenicity of our Covid-19 vaccine candidate in this important younger age population,” Moderna Chief Executive Stéphane Bancel has stated. On the basis of the literature we’ve discussed here, it is clear that his statement is patently false. Alarmingly, we have come to learn that dosing has already been started by Moderna.
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. This potentially poses a monumental risk to the children in our opinion and based on the foregoing analysis of how vaccines have been developed and implemented to protect the population. Short-term analysis of a few weeks or months can potentially lead to long-term irreversible harm especially to a younger and growing populace of children with 70-100 years of life ahead of them. The potential harms may lead to a future healthcare crisis from such harm of biblical proportions if tried and tested safety guardrails are removed.
This really is a question of risk-management and parents must seriously consider that Covid-19 is a far less dangerous illness for children than influenza. 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? The children should live normally, and if exposed to SARS-CoV-2 we can rest assured that in the vast majority of cases, they will have no to only mild symptoms while at the same time developing naturally acquired immunity, and harmlessly; an immunity that is definitely superior to that which might be caused by a vaccine. This approach would also accelerate the development of the much needed herd immunity about which much has been written.
In addition to concerns related to immediate or long-term sequelae of the new mRNA vaccines in children, there are emerging data suggesting that the vaccines might not be as effective as initially reported. They do not provide so-called sterilizing immunity or neutralizing antibodies as initially proposed. Bansal for example stated as to the Moderna and Pfizer vaccines “[i]t is still unclear whether they protect people from becoming infected, or from spreading the virus to others. That poses a problem for herd immunity.” Could Dr. Fauci and the CDC’s plea to wear face masks and social distance after vaccination be a tacit ‘veiled’ admission that the Covid-19 vaccine does not work effectively? If so, this is a real problem and concern for this is not how the vaccine is being sold to the public, especially now that they are being told even with the vaccine, you still cannot travel or visit family etc. or get back to ‘normal’ life.
In addition, there is the 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 or were found to have an increased frequency of infection.” 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 too early to tell how this will play out with these Covid-19 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.
We are hoping this works out. But we are concerned that insofar as testing of safety is concerned, the sample size of 6,750 or so children reported by Moderna is not powered to detect anything significant about safety, which is a critically important issue. Safety is one of the most important if not the most important primary endpoint when it comes to vaccination in general and vaccination of children who don’t even need the vaccine in the first place in particular. Indeed, as indicated, there are initial reports of adverse events post-vaccination and as such these must be clarified and validated. However, there is a safety signal here with these vaccines and any other drug or device or vaccine with these signals, then there would have been a pause put in place by now.
Why then? Why move to vaccinate children? The expedited emergency use of vaccines is also creating turmoil in the European Union, where 19 countries have suspended the use of the Astra Zeneca vaccine due to concerns related to ‘excess clotting and related deaths after vaccinations.’ Physicians and scientists are asking for answers to the questions of such encountered harms in Europe. The physicians state, “We note that a wide range of side effects is being reported following vaccination of previously healthy younger individuals with the gene-based Covid-19 vaccines… While we recognize that these occurrences might, every one of them, have been unfortunate coincidences, we are concerned that there has been and there continues to be inadequate scrutiny of the possible causes of illness or death under these circumstances, and especially so in the absence of post-mortems examinations.” These physicians state further, “There are serious concerns, including but not confined to those outlined above, that the approval of the Covid-19 vaccines by the EMA was premature and reckless, and that the administration of the vaccines constituted and still does constitute “human experimentation,” which was and still is in violation of the Nuremberg Code.”
Let us be clear. We have serious concern with this position adopted by Dr. Fauci and the reported coming Moderna trial of children and ask that this be reversed as it has no basis and entirely not needed given the exceedingly low risk profile of children and the potential for harms. In this situation, the harms far outweigh any possible benefits and this must not go forward, as we argue. We base this on the existing children’s risk evidence. In conclusion, the issue of vaccines in children is really a risk management question for parents and any decision-maker. We insist that the CDC and Dr. Fauci as well as the NIH wait at least 2 to 3 years for the safety data to emerge from the current vaccines and then allow for full regulatory approval of these vaccines and not move forward with experimental vaccines in children. The science as to exceedingly low risk for children is defined and is settled. Yet we have zero, zero long-term studies on the safety of these vaccines both in adults and now threateningly, our children.
We ask the CDC and other governmental agency spokespersons to give clarity to this burgeoning societal risk. As indicated above, we ask that testing of the vaccines in children be halted post-haste. This is based not only on putative risks associated with mass vaccination but even more specifically because, and as we have said above, children simply do not need a vaccine for Covid-19. Further, we request that governmental agencies elucidate the risk-benefits of such vaccines to the children before proceeding to another “emergency use authorization” of vaccines in this population.
We also write this as a call for caution. This really is about risk management decisions we as free people (as parents) are allowed to make in the USA. This is not only about science. It seems that the medical experts and Moderna are ignorant of the risk data in children as well as the current epidemiology of Covid-19. We ask them to urgently consult the body of pediatric evidence. Remember also, children cannot give proper informed consent e.g. an 8-month-old, a one-year-old. This is a very important ethical matter. The death rate in children under 12 is as close to zero as we can get. We have masked our children, closed schools, locked them down, driven surges in suicides in adults as well as our children due to these policies, and now we seek to vaccinate children with an experimental vaccine for which we have no data on the long-term harms. This is very unsafe in our opinion. The long-term safety data is not there nor will be there based on what Moderna has proposed.
Moreover, with such low risks in children for getting and spreading Covid-19 virus, or getting seriously ill from it, then we ask again, why not allow our children to live reasonably normal lives, free, being exposed naturally as part of day-to-day life, and developing natural immunity harmlessly, with sensible precautions and simultaneous societal mitigations (which must always be in place as a key aspect of responding) that focuses on doubling down and tripling down on safeguards for our high-risk e.g. elderly, persons with comorbidities, and obese persons? With an aggressive focus on hygiene, sanitation, and disinfecting. Even study of the role of orofecal spread that has been sidelined. If the goal is population-level herd immunity, then low-risk exposure and infection in children and young persons who are well and healthy in any society is the one tried and true strategy for getting there harmlessly and faster. Why subject our children to a vaccine with possible side effects when we can get there harmlessly? What level of side effects would Dr. Fauci and the vaccine makers want to accept in subjecting our low-risk children to this? This makes absolutely no sense. Are there factors other than science at play here?
In closing, our children are not ‘tiny adults’ and their physiological response will be drastically different to adults. In fact, it could be devastating to the vaccine. It is not even if they show that the vaccine is safe for kids, the issue is there is no basis for it, none! The CDC and experts like Dr. Fauci have been wrong on lockdowns, on school closures, and on mask mandates. Just plain wrong! They have all created an utter mess for our societies as we begin emerging from the pain of the punitive unsound lockdowns and school closures. Parents must now step up and demand that Dr. Fauci, CDC, NIH, and Moderna and other vaccine developers (and any entity with interests in the development of these vaccines) make their case for vaccinating their children. Do not simply accept this for there is no credible reason for it. We ask you as parents to adopt the words ‘risk-management’ and ‘cost-benefit’ as your guiding principles now on all things Covid-19, especially for your children’s sake. You have to assess the facts and demand these from them. You must question these medical experts who have been wrong on pretty much all things Covid-19-related. Catastrophically wrong! Do not shy away from this responsibility for the implications are way too great to do otherwise. Do not let our governments and media medical experts put a ‘chill’ on us as parents and guardians of our children, and silence us from pushing back and asking needed questions.
You should know that the scientific community and dissenters, contrarians, and skeptics are already attacked, slandered, and smeared by the media, politicians, and even other scientists. I am and was, yet today, myself and our anti-lockdown anti-closure positions are being championed and embraced for what was done was a pure failure. We were guilty of considering the ‘totality’ of the risks, particularly those from the societal restrictions as they caused more harms and deaths than the virus itself. Our positions focused around an ‘age-risk’ targeted and more focused approach that secured the elderly and high-risk persons principally. Top preeminent scientists such as Dr. Scott Atlas, Dr. John Ioannidis, Dr. Carl Heneghan, Dr. Sunetra Gupta, Dr. Martin Kulldorff, Dr. Kulvinder Gill, Dr. Harvey Risch, Dr. Peter McCullough, Dr. Ramin Oskoui, Dr. Jonas Ludvigsson, Dr. Jay Bhattacharya, and Dr. Abir Ballan are slandered and smeared in lieu of real substantive scientific debate. They are assaulted and names and careers severely damaged by the media. Even United States Senators such as Ron Johnson (Wisconsin) are slandered and smeared by the media television medical experts for his questioning of the vicious lockdown decisions and championing of early outpatient therapy for Covid-19 symptomatic persons (combined and sequenced antivirals, corticosteroids, and anti-platelet therapeutics that are safe, effective, available, and cheap).
Vaccinating our children with a possibly harmful (untested) vaccine to them and with no basis given their risk profile, must be pushed back upon hard by parents. Like these mentioned contrarians and skeptics who have raised the ‘inconvenient truths’ surrounding Covid-19 responding, parents now have a very equal, sensitized, focused, and critical role in raising the right questions and taking a stand. Parents are the voices of their children now on vaccinating their children and on the other looming disaster, Covid-19 ‘vaccine passports,’ that are as illogical and dangerous as vaccines for children under 12! Americans must stand up now to this!
We end by saying, we should think twice, then think twice again, and then even think again one more time, before vaccinating kids against Covid-19. The data or evidence or science is not there to support this.
- Paul E Alexander MSc PhD, McMaster University and GUIDE Research Methods Group, Hamilton, Ontario, Canada [email protected]
- Howard C. 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
- Dr. Parvez Dara, MD, MBA, [email protected]