Pfizer 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 household transmission 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 1, 2, 3, 4). 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:
- 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. here, here, here, here, here).
- Recent research (August 2021) by Loske deepens 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.”
- 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).
- 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.
- 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).
- 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.”
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) (here, here, here, here, here, 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.
- Dr Alexander holds a PhD. He has experience in epidemiology and in the teaching clinical epidemiology, evidence-based medicine, and research methodology.
- Dr Alexander is a former Assistant Professor at McMaster University in evidence-based medicine and research methods;
- Former COVID Pandemic evidence-synthesis consultant advisor to WHO-PAHO Washington, DC (2020) and former senior advisor to COVID Pandemic policy in Health and Human Services (HHS) Washington, DC (A Secretary), US government;
- Worked/appointed in 2008 at WHO as a regional specialist/epidemiologist in Europe's Regional office Denmark.
- Worked for the government of Canada as an epidemiologist for 12 years
- Appointed as the Canadian in-field epidemiologist (2002-2004) as part of an international CIDA funded, Health Canada executed project on TB/HIV co-infection and MDR-TB control (involving India, Pakistan, Nepal, Sri Lanka, Bangladesh, Bhutan, Maldives, Afghanistan, posted to Kathmandu);
- Employed from 2017 to 2019 at Infectious Diseases Society of America (IDSA) Virginia USA as the evidence synthesis meta-analysis systematic review guideline development trainer;
- Currently a COVID-19 consultant researcher in the US-C19 research group