On October 29, 2021, the Food and Drug Association (FDA) extended its Emergency Authorization for the Pfizer-BioNTech “vaccine” to be given to reduce serious COVID-19 infections in children aged 5 to 11 years. Unfortunately, the FDA provided little evidence for their decision except for a minimal-sized “immunobridging” study which incorrectly considered blood antibody levels to be the same thing as immunity to the COVID-19 virus. It is not. Especially when using an mRNA “vaccine” that is demonstrably no longer working in the older age groups.
The Pfizer COVID-19 mRNA vaccine is not really a “vaccine” in the true sense of the word. It does not provide a long-term immunity like the existing vaccines for measles, polio, chickenpox, and smallpox. Rather, it is experimental nucleic acid preparation associated with rare but catastrophic effects in individuals aged 12 and above. Any discussion of the Benefit / Risk of the Pfizer-BioNTech and other mRNA “vaccines” for consideration in children aged 5 to 11 should be limited to physicians and parents of children with medical conditions known to be at risk for COVID-19. Alternatively, successful early, drug treatments for COVID-19 are available.
1. Unlike Adults, Children Are Naturally Resistant to Serious COVID-19 Infection.
For a variety of infectious diseases, children respond differently than adults. COVID-19 is generally considered to be a self-limiting infection of the upper airway in the 5 to 11 age group creating only mild symptoms or no symptoms at all. 1
With respect to fatal outcomes, the Infection Fatality Rate (IFR) of COVID-19 in children is an almost infinitesimal 0.001% to 0.002% in those aged 5-9 years old, with a mean increase in the IFR of 0.59% with each five-year increase in age past ten years and older. 2 Overwhelmingly, childhood COVID-19 deaths in the 5 to 11 age group are due to serious pre-existing comorbidities.
• The reasons for this childhood resistance to severe COVID-19 include a low number of COVID virus receptor proteins in the nose and mouth, together with the fact that this age group demonstrates a robust cross-reactive innate immunity to a variety of RNA viral infections. 3,4
• Children are not significant transmitters of the COVID-19 virus to adults or to each other, further adding to the minimal role that children have played in the COVID-19 pandemic. 5,6
• There are currently over 79 international, high-quality research papers demonstrating that convalescing COVID-19 patients develop a natural, robust, cross-reactive, and long-lasting immunity superior to that of individuals given the Pfizer COVID mRNA “vaccine.” 7
In contrast, there is evidence that convalescent COVID-recovered individuals with new natural immunity may be at a higher risk of adverse vaccine effects if they are given the Pfizer mRNA “vaccine” compared to naïve individuals not previously infected. 8,9,10 The FDA has absolutely no idea if this would also be the case for COVID-recovered and then vaccinated 5 to 11-year-old children.
It is important to realize that a few children in the 5-11 age group with mild or asymptomatic COVID-19 virus exposures may develop a serious generalized inflammatory state a few weeks later. This is termed the Multisystem Inflammatory Syndrome in Children (MIS-C). Some scientists are concerned that the Pfizer COVID-19 mRNA “vaccine” may itself trigger MIS-C. 11,12
The current temporary FDA Commissioner Janet Woodcock MD has recently stated, “the FDA is incapable of accurately monitoring the serious adverse side-effects associated with “vaccination” using the experimental Pfizer COVID-19 mRNA preparation.” 13 Therefore, any tally of the true incidence of MIS-C linked to the administration of the Pfizer “vaccine” in children will likely be a gross undercount with a lack of transparency to parents.
2. The FDA Classifies the Pfizer COVID-19 injection as a Biologic Product, and therefore, it is not a “Vaccine.”
The Pfizer-BioNTech COVID-19 mRNA preparation BNT162b2, and the parallel product called “Comirnaty” in Europe,was created to protect against the SARS-CoV-2 virus (the cause of COVID-19). It is designated as a “CBER-Regulated Biologic Product,” which can reduce the severity of COVID-19 once an individual is infected with the virus. It is an experimental treatment that falls under the Coronavirus Treatment Acceleration Program. It is not a vaccine. At most, it seems to provide roughly six months of limited protection against the early strains of the COVID-19 virus. 14
3. The Pfizer mRNA COVID-19 Biological Product (“Vaccine”) is not working as promised.
The original early strains of the COVID virus are now essentially extinct, mutating into other dominant strains such as the widespread Delta variant and its accompanying viral quasi-species that are vaccine-resistant.
Consequently, when considering a childhood vaccination decision, parents should be aware of several facts;
• The Pfizer Injection “Does Not Reliably Protect Against COVID-19 Infection.Fully-vaccinated individuals can still be infected with the Delta strain of COVID-19. 15,16,17
• These fully-vaccinated but newly-infected individuals can transfer their COVID infection to both unvaccinated and other fully-vaccinated individuals. 18
• The Pfizer Injection Does Not Reliably Protect Against More Severe Cases of Covid.
An Israeli study of 2.5 million patients found that fully vaccinated individuals were 6 to 13 times more likely to get infected with the Delta COVID variant than individuals that develop a natural immunity from a previous COVID-19 infection. 19
• In addition, the risk of developing symptomatic COVID-19 was 27 times higher among fully-vaccinated individuals, and their risk of hospitalization was eight times higher than individuals with a natural-developed immunity. 19
Because the Pfizer mRNA COVID-19 Biological Productcanno longerreliably prevent infection, reinfection, viral transmission, or death from COVID-19: it is not a “vaccine.” This was reaffirmed on August 26, 2021, when CDC Director Walensky stated that the COVID vaccines no longer stop vaccinated individuals from catching or spreading COVID-19.
The biased mainstream media and the CDC responded by publishing an earlier deeply flawed and statistically small study claiming that the COVID-19 “vaccines” provide greater protection against reinfection than natural immunity. Yet, there are over 79 international, peer-reviewed, high-quality studies that demonstrate that a naturally-acquired immunity is far superior to that provided by the mRNA-based “vaccines.” 7
4. The Pfizer Injection Is Associated with Rare but Severe, Crippling Side-Effects and Death.
In 1990, the FDA and CDC created the Vaccine Adverse Event Reporting System (VAERS) to receive reports about suspected vaccine side-effects. Unfortunately, this system is grossly antiquated and characterized by the shocking under-reporting of adverse vaccine events. Yet this is the major surveillance system now being used by the FDA and CDC to monitor the safety of the still-experimental Pfizer COVID-19 mRNA preparation and other COVID mRNA “vaccines” in the United States.
The Pfizer-BioNTech COVID-19 mRNA Biological Product BNT162b2 was first issued an FDA Emergency Use Authorization (EUA) in December 2020 for use in individuals 16 years of age and older. However, despite the under-reporting by VAERS, by February 2021, some scientists were calling for a halt to the use of all the experimental COVID mRNA “vaccines.”
In the first four months of their introduction, these experimental COVID-19 “vaccines” accumulated more deaths and severe adverse events on VAERS than all other types of vaccines combined over the previous decade. Moreover, irrespective of the serious undercounting of the adverse effects reported on VAERS, as seen in Figure 1, the number of deaths per million administered COVID -19 vaccine doses has increased more than 10-fold compared to all other vaccines together. 20 What is concerning is that there is no way to tell who will suffer a deadly vaccine side-effect and who will not. All we know at the moment is that receiving a second dose of one of the mRNA vaccines seems to be a factor.
The extremely wide range of serious injuries and hospitalizations associated with the mRNA vaccines are just as alarming as the deaths.These include vaccine-induced heart damage in young males, the precipitation of heart attacks, strokes, and limb amputations due to abnormal blood clotting, a possible phenomenon called Antibody-Dependent Enhancement (ADE), and a range of serious neurological complications including partial paralysis and blindness. 21
The long-term effects caused by the rapid dissemination of mRNA “vaccine” nanoparticles from their injection site into distant tissues remains completely unknown, along with the possible ability of the mRNA “vaccines” to trigger lethal autoimmune diseases months to years later. 21
Despite the continued and repeated calls for caution made by outside scientists, the dangers of the current COVID-19 mass “vaccination” program have been minimized by senior personnel at the FDA, the National Institutes of Health (NIH), and the Centers for Disease Control (CDC), who have failed to act on the side of caution. 21,22,23
On September 22, 2021, the FDA amended its authorization for the ineffective Pfizer-BioNTech COVID-19 “Vaccine” to allow the use of an additional booster dose. 24 Safety concerns over this decision caused a serious conflict between the FDA leadership under Janet Woodcock, and two senior FDA scientists promptly resigned. 25
The overwhelming clinical evidence showing that COVID-19 is a treatable condition makes this decision even more troublesome. Early outpatient multidrug therapy for high-risk infections can result in an 85% reduction in COVID-19 hospitalizations and death (achieved by using existing FDA-approved drugs) incorrectly suppressed by Dr. Anthony Fauci at the NIH and Dr. Stephen Hahn and Dr. Janet Woodcock (temporary FDA Commissioner). 26
5. Countries Are Now Opting–Out of Mass Vaccination Mandates
Realizing that their vaccination programs are not working, the Britain and Israel are considering dropping vaccine passports and halting the practice of businesses demanding that individuals disclose their vaccine status. In addition, the U.S. state of Florida has dropped its vaccine mandates entirely.
Due to an unacceptably high rate of potentially fatal vaccine-induced inflammation of the heart and/or the pericardium (the membrane surrounding the heart), during October 2021, all the Scandinavian countries simultaneously halted or discouraged the use of Moderna’s COVID-19 mRNA vaccine for males under the age of 30. This includes Sweden, Finland, Iceland, and Norway. In Denmark this was for all individuals under 18. 27
The concept of local, state, and federal governments mandating ill-conceived policies concerning public health is now being challenged in other areas outside of vaccination. Most particularly mask mandates in children attending school. In Florida, Emergency Rule 64DER21-15 has recently been affirmed, which empowers parents to decide if their children should wear masks at school,citing solid data demonstrating that mask-wearing by children provides little barrier to COVID-19 infection. 28
6. Mass COVID-19 Vaccination is a Failed Doctrine.
With all of the approved mRNA “vaccines” now showing clear signs of failure, the FDA has desperately reversed its banned practice of administering a mRNA booster dose different from the type of mRNA vaccine used for an individual’s primary vaccination. The FDA justification for this is a recent NIH review of the data from a small volunteer cohort. 24 This rushed and incomplete study is “junk” science, and it suggests a state of desperate panic at the NIH, FDA, and CDC to keep the mRNA vaccines in play.
Why are we injecting experimental “vaccines” into children when this does not reliably protect them from infection; when it may make them more prone to hospitalization if they get infected with COVID-19; and when the vaccination is associated with rare but catastrophic major side-effects as documented in older individuals? In what universe does this make sense?
With the present mRNA vaccines, there is no positive “Benefit over Risk” for vaccinating children in the 5 to 11 age group for COVID-19. The unknowns are simply too great. For example, there is no way to know if a vaccinated child with comorbidities will have a higher risk for adverse events if they later catch COVID-19 (known comorbidities associated with an increased COVID-19 risk include obesity, diabetes, chronic lung disease, sickle cell disease, and immunosuppression). Pediatricians and parents together should be making these decisions, not state governors, school boards, or federal bureaucrats and politicians.
It must be remembered that the countries with the highest COVID-19 “vaccination” rates are now showing the highest increases in COVID-19 cases. 29 The policy of mass vaccination is not working.
7. The Mass Vaccination Policy Requires Accountability
The start of the COVID-19 pandemic was characterized by worries over a lack of accurate data from China, a British computer model that was indicating catastrophic infection and mortality rates, and a national shortage of drugs, ventilators, medical personnel, and personal protective equipment. Consequently, by mid-February 2020, multiple simultaneous corrective measures were quickly initiated to address all these challenges. New vaccine development was only one measure and there was no guarantee this would work unless a portion of the COVID virus could be found that was very slow to mutate.
As safe, effective, and inexpensive outpatient drug treatments began to achieve their rightful predominant role for pandemic control, this modality was brutally and incorrectly quashed by the FDA in favor of a program of mass vaccination using the newly developed and highly experimental mRNA “vaccines,” and the use of the expensive drug Remdesivir for hospitalized patients. As has now been shown, neither of these FDA measures have been able to control the pandemic and the long-term side effects of this mass vaccination effort remains unknown at this time.
By the end of July 2020, the overwhelming positive effects and safety of the inexpensive early drug treatments for COVID-19 were well documented. Yet this data was ignored by the CDC, NIH and FDA who incorrectly continued to drive mass vaccination with unknown side-effects forward as a national policy. The real question is why?
Enough is enough and it is time for the FDA and the NIH to face the truth. Mass vaccinations cannot control a pandemic that involves a fast-mutating RNA virus. Using drugs like Remdesivir for “in-hospital” treatments will also not control a pandemic like COVID-19. The key to controlling COVID-19 is early outpatient anti-viral drug treatment accompanied by temporary home quarantine.
The subversion of proven safe, cheap, and effective early outpatient treatments for COVID-19 was intentional and it represents a national scandal. The replacement of an early treatment doctrine with an ill-advised U.S. mass vaccination program involving highly experimental mRNA “vaccines” was unwarranted, and the FDA should have halted it in February 2021. A formal investigation is almost a legal mandate now following the recent release of a paper in the British Medical Journal; 30
P.D. Thacker. Researcher blows the whistle on data integrity issues in Pfizer’s vaccine trial BMJ 2021;375:n2635 Published November 2. doi: https://doi.org/10.1136/bmj.n2635
It is past time for a comprehensive, true oversight of the mass vaccination program. The Government Accountability Office should be tasked to work together with a specially-designated Senate Committee and a panel of outside advisors, to investigate the actions of Dr. A. Fauci (NIH); Dr. Stephen Hahn (2020 FDA Commissioner); and Dr. Janet Woodcock (now the current Acting FDA Commissioner) who earlier recused herself from all vaccine decisions due to her conflicts-of-interest).
In addition, the conflict-of-interest-ridden CDCAdvisory Committee on Immunization Practices (ACIP) and some of the 20 members of the FDA Vaccines and Related Biological Products Advisory Committee (FDA/ VRBPAC) need a closer examination.
Thousands of Americans have been permanently injured and thousands killed by the mRNA “vaccines.” Full accountability is required over the intentional suppression of early drug treatments in favor of an incorrect national mass vaccination program.
2. O’Driscoll, M., Ribeiro Dos Santos, G., Wang, L. et al. Age-specific mortality and immunity patterns of SARS-CoV-2. Nature 590, 140–145 (2021). https://doi.org/10.1038/s41586-020-2918-0
3. Patel AB, Verma A. Nasal ACE2 Levels and COVID19 in Children. JAMA. 2020 June 16;323(23):2386-2387. doi: 10.1001/jama.2020.8946. Nasal ACE2 Levels and COVID-19 in Children – PubMed (nih.gov)
4.Yang F, Nielsen SCA, Hoh RA, Röltgen K, Wirz et.al.,. Shared B cell memory to coronaviruses and other pathogens varies in human age groups and tissues. Science. 2021 May 14;372(6543):738- 741. doi: 10.1126/science.abf6648. Epub 2021 April 12. PMID: 33846272; PMCID: PMC8139427. Shared B cell memory to coronaviruses and other pathogens varies in human age groups and tissues. – Abstract – Europe PMC
5.Munro APS, Faust SN. Children are not COVID19 super spreaders: time to go back to school. Arch Dis Child. 2020 Jul;105(7):618-619. Erratum in: Arch Dis Child. 2021 Feb;106(2): e9. PMID: 32371442 Children are not COVID-19 super spreaders: time to go back to school – PubMed (nih.gov)
6. Ludvigsson JF. Children are unlikely to be the main drivers of the COVID-19 pandemic – A systematic review. Acta Paediatr. 2020 Aug;109(8):1525to1530. doi: 10.1111/apa.15371. Children are unlikely to be the main drivers of the COVID-19 pandemic – A systematic review – PubMed (nih.gov)
8. C. Menni,K. Klaser, A May, et.al Vaccine side-effects and SARS-CoV-2 infection after vaccination in users of the COVID Symptom Study app in the UK: a prospective observational study. Volume 21, Issue 7, P939-949, July 1, 2021. April 27, 2021 doi: https://doi.org/10.1016/S1473-3099(21)00224-3
9. R. K. Raw, C. Kelly, J. Rees, et.al., Previous COVID-19 infection but not Long-COVID is associated with increased adverse events following BNT162b2/Pfizer vaccination. 2021.04.15.21252192; in peer review. doi: https://doi.org/10.1101/2021.04.15.21252192
10. Efrati, M. Catalogna, A. Hamad, R. et al. Safety and humoral responses to BNT162b2 mRNA vaccination of SARS-CoV-2 previously infected and naive populations. Sci Rep 11, 16543 (2021). https://doi.org/10.1038/s41598-021-96129-6
11. Vogel TP, Top KA, Karatzios C, Hilmers DC, Tapia LI, Moceri, P, et al. Multisystem inflammatory syndrome in children and adults (MIS-C/A): Case definition & guidelines for data collection, analysis, and presentation of immunization safety data. Vaccine. 2021;39:3037–49; Epub ahead of print. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7904456/
12. Salzman MB, Huang C, O’Brien CM, Castillo RD. Multisystem Inflammatory Syndrome after SARS-CoV-2 infection and COVID-19 vaccination. Emerg Infect Dis. 2021;27(7):1944-1948. https://doi.org/10.3201/eid2707.210594
14. FDA, Coronavirus (COVID-19) | CBER-Regulated Biologics, https://www.fda.gov/vaccines-blood/biologics/industry-biologics/coronavirus-covid-19-cber-regulated-biologics; FDA, Coronavirus Treatment Acceleration Program (CTAP) https://www.fda.gov/drugs/coronavirus-covid-19-drugs/coronavirus-treatment-acceleration-program-ctap.
15. E. Dolgin. COVID vaccine immunity is waning. Nature 597, 606-607 (2021)doi: https://doi.org/10.1038/d41586-021-02532-4
17. C.B. Acharya, J. Schrom, A. M. Mitchell,et.al., No Significant Difference in Viral Load Between Vaccinated and Unvaccinated, Asymptomatic and Symptomatic Groups Infected with SARS-CoV-2 Delta Variant. doi: https://doi.org/10.1101/2021.09.28.21264262 in peer review. No Significant Difference in Viral Load Between Vaccinated and Unvaccinated, Asymptomatic and Symptomatic Groups Infected with SARS-CoV-2 Delta Variant | medRxiv
18. K.K. Riemersma, B.E. Grogan, A. Kita-Yarbro, et al., Shedding of Infectious SARS-CoV-2 Despite Vaccination. https://doi.org/10.1101/2021.07.31.21261387 (2021). In peer review.
19. S. Gazit, R. Shlezinger, G. Perez. Et.al., Comparing SARS-CoV-2 natural immunity to vaccine-induced immunity: reinfections versus breakthrough infections. August 25, 2021 https://doi.org/10.1101/2021.08.24.21262415 in peer review.
20. Case 4:21-cv-07894 Document 1 Filed 10/07/21 United States District Court for The Northern District of California, Oakland Division. https://rickjaffeesq.com/wp-content/uploads/2021/10/kaiser1.pdf
21. R. Bruno, P. McCullough, T. Forcades, et.al., SARS-CoV-2 mass vaccination: Urgent questions on vaccine safety that demand answers from international health agencies, regulatory authorities, governments and vaccine developers. https://www.authorea.com/users/414448/articles/522499-sars-cov-2-mass-vaccination-urgent-questions-on-vaccine-safety-that-demand-answers-from-international-health-agencies-regulatory-authorities-governments-and-vaccine developers?commit=e6eec0208672efb4629eaadaa7ef7864c1772909
22. Daily Expose. September 9, 2021
FACT CHECK – 70% of Covid-19 deaths are among the VACCINATED population; not the unvaccinated population as claimed by Boris Johnson, the BBC & Sky News – Rights and Freedoms (wordpress.com)
23. Public Health England. SARS-CoV-2 variants of concern and variants under investigation in England Technical briefing September 22 3 2021
SARS-CoV-2 variants of concern and variants under investigation (publishing.service.gov.uk)
25. J. Brufke, Two senior FDA officials resign over Biden administration booster shot plan, New York Post September 1, 2021 2:01pm Two senior FDA officials resign over Biden administration booster shot plan (nypost.com)
26. McCullough PA, Alexander PE, Armstrong R, et al. Multifaceted highly targeted sequential multidrug treatment of early ambulatory high-risk SARS-CoV-2 infection (COVID-19). Rev Cardiovasc Med (2020) 21:517–530. doi:10.31083/j.rcm.2020.04.264 Multifaceted highly targeted sequential multidrug treatment of early ambulatory high-risk SARS-CoV-2 infection (COVID-19) – PubMed (nih.gov)
29. Subramanian, S.V., Kumar, A. Increases in COVID-19 are unrelated to levels of vaccination across 68 countries and 2947 counties in the United States. Eur J Epidemiol (2021). https://doi.org/10.1007/s10654-021-00808-7
30. P.D. Thacker. Researcher blows the whistle on data integrity issues in Pfizer’s vaccine trial BMJ 2021;375:n2635 Published November 2. doi: https://doi.org/10.1136/bmj.n2635
Dr. Steven Hatfill is a specialist physician and a virologist with Master’s degrees in Microbiology, Medical Biochemistry, and Experimental Hematology. His medical fellowships include Oxford University, the National Institutes of Health in Bethesda, and the National Research Council. He studied the Ebola Virus at the US Army Institute for Infectious Diseases at Fort Detrick. He is board-eligible in Hematological Pathology. He has numerous peer-reviewed scientific publications and is a Senior Fellow at the London Center for Policy Analysis.
He is the lead author of “Three Seconds Until Midnight” prophetically published two months before the US COVID-19 outbreak. From February 2020 until the 2021 transition, he served daily as an outside medical / scientific advisor for COVID-19 to the Executive Office of the President of the United States.
Dr. Hatfill does not purport to reflect the opinions or views of any organization with which he is affiliated. Instead, this article provides a summary of existing peer-reviewed research with defendable conclusions.