Why are the CDC, NIH and FDA ignoring the risks and limitations of these biologics?
On 29 October 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. 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 an experimental nucleic acid preparation that is associated with rare but catastrophic side effects in individuals aged 12 and older. The administration of the Pfizer-BioNTech “vaccine” for children aged 5 to 11 should be limited to those children with medical conditions known to be at risk for COVID-19, and then only under a strict physician’s consideration and supervision. 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. In the 5 to 11 age group COVID-19 is generally considered to be a self-limiting infection of the upper airway with only mild symptoms of COVID-19 infection 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 10 years and older.2 Overwhelmingly, childhood COVID-19 deaths in the 5 to 11 age group are due to serious pre-existing comorbidities.
- The reason for the childhood resistance to severe COVID disease 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 actually be at a higher risk of adverse vaccine effects if they are then given the Pfizer mRNA “vaccine” preparation when compared to naïve individuals not previously infected.8,9,10 The FDA has absolutely no idea if this would also be the case for a vaccinated 5 to 11-year-old child).
It is important to realize that a small number of 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 that “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, the true incidence of MIS-C generated by the administration of the Pfizer “vaccine” in children will most 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. It is not a ”Vaccine.”
The Pfizer-BioNTech COVID-19 mRNA preparation BNT162b2, (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” that can reduce the severity of COVID-19 once an individual is infected with the COVID-19 virus. It is an experimental treatment that falls under the Coronavirus Treatment Acceleration Program. It is not a vaccine. At most, it has provided only a six-month period of protection against serious infection by 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, having now mutated into other dominant strains such as the widespread Delta variant and its 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 as well as other fully-vaccinated individuals.18
- The Pfizer Injection Does Not Reliably Protect Against More Severe Disease.
An Israeli study of 2.5 million patients and found that fully vaccinated individuals were 6 to 13 times more likely to get infected with the Delta COVID variant, than individuals that developed 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 8 times higher compared to individuals with a natural developed immunity.19
Because the Pfizer mRNA COVID-19 Biological Product no longer reliably prevents infection, re-infection, viral transmission, or death from COVID-19. It is a failed “vaccine”. This was reaffirmed on 26 August 2021, when CDC Director Walensky stated that the COVID vaccines no longer prevent vaccinated individuals from catching or spreading COVID-19.
Yet the biased mainstream media and the CDC itself 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. To reiterate, there are over 79 international, peer-reviewed, high-quality studies that demonstrate a naturally acquired immunity is far superior to that provided by COVID-19 mRNA “vaccination.” 7
4. The Pfizer Injection Is Associated with 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. 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 experimental Pfizer COVID-19 mRNA preparation and other COVID mRNA “vaccines” in the United States.
The Pfizer-BioNTech COVID-19 mRNA Biological Product BNT162b2 (loosely called the “Pfizer COVID-19 Vaccine”) was first issued an FDA Emergency Use Authorization (EUA) on December 2020. It was for use in individuals 16 years of age and older. In spite of the under-reporting by VAERS, by February 2021, some scientists were already calling for a halt to the use of all experimental COVID mRNA “vaccines”.
- In the first four months of their introduction, the experimental COVID-19 “vaccines” racked up more deaths and severe adverse events on VAERS than all other types of vaccines combined over a period of 32 years.
Irrespective of the serious undercounting of the adverse effects being 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 when compared to all other vaccines together.20 What is terrifying, is that there is no way at present to tell who will suffer a deadly vaccine side-effect and who will not. All we know is that receiving a second dose of one of the mRNA vaccines seems to be a factor.
Just as alarming as the deaths are the extremely wide range of serious injuries and hospitalizations associated with the mRNA and DNA vaccines. 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 depositing in distant tissues remains completely unknown, along with the plausible ability of the mRNA “vaccines” to trigger lethal autoimmune diseases months to years later. 21
Despite the continuing, 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 22 September 2021, the FDA amended its authorization for the ineffective Pfizer-BioNTech COVID-19 “Vaccine” to allow the use of an additional booster dose. Safety concerns over this decision caused a serious conflict between the FDA leadership under Janet Woodcock, and two senior FDA scientists promptly resigned.24
This decision is made even more troublesome by the overwhelming evidence proving that COVID-19 is a treatable condition and that early outpatient multidrug therapy for high-risk infections can cause an 85% reduction in COVID-19 hospitalization and death.
This is by using existing FDA-approved drugs, that were incorrectly suppressed by Dr. Anthony Fauci at the NIH and by Dr. Stephen Hahn and Dr. Janet Woodcock at the FDA.25( Dr. Woodcock is now the temporary FDA Commissioner.)
5. Mass Vaccinations For The Pandemic Control of COVID-19 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 an mRNA booster dose that is 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 458 volunteer cohort.26 This rushed, incomplete study represents “junk” science and it is suggestive of a state of desperate panic at the NIH, FDA, and CDC, to keep the mRNA vaccines in play.
Enough is enough and it is time to face the truth;
With the present mRNA vaccines, there is no all-encompassing positive Benefit over Risk for vaccinating children in the 5 to 11 age group for COVID-19. 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 from an mRNA “vaccine” that does not work well. Known comorbidities associated with an increased COVID-19 risk include obesity, diabetes, chronic lung disease, sickle cell disease, or immunosuppression. Again, this is for a child’s physician to carefully decide.
It must be remembered that this possibility is evidenced by the irrefutable fact that the countries with the highest COVID-19 “vaccination” rates are now showing the highest increases in COVID-19 cases.27 The COVID mRNA “vaccines” are not working reliably.
It is now past time for the Government Accountability Office (GAO) as well as a specially-designated Senate Committee with a panel of outside advisors, to be formed to investigate the actions and motives from January 2020 to date, concerning the decisions made by Dr. A. Fauci at the NIH and the conflict-of-interest ridden CDCAdvisory Committee on Immunization Practices (ACIP).
Particular attention should be given to Dr. Stephen Hahn (the 2020 FDA Commissioner and Dr. Janet Woodcock (the current temporary FDA Commissioner who earlier recused herself from all vaccine decisions because of her conflicts of interest.)
Both these individuals played a major role in blocking the use of hydroxychloroquine for early-stage COVID-19 in outpatients.
In addition, some of the 20 members of the FDA Vaccines and Related Biological Products Advisory Committee (FDA/ VRBPAC) need a close examination for conflicts-of-interest and openly cleared of any possible role in the subversion of the proven safe, cheap, and effective early outpatient treatments for COVID-19 and the replacement of this doctrine with an ill-advised, mass vaccination program involving highly experimental mRNA and DNA Biological Products.
This is almost a legal mandate following the recent release of a paper in the British Medical Journal which states that P.D. Thacker “blows the whistle on data integrity issues in Pfizer’s vaccine trial.”
Thousands of Americans Have Been Permanently Injured and Killed by Experimental mRNA Vaccination and a Full Accountability Is Now Mandatory.
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 where he studied the Ebola Virus at the U.S. 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 U.S. 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. This article provides a summary of existing peer-reviewed research with defendable conclusions.
Dr. Steven Hatfill MD, MS, MS, M.Med; November 3, 2021
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
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
3. Patel AB, Verma A. Nasal ACE2 Levels and COVID19 in Children. JAMA. 2020 Jun 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 Apr 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 01, 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).
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. NIH
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 https://www.nature.com/articles/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 22 3 September 2021 SARS-CoV-2 variants of concern and variants under investigation (publishing.service.gov.uk)
24. J. Brufke, Two senior FDA officials resign over Biden administration booster shot plan, New York Post September 1, 2021 Two senior FDA officials resign over Biden administration booster shot plan (nypost.com)
25. 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)
27. 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