The Pfizer-BioNTech COVID-19 mRNA preparation BNT162b2, is now renamed Comirnaty. It is identical to the original and still highly controversial Pfizer-BioNTech BNT162b2 mRNA preparation.

·         The BNT162b2, mRNA preparation and the other mRNA vaccines create only a short-term immunity to the original Wuhan and early Alpha and Beta clades of the SARS-CoV-2 virus, the causative agent of COVID-19.

·         Both the Wuhan and Alpha viral clades are now essentially extinct. They have mutated into other SARS-CoV-2 variants that are now showing ever increasing mRNA vaccine resistance.

·         The FDA-licenced BNT162b2 preparation, like the other mRNA vaccines, cannot reliably prevent infection with the now dominant Delta clade of the SARS-CoV-2 virus.^1,2

·         Fully vaccinated individuals who become infected with the Delta clade of SARS-CoV-2 exhibit the same high viral loads in their upper airways as unvaccinated individuals with an established COVID infection.³

·         Consequently, fully vaccinated individuals who become infected with the current Delta clade of SARS-CoV-2, can infect both unvaccinated as well as fully vaccinated individuals.⁴

·         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 some SARS-CoV-2 variants than individuals that have developed a natural exposure from a previous COVID-19 infection.⁵

·         In addition, the risk of developing symptomatic Covid was 27 times higher among fully-vaccinated individuals compared to individuals with a natural immunity, and their risk of hospitalization was 8 times higher. ⁵

These findings are not surprising, since infection with the virus induces an immune response to many of the different proteins of the COVID virus, whereas the mRNA vaccines are directed against only one protein target, the Spike Protein.

There is also now considerable evidence that COVID-recovered individuals may be at a higher risk of  adverse effects if they are administered the current mRNA vaccines, compared to those not previously infected.^6,7,8

In summary, the Pfizer-BioNTech COVID-19 BNT162b 2/ Comirnaty mRNA preparation was originally stated to be 90.5% effective (95% CI 61.0–98.9) in preventing symptomatic COVID-19, with an efficacy 88.9% (95% CI 20.1–99.7) with respect to preventing severe disease.⁹ At this time, these figures are no longer true. Despite 60% - 70% of the U.S. population estimated as being vaccinated, infections and deaths surged in the summer of 2021. The vaccines are clearly not working as advertised. This was noted on the floor of the U.S. Senate at the end of September 2021.²

In contrast, an unvaccinated individual who contracts SARS-CoV-2 will develop a dramatically better immunity and cross-strain reactivity against COVID-19 variants, than an individual fully vaccinated with the Pfizer-BioNTech BioNTech BNT162b2 / Comirnaty mRNA preparation or other mRNA vaccine preparations.^10,11,12

The FDA is Incapable of Monitoring Vaccine Safety and Efficacy

On Aug. 21, 2021, the Temporary FDA Commissioner Janet Woodcock MD, gave full approval to the Comirnaty vaccine for COVID-19— for individuals 16 years of age and older. Roughly a year earlier, Dr. Woodcock had declared a conflict of interest and had recused herself from all mRNA vaccine decisions.

·         Her summary announcement states: “as the first FDA-approved COVID-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product.”

·         The U.S. Centers for Disease Control and Prevention (CDC) also states that the COVID-19 mRNA vaccines are safe and effective "under the most intense safety monitoring in United States history.”

The FDA and CDC statements on high standards for mRNA safety and effectiveness are completely untrue.

The original FDA Approval Letter for the Pfizer vaccine had a final vaccine approval date not scheduled until 2024. Yet on 23 August 2021, the Pfizer-BioNTech COVID-19 BNT162b 2/ Comirnaty mRNA preparation was FDA approved - without a panel review.

This was despite growing evidence of vaccine-induced miscarriages, myocarditis in young males, dissemination of the vaccine nanoparticles from the injection site into the general circulation, vaccine-associated heat attacks, strokes, suggestions of possible Antibody Dependent Enhancement (ADE) of infection, an increasing number of serious neurological and cardiac conditions, as well as vaccine-related deaths. 

·         In reality, the U.S. lacks an effective surveillance system that can rapidly and accurately detect vaccine injuries and deaths. Instead, the FDA has been forced to rely on an antiquated 32-year-old passive data collection mechanisms, primarily the Vaccine Adverse Event Reporting System (VAERS) to determine if the experimental mRNA vaccines are effective and if they are causing serious harm.

·         The accuracy of VAERS in the past has been highly variable depending on the vaccine and adverse vaccine effects involved.

For example, VAERS was only able to capture 12% of the cases of a serious paralyzing condition (Guillain-Barré Syndrome) during the 2012-13 influenza season, and only an estimated 15% to 55% detection rate of all the cases occurring during the 2009 H1N1 influenza vaccine administration. The system is typified by gross under-reporting of other adverse vaccine events .¹³

·         In a letter to Pfizer dated 23 August, 2021 concerning its COVID-19 mRNA vaccine, the FDA admitted that it was incapable of tracking adverse mRNA vaccine side effects when it stated:

“Furthermore, the pharmacovigilance system that FDA is required to maintain under section 505(k)(3) of the FDCA is not sufficient to assess these serious risks”. ¹⁴

·         The FDA has now shifted the responsibility for adverse event detection over to Pfizer as part of its agreement to license the Comirnaty mRNA preparation for COVID-19.¹⁴

·         Both the CDC and the FDA are using incomplete data and demonstrating unreasonable bias in their pro-vaccine decisions. They are not erring on the side of caution.

·         On 1 May 2021, the FDA purposely stopped counting the number of vaccine “breakthrough” infections in the United States unless they result in hospitalization or death. As a result, the current efficacy of the vaccines in preventing symptomatic illness is unknown because of a lack of data. What is clear is that the Pfizer vaccine preparations are not reliably preventing infection.

In response, the FDA downgraded the effectiveness of the Pfizer-BioNTech COVID-19 BNT162b 2/ Comirnaty mRNA preparation from “providing immunity,” to simply helping to protect individuals against the severe composite outcomes of hospitalization and death. This was the actual data that came out of the original initial clinical trials. 

Even this is now subject to question.  Accumulating data from the United Kingdom and other areas indicates the Pfizer-BioNTech COVID-19 BNT162b 2/ Comirnaty and the other mRNA preparations are not protecting against hospitalizations and death. (Figure 1).

 Figure 1. Public Health England Technical briefing 22 3 September 2021.^15,16

·         In Britain - 80% of people over 16 are fully vaccinated. Yet the data show that only about 25% of deaths in Britain are among the unvaccinated. ^15,16

·         While the British data appears to have many potential confounders that limit the actual accuracy of this all-age comparison for death, the trend does appear to be real.

·         In the U.S., despite errors in reporting and counting the number of vaccines administered, according to VAERS, the number of deaths per million vaccine doses has increased overall to more than 10-fold.¹⁷      

·         The British study also revealed that vaccinated people over the age of 40 are now MORE likely to get COVID-19 than the unvaccinated. This reinforces the statement that vaccination mandates for individuals with natural immunity, introduces unnecessary risks without commensurate benefits—either to individuals or to the population as a whole.¹⁶

·          Realizing that their vaccination programs are not working, the British and Israelis are now considering dropping vaccine passports and halting the practice of making private businesses check vaccine status.

The Experimental mRNA Vaccine Trials Were Rushed and Incomplete

The now identified role of SARS-CoV-2 “Spike” glycoprotein in inducing the capillary inflammation that is characteristic of COVID-19 infection, is extremely relevant given that the Pfizer-BioNTech COVID-19 BNT162b 2/ Comirnaty mRNA vaccine and other types of mRNA vaccine preparations, induce the manufacture of Spike glycoprotein in the cells of its recipients.

·         The lack of proper testing and review of the animal biodistribution data for the Pfizer mRNA vaccine preparation prior to clinical trials, ignored data showing the rapid spread of the mRNA nanoparticles of the vaccine from the initial injection site into other tissues throughout the body .¹⁸

·         Following vaccine nanoparticle injection, the test animals began to produce spike protein markers on the surface of the cells in the regional lymph nodes, the bone marrow, the lining of the systemic capillaries, lungs, liver, spleen, adrenal glands and gonads.¹⁸

·         The presence and pathological significance of this animal biodistribution data in humans is poorly documented, but it must be noted that the Pfizer/BioNTech vaccines introduce mRNA into multiple cell types throughout the body which then make a modified SARS-CoV-2 Spike Protein on their cell surface to trigger an immune response.

·   The viral Spike Protein is linked to several serious pathophysiological developments in COVID-19.¹⁷ This fact was not recognized during vaccine development and scientists did not understand the human risks of this protein when they included its mRNA code into so-called “vaccines”.

What is certain, is that the FDA authorization was based on safety data generated from human trials lasting less than 3.5 months. As the U.S. mass vaccination program progressed, it has been accompanied by an abnormally high rate of real-world serious adverse effects, including deaths.

As early as February 2021, some scientists were calling for a halt to the mass vaccination program. In their first four months, these experimental COVID-19 “vaccines” have accumulated more deaths and severe adverse events than all the other vaccines combined in VAERS’s entire 30-year history.

Despite continuing calls for caution, the risks of SARS-CoV-2 vaccination continue to be minimized or ignored by health organizations and government authorities.¹⁷ This has raised serious major conflicts between the leadership of the FDA and some of its scientists.¹⁹

The current mRNA vaccines are not reliably protecting individuals from infection or infection transmission. The rate of occurrence of adverse effects and the wide range of the types of adverse effects reported to date, demonstrate the need for a better understanding of the benefits / risks of mass vaccination.

Still emerging data suggests that the Pfizer mRNA vaccine may have the potential to cause vaccine-driven disease enhancement and a reprograming of the human immune system.^{20, 21} This raises serious questions regarding the long-term effects of any vaccine based on the mRNA of the dangerous Spike Protein.²² 

Summary

The scientific discovery of vaccines represents one of the major advances in public health. However, the COVID-19 virus is not like the viruses that cause mumps, rubella, measles, smallpox, yellow fever and polio, which mutate slowly. In contrast, the COVID-19 virus mutates quickly, and until a universal coronavirus vaccine can be found, the virus will always be one step ahead of new vaccine development.

Currently, there is no relationship between the percentage of population vaccination and the reduction of new COVID-19 cases during an infection cycle. In 68 surveyed nations, new COVID-19 cases are abnormally unrelated to the level of national vaccination. In the United States, the increases in new COVID-19 cases are unrelated to the high levels of vaccination across 2947 surveyed counties.²³ 

The current COVID mRNA vaccines can neither reliably stop an individual from catching an infection with some new variants of the COVID virus, nor stop them from transmitting this infection to someone else. It was the wrong approach for the US to take for national pandemic control.

Nevertheless, on 24 August, 2021, after a supposedly careful consultation with medical experts and military leaders and with the support of the White House, the current Sec Def Lloyd J. Austin III stated that mandatory COVID-19 vaccinations for service members are necessary to protect the health and readiness of the force. 

·         This policy demonstrates a profound, deep, misunderstanding of the COVID-19 virus, the mRNA vaccines and the current COVID-19 pandemic.

·         In reality, the current mandatory vaccination mandate will not reliably protect the health of our U.S. Special Operations air, naval and ground forces and the intelligence agencies that support them.

·         Instead, this mandate has the potential to generate both short and long-term incapacitating side effects within the age group that typifies Special Operations soldiers and contractors. Alternatively, it may increase the severity of COVID-19 in some fully vaccinated personnel who are later infected with one of the continuously evolving SARS-CoV-2 viral clades.

While there is no clear evidence yet of the occurrence of ADE and vaccine-related autoimmunity and immunopathology in early volunteers immunized with the SARS-CoV-2 vaccines, the safety trials to date have not specifically addressed these adverse effects. Given that the follow-up of volunteers did not exceed 2 to 3.5 months after the second vaccine dose, it is unlikely such serious adverse effects would have been observed during clinical trials.

·         The actual long-term effects of the mRNA vaccines remain completely unknown at this time and their existence cannot be ruled out.

·         In addition, there are now serious new questions involving fertility effects, the Long-Post Vaccination Syndrome and immune system reprogramming with the loss of Natural Killer lymphocyte populations and a possible susceptibility to cancer. All of these questions need urgent research.

The current national mass vaccination program is not working and thousands of Americans have been seriously injured or died from vaccine administration. The true figures are unknown as a result of the failure of the CDC and FDA to develop an effective monitoring system.

The soldiers comprising the air, sea, and ground U.S. Special Operations forces and their supporting military intelligence and technical systems, are strategic assets that require months to select and train, and several more years to acquire experience in their specialized operational and supportive tasks.

There is currently a fear of the mRNA vaccines among the special operations and military intelligence communities, especially when the immune status of soldiers with previous infections are ignored and they are still mandated to get the vaccines. This is to the point where hundreds of soldiers and civilian contractors may take the choice of leaving their units completely or take an early retirement, rather than be vaccinated with a vaccine with potential serious side effects that is no longer protective.

Special Operations soldiers require a high standard of individual fitness that should not be compromised by experimental mRNA vaccines that lack a guarantee of only minimal side effects, especially when effective, verified, and safe COVID-19 drug treatments are available and the age group involved has a lack of unvaccinated comorbidity risk for serious injury and death from a COVID-19 infection, a risk that is even further reduced by the use of effective anti-viral medications.

Recommendations:

·         COVID-19 infection is unequivocally a treatable condition. Early treatment with one of several antiviral drugs at the first onset of symptoms shows a 100 % benefit in quickly moderating COVID-19 infection.^{17, 25}

·         Early multi-drug-therapy for even high-risk older patients results in an 85% reduction in COVID-19 hospitalization and death ^17,25

·         Safe antiviral drug prophylaxis is also available for units and dependents if the situation demands. ²⁶

Consequently, it is recommended that the U.S. Joint Special Operations Command and National Military Intelligence forces should return to the original U.S. National Pandemic Plan for Respiratory Viruses.

This would entail;

1.      Continuous on-site unit-surveillance for early viral outbreak cases using FDA-certified thermal camera systems.

2.      Group soldier/contractor education for COVID signs and symptoms, together with a central 1-800 Nurse Triage Line.

3.      This phone Triage Line will operate in conjunction with a small on-site clinics for rapid PCR diagnosis and rapid early outpatient treatment using safe, effective, antiviral drugs with the brief home quarantine of COVID-19 cases with post-exposure treatment of dependents.

4.      Unlike mass vaccination programs with ineffective mRNA vaccines, early drug treatment protocols can control community transmission and minimize infection severity, while allowing personnel to develop a broad, cross-reactive natural immunity to future COVID-19 clades.

References:

1. 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

2. Not Making Headlines: Sen. Ron Johnson Just Exposed on Senate Floor that the COVID Vaccines Do Not Appear to Work as Advertised (VIDEO) (thegatewaypundit.com)

3. 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

4.  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.

5.  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.

6.  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

7.  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

8. M. Efrati, A. Catalogna, R. Hamad,. 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

9. Y.N. Lamb. BNT162b2 mRNA COVID-19 Vaccine: First Approval. Drugs. 2021;81(4):495-501. doi:10.1007/s40265-021-01480-7 

BNT162b2 mRNA COVID-19 Vaccine: First Approval | SpringerLink

10.  R. Carlson,  Most recovered COVID-19 patients mount broad, durable immunity after coronavirus infection. July 26, 2021  Natural Immunity After COVID-19 Found Durable and Robust — Precision Vaccinations

11.  M. Wadman Science, Vol 373, Issue 6559.

Having SARS-CoV-2 once confers much greater immunity than a vaccine—but vaccination remains vital | Science | AAAS

12.  S. Attkisson.  Covid-19 natural immunity compared to vaccine-induced immunity: The definitive summary September 12, 2021.

Covid-19 natural immunity compared to vaccine-induced immunity: The definitive summary | Sharyl Attkisson  

13.  E.R. Miller, M.M. McNeil, PL Moro, et.al., The reporting sensitivity of the Vaccine Adverse Event Reporting System (VAERS) for anaphylaxis and for Guillain-Barré syndrome. Vaccine. 2020 Nov 3;38(47):7458-7463. doi: 10.1016/j.vaccine.2020.09.072.

https://pubmed.ncbi.nlm.nih.gov/33039207/

14.  August 23, 2021 Approval Letter - Comirnaty (fda.gov) page 6.

15.  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)

https://theexpose.uk/2021/09/09/fact-check-boris-bbc-sky-news-lie-about-unvaccinated-death-rate/

16. 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)

17. R. Bruno, P. McCullough, T. Forcades i Vila, 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.andrewbostom.org/wp-content/uploads/2021/05/Bruno-et-al.-Vaccine-Safety-Urgent-Manuscript-Preprint-May-8-2021.pdf

18.  SARS-CoV-2 mRNA Vaccine (BNT162, PF-07302048) 264. https://www.docdroid.net/xq0Z8B0/pfizer-report-japanese-government-pdf

19.  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)

20.  F.K. Foshe, B. Geckin, G.J. Overheul. The BNT162b2 mRNA vaccine against SARS-CoV-2 reprograms both adaptive and innate immune responses. May 6, 2021 still in peer review.  https://doi.org/10.1101/2021.05.03.21256520

21. B.K. Patterson, H. Seethamraju, K. Dhody, Disruption of the CCL5/RANTES-CCR5 Pathway Restores Immune Homeostasis and Reduces Plasma Viral Load in Critical COVID-19.preprint doi: https://doi.org/10.1101/2020.05.02.20084673  in peer review.

22. Y. Lei, J. Zhang, C.R. Schiavon. SARS-CoV-2 Spike Protein Impairs Endothelial Function via Downregulation of ACE 2. Circulation Research. 31 Mar 2021.128:1323–1326. https://doi.org/10.1161/CIRCRESAHA.121.318902  

23. 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

24. P.A. McCullough, R.J. Kelly, G. Ruocco  W.W. O'Neill, H.A. Risch, et. al., Pathophysiological Basis and Rationale for Early Outpatient Treatment of SARS-CoV-2 (COVID-19) Infection. Am J Med. 2021 Jan;134(1):16-22. doi: 10.1016/j.amjmed.2020.07.003. Pathophysiological Basis and Rationale for Early Outpatient Treatment of SARS-CoV-2 (COVID-19) Infection - PubMed (nih.gov)

25. HCQ for COVID-19: real-time analysis of all 358 studies (c19hcq.com)  ( select drug from treatment list).P. Kory P, G.U. Meduri, J. Varon, et.al.,. Review of the Emerging Evidence Demonstrating the Efficacy of Ivermectin in the Prophylaxis and Treatment of COVID-19. Am J Ther. 2021;28(3):e299-e318. Published 2021 Apr 22. doi:10.1097/MJT.0000000000001377

26. Review of the Emerging Evidence Demonstrating the Efficacy of Ivermectin in the Prophylaxis and Treatment of COVID-19 (nih.gov)