Comments for upcoming VRBAC Meeting Jan 26 2023
A Call For an FDA Criminal Investigation and Replacement of Current Advisory Committee Members With Those WITHOUT Conflicts of Interest
The DATA Don’t LIE.
I had just finished correcting a 149 page summary of the immunology of the COVID-19 vaccines with 255 references when the CHD requested that people should submit comments for the upcoming FDA VRBPAC January 26, 2023 meeting [1].
In this massive document, the above Table from the UK Office for National Statistics (ONS) stood out as the most significant to address if in fact the COVID-19 vaccines were safe and effective.
One has to weigh the risks versus the benefits. For a product intended to save lives, one has to examine all-cause deaths. This is because a product that saves lives from one cause but introduces the same or more deaths due to another cause makes no sense for approval.
Focusing on the first column with all-cause mortality rate ratios of ever vaccinated over never vaccinated (per 100,000 person-years) we can see from January 2021 through to May 2022, except for the month of February 2021, all were over 1, and in fact increased with time. This increase is due in part to selection of variants by the vaccines which in the vaccinated make them more prone to infection and as can be seen here in column 2, more likely to die from COVID-19. However, the larger increase in death rates in the vaccinated has to do with column 3, the non-COVID-19 deaths reflecting in part the toxicity of the COVID-19 spike vaccines especially the gene therapy mRNA vaccines [2] and even the viral vector vaccines.
From Table 2, the relative risk for the all-cause mortality ratio from January 2021 to May 2022 was 6.37 with a p value of 0.0001 which is very highly significant. This tells you these vaccines are deadly killing 6.37-fold more people than people saved. This is very unusual for any product authorized by the FDA even if only under the emergency use access. However these products such as the Pfizer-BioNTech mRNA vaccine surprisingly were awarded regulatory approval based on their flimsy evidence.
THINK ABOUT IT, THE FDA (HC, MHRA) AUTHORIZED FOR THE INNOCULATION OF THE MASSES, A GENE THERAPY PRODUCT THAT KILLS 6.37-FOLD MORE PEOPLE THAN IT HELPS.
This is nothing short of criminal!
In addition, in Table 2 we can see that since October 2021 in the UK when the first booster dose was offered, that COVID-19 mortality rates shot up such that those with 3 doses of vaccine (mostly the Pfizer-BioNTech mRNA vaccine) were 3.17-fold more likely to die from or with COVID-19 than the unvaccinated.
In fact, if the regulatory agencies were doing their duties, they would have all examined the mortality data for the month of January 2021, and grouped the data under all-cause, COVID-19 and non-COVID-19 mortality rate ratios. According to the above data, in the first week of February 2021, the mass vaccination program should have been halted. Upon seeing this data, Dr. Peter McCullough concurred. It is not only a travesty that the mass vaccination program continued, but clearly it is criminal.
Here is the overall conclusion from the 149 page document [1].
Figure 1. The LB-FMs that produce HERV-K102 Particles which are then released by cell lysis which makes up trained (INNATE) immunity. This provides heterologous protection non-specifically against infectious diseases, tumors and surprisingly chronic diseases (how this is possible is revealed in the 149 page document, submitted for publication).
“As was expected, the strategy of generating adaptive IgG antibodies to spike protein as a means to protect citizens and contain an RNA virus pandemic has been proven to be ineffective, as well as the use of the mRNA and virus vector vaccines due to their toxicity. On the other hand, a new pandemic preparedness paradigm based on the stimulation of trained (INNATE) immunity involving human endogenous retrovirus - K102 (HERV-K102) particle production in WDR74 positive, lipid body negative foamy macrophages (LB-FMs see Figure 1), has been validated as the sole strategy for taming RNA virus pandemics, since there is no possibility for selection of immune escape variants.
Incidentally, the INNATE HERV-K102 trained immunity protector system is favored by optimal vitamin D3 levels and supported by the early COVID-19 treatment protocols (involving alpha-fetoprotein antagonists, such as zinc, flavonoids, ivermectin [3]). There is some additional direct evidence that trained immunity and/or HERV-K102 replication might provide sterilizing immunity against the RNA enveloped pandemic viruses, SARS-CoV-2 [4] and/or HIV-1 (Figure 2) ”
Figure 2. Commercial Sex Workers (CSW) Resistant to HIV-1 Acquisition and who are SERONEGATIVE (HIV Exposed Seronegative = HESN) Exhibit Increased Copy Number of HERV-K102 in Genomic DNA
This shows that HERV-K102 replicative activity which involves integration into host genomic DNA is associated with sterilizing immunity. Normal healthy controls was 0.88 +/- 0.37 p= 0.0001. Note only the CSW but not the patients with HIV-1 are significantly different from the normal healthy controls. From Laderoute M et al, Open AIDS Journal, 2015.
HERE are the 4 main comments to the FDA.
1) It was extremely unexpected that the FDA would provide EUA for an intervention (gene therapy: mRNA and/or viral vector vaccines) involving the induction of IgG antibodies especially neutralizing antibodies with specificity for SARS-CoV-2 spike protein when by the time of the submissions to the FDA, it was well established in the literature that these antibodies were not protective but caused progression to more severe disease including DEATH [5] (and see references 61-73 in reference 1). This issue concerning ADE of infection leading to more severe disease and death, was often associated with early IgG responses (see refs. 44, 72, 81-86 in reference 1) in the upper respiratory tract (URT) that occurred before innate immunity could eliminate live infectious SARS-CoV-2 virions, and where in fact the IgG antibodies through ADE mediated infection of the protector LB-FMs which resulted in the loss of trained innate immunity in both the upper [6] and lower [7] respiratory tracts (LRT) (reviewed in ref. 1).
2) The FDA appears to have overlooked the issue that the second dose of the mRNA and adenovirus vaccines strongly induces IgG against spike protein in the URT (saliva, NPS etc) whereas during natural infection the appearance of IgG to spike protein seldom occurs unless there is severe or critical COVID-19 disease [8,9] . While ADE occurs both in the URT and LRT, only the URT involves the selection of variants via the classical FCGR2A (for IgG1/IgG3 isotypes) [6,7]. On the other hand, the LRT involves a novel mechanism of switch from primary receptor interaction (spike:ACE2) to secondary receptor interaction (spike:BSG) but where antibody isotypes are completely irrelevant [7]. Thus, prior to mass vaccination there was little selection pressure for the emergence of the alpha/delta variants (see Our World in DATA) [10] since there were few cases of IgG to spike protein in the URT. However, following the widespread introduction of the COVID-19 second dose which generates most of the spike-specific IgG in the URT, it selected for immune escape variants as witnessed in the UK and Canada [1]. Indeed based on a comprehensive study of mutations, it has been suggested the SARS-CoV-2 pandemic was destined to end by May 2021 [11] except the selection of variants by the second dose of the vaccines prolonged the pandemic [1]. By this time most nations were just starting to roll out the second doses, and should have been stopped as it would have ended the pandemic.
3) Unexpectantly, the FDA did not consider the quintessential risk-benefit analysis which requires an assessment of the relative ratios (relative risk) of death rates per 100,000 person years for ever vaccinated over never vaccinated for all-cause mortality. From the UK office for National Statistics published July 6, 2022 [13] and as summarized in Table 2, the COVID-19 vaccines failed this test miserably . Even the randomized clinical trial data shown in Table 4 [1] from a systematic review [14] showed a complete failure to pass this test of risk-benefit except for the Janssen one dose vaccine. However for the latter, data manipulation and exclusion of deaths occurring during the first 28 days following the vaccine administration [15] cannot be ruled out.
4) Unexpectantly, the FDA did not require NOR examine the relative ratios (relative risk) of death rates per 100,000 person years for ever vaccinated over never vaccinated for all-cause, COVID-19 and non-COVID-19 mortality for the month of January 2021 from each of the manufacturers and which should have been made openly available by the CDC (overall results for the USA or at least a subset of the States). If they had and had the results been similar to the UK (Table 1), the COVID-19 vaccine would have been stopped by the first week in February 2021, which would have saved hundreds of thousands of people serious morbidity and mortality [2].
[1] Laderoute MP. Controversies Concerning the Immunology of the COVID-19 Adaptive Immunity Vaccines. (Submitted)
[2] Seneff S, Nigh G, Kyriakopoulos AM, McCullough PA. Innate immune suppression by SARS-CoV-2 mRNA vaccinations: The role of G-quadruplexes, exosomes, and microRNAs. Food Chem Toxicol. 2022 Apr 15;164:113008. doi: 10.1016/j.fct.2022.113008.
[3] Laderoute M. Ivermectin may prevent and reverse immunosenescence by antagonizing alpha-fetoprotein and downmodulating PI3K/Akt/mTOR hyperactivity. Open Heart, April 29, 2021. https://openheart.bmj.com/content/8/1/e001655.responses#ivermectin-may-prevent-and-reverse-immunosenescence-by-antagonizing-alpha-fetoprotein-and-downmodulating-pi3k-akt-mtor-hyperactivity.
[4] Tartof SY, Slezak JM, Fischer H, et al. Effectiveness of mRNA BNT162b2 COVID-19 vaccine up to 6 months in a large integrated health system in the USA: a retrospective cohort study. Lancet. 2021 Oct 16;398(10309):1407-1416. doi: 10.1016/S0140-6736(21)02183-8. (please see Supplemental Table 5)
[5] Huang AT, Garcia-Carreras B, Hitchings MDT, et al. A systematic review of antibody mediated immunity to coronaviruses: kinetics, correlates of protection, and association with severity. Nat Commun. 2020 Sep 17;11(1):4704. doi: 10.1038/s41467-020-18450-4.
[6] Ziegler CGK, Miao VN, Owings AH, et al. Impaired local intrinsic immunity to SARS-CoV-2 infection in severe COVID-19. Cell. 2021 Sep 2;184(18):4713-4733.e22. doi: 10.1016/j.cell.2021.07.023.
[7] Ren X, Wen W, Fan X, et al. COVID-19 immune features revealed by a large-scale single-cell transcriptome atlas. Cell. 2021 Apr 1;184(7):1895-1913.e19. doi: 10.1016/j.cell.2021.01.053.
[8] Guerrieri M, Francavilla B, Fiorelli D, et al. Nasal and salivary mucosal humoral immune response elicited by mRNA BNT162b2 COVID-19 vaccine compared to SARS-CoV-2 natural infection. Vaccines (Basel). 2021 Dec 18;9(12):1499. doi: 10.3390/vaccines9121499.
[9] Aksyuk AA, Bansal H, Wilkins D, et al. AZD1222-induced nasal antibody responses are shaped by prior SARS-CoV-2 infection and correlate with virologic outcomes in breakthrough infection. Cell Rep Med. 2022 Dec 15:100882. doi: 10.1016/j.xcrm.2022.100882.
[10] Mathieu E, Ritchie H, Rodes-Guirao L et al., Coronavirus Pandemic (COVID-19). Published on-line at OurWorldInData.org. 2020, Retrieved from: https://ourworldindata.org/coronavirus.
[11] Kistler KE, Huddleston J, Bedford T. Rapid and parallel adaptive mutations in spike S1 drive clade success in SARS-CoV-2. Cell Host Microbe. 2022 Apr 13;30(4):545-555.e4. doi: 10.1016/j.chom.2022.03.018.
[12] Servellita V, Morris MK, Sotomayor-Gonzalez A, et al. Predominance of antibody-resistant SARS-CoV-2 variants in vaccine breakthrough cases from the San Francisco Bay Area, California. Nat Microbiol. 2022 Feb;7(2):277-288. doi: 10.1038/s41564-021-01041-4.
[13] Office for National Statistics (UK). Deaths involving COVID-19 by vaccination status, England: Deaths occurring between 1 January 2021 and 31 May 2022. Age-standardised mortality rates and raw death numbers for deaths involving COVID-19 by vaccination status, broken down by age and /or sex group. https://www.ons.gov.uk/peoplepopulationandcommunity/birthsdeathsandmarriages/deaths/bulletins/deathsinvolvingcovid19byvaccinationstatusengland/deathsoccurringbetween1january2021and31may2022.
[14] Graña C, Ghosn L, Evrenoglou T, et al. Efficacy and safety of COVID-19 vaccines. Cochrane Database Syst Rev. 2022 Dec 7;12(12):CD015477. doi: 10.1002/14651858.CD015477.
[15] Sadoff J, Le Gars M, Shukarev G, et al. Interim results of a phase 1-2a trial of Ad26.COV2.S Covid-19 vaccine. N Engl J Med. 2021 May 13;384(19):1824-1835. doi: 10.1056/NEJMoa2034201.
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HERE are the concluding remarks:
In short, with the advent of the SARS-CoV-2 pandemic, which may or may not have been created with funding from the NIH, (many scientists believe the pandemic started as an accidental release of SARS-CoV-2 from the Wuhan Institute of Virology), the FDA appears to be derelict in their duties to protect the public from harm from these dangerous gene therapy COVID-19 vaccines (and so called antivirals) and has abandoned the principles of evidence-based medicine and proper and intense review of product safety and efficacy, purity (consistent batches and oversight of chemistry and manufacturing issues), pharmacology, risk vs benefit, and so on.
The FDA is currently unable to perform its duties in a science-based manner and those in charge of making the decisions for the COVID-19 vaccines, should be fired (without pay or benefits) and subject to criminal investigations. Similarly, the current members of the sham advisory committee should be replaced with scientists and clinicians with NO CONFLICTS OF INTEREST.
This is my honest opinion and I have no conflict of interest.
Dr. Marian Laderoute
In fact topping up ones's Vit D3 levels to >50 ng/ml has been estimated to be superior to any adaptive immunity vaccine. [Borsche L, Glauner B, von Mendel J. COVID-19 mortality risk correlates inversely with vitamin D3 status, and a mortality rate close to zero could theoretically be achieved at 50 ng/ml 25(OH)D3: results of a systematic review and meta-analysis. Nutrients. 2021 Oct 14;13(10):3596. doi: 10.3390/nu13103596.] This is because adequate Vit D3 prevents the ability of SARS-CoV-2 to convert the protector LB-FMs to LB+FMs which instead provide an immunologically privileged site for SARS-CoV-2 replication [Dias SSg et al, PLoS Pathogens, Dec 2020].
Please go to https://www.regulations.gov/commenton/FDA-2022-N-2810-0001 and file your comment regarding the vaccines that EUA and regulatory approval should be immediately rescinded. Download and post my submission as an attached file in your comment. I thank you in advance.