Letter to the [[willfully ignorant]] Mandating Employer

Hello. Regarding the mandate for all employees. I have several questions on behalf of myself and colleagues that I trust you should be able to answer. If you cannot answer, please simply state such. I hold informed consent and education in high regard and strive to be vigilant of industry-biased and corporation funded “science” that has tarnished aspects and the history of western medicine; therefore, I appreciate the opportunity to address some global concerns. I have also attached references to peer-reviewed articles to add the breadth of data to my inquiry.

The below questions are based on the August 23, 2021 Summary Basis for Regulatory Action – Comirnaty (SBRA) found at https://www.fda.gov/media/151733/download as well as the Prescribing Information (PI) found at https://www.fda.gov/media/151707/download (a) or https://www.fda.gov/media/144413/download (b). Additional supporting documents from the FDA are found at: https://www.fda.gov/vacines-blood-biologics/qa-comirnaty-covid-19-vaccine-mrna

First and foremost, as [[this employer]] moves into requiring COVID-19 vaccines for staff, is there a plan to explicitly carry Comirnaty once it is in production? There are currently two vaccines produced by Pfizer. The EUA authorization explicitly states that “As the vaccination provider, you must communicate to the recipient or their caregiver, information consistent with the “Vaccine Information Fact Sheet for Recipients and Caregivers” (and provide a copy or direct the individual to the website www.cvdvaccine.com to obtain the Vaccine Information Fact Sheet) prior to the individual receiving each dose of Pfizer-BioNTech COVID-19 Vaccine, including: FDA has authorized the emergency use of the Pfizer-BioNTech COVID-19 Vaccine, which is not an FDA-approved vaccine. The recipient or their caregiver has the option to accept or refuse Pfizer-BioNTech COVID-19 Vaccine. The significant known and potential risks and benefits of Pfizer-BioNTech COVID-19 Vaccine, and the extent to which such risks and benefits are unknown (PI(b), p.9-10).”

Next, I’d like to understand your clinical study methodology. It appears that safety and immunogenicity (BNT162-01) was based off a 24-patient sample in Germany (SBRA, p. 15, Table 6). It also states that no control group was used in the same table. Do we believe this methodology was sound and the sample size is adequate in representing our employees? Can you shed some light on how so? I am specifically interested in how a control group doesn’t apply here and how 24 participants from Germany is an adequate sample size for our target population. Again, this was the safety and immunogenicity study, so my concern is that safety took a backseat.

You will also find that study ID C4591001 to evaluate efficacy is ongoing and notes it had a placebo group that was first a dose-finding study, then stratified to include participates at high risk of acquiring COVID-19 for a duration of up to 7 days after the second dose without evidence of prior COVID-19 infection (SBRA, p.16; PI, p.18). I would like some clarity about this 7-day window after the 2nd dose as we have all been told people are not “fully vaccinated” until two weeks after the 2nd dose. I struggle to understand why we adopted 14 days when their efficacy study does not extend past 7 days. How does this short efficacy period justify the unknown risks thereafter?

Further, this study (C4591001) is no longer using a gold-standard placebo as it became unblinded December 14, 2020 and placebo groups were offered the EUA vaccine (SBRA, p.17). Does [[this employer]] find this approach worrisome? The PI(a) has a conflicting timeline and states that the participants were unblinded on December 11, 2020 (p.7). Is this study acceptable to validate the concerns of safety in the short-term for all employees? I can only see that it provides up to 6 months of data, nothing more. According to Peter Doshi, the editor of the BMJ, only 7% of the control group was still considered true placebo at the cutoff of the study by March 13, 2021 yet they were still counted in the placebo arm (https://blogs.bmj.com/bmj/2021/08/23/does-the-fda-think-these-data-justify-the-first-full-approval-of-a-covid-19-vaccine/).

The plan for Comirnaty’s “risk and associated uncertainties” mitigation is through labeling and postmarketing studies (SBRA, p.24). From what I can tell, this means that data is still unclear and mandating this product is an ethical challenge as people in studies should always be provided with fully informed consent free of coercion. I am sure you are aware that long-term safety data will not be known for several years from any of these products and the safety clinical trials are yet to start for COMIRNATY with an end goal for December 2022 based on the registry: https://clinicaltrials.gov/ct2/show/NCT04815031. Emergency department employees provide individualized care to our patients, should we also be afforded the same treatment based on our individual health status and our willingness to consent to these yet known risks?

Section 13.1 of the PI(a) states that “Comirnaty has not been evaluated for the potential to cause carcinogenicity, genotoxicity, or impairment of male fertility” (p.15). With the use of a new mRNA technology in humans, one would postulate that genotoxicity and carcinogenicity are important factors to understand or at least evaluate prior to forcing it upon otherwise healthy people? Am I missing something?

My biggest concern is what is looming in the upcoming cold/flu season. We have no data on whether this product will cause antibody-dependent enhancement or “vaccine-associated enhanced disease” or “vaccine-associated enhanced respiratory disease” (SBRA, p.25) as acknowledged in all previous coronavirus and similar pathogen animal trials:

  1. A Double-Inactivated Severe Acute Respiratory Syndrome Coronavirus Vaccine Provides Incomplete Protection in Mice and Induces Increased Eosinophilic Proinflammatory Pulmonary Response upon Challenge (https://doi.org/10.1128/JVI.06048-11)
  2. Cellular Immune Responses to Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV) Infection in Senescent BALB/c Mice: CD4+ T Cells Are Important in Control of SARS-CoV Infection (https://doi.org/10.1128/JVI.01281-09)
  3. Evasion by Stealth: Inefficient Immune Activation Underlies Poor T Cell Response and Severe Disease in SARS-CoV-Infected Mice (https://doi.org/10.1371/journal.ppat.1000636)
  4. Immunization with inactivated Middle East Respiratory Syndrome coronavirus vaccine leads to lung immunopathology on challenge with live virus (https://doi.org/10.1080/21645515.2016.1177688)
  5. Immunization with Modified Vaccinia Virus Ankara-Based Recombinant Vaccine against Severe Acute Respiratory Syndrome Is Associated with Enhanced Hepatitis in Ferrets (https://doi.org/10.1128/JVI.78.22.12672-12676.2004)
  6. Immunization with SARS Coronavirus Vaccines Leads to Pulmonary Immunopathology on Challenge with the SARS Virus (https://doi.org/10.1371/journal.pone.0035421)
  7. Pathogenic priming likely contributes to serious and critical illness and mortality in COVID-19 via autoimmunity (https://doi.org/10.1016/j.jtauto.2020.100051)
  8. Structural Basis of SARS-CoV-2 and SARS-CoV Antibody Interactions (https://doi.org/10.1016/j.it.2020.09.004)
  9. Two Different Antibody-Dependent Enhancement (ADE) Risks for SARS-CoV-2 Antibodies (https://doi.org/10.3389/fimmu.2021.640093)
  10. Vaccine Efficacy in Senescent Mice Challenged with Recombinant SARS-CoV Bearing Epidemic and Zoonotic Spike Variants (https://doi.org/10.1371/journal.pmed.0040080)

Was [[this employer]] aware of the problems in these trials prior to this policy change? I fear this outcome for staffing burdens this winter when challenged with similar respiratory pathogens. When faced with increased rates of infection, is it wise to add selective pressures onto these viruses to mutate around our interventions? Can you explain how these biologics do not contribute to immune escape nor cause an explosion of variants? Several world renown virologists hold these concerns forefront and are trying to sound the alarm. I know that [[this employer]] cares about mitigating risk for their employees, so I am wondering if these concerns were addressed or if you can share your position on these matters.

  1. Antibody-dependent enhancement of coronavirus (https://doi.org/10.1016/j.ijid.2020.09.015)
  2. Two Different Antibody-Dependent Enhancement (ADE) Risks for SARS-CoV-2 Antibodies (https://doi.org/10.3389/fimmu.2021.640093)
  3. COVID-19 Tragic Pandemic: Concerns over Unintentional “Directed Accelerated Evolution” of Novel Coronavirus (SARS-CoV-2) and Introducing a Modified Treatment Method for ARDS (https://doi.org/10.1002/ctm2.284)
  4. Out of the frying pan and into the fire? Due diligence warranted for ADE in COVID-19 (https://doi.org/10.1016/j.micinf.2020.06.006)
  5. Antigenic Evolution on a Global Scale Reveals the Potential Natural Selection of Severe Acute Respiratory Syndrome-Coronavirus 2 by Pre-existing Cross-Reactive T-Cell Immunity (https://doi.org/10.3389/fmicb.2021.599562)
  6. Structural Basis of SARS-CoV-2 and SARS-CoV Antibody Interactions (https://doi.org/10.1016/j.it.2020.09.004)
  7. Health Care Policy Makers’ Response to COVID-19 Pandemic; Pros and Cons of “Flattening the Curve” from the “Selective Pressure” Point of View: A Review (https://doi.org/10.18502/ijph.v49i6.3356)
  8. Antibody Dependent Enhancement Due to Original Antigenic Sin and the Development of SARS (https://doi.org/10.3389/fimmu.2020.01120)
  9. Review of COVID-19 Variants and COVID-19 Vaccine Efficacy: What the Clinician Should Know? (https://doi.org/10.14740/jocmr4518)
  10. Is COVID-19 receiving ADE from other coronaviruses? (https://doi.org/10.1016/j.micinf.2020.02.006)
  11. Vaccine-associated enhanced disease: Case definition and guidelines for data collection, analysis, and presentation of immunization safety data (https://doi.org/10.1016/j.vaccine.2021.01.055)
  12. Role of antibody-dependent enhancement (ADE) in the virulence of SARS-CoV-2 and its mitigation strategies for the development of vaccines and immunotherapies to counter COVID-19 (https://doi.org/10.1080/21645515.2020.1796425)
  13. What are the roles of antibodies versus a durable, high quality T-cell response in protective immunity against SARS-CoV-2? (https://doi.org/10.1016/j.jvacx.2020.100076)
  14. The SARS-CoV-2 Delta variant is poised to acquire complete resistance to wild-type spike vaccines (https://doi.org/10.1101/2021.08.22.457114)
  15. Epitope profiling reveals binding signatures of SARS-CoV-2 immune response in natural infection and cross-reactivity with endemic human CoVs (https://doi.org/10.1016/j.celrep.2021.109164)
  16. Vaccine- and natural infection-induced mechanisms that could modulate vaccine safety (https://doi.org/10.1016/j.toxrep.2020.10.016)
  17. Risk of rapid evolutionary escape from biomedical interventions targeting SARS-CoV2 spike protein (https://doi.org/10.1371/journal.pone.0250780)

With the clinical trial data cutoff date of March 13, 2021, there was no evaluation of this vaccination against this evolving “Delta” or subsequent variants. We lack supporting evidence to suggest that the biologics modeled off the old mutation has any effect on Delta, as that was not the dominant variant during the study period per the CDC’s own website (https://covid.cdc.gov/covid-data-tracker/#variant-proportions). Could you provide me with the studies to support a decreased risk of infection for those previously vaccinated in light of the “breakthrough” infections? What is the take on current trends that show vaccinated can contract and spread disease? If this is so, can you clarify how this would be of benefit to [[this employer’s]] staff? We all work with these patients. We have seen the previously vaccinated COVID-positive ICU patient and fear that for ourselves as our risks are greater than the general population. Our risks will always be higher for potential ADE because we work in an environment that is not lacking in respiratory pathogens.

With the initiation of COVID-19 EUA products, have [[this employer’s]] staff had training on the use of VAERS to report adverse events surrounding vaccine administration or “breakthrough” infections that has now shifted to a health department data collection? This is mandated by the CDC and FDA, but I have met several providers and nurses that have never heard the term “VAERS” or Vaccine Adverse Events Reporting System, much less input any data into it. VAERS has been inundated with data that is unmonitored and ill organized since the use of the COVID-19 EUA products (https://vaers.hhs.gov/data/datasets.html?). If [[this employer]] evaluated these tools prior to the policy change, can this be shared with fellow employees? Since this is a policy mandate, will [[this employer]] accept any responsibility for negative health outcomes of those they mandated to take these products? As this policy seemingly removes personal choice, I was also wondering if there were any arbitration or mediation clauses that would impede a formal litigation process.

As far as efficacy, Comirnaty’s package insert explicitly states in Section 5.5 that it “may not protect all vaccine recipients” (PI(a), p.6) which is also reiterated on the FDA website. Since the US has not provided transparent data, we must use the United Kingdom’s data as it is organized by age, vaccination status, genomic sequencing of variant, and deaths in each group. The most recent is found here: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1012644/Technical_Briefing_21.pdf, though there should be an additional update soon.

The groups suffering the most are above age 50. Delta is shown to be very contagious; however, the case-fatality rate for the Delta variant, of most concern currently, is the most interesting portion (p. 22-23). Fully vaccinated more than 14 days has 679 total deaths in a population of 73,372 total cases. This is a case-fatality rate of 0.93%. Compared to the unvaccinated that have a total death toll of 390 in a population of 183,133 which is a 0.21% case-fatality. So, with this data in mind, who is at more risk of adverse outcome? While unvaccinated have contracted more disease, the severity of the outcome (death) is not as high as those previously vaccinated. Is this data indicating vaccine-associated enhanced disease or am I mistaken? I have not seen any convincing arguments to the contrary and was hoping you held a different perspective on this data because its implications are grave.

Update: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1014926/Technical_Briefing_22_21_09_02.pdf The update follows the same trend with the following:
Vaccinated 14 days post-dose 2: Cases 113,823 with Deaths 1,091 (calculated case-fatality rate of 0.96%)
Unvaccinated: Cases 219,716 with Deaths: 536 (calculated case-fatality rate of 0.24%)

I am concerned that healthcare organizations are rushing to place these policies on their staff without solid scientific evidence, as it is not yet available. Why has mandating become acceptable when, even as nurses and providers, we are to give informed consent to our patients? Is our consent inferior to that of our patients? Can personal responsibility apply to these health choices? The following studies are a warning of the risks outweighing the benefits of vaccination and considerations for natural immunity. The great news is that your employees have spent countless hours in the presence of COVID-19 patients and may already have superior protection.

  1. The Safety of COVID-19 Vaccinations—We Should Rethink the Policy (https://doi.org/10.3390/vaccines9070693)
  2. Longitudinal analysis shows durable and broad immune memory after SARS-CoV-2 infection with persisting antibody responses and memory B and T cells (https://doi.org/10.1016/j.xcrm.2021.100354)
  3. SARS-CoV-2 infection induces long-lived bone marrow plasma cells in humans (https://doi.org/10.1038/s41586-021-03647-4)
  4. Longitudinal observation of antibody responses for 14 months after SARS-CoV-2 infection (https://doi.org/10.1016/j.clim.2021.108814)
  5. Is a COVID-19 vaccine developed by nature already at work? (https://doi.org/10.1016/j.mehy.2020.110335)
  6. What are the roles of antibodies versus a durable, high quality T-cell response in protective immunity against SARS-CoV-2? (https://doi.org/10.1016/j.jvacx.2020.100076)
  7. Risk of SARS-CoV-2 reinfection after natural infection (https://doi.org/10.1016/S0140-6736(21)00662-0)

I do not know all the details surrounding or informing this policy, but things are not adding up. Please do your best to support counterpoints with references like I have provided for you here. This is a serious discussion and has major implications for the individual and we need these answers.

Thank you for your time,

“just a nurse”

CDC “Delta” Science Contradicts Their Cited References

The CDC published an article about “science” and the Delta variant. It is found here: https://www.cdc.gov/coronavirus/2019-ncov/variants/delta-variant.html.

While the CDC’s strong language suggests that:

  1. The Delta variant is more contagious.
  2. Vaccinations cause lesser illness.
  3. Unvaccinated exhibit greater transmission.
  4. Fully vaccinated have shorter infectious periods, 

Their cited references DO NOT SUPPORT these declarations.

When read beyond the headlines, many of their cited references disagree with the allegations made on the CDC website. Please evaluate them for yourself as only brief highlights are given below.

**And, as an aside, I use the term “vaccine” under duress. I personally consider all the mRNA technology gene therapy/genetic engineering and NOT vaccine technology. The evaluated sources call them “vaccines,” so to avoid confusion I kept the terminology uniform. It’s basically prion disease if you want to get technical.**

Let’s get started.

Reference #1 (https://www.nejm.org/doi/10.1056/NEJMoa2108891

These authors state that vaccines are efficacious at preventing symptomatic disease. This does not mean that it prevents asymptomatic infection or stops transmission. It goes on to state, “…it appears that strains with mutations at that site [one of which is the Delta variant] may have increased replication, which leads to higher viral loads and increased transmission.” While vaccinated people are not always symptomatic, they can still transmit virions. Further, while the CDC claims that vaccines are effective, this study explicitly states, “Data on the effectiveness of Covid-19 vaccines against clinical outcomes with this variant have been limited.” The CDC asserts that vaccines prevent death or severe disease, and this study also claims, “The numbers of cases and follow-up periods are currently insufficient for the estimation of vaccine effectiveness against severe disease, including hospitalization and death.”

Reference #2 (https://doi.org/10.1056/NEJMoa2108891)

This source is fascinating as it is a direct contradiction to the pro-investigational vaccine paradigm. This MMWR was from Barnstable County, Massachusetts, where 74% of the outbreak population was fully vaccinated at least two weeks prior to this gathering. A total of 5 people were hospitalized with symptomatic disease, for which 4 were vaccinated, leaving 1 unvaccinated hospitalization of that remaining 26%, nobody died. Does this not cause concerns for immune escape, vaccine failure, or potentially increased susceptibility in the vaccinated due to non-lethal antigenic pressures? 

Reference #3 (https://doi.org/10.1101/2021.07.28.21261295

The author has glaring conflicts of interest in Sanofi and Roche that both provide covid-19 testing or vaccine manufacturing. They cite using up to the 45-cycle threshold for testing when we know that accuracy is diminished after approximately 22-25 cycles. How did they account for false positives? Those that developed symptoms within 14 days of vaccination were excluded from the study. While vaccinated were collected from 5 study sites, the unvaccinated were from a single site uncovering systemic bias as testing methods differed. The study also states that “Vaccine-breakthrough patients were significantly more likely to be asymptomatic… Notably, in contrast to existing studies that showed lower viral load in vaccinated patients, initial viral load indicated by PCR Ct values was similar between vaccinated and unvaccinated patients with B.1.617.2.” This statement solidifies the fact that vaccinated cohorts can still transmit covid-19 without outward symptoms, which should be concerning when considering mass vaccination to “protect the vulnerable.” The CDC ignores this fact and publishes that “fully vaccinated people with symptomatic breakthrough infections, can transmit it to others” when this clearly states that vaccine breakthrough patients were asymptomatic. Logically, the asymptomatic person with a high viral load is more of a risk to vulnerable populations than those with symptoms that would typically avoid their daily routines. Illness can prevent people from going to work and infecting others, but asymptomatic illness encourages this.

Reference #4 (https://doi.org/10.1101/2021.07.05.21260050)

This author has a direct competing interest as he sits on advisory boards for covid vaccines with AstraZeneca and Pfizer. Table One excludes the unvaccinated cohort from the dataset. While rates of infection are higher in the unvaccinated, deaths and hospitalizations are unclear. What is deciphered is that Delta is contagious, for which the CDC agrees. However, the CDC further asserts that “Vaccines are playing a crucial role in limiting spread of the virus and minimizing severe disease.” Interesting to note: “The emergence of novel SARS-CoV-2 variants of concern has slowed progress against the pandemic in three distinct ways: (i) by increasing transmissibility and the disease’s reproduction number; (ii) by increasing immune escape and diminishing vaccine effectiveness; and (iii) by increasing the virulence of SARS-CoV-2 infection.” This is a direct contraindication of the CDC’s statement of vaccine efficacy.

Reference #5 (https://doi.org/10.1101/2021.07.07.21260122

This study concludes that the antigenic changes with the Delta variant display “higher viral replication… increased transmissibility or could exhibit an increased propensity for escape from host immunity, and therefore pose an increased risk to global public health.” This agrees with the fact that Delta is more contagious in all populations, including those vaccinated. 

Reference #6 (https://doi.org/10.21203/rs.3.rs-637724/v1

This source relays concerns about transmission between healthcare workers in populations of highly vaccinated. It further explicitly states, “the Delta variant shows 8 fold approximately reduced sensitivity to vaccine-elicited antibodies compared to wild type.” The CDC completely ignores this information yet cites it as a reference? This does not support the push for vaccination programs. 

Reference #7 (https://doi.org/10.1101/2021.07.19.21260808

This article states, “data are consistent with the potential ability of fully vaccinated individuals to transmit SARS-CoV-2 to others.” Though this source claims less lethality for vaccinated cohorts, the article does not separate the data from vaccinated versus vaccinated. Further, it shows the death rate and hospitalizations are lower as compared to the variants otherwise specified. The CDC reverses this by publishing, “patients infected with the Delta variant were more likely to be hospitalized than patients infected with Alpha or the original virus strains.” This is false.

Reference #8 (https://doi.org/10.1101/2021.06.28.21259420)

This study does not have transparent data to review. Further, it considers only symptomatic cases for which the large control group has symptoms but covid negative status. Are these vaccinated more susceptible to other viral illnesses due to immune system modulation by the current vaccines? Why are hospitalization and death in the same category? Where is the information on those with prior illness or unvaccinated? Furthermore, these groups are only monitored for 14 days post-vaccine #1 and 7 days post-vaccine #2. This is a menial period to make sweeping judgments for “highly effective” per the CDC. Is the theoretical 14-day window an advantageous endpoint?

Reference #9 (https://doi.org/10.2139/ssrn.3861566

This study has a very small sample. Its data reflects a positive association with comorbidities; increased delta cases in vaccinated compared to other variants (due to the retrospective design); increased supplemental oxygen demands; and lower ICU admission/death rate compared to different variants. It also raises concerns of “mutations particularly in key areas of the immunodominant spike protein… that [has] been associated with increased transmissibility, evasion of immunity from infection and vaccination.” This is contrary to the push for vaccinations at the conclusion of the paper. It is no surprise that they declare conflicts of interest due to personal fees from Sanofi and Roche. 

Reference #10 (https://doi.org/10.1101/2021.07.31.21261387)

This paper starts by saying, “The SARS-CoV-2 Delta variant and its sublineages (B.1.617.2, AY.1, AY.2, AY.3; [1]) can cause high viral loads, are highly transmissible, and contain mutations that confer partial immune escape.” This statement is unfavorable for current vaccination strategies. The authors further outline “similar viral loads in nasal swabs, irrespective of vaccine status, during a time of high and increasing prevalence of the Delta variant. Infectious SARS-CoV-2 was isolated from 51 of 55 specimens (93%) with Ct <25 from both vaccinated and unvaccinated persons, indicating that most individuals with Ct values in this range (Wilson 95% CI 83%-97%) shed infectious virus regardless of vaccine status.” Ironically, this study closes with, “it is essential for public health policy to encourage vaccination while also planning for contingencies, including diminished long-term protection.” This statement is contradictory to the entire study and an utterly unjustified declaration.

Reference #11 (https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1005517/Technical_Briefing_19.pdf

This is the most interesting citation as it shows data that concludes increased cases in unvaccinated populations but more deaths in the fully vaccinated population overall. This UK data is alarming as the case-fatality rates make Delta more lethal in the vaccinated population. Vaccinated Delta cases (28,773) with vaccinated deaths within 28 days (224) is a case fatality of 0.78%; however, unvaccinated Delta cases (121,402) with unvaccinated deaths within 28 days (165) is a case fatality rate of 0.14%. This is a five-fold increased risk of death for the vaccinated population. While supportive in claims of contagion, it is contrary to assertions that “Unvaccinated people remain the greatest concern,” as stated by the CDC. Looks like the vaccinated should be priority as they fare worse…?

Reference #12 (https://doi.org/10.1016/S0140-6736(21)01358-1

This study asserts, “the effect of vaccination (at least 28 days after first or second dose) was to reduce the risk of hospital admission” and further evaluates “that there was no evidence of a differential vaccine effect on hospital admissions among those first testing positive.” With a disclaimer at the end: “Given the observational nature of these data, estimates of vaccine effectiveness need to be interpreted with caution.”

Reference #13 (https://khub.net/web/phe-national/public-library/-/document_library/v2WsRK3ZlEig/view_file/479607329)

This limited study does not provide raw data to compare the severity of disease and death in different groups based on vaccination status. It also poses a disclaimer stating that it was “not possible to estimate vaccine effectiveness against severe disease.” This is, again, a contradiction to the CDC’s claim that “the vaccine still provides strong protection against serious illness and death.”

Reference #14 (https://doi.org/10.1056/NEJMoa2107058

This study evaluates healthcare workers, PPE, and viral load with symptoms. It does not consider hospitalizations, deaths, oxygen demands, or “severity” outcomes but illustrates vaccinated populations have less RNA viral load and marginally fewer self-reported sick days. The authors further guess, “The mechanisms by which vaccination attenuates Covid-19 are largely unknown, but the effect is probably due to recall of immunologic memory responses that reduce viral replication and accelerate the elimination of virally infected cells. The biologic plausibility of these benefits is supported by the observation of similar phenomena in studies of other vaccines.” These assumptions seek to compare novel mRNA technology to the traditional vaccine strategies, which are entirely different. How can we draw conclusions of investigational-phase technology from the studies of unrelated products?

Reference #15 (https://doi.org/10.1101/2021.06.03.21258293)

These authors state a shift in the dominant variant and increase in the positive cases but do not determine hospitalizations or deaths. An increase in positive cases is consistent with CDC’s statement that Delta is more contagious. 

Again, you are the only person that can make the decision to consent to an investigational product that is heavily promoted by entities indebted to pharmaceutical giants. Beware of the conflicts of interest. The gatekeeper to informed consent is your own ability to draw conclusions from the data. This is easier said than done in the environment of today when “the data” is concealed, buried, and wrongfully interpreted by those in power positions.

I will leave you with some questions to consider:
How are government agencies allowed to make statements that are not grounded in research?
Why aren’t our investigational journalists critically reviewing these agencies?
If EUA products were such a good intervention, why do we need to mandate them?
Who is making the decision to mandate? What are their credentials?
If EUA products were so safe, why is liability from harms completely removed?
If health entities really cared about health, wouldn’t they have already mandated clean drinking water for the entire planet?
Science demands criticism and discourse, why are questions/thoughts labeled “misinformation” if they do not clearly promote “vaccine” uptake?

Do not be coerced and please keep a questioning mind. The only way to grow is through discussion. If something was truly lifesaving do you really think that Big pHARMa would “mandate” every person on the planet access “for free?” Because that’s what they do, right? What’s not to love about violating someone’s bodily autonomy and creating barriers to employment, goods, and services. Totally normal. Nothing to see here, right? I’ve said this since April 2020: the next currency is compliance. We all need to stand up against that. Once your ability to make independent decisions about your body is gone, so is your life. That is not a future I wish upon my children.

Shalom, light, and love…

Transfection Not Vaccination

Looks like we’ve confused some terminology in the last year when understanding the mechanisms of mRNA in translation as opposed to traditional vaccination strategies. Let me break it down.

Traditionally, scientist combine part of a pathogen with some other agents to elicit an immune response. This fragment of the causative organism should be recognized as foreign by the immune system. The immune system then flags it, memorizes its structure, and destroys it. At the next exposure, the immune system attacks the pathogen before the onset of illness. Illness averted. Novel theory, should everything go as planned.

Moving on, now, to transfection which is actually quite different. It basically makes your body produce the part of the pathogen by inserting a genetic code and using your body to do the creating… and destruction. I’m sure you can see what part of that can be problematic when it comes to the immune system flagging something your body is manufacturing as foreign…?

If you want a visual of this process, Khan Academy is always such a great reference.

mRNA is like a recipe
ribosomes are the kitchen/oven
tRNA is the baker adding ingredients
protein is the cake
Aaand, cake is life… amiright?
Well, proteins are the BUILDING BLOCKS OF LIFE… so they’re kind of a big deal.

This whole process is known as transfection when done with a foreign particles.

So, this time, scientists picked a part of the pathogen, the Spike glycoprotein, for your body to create. Then *hopefully* your immune system destroys (while sparing your self cells) and attacks it at next exposure before onset of illness. Illness averted…? Except this technology has never been used in humans and has gone horribly wrong in animal trials during challenge phases:

*A Double-Inactivated Severe Acute Respiratory Syndrome Coronavirus Vaccine Provides Incomplete Protection in Mice and Induces Increased Eosinophilic Proinflammatory Pulmonary Response upon Challenge (https://doi.org/10.1128/JVI.06048-11)
*Cellular Immune Responses to Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV) Infection in Senescent BALB/c Mice: CD4+ T Cells Are Important in Control of SARS-CoV Infection (https://doi.org/10.1128/JVI.01281-09)
*Evasion by Stealth: Inefficient Immune Activation Underlies Poor T Cell Response and Severe Disease in SARS-CoV-Infected Mice (https://doi.org/10.1371/journal.ppat.1000636)
*Immunization with inactivated Middle East Respiratory Syndrome coronavirus vaccine leads to lung immunopathology on challenge with live virus (https://doi.org/10.1080/21645515.2016.1177688)
*Immunization with Modified Vaccinia Virus Ankara-Based Recombinant Vaccine against Severe Acute Respiratory Syndrome Is Associated with Enhanced Hepatitis in Ferrets (https://doi.org/10.1128/JVI.78.22.12672-12676.2004)
*Immunization with SARS Coronavirus Vaccines Leads to Pulmonary Immunopathology on Challenge with the SARS Virus (https://doi.org/10.1371/journal.pone.0035421)
*Pathogenic priming likely contributes to serious and critical illness and mortality in COVID-19 via autoimmunity (https://doi.org/10.1016/j.jtauto.2020.100051)
*Structural Basis of SARS-CoV-2 and SARS-CoV Antibody Interactions (https://doi.org/10.1016/j.it.2020.09.004)
*Two Different Antibody-Dependent Enhancement (ADE) Risks for SARS-CoV-2 Antibodies (https://doi.org/10.3389/fimmu.2021.640093)
*Vaccine Efficacy in Senescent Mice Challenged with Recombinant SARS-CoV Bearing Epidemic and Zoonotic Spike Variants (https://doi.org/10.1371/journal.pmed.0040080)

Everyone touts how the vaccine stays in your injected muscle and “does not move” about the cabin… what if its ingredients had some questionable qualities that allow it to do just that? You be the judge…

https://www.fda.gov/media/144413/download
https://guardianconsulting.com/wp-content/uploads/2020/12/Moderna-COVID-19-vaccine_FULL_EUA.pdf
https://www.janssenlabels.com/emergency-use-authorization/Janssen+COVID-19+Vaccine-HCP-fact-sheet.pdf

So what are these lipid nanoparticles?
In short, most of the literature is focused on how a lipid nanoparticle can assist a product to pass the blood brain barrier. That’s a little odd. Cell membranes contain lipids so these lipid nanoparticles allow attachment of these mRNA products so that it may enter the cytosol for action. What purpose does the mRNA have specific to the brain? Your guess is as good as mine, but make your own conclusions for the research surrounding lipid nanoparticles (that are in both the Moderna and Pfizer concoctions).

Basophil reactivity to BNT162b2 is mediated by PEGylated lipid nanoparticles in patietnts with PEG allergy (https://doi.org/10.1016/j.jaci.2021.04.032)
Design of lipid nanoparticles for in vitro and in vivo delivery of plasmid DNA (http://doi.org/10.1016/j.nano.2016.12.014)
Development and screening of brain-targeted lipid-based nanoparticles with enhanced cell penetration and gene delivery properties (https://doi.org/10.2147/IJN.S215941)
Enhanced target cell specificity and uptake of lipid nanoparticles using RNA aptamers and peptides (https://doi.org/10.3762/bjoc.17.75)
Functionalized lipid nanoparticles for subcutaneous administration of mRNA to achieve systemic exposures of a therapeutic protein (https://doi.org/10.1016/j.omtn.2021.03.008)
Future considerations for the mRNA-lipid nanoparticle vaccine platform (https://doi.org/10.1016/j.coviro.2021.03.008)
Immune response scenario and vaccine development for SARS-CoV-2 infection (https://doi.org/10.1016/j.intimp.2021.107439)
Intracellular Routing and Recognition of Lipid-Based mRNA Nanoparticles (https://doi.org/10.3390/pharmaceutics13070945)
Lipid Nanoparticles as Carriers for Bioactive Delivery (https://doi.org/10.3389/fchem.2021.580118)
Lipid Nanoparticles: A Novel Approach for Brain Targeting (https://doi.org/10.2174/2211738506666180611100416)
Lipid Nanoparticle-Mediated Delivery of mRNA Therapeutics and Vaccines (https://doi.org/10.1016/j.molmed.2021.03.003)
Potential SARS-CoV-2 vaccines: Concept, progress, and challenges (https://doi.org/10.1016/j.intimp.2021.107622)
Recent advances in drug delivery applications of cubosomes, hexosomes, and solid lipid nanoparticles (https://doi.org/10.1016/j.apsb.2021.02.013)
SARS-CoV-2 RNA reverse-transcribed and integrated into the human genome (https://doi.org/10.1101/2020.12.12.422516)

Janssen is not spared as it contains polysorbate-80 which does not have the most reassuring SDS. Again, you can decide for yourself…

A Novel Formulation Based on 2,3-Di(tetradecyloxy)propan-1-amine Cationic Lipid Combined with Polysorbate 80 for Efficient Gene Delivery to the Retina (https://doi.org/10.1007/s11095-013-1271-5)
Biologic excipients: Importance of clinical awareness of inactive ingredients (https://doi.org/10.1371/journal.pone.0235076)
Cationic and anionic unloaded polymeric nanocapsules: Toxicological evaluation in rats shows low toxicity (https://doi.org/10.1016/j.biopha.2019.109014)
Complement activation associated with polysorbate 80 in beagle dogs (https://doi.org/10.1016/j.intimp.2012.10.021)
Considerations for the Use of Polysorbates in Biopharmaceuticals (https://doi.org/10.1007/s11095-018-2430-5)
COVID-19 Vaccine-associated Anaphylaxis and Allergic Reactions: Consensus Statements of the KAAACI Urticaria/Angioedema/Anaphylaxis Working Group (https://doi.org/10.4168/aair.2021.13.4.526)
Non‐IgE‐mediated hypersensitivity induced by multivitamins containing Tween‐80 (https://doi.org/10.1111/1440-1681.13089)
Reducing or Eliminating Polysorbate Induced Anaphylaxis and Unwanted Immunogenicity in Biotherapeutics (https://www.neurelis.com/sites/default/files/pdf/Reducing%20or%20Eliminating%20Polysorbate%20Induced%20Anaphylaxis%20and%20Unwanted%20Immunogenicity%20in%20Biotherapeutics.pdf)
Successful SARS-CoV-2 vaccine allergy risk-management: The experience of a large Italian University Hospital (https://doi.org/10.1016/j.waojou.2021.100541)
Surface-modified polycaprolactone nanoparticles for the brain-targeted delivery of nevirapine (https://doi.org/10.1007/s11051-020-04831-9)

At the very least, these investigational products are just that… under investigation. And, no, nobody should be allowed to coerce you with free food, cars, money, lottery, employment retention, or otherwise to be part of this gene therapy exercise and be totally free from liability. We have be here before and it was not pretty. More on that to come.

Shalom, light, and love…

Plandemic Perspective: Part III

**Originally posted on 06/13/2020**

Here comes another perspective. Y’all ready? We have now clearly outlined how masks are NOT SUPPORTED by scientific evidence. See my previous (lengthy) mask post. Select govt officials want “community encouragement” and PEER PRESSURE to drive these unhealthy actions. Police do not want involved for very good reasons. Have we considered the safety issues?I fully believe that masks are DANGEROUS and I’ll tell you why…

1) masks do not allow you to read facial expressions

2) masks degrade situational awareness

3) masks hinder lip-reading and inhibit communication

4) masks create fear and division

These are all recipes for a very dangerous social situation. If there is a violent event, it would be VERY DIFFICULT to identify perpetrators when every person is wearing a mask. If someone is running toward you with a mask, you cannot quickly differentiate scared from angry, confused, or happy. Any person that runs at you with a mask during a high-stress event will be treated as the enemy because the human body protects itself. And, it will always protect itself by erring on the side of caution!

Now imagine a mass casualty event. How are security persons, first responders, or fellow good samaritans supposed to identify who-is-who in a sea of masks?! They CANNOT. Anyone can quickly escape with a mask on, if everyone is wearing a mask! Or: Everyone will be treated like a suspect until cleared. I cannot imagine the trauma generated from a situation like that.

This is not the world you want. You just don’t. Why are we afraid to BREATHE around each other?! We are sending the message that we cannot even exist together. We no longer communicate a simple smile in passing. Have you felt how alienating it is to smile to masked people? I constantly feel judged, shamed, hated, and uncomfortable around masked people. Yet, I smile anyways. I can’t tell if you’re smiling back in your mask and your eyes only show me fear.

We have got to start thinking about the social repercussions of distancing and masking. Humans are SOCIAL beings and these demented recommendations are just that — RECOMMENDATIONS. Not laws, nor do you want them to become laws. YOU CAN SAY NO. NO IS AN ANSWER. I behoove you to stand up and flatten the fear!

Take off the masks, smile at your neighbor, and live in the world you want to see. Support your community health, feel safe using your face, and for goodness sake DON’T PUT THAT GARBAGE ON YOUR CHILD’S FACE.

*If you disagree, fine. Let’s talk or maybe you can simply exit stage left… ✌

Plandemic Perspective: Part II

**Originally posted on May 19, 2020**

I am getting exhausted trying to explain why all of these “recommendations” from govt agencies in regards to the use of cloth masks (and otherwise) are absolute GARBAGE. Foremost, adjusting your mask after touching surfaces exposes your face to whatever was on your hands. Cloth masks create a HUMID environment that is ideal for microbial growth. Cloth masks increase airway resistance and can lower oxygen levels. I cannot find studies nor reviews that are in support of using masks in community settings. Most studies are against using cloth masks. Surgical masks aren’t very impressive either.

Basically, EVERYONE NEEDS TO GET COMFORTABLE READING BEYOND HEADLINES. Look at the references of these sweeping “guidelines” and you will see that none of this is rooted in science. Absolutely. None. Of. It.

I am embarrassed for these ‘official’ agencies. We seriously went from being particular about donning and doffing PPE to teaching people how to cut a T-shirt to put over their face. 🤦🏻‍♀️

DOIs to available studies (copy and paste them onto search engines):

10.5603/CJ.a2020.0054
10.1016/S2213-2600(20)30134-X
10.1136/bmj.m143510.1136/bmj.m1422
10.1038/jes.2016.42
10.1136/bmjopen-2014-006577
10.1093/annhyg/meq044

**This portion originally posted May 20, 2020**

Stop hiding under the guise of “public health.” All you health professionals should be shouting from the rooftops about how cloth, t-shirt, scarf masking is overall risky and DOES NOT prevent viral transmission.

Let’s talk about REAL health and the importance of supporting your immune system with nutrition, hydration, and healthy interaction with your environment. Get outside and breathe some fresh air!

Are we going to fear the millions of viruses, bacteria, and fungi that could potentially cause us illness for the rest of our lives, or just this single variant? YOU ONLY HAVE NOW TO LIVE. I suggest you start.