If, for the first time we are going to rollout a vaccine and ask the whole world to take it, it better be nothing less than safe.
How safe does a vaccine have to be?
Let's start with the influenza vaccine, a vaccine which a large proportion of the population receives every year. During the 2020-2021 flu season, approximately 80 million Americans were vaccinated1. 165 deaths were reported2. This works out to a death rate of 0.21 deaths / 100,000 people. This is considered acceptable from a medical standpoint.
How do those figures compare to the COVID-19 vaccines?
By the beginning of 2023, approximately 268 million Americans had received at least one vaccination3. There were 34,746 reported deaths4. This works out to 7.71 deaths / 100k, a rate 37x higher than deaths reported from the influenza vaccine. Additionally, a temporal relationship exists between vaccination and death, with 50% of deaths reported within 48 hours of vaccination and 80% within a week4.
By December 2021, the total number of reported deaths associated with the COVID-19 vaccines was more than double the number of deaths associated with all other vaccines combined since the year 19905.
1 - https://www.cdc.gov/flu/fluvaxview/dashboard/vaccination-administered.html
2 - https://www.openvaers.com/openvaers
3 - https://ourworldindata.org/covid-vaccinations?country=USA
4 - https://openvaers.com/covid-data/mortality
5 - https://vaersanalysis.info/wp-content/uploads/2022/09/image3_09162022.png
The deaths, in both cases, were reported to the Vaccine Adverse Event Reporting System (VAERS). VAERS is a pharmacovigilance system meant to detect vaccine safety risk signals that were not discovered during the initial clinical trials. You'll hear two common arguments against the data in this system:
Comparing these AEs with other pharmacovigilance systems as well as other vaccines painted a similarly stark picture. V-Safe, whose data was purposely withheld until court order after Freedom of Information Act (FOIA) request1, is another pharmacovigilance system which urged participants to report symptoms. Comparing V-Safe reports to VAERS found 17 post-vaccination symptoms were actually under-reported by a factor (URF) of 61x. Of particular note were hospitalization and ER/ED visits which were both under-reported by 10x and 30x respectively2. Another report comparing adverse events to the more traditional influenza vaccine showed increased rates of serious adverse events (28x), death (91x), and myocardial infarction (126x)3.
Similar results were found in the UK VAERS-equivalent system Yellow Card4, with a report released in August 2021 concluding the following:
"An immediate halt to the vaccination program is required whilst a full and independent safety analysis is undertaken to investigate the full extent of the harms." - Dr. Tess Lawrie
Even the World Health Organization's (WHO) own VigiAccess database and the European Union's (EU) EudraVigilance database show the same results, with yet another report released in early 20225 concluding the following:
"There is sufficient evidence of adverse events relating to Covid-19 vaccines to indicate that a product recall is immediately necessary."
Other data sources have been analyzed as well, including the FDA's own Medicare health database, containing information on 25 million people aged 65+. The results conferred with previous observations, showing increased rates of pulmonary embolism (54%), acute myocardial infarction (42%), disseminated intravascular coagulation (91%), and immune thrombocytopenia (44%) compared to historic rates6.
Reported adverse events from pharmacovigilance systems around the world all agree that a clear safety signal exists and we knew about it as early as 2021. It is the responsibility of our public health agencies to investigate these correlations and determine if a causal relationship exists. Refusal to perform this function renders the entire purpose of pharmacovigilance useless7, and the FDA has been roundly critized for not following up on these potentially serious safety signals8. In the past, adverse events reported to VAERS alone were used to suspend the use of the rotavirus vaccine in infants9. For the COVID-19 vaccines, however, we've had to rely mostly on independent analysts for answers. In early 2021, an interim report found that the vaccine could not be ruled out in 86% of the first 250 deaths reported to VAERS10.
1 - https://www.icandecide.org/wp-content/uploads/2021/12/001-COMPLAINT-24.pdf
2 - https://vaersanalysis.info/2022/10/08/estimating-the-under-reporting-factor-urf-in-vaers-by-way-of-the-recently-released-v-safe-data
3 - https://drive.google.com/file/d/1IAzK4a58a7M4ajHKOpqe-9KD9PdYAVpr
4 - https://ebmcsquared.org/wp-content/uploads/2021/08/UpdatedReportYellowCardData_20210809.pdf
5 - https://worldcouncilforhealth.org/resources/covid-19-vaccine-pharmacovigilance-report
6 - https://www.sciencedirect.com/science/article/pii/S0264410X22014931
7 - https://www.cdc.gov/mmwr/preview/mmwrhtml/mm4843a5.htm
8 - https://www.bmj.com/content/379/bmj.o2527
9 - https://www.publichealthpolicyjournal.com/_files/ugd/adf864_4588b37931024c5d98e35a84acf8069a.pdf
10 - https://www.researchgate.net/publication/352837543_Analysis_of_COVID-19_vaccine_death_reports_from_the_Vaccine_Adverse_Events_Reporting_System_VAERS_Database_Interim_Results_and_Analysis
This is the first time in history that an mRNA vaccine has been deployed to the general public. Prior to COVID-19, only two clinical trials consisting of just 458 individuals had ever been inoculated with an mRNA vaccine1,2.
Like most vaccines, it was originally thought that the nanoparticles delivered by the mRNA vaccines would stay at the injection site. However, when this was tested in animal models it was found that the nanoparticles circulated throughout the body, concentrating in the adrenals, spleen, and ovaries to a small degree3,4 (p. 47). This aligns with previous research highlighting potential adverse effects of nanoparticles on the reproductive system5. Additionally, the CDC attest to the fact mRNA lasts just a few days in our bodies6. However, multiple studies have found that mRNA and the Spike protein that go along with it were detected in humans much longer than that7,8,9. One study, published August 2023, detected Spike in blood a staggering six months post-vaccination10.
By early 2023 studies had been published questioning the inherent safety of mRNA-based vaccines altogether. One such study concluded that the entire mRNA platform itself may be culpable11 for vaccine-related AEs. Another found that mRNA in vaccines can disrupt the function of MicroRNAs which can affect severity of disease once contracted, contribute to other longer-term diseases, influence cancer development, and suppress cancer-suppressor genes12.
1 - https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(17)31665-3/fulltext
2 - https://www.sciencedirect.com/science/article/pii/S0264410X19305626
3 - https://report24.news/wp-content/uploads/2021/06/pfizer_Study_pharmacokinetics.pdf
4 - https://www.ema.europa.eu/en/documents/assessment-report/spikevax-previously-covid-19-vaccine-moderna-epar-public-assessment-report_en.pdf
5 - https://www.dovepress.com/potential-adverse-effects-of-nanoparticles-on-the-reproductive-system-peer-reviewed-fulltext-article-IJN
6 - https://www.cdc.gov/coronavirus/2019-ncov/vaccines/different-vaccines/overview-COVID-19-vaccines.html#mrna
7 - https://www.cell.com/cell/fulltext/S0092-8674(22)00076-9
8 - https://onlinelibrary.wiley.com/doi/10.1111/apm.13294
9 - mdpi.com/2227-9059/10/7/1538/htm
10 - https://onlinelibrary.wiley.com/doi/full/10.1002/prca.202300048
11 - https://www.mdpi.com/2571-8800/6/2/17
12 - https://www.mdpi.com/1422-0067/24/2/1404
The CDC currently describes the Spike protein produced by all of the COVID-19 vaccines as "harmless"1 to humans despite overwhelming evidence to the contrary. The pathogenicity of the Spike protein is far reaching, from endothelial and thrombotic disorder2,3,4,5, to cellular damage and death6,7, to inhibition of DNA repair8, and even inflammation of the brain itself9 contributing to long-term neurological complications10.
The primary argument against this idea is that the Spike protein encoded by the vaccine is locked in it's S1 conformation, whereas the Spike in the wild virus is not. While true, the S1 protein alone has been shown to exhibit similar effects in the endothelium and brain11,12,13,14,15,16,17. As it relates to effects seen post-vaccination, one study found increased endothelial inflammation18 whereas another found spike antigen concentrations in the blood similar to that of acute infection19. Coincidentally, soluble Spike protein was found to be the cause of the severe thrombotic side effects in the vector-based COVID-19 vaccines20.
Several studies have since shown how the Spike protein in the vaccines is likely causing harm, calling for an abudance of caution21 and insist further study be an urgent and vital public health priority22.
Sadly, even prior to the roll-out of the mass vaccination campaign multiple studies had already cautioned against the use of the Spike protein23,24,25, citing uncertainty related to long-term safety.
1 - https://archive.cdc.gov/#/details?url=https://www.cdc.gov/coronavirus/2019-ncov/vaccines/different-vaccines/overview-COVID-19-vaccines.html
2 - https://www.frontiersin.org/articles/10.3389/fcvm.2021.687783
3 - https://academic.oup.com/eurheartj/article/42/Supplement_1/ehab724.3383/6391566
4 - https://journals.plos.org/plospathogens/article?id=10.1371/journal.ppat.1009128
5 - https://jhoonline.biomedcentral.com/articles/10.1186/s13045-020-00954-7
6 - https://europepmc.org/article/ppr/ppr232448
7 - https://www.nature.com/articles/s41375-021-01332-z
8 - https://www.mdpi.com/1999-4915/13/10/2056
9 - https://www.sciencedirect.com/science/article/pii/S096999612030406X
10 - https://www.biorxiv.org/content/10.1101/2023.04.04.535604v1.full
11 - https://www.mdpi.com/1999-4915/13/11/2209
12 - https://portlandpress.com/bioscirep/article/41/8/BSR20210611/229418/SARS-CoV-2-spike-protein-S1-induces-fibrin-ogen
13 - https://journals.physiology.org/doi/full/10.1152/ajplung.00223.2021
14 - https://www.biorxiv.org/content/10.1101/2021.06.20.448993v1
15 - https://www.nature.com/articles/s41593-020-00771-8
16 - https://www.sciencedirect.com/science/article/pii/S0006291X2100499X
17 - https://www.nature.com/articles/s41598-022-09410-7
18 - https://www.ahajournals.org/doi/abs/10.1161/circ.144.suppl_1.10712
19 - https://www.cell.com/cell/fulltext/S0092-8674(22)00076-9
20 - https://www.researchsquare.com/article/rs-558954/v1
21 - https://www.oncotarget.com/article/28088
22 - https://www.cell.com/trends/molecular-medicine/fulltext/S1471-4914(22)00103-4
23 - https://www.mdpi.com/2076-393X/9/1/36
24 - https://www.mdpi.com/1424-8220/21/17/5857/htm
25 - https://www.sciencedirect.com/science/article/pii/S1521661620304253
In late August 2021, clinical trial data from Moderna (and others) were reanalyzed revealing that 26.19% (3,985) of the 15,210 individuals in Moderna trial suffered a severe adverse event (SAE) within a month of vaccination. This was 322% higher compared to the control group (943)1. In September 2021, a 6-month follow-up of participants in the Pfizer trial was released. Data showed comparable rates of non-serious adverse events, but a marked increase in severe (+75%) and serious (+10%) adverse events, as well as death (+43%, 20 after unblinding) among the vaccinated group. Notably, four deaths were attributed to cardiac arrest in the vaccinated compared to just one in the placebo group2. Another study reanalyzing the clinical trial data found that the excess risk of SAE (12.5 per 10,000) exceeded the risk reduction of COVID-19 hospitalization in both Pfizer and Moderna trials (2.3 and 6.4 per 10,000)3.
Apart from the clinical trial data no other randomized controlled trial (RCT) exists. In fact, the clinical trials were actual unblinded (ie: control group all vaccinated) afer just six months, permanently leaving questions about long-term safety unanswered4. Despite this, many studies have attempted to answer this question on their own. One such study analyzed data from 128 countries and found an increase in both COVID-19 related cases and death due directly to the vaccine5. Another analyses of 31 countries showed all-cause mortality increased more the higher the vaccination uptake6. Other studies found 5 to 10 percent increased mortalities in Japan and Germany7, 14% in Australia8, following the roll out of the vaccine but not COVID-19 itself. In a further effort to corroborate eixsting evidence, one study went as far as to review 325 autopsy cases related to COVID-19 vaccination. Their results showed the cause of death was consistent with known vaccine AEs and concluded high likelihood of a causal link between COVID-19 vaccines and death9.
The data which exists on the safety of booster shots offers up equally dismaying results. Two studies showed prior COVID-19 infection was associated with a higher risk of adverse event post-vaccination10,11. In fact, one study comparing veterans showed a higher hospitalization rate the more doses they had received12.
1 - https://www.scivisionpub.com/pdfs/us-covid19-vaccines-proven-to-cause-more-harm-than-good-based-on-pivotal-clinical-trial-data-analyzed-using-the-proper-scientific--1811.pdf
2 - https://www.nejm.org/doi/10.1056/NEJMoa2110345
3 - https://www.sciencedirect.com/science/article/pii/S0264410X22010283
4 - https://www.bmj.com/content/373/bmj.n1244
5 - https://vector-news.github.io/editorials/CausalAnalysisReport_html.html
6 - https://www.preprints.org/manuscript/202302.0350/v1
7 - https://journals.sciencexcel.com/index.php/mcs/article/view/411/413
8 - https://www.researchgate.net/publication/366445769_Probable_causal_association_between_Australia%27s_new_regime_of_high_all-cause_mortality_and_its_COVID-19_vaccine_rollout
9 - https://zenodo.org/record/8120771
10 - https://www.journalofinfection.com/article/S0163-4453(21)00277-2/fulltext
11 - https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2794464
12 - https://academic.oup.com/jid/advance-article/doi/10.1093/infdis/jiad195/7187858
Of all the adverse events, myo/pericarditis remains the most widely discussed to date. You've probably heard that post-vaccination myocarditis is both rare and mild, the science tells a different story:
Many justify the risk by claiming that rates of myo/pericarditis are higher still after infection than vaccination, however, a study of 200,000 found no difference between the background rate of myocarditis in uninfected compared to those recovering from a COVID-19 infection10. Moreover, myocarditis was 2-6x more prevalent in males aged 16-24 after vaccination compared to COVID-19 infection6. Similar findings were observed in men up to the age of 40, with myocarditis 3-6x more prevalent after vaccination than infection6, 7.
In terms of severity, several papers have demonstrated the seriousness and long-term impact of this adverse event for males aged 12-29. Firstly, approximately 96% (784/813) of cases required hospitalization12. One case study showed the potential for myocardial fibrosis in 100% (13/13) of patients13. Another showed late gadolinium enhancement (LGE), a predictor of cardiovascular death, in 69% (11/16) of patients at 3-8 months follow-up14. Another showed 26% (104/393) of individuals recovered were on myocarditis medication, cardiac abnormalities were found in 54% (81/151), and 32% (125/393) were not cleared for physical activity at 90-day follow-up15. Additionally, those hospitalized with myo/pericarditis are told to refrain from competitive athletics and other vigorous exercise for at least 6 months16. More dramatically still are the results of a paper out of Florida, which found an 84% increase in the relative incidence of cardiac-related death among males 18-39 years old within 28 days following mRNA vaccination17.
Other studies have acknowledged the true long-term risk is unknown and requires more study18,19,20. One pre-pandemic study of short/long-term outcomes of myocarditis showed an indicator of heart function (ejection fraction) did not recover to normal levels in 50% (99/210) of patients at two year follow-up21. From a regulatory perspective, post-marketing surveillance should have caught this safety signal a long time ago but the FDA has stated that existing pharmacovigilance systems are insufficient to assess these serious risks22. The risk of this adverse event is made even greater by the fact that we simply don't know what is causing it or why it affects young males disproportionately more than other groups. Such is the risk that a pre-eminent cardiologist published a paper calling for a global suspension of the mRNA vaccines23.
Never before in medical history has a product so tightly related to severe reactions and death remained on the market and had its use advocated for by trusted public health officials, than the COVID-19 vaccines.
1 - https://academic.oup.com/cid/article/75/4/673/6445179
2 - https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2793551
3 - https://onlinelibrary.wiley.com/doi/10.1002/pds.5439
4 - https://www.fda.gov/media/150054/download
5 - https://onlinelibrary.wiley.com/doi/10.1111/eci.13759
6 - https://jamanetwork.com/journals/jamacardiology/fullarticle/2791253
7 - https://www.ahajournals.org/doi/10.1161/CIRCULATIONAHA.122.059970
8 - https://www.mdpi.com/2414-6366/7/8/196
9 - https://www.nature.com/articles/s41467-022-31401-5
10 - https://academic.oup.com/cid/article/74/11/1933/6353927
11 - https://www.mdpi.com/2077-0383/11/8/2219
12 - https://jamanetwork.com/journals/jama/fullarticle/2788346
13 - https://www.jpeds.com/article/S0022-3476(21)00665-X/fulltext
14 - https://www.jpeds.com/article/S0022-3476(22)00282-7/fulltext
15 - https://www.thelancet.com/journals/lanchi/article/PIIS2352-4642(22)00244-9/fulltext
16 - https://www.ahajournals.org/doi/10.1161/CIRCULATIONAHA.113.001372
17 - https://floridahealthcovid19.gov/wp-content/uploads/2022/10/20221007-guidance-mrna-covid19-vaccines-analysis.pdf
18 - https://jamanetwork.com/journals/jamacardiology/fullarticle/2783052
19 - https://www.nejm.org/doi/10.1056/NEJMoa2110475
20 - https://publications.aap.org/pediatrics/article/148/5/e2021053427/181357
21 - https://www.ahajournals.org/doi/full/10.1161/CIRCRESAHA.118.313578
22 - https://www.fda.gov/media/151710/download
23 - https://insulinresistance.org/index.php/jir/article/view/71/221
Sadly, significant safety concerns just don't seem to end.
1 - https://www.vox.com/21454359/fauci-rand-paul-covid-19-vaccine-trust-cdc-fda
2 - https://www.icandecide.org/wp-content/uploads/2020/10/Conflicted-Members-on-DSMBs-for-COVID-19-Vaccines-Final.pdf
3 - https://www.bmj.com/content/375/bmj.n2635
4 - https://cdn.locals.com/documents/47656/47656_e41yu6vd2x117dq.pdf
5 - https://www.bmj.com/content/379/bmj.o2628
6 - https://www.ema.europa.eu/en/documents/rmp-summary/comirnaty-epar-risk-management-plan_en.pdf
7 - https://www.ema.europa.eu/en/documents/assessment-report/spikevax-previously-covid-19-vaccine-moderna-epar-public-assessment-report_en.pdf
8 - https://www.spectator.co.uk/article/The-Covid-vaccines-may-affect-periods.-Are-we-allowed-to-talk-about-this
9 - https://cf5e727d-d02d-4d71-89ff-9fe2d3ad957f.filesusr.com/ugd/adf864_2bd97450072f4364a65e5cf1d7384dd4.pdf
10 - https://www.saveusnow.org.uk/covid-vaccine-scientific-proof-lethal
When Pfizer reported the results of its clinical trials efficacy of the vaccine was said to be 95%1 against the original Wuhan strain. What exactly does that mean and how it is calculated?
Essentially, the infection risk of the placebo group was 162/18,325 (0.88%) and the infection risk of the vaccinated group was 8/18,196 (0.044%). Notably, both groups' had a less than 1% risk of infection. The efficacy in this case refers to the relative risk reduction, which is calculated as the percentage reduction in infection risk between groups. The efficacy of the Moderna vaccine was calculated similarly.
Another important figure to consider is absolute risk reduction. It is calculated by subtracting the percentage of positive cases in the vaccinated group from the placebo group. In this case, 0.88% - 0.044% = 0.84%2 (ie: the placebo group only had a 0.84% higher chance of infection compared to the vaccinated group). Much less impressive than touting 95% effectiveness, this figure is vital to properly evaluate overall vaccine effectiveness but was not provided in data to the FDA3.
1 - https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-conclude-phase-3-study-covid-19-vaccine
2 - https://www.thelancet.com/journals/lanmic/article/PIIS2666-5247(21)00069-0/fulltext
3 - https://www.mdpi.com/1648-9144/57/3/199/htm
Before we continue, it is important to start by saying the risk of contracting the disease, hospitalization, and death is heavily influenced by age group.
Case Fatality Rate is defined as the proportion of death because of a specific disease among those diagnosed with it. As we can see by the chart on the right, CFR for COVID-19 is quite low for those under 50 but takes a dramatic jump upwards for each group above 501.
CFR is sometimes criticized as it only counts confirmed cases. The infection fatality rate uses seroprevalence (antibody) data collected from around the world and is generally considered a far more accurate measure of the severity of a virus2,3,4. In a follow-up study to IFR originally published by the WHO5, data from 50 countries suggested an average global IFR as low as ~0.15%6. In other words, COVID-19 for all age groups has a survival rate of 99.85%.
Data from the CDC corroborates this research, showing a 25x risk of death for those aged 50-64, 60x for those aged 65-74, and 140x for those aged 75-847, when compared to the reference 18-29 age group.
1 - https://ourworldindata.org/mortality-risk-covid?#case-fatality-rate-of-covid-19-by-age
2 - https://www.nature.com/articles/s41586-020-2918-0
3 - https://www.bmj.com/content/371/bmj.m4509
4 - https://link.springer.com/article/10.1007/s10654-020-00698-1
5 - https://www.who.int/bulletin/online_first/BLT.20.265892.pdf
6 - https://onlinelibrary.wiley.com/doi/10.1111/eci.13554
7 - https://www.cdc.gov/coronavirus/2019-ncov/covid-data/investigations-discovery/hospitalization-death-by-age.html
A big question at the beginning of the pandemic was whether vaccinating could protect others. This argument was used as a justification for vaccine mandates even as data was published showing the vaccines are as ineffective as they are unsafe.
As soon as the first major variant, Delta, overtook the original Wuhan strain studies were already showing substantial declines in vaccine effectiveness less than six months post-vaccination2,3,4,5,6,7,8,9,10,11. After the emergence of the Omicron variant, studies showed protection waned even more quickly. Vaccine effectiveness against Omicron declines to less than ~20% 2-3 months12,13,14,15,16 post-vaccination. Subsequent doses of vaccine (3+) fared no better, showing similarly rapid decreases in efficacy17, 18 and effectiveness19,20,21. Around a similar timeframe, Omicron-targeting (BA.4/BA.5) bivalent vaccines were authorized under emergency use. Studies quickly showed these new vaccines were neither more effective than the original vaccines22,23, but also were not effective against circulating variants (XBB.1, BA.2.75.2, BQ.1.1) at the time24,25,26.
Another question had to do with whether or not vaccination reduced overall viral load. Data showed that once infected with Delta the viral load was similar regardless of vaccination status27,28,29, with fully vaccinated individuals capable of efficiently transmitting infection30. Another study found that boosted individuals were 3x more likely than unvaccinated to shed live virus after 10 days31. In one study which looked at data from 68 countries, no meaningful relationship between percentage of the population fully vaccinated and new COVID-19 cases could be found32.
As you read this keep in mind that the FDA's own guidelines state that the efficacy of COVID-19 vaccines must be at least 50%33 (p. 17).
1 - https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)01290-3/fulltext
2 - https://www.ejinme.com/article/S0953-6205(21)00271-5/fulltext
3 - https://www.naturalnews.com/files/Salus_Humetrix_VE_study_2021_09_28.pdf
4 - https://www.science.org/doi/10.1126/science.abl9551
5 - https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3949410
6 - https://www.science.org/doi/10.1126/science.abm0620
7 - https://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2821%2902183-8
8 - https://www.medrxiv.org/content/10.1101/2021.08.06.21261707v3
9 - https://www.nejm.org/doi/full/10.1056/NEJMoa2114114
10 - https://www.cell.com/med/fulltext/S2666-6340(21)00406-2
11 - https://www.mdpi.com/2076-393X/10/1/64
12 - https://www.nature.com/articles/s41591-022-01753-y
13 - https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2792295
14 - https://www.science.org/doi/10.1126/science.abq1841
15 - https://www.nejm.org/doi/full/10.1056/NEJMoa2210058
16 - https://link.springer.com/article/10.1007/s10654-021-00808-7
17 - https://www.nejm.org/doi/full/10.1056/NEJMoa2201570
18 - https://www.nejm.org/doi/10.1056/NEJMc2202542
19 - https://www.bmj.com/content/377/bmj-2022-071113
20 - https://www.nejm.org/doi/full/10.1056/NEJMc2211283
21 - https://www.sciencedirect.com/science/article/pii/S0264410X23003158
22 - https://www.thelancet.com/journals/laninf/article/PIIS1473-3099(23)00181-0/fulltext
23 - https://www.biorxiv.org/content/10.1101/2022.10.22.513349v1
24 - https://www.nature.com/articles/s41591-022-02162-x
25 - https://www.cell.com/cell/fulltext/S0092-8674(22)01531-8
26 - https://www.nature.com/articles/s41591-022-02162-x
27 - https://academic.oup.com/ofid/article/9/5/ofac135/6550312
28 - https://journals.plos.org/plospathogens/article?id=10.1371/journal.ppat.1010876
29 - https://linkinghub.elsevier.com/retrieve/pii/S0264410X2201458X
30 - https://www.thelancet.com/journals/laninf/article/PIIS1473-3099(21)00648-4
31 - https://www.nejm.org/doi/full/10.1056/NEJMc2202092
32 - https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2796615
33 - https://www.fda.gov/media/139638/download
To deflect from neglible protection against symptomatic disease, the benefit of vaccination has now shifted to protection against severe disease. However, even this is disputed, with one study concluding the very claim itself lacked empiric evidence1. Other studies have shown protection against hospitalization from the original, monovalent vaccines (2/3 dose) declined to ~30% after 4-5 months2,3, whereas protection from natural immunity remained as high as ~60% after 10 months3. Even the CDC's own data showed protection against hospitalization declined to 21% just 4 months after bivalent vaccination4.
On the topic of natural immunity, you've probably heard it compared to the immunity gained from vaccination. Let's be very clear: natural immunity has always been the gold standard in immunity. COVID-19 is no different. As early as October 2021, over 160 studies had already shown natural infection leads to a robust, long-lived immune memory, and that those with natural immunity were unlikely to benefit from vaccination5. Yet despite the extent of the evidence the CDC continues to misinform the public as a matter of national policy, using just a single study to proclaim vaccination indeed offers better protection than natural immunity6.
From here, the data on effectiveness becomes highly concerning. In late 2022, a study showed that vaccine effectiveness actually became negative, meaning that vaccinated individuals had higher rates of infection than unvaccinated7. Other studies have confirmed these findings, demonstrating rates of infection were similar to or higher than unvaccinated 5-6 months post-vaccination8,9. Even more studies have shown that the risk of contracting COVID-19 goes up with each vaccination received11,12
The burning question became: How could a vaccine possibly cause those who took it to become more likely to become infected than those that didn't? By early 2023, answers started to emerge. Two studies had discovered that the immune systems of individuals who had previously received two or more vaccines had undergone a dramatic shift. Specifically, they showed that the neutralizing IgG1/3 antibodies were being replaced by non-neutralizing, tolerant IgG412,13. A further study, released in August 2023, showed that after the immune response after the third dose was made up of ~40% IgG4 antibodies14. The repercussions of such a change in the immune response to COVID-19 cannot be understated. IgG4 antibodies prevent elimination of the virus, leading to persistent and chronic infection15. High levels of IgG4 is a predictor of COVID-19 mortality16. Additionally, high levels of IgG4 can also lead to auto-immunity, autoimmune myocarditis, and promote cancer growth17.
1 - https://www.jpands.org/vol28no1/ophir.pdf
2 - https://www.nejm.org/doi/full/10.1056/NEJMc2210093
3 - https://www.medrxiv.org/content/10.1101/2023.01.18.23284739v1
4 - https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2023-09-12/05-COVID-Link-Gelles-508.pdf
5 - https://brownstone.org/articles/research-studies-affirm-naturally-acquired-immunity
6 - https://www.cdc.gov/media/releases/2021/s0806-vaccination-protection.html
7 - https://www.medrxiv.org/content/10.1101/2022.06.28.22276926v4
8 - https://www.bmj.com/content/378/bmj-2022-071249
9 - https://www.nature.com/articles/s41467-023-35815-7
10 - https://academic.oup.com/ofid/article/10/6/ofad209/7131292
11 - https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2794886
12 - https://www.science.org/doi/10.1126/sciimmunol.ade2798
13 - https://www.frontiersin.org/articles/10.3389/fimmu.2022.1020844/full
14 - https://www.nature.com/articles/s41598-023-40103-x
15 - https://www.mdpi.com/2218-273X/13/9/1338
16 - https://www.ejinme.com/article/S0953-6205(21)00312-5/fulltext
17 - https://www.mdpi.com/2076-393X/11/5/991
By March 2020, the WHO, NIH, and CDC had not provided any guidance to clinicians on how to treat the disease. Instead of treatment, we became conditioned to wear a mask, wait in isolation, and be saved by the vaccine.
Due to this lack of guidance, a collaboration of almost 60 doctors from around the world culminated in the world's first multi-drug, early treatment protocol for COVID-191.
One drug included in that treatment protocol was hydroxychloroquine. Data from nine studies found hydroxychloroquine-based multi-drug regimens were associated with a 60% reduction in mortality in nursing homes2. Another study found that when this multi-drug regimen was used in early treatment, hospitalizations were reduced by 85% and deaths by 75%3.
Even now, our health institutions have no plans for large-scale trials in the use of any of the drugs within the multi-drug treatment protocol. Medical experts have no choice but to act on clinical judgment supported by their understanding of pathophysiology and the totality of the evidence concerning therapy4.
1 - https://rcm.imrpress.com/article/2020/2153-8174/RCM2020264.shtml
2 - https://www.sciencedirect.com/science/article/pii/S0306987721001419
3 - https://www.imrpress.com/journal/RCM/21/4/10.31083/j.rcm.2020.04.260
4 - https://www.amjmed.com/article/S0002-9343(21)00084-X/fulltext
As a result of the failure of our public health agencies, many early treatment groups have sprung up all over the world.
Front Line COVID-19 Critical Care Alliance
Formed by leading critical care specialists in March 2020, at the beginning of the Coronavirus pandemic, the ‘Front Line COVID-19 Critical Care Alliance’ is now a 501(c)(3) non-profit organization dedicated to developing highly effective treatment protocols to prevent the transmission of COVID-19 and to improve the outcomes for patients ill with the disease.
Canadian Covid Care Alliance
Our alliance of independent Canadian doctors, scientists and health care practitioners is committed to providing top-quality and balanced evidence-based information to the Canadian public about COVID-19 so that hospitalizations can be reduced, lives saved, and our country safely restored as quickly as possible.
Association of American Physicians and Surgeons
A non-partisan professional association of physicians in all types of practices and specialties across the country. Since 1943, AAPS has been dedicated to the highest ethical standards of the Oath of Hippocrates and to preserving the sanctity of the patient-physician relationship and the practice of private medicine.
British Ivermectin Recommendation Development Group
A truly grassroots initiative bringing together clinicians, health researchers and patient representatives from all around the world to advocate for the use of Ivermectin against COVID-19.
Truth For Health Foundation
A physician-founded 501(c)3 public charitable foundation created to provide truthful, balanced, medically sound, research-based information and cutting edge updates on prevention and treatment of common medical conditions, including COVID-19.
Terapia Domiciliare
An informal group of citizens and doctors born to provide support to citizens during the COVID-19 emergency, to exchange clinical information and develop a home care protocol in the absence of specific directives.
Covid Medical Network
A group of Australian senior medical doctors and health professionals concerned with the health impacts of lockdowns, as well as the lack of good information available to the general public in regards to COVID-19.
On the topic of treatment, one drug stands out from the rest in the amount of censorship and resistance it has encountered, Ivermectin.
Ivermectin was discovered in 1975 and its inventors won a Nobel Prize for it in 2015. It is on the WHO's "List of Essential Medicines" and over 3.7 billion doses have been distributed since 1987. Since its development 40 years ago it has made historic impacts on global health by eradicating pandemics of parasitic diseases across multiple continents. It's track record is so strong at eradicating diseases and being used in new ways that it is often referred to as a "wonder" drug1.
Regarding the totality of the evidence, from in-vitro, in-vivo, in-silico, pharmacologic, clinical observations, observational controlled trials, meta-analyses of randomized controlled trials, to epidemiological studies, have all shown benefit in regards to the treatment of COVID-192.
As of March 2022, there have been 79 studies regarding the treatment and prophylaxis of COVID-19 with Ivermectin from 766 scientists with 85,814 patients. Overall, these studies have shown statistically significant improvements in mortality, hospitalization, recovery, cases, and viral clearance3. Ivermectin is currently being used as a treatment for COVID-19 widely in 18 countries around the world4.
1 - https://www.jstage.jst.go.jp/article/pjab/87/2/87_2_13/_article
2 - https://covid19criticalcare.com/wp-content/uploads/2021/08/SUMMARY-OF-THE-EVIDENCE-BASE-FINAL.pdf
3 - https://ivmmeta.com/#fig_fpall
4 - https://ivmstatus.com/
In May 2021, the Indian Bar Association sued the World Health Organization for deliberately suppressing data regarding effectiveness of the drug Ivermectin, with an intent to dissuade the people of India from using it1. Despite overwhelming scientific evidence of its effectiveness at treating COVID-19, the current stance of the WHO is that it should only be used in clinical trials2. On platforms such as Youtube, your content will be removed if it recommends the use of the drug, regardless of your credentials3. In late August 2021, a press conference by the chairman of the Tokyo Medical Association recommending the use of Ivermectin was deleted from Youtube4.
Still today, early treatment protocols are roundly criticized and blanketed as "not effective" or "unproven". Yet, doctors from all around the world are fighting just to be able to use them. The reasons as to why such vehement opposition to these protocols exist are not obvious, but calling into question whether conflicts of interest play a role would not be unreasonable. Pharmaceutical companies such as Pfizer and Moderna stand to profit almost $50 billion dollars from the sale of vaccines5, however, the authorization of those vaccines is predicated on the basis that no other effective treatments exist6 (p. 3).
If a cheap, generic drug like Ivermectin were to be recognized as an effective treatment for COVID-19, it would jeopardize the rollout of the vaccine program. Simply put, it would cost the pharmaceutical companies too much money7. Medicine has become politicized. Ask yourself why, in a global pandemic, our governmental agencies hold more power than our medical experts? While the list of crimes committed by authorities during the COVID-19 pandemic is a long one, perhaps the biggest crime of all is the purposeful suppression of safe and effective treatments8, and the many thousands of human lives that have been lost as a result.
1 - https://indianbarassociation.in/wp-content/uploads/2021/05/IBA-PRESS-RELEASE-MAY-26-2021.pdf
2 - https://app.magicapp.org/#/guideline/nBkO1E/section/LAQX7L
3 - https://support.google.com/youtube/answer/9891785
4 - https://halturnerradioshow.com/index.php/en/news-page/world/breaking-news-chairman-of-tokyo-medical-association-tells-doctors-to-prescribe-ivermectin-for-covid-treatment
5 - https://www.reuters.com/breakingviews/booster-jabs-are-easy-money-pfizer-moderna-2021-08-13/
6 - https://www.fda.gov/media/144412/download
7 - https://www.biznews.com/thought-leaders/2021/05/12/mailbox-ivermectin
8 - https://www.lifesitenews.com/opinion/the-biggest-crime-committed-during-the-vaccine-heist-is-the-censorship-of-ivermectin/
If you are getting this information for the first time, you must ask yourself why. How could it be that such important information does not see the light of day? A large part of the answer lies within the "Trusted News Initiative", created on December 10th, 20201.
It was a partnership between the corporate media (CNN, CNBC, ABC, etc) as well as social media and local media whose goal was to produce, solely, information promoting vaccines and the use of vaccines.
It is unknown whether this initiative was created in good faith but it's proliferation led to the suppression of all dissenting opinions, including those of medical experts around the world, regarding vaccine safety and early treatment programs.
Now, we only ever hear one story on the vaccine: It's good for you, take it. This initiative created a single, indestructible narrative. Anything that comes out counter to this narrative, even if it comes from medical experts, is quickly and systematically dismissed as "misinformation".
1 - https://www.bbc.com/mediacentre/2020/trusted-news-initiative-vaccine-disinformation
Doctors all around the world doctors have been chastised, suspended, and even jailed for using simple medications in an attempt to reduce hospitalization and mortality in their patients.
In Australia, if a doctor prescribes an outpatient medicine, hydroxychloroquine, that doctor could face imprisonment1. France followed suit by banning it's use outright2. In the Philippines, prescribing Ivermectin could result in prosecution3. In September 2021, Australia banned medical practitioners from prescribing Ivermectin altogether4.
These drugs, and others, are now included in early patient treatment protocols5 that are being used effectively6 around the world.
Ask yourself, when have doctors ever faced imprisonment for trying to help patients? Medicine is an art and a science, it takes judgement. Ask yourself why, in the middle of a global pandemic, we are not taking the opinions of the experts in their field seriously.
1 - https://www.health.qld.gov.au/system-governance/legislation/cho-public-health-directions-under-expanded-public-health-act-powers/prescribing-dispensing-or-supply-of-hydroxychloroquine-direction
2 - https://www.leparisien.fr/societe/l-hydroxychloroquine-n-est-plus-autorisee-en-france-contre-le-covid-19-27-05-2020-8324493.php
3 - https://newsinfo.inquirer.net/1426194/pma-warns-doctors-do-not-prescribe-ivermectin-outside-permitted-hospitals-or-face-prosecution
4 - https://www.theguardian.com/australia-news/2021/sep/10/australian-drug-regulator-bans-ivermectin-as-covid-treatment-after-sharp-rise-in-prescriptions
5 - https://www.amjmed.com/article/S0002-9343(20)30673-2/fulltext
6 - https://www.imrpress.com/journal/RCM/21/4/10.31083/j.rcm.2020.04.260
The COVID-19 pandemic has been a global disaster. Despite contagion control efforts, we continue to see poor outcomes for hospitalization and death. The pre-hospital phase is the time for therapeutic intervention. Early treatment with a multi-drug protocol has been shown highly effective in reducing hospitalization and death.
The vaccines are not as safe as we were assured they would beb>. From the fact this is the first time mRNA vaccines have been used en masse in humans, to the unprecedented number of reported adverse reactions and deaths, to the many ways the S-protein exhibits toxic effects in humans.
The vaccines are not as effective as we were assured they would be. From initial estimates of vaccine efficacy of 95%, effectiveness against symptomatic infection has dwindled down to as low as 30%. It is now clear that "booster" shots may be needed indefinitely. Multiple outbreaks of COVID-19 have produced cases predominantly in the fully vaccinated. Many governments around the world still do not recognize immunity from natural infection.
Yet, governments around the world insist on pushing forward these vaccines. Governments around the world continue to suppress and censor effective treatment protocols that our medical experts have been using and collaborating on since the beginning of the pandemic. Governments around the world continue to push forward with vaccination passports. Governments around the world press on with "booster" shots, despite a profound lack of adequate long-term safety data and the effect vaccines themselves have on the evolutionary pressure of the virus.
The Nuremberg Code are a set of research ethics principles created as a result of human experimentation by Nazi doctors during World War II. The principle of autonomy states: No one, under any circumstances, will have anything forced into their body under any form of pressure, coercion, of threat of reprisal. Yet, we are being pressured, we are being coerced, and we are being threatened.
We need to start demanding the truth.