Vaccine Adverse Events Reporting System, USA

UPDATED: 946,461 Reports Through December 3, 2021

What is VAERS?

Established in 1990, the Vaccine Adverse Event Reporting System (VAERS) is a national early warning system to detect possible safety problems in U.S.-licensed vaccines. VAERS is co-managed by the Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA). VAERS accepts and analyzes reports of adverse events (possible side effects) after a person has received a vaccination. Anyone can report an adverse event to VAERS. Healthcare professionals are required to report certain adverse events and vaccine manufacturers are required to report all adverse events that come to their attention.

VAERS is a passive reporting system, meaning it relies on individuals to send in reports of their experiences to CDC and FDA. VAERS is not designed to determine if a vaccine caused a health problem, but is especially useful for detecting unusual or unexpected patterns of adverse event reporting that might indicate a possible safety problem with a vaccine. This way, VAERS can provide CDC and FDA with valuable information that additional work and evaluation is necessary to further assess a possible safety concern.

Related: Australian Covid Vaccine Data

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No Vaccine Data for Pregnancy

Thrombosis Out of the Blue

Thousands of Adverse Reactions

Vaccine Manufacturers Indemnified

Don’t Tell the Public

Texas Senate Committee Throws Out Mandatory COVID Vaccination

Professor Dolores Cahill Discusses Covid Vaccination Effects

Canada: Moderna Vaccine Wrecks Havoc on Lytton BC

The post US Vaccine Adverse Event Reporting System (VAERS) COVID Vaccine Data appeared first on The Truth About Covid Vaccines.

Source: Hansard

[This post contains video, click to play]

Mr CRAIG KELLY (Hughes) (10:24): I move:

That this bill be now read a second time.

Firstly, I’d like to thank Carston, the truck driver who drove me to Parliament House this morning. God bless the truck drivers of Australia. I dedicate this bill to them.

Fifty-eight years ago, when I was born, I won one of the greatest lotteries in life because I was born in the free and democratic nation of Australia. I was bestowed, as my birthright, as an Australian, freedoms and liberties that have only ever been enjoyed by a small percentage of people throughout human history. Those freedoms that were my birthright did not come for free. They were fought for and won in places with names such as Beersheba, Fromelles, Pozieres, Bullecourt, the Coral Sea, Tobruk, Kapyong, Long Tan and thousands of others.

As politicians, we are reminded every single day when we come to this place. We look out the main entrance and we see in perfect alignment across Old Parliament House, across Lake Burley Griffin, up Anzac Parade and to the War Memorial. It’s a reminder that the freedoms and liberties that we enjoy have been won by the sacrifices of over 100,000 Australians who have given their lives in war to protect and safeguard those freedoms.

One of the great things about our nation is that we have extended those freedoms to others that have come across the seas. So when someone is a new migrant and decides to take an oath of citizenship and declare their allegiance to our country, they obtain the same birthrights that I have as an Australian—the same freedoms and liberties. As a nation, we work hard to bring those same freedoms and liberties that are the birthrights of every single Australian to others around the world. We participate in and we sign and commit to international treaties such as the Universal Declaration of Bioethics and Human Rights.

Article 6.1 of this treaty, to which Australia is a signatory, provides:

Any preventive, diagnostic and therapeutic medical intervention is only to be carried out with the prior, free and informed consent of the person concerned, based on adequate information. The consent should, where appropriate, be express and may be withdrawn by the person concerned at any time and for any reason without disadvantage or prejudice.

That is what we as a nation have signed up to in an international treaty, yet we find here in 2021 that the freedoms and the birthrights of Australians have been stolen—stolen mostly by unelected bureaucrats and cowardly politicians that are violating human rights and that are violating the principles of the Universal Declaration of Bioethics and Human Rights.

Let’s be absolutely clear about this: New South Wales Premier Berejiklian and health minister Hazzard, with New South Wales parliament suspended, are engaging in conduct which is a violation and abuse of human rights.

The coercion and the bullying of Australians to undergo any type of medical intervention is a violation of human rights in a violation of the principles of Australia’s international human rights obligations. Domestic passports are a violation of human rights, and yet we stand here in this parliament today with medical apartheid being enforced across the nation.

‘Submit or you will never get your freedoms back. You will be excluded from society, denied the freedom to travel, denied access to our beaches, denied access to our national parks.’ This should outrage every single one of us. ‘Also, you’ll be prevented from opening your business. We will deny you the freedom to earn a living. You will lose your job. You will lose your family home, unless you submit to taking a medical intervention.’ This is something that we have fought against. This is something against the Anzac spirit. What is wrong with you people? And this is from a party in New South Wales that on their website boasts that they supposedly believe ‘in the inalienable rights and freedoms of all people’? What a fraud!

This statement is a fraud upon the electorate of Australia, a betrayal of Liberal Party values and a betrayal of everything it means to be an Australian.

Shame on you, Berejiklian. Shame on you, Hazzard. Shame on you, Palaszczuk, Shame on you, Andrews. Shame on the lot of you.

When you use threats of inflicting disadvantage or inflicting prejudice on Australians because they don’t submit to your demands for medical intervention, you are engaging in abuses of human rights. History will condemn you for eternity as violators of human rights. Shame on every member of this House that cowardly hides under their desk and refuses to speak up to defend the freedoms and liberties of Australians.

Some may argue it’s okay to abuse human rights in these circumstances. That appears to be the formal position of the Liberal Party, the Labor Party, the Nationals and the Greens. Firstly, this position relies on the Doherty modelling; however, this modelling is fundamentally flawed. It uses assumptions that are both out of date and erroneous. Just look at the data out of Israel, and it will show you that the Doherty modelling’s assumptions are dodgy at the best. Remember, we’re not just talking about any old medical intervention; we are talking about a medical intervention that has zero long-term safety data. If you don’t believe me, I will quote directly from the TGA’s recent report, dated July 2021. I go to page 30 of 37. It talks about Pfizer’s application, and it says:

… the submitted data have the following limitations: The long-term efficacy and safety is not known.

But it’s even worse than that. It goes on. They admit here:

The VE—

which is the vaccine efficacy—

against variants of concern—

which of course would be delta—

has not been assessed.

These are the TGA’s own documents. This means it hasn’t been assessed against delta, and we have no idea what the long-term safety data is. And yet we are mandating this upon millions of Australians and forcing them with the threat that they will lose their jobs, they’ll be unable to put food on the table for their family and they won’t be able to pay their mortgage. What is wrong with you people? Seriously! It even gets worse.

Therefore, the purpose of this bill is to incorporate the Universal Declaration on Bioethics and Human Rights into Australian law, to hold those that violate and abuse human rights to account, and to bring them to justice. I commend this bill to the House, and I call on the government to urgently bring it up for debate and for a vote and let history record where every member of this parliament sits on this issue.

The SPEAKER: Is the motion seconded?

Mr Christensen: The motion is seconded.

Worse Than the Disease? Reviewing Some Possible Unintended Consequences of the mRNA Vaccines Against COVID-19

Powerful Sydney Freedom Day PROTEST VIDEO

Data from Israel shows very high number of COVID-19 cases in double jabbed. Vaccines not stopping transmission.

Independent Lab Tests Reveal At Least 62% of mRNA Vaccine Recipients Are Experiencing Capillary Clotting: Canada

The post CRAIG KELLY – Bill to Parliament: No Requirement for Medical Treatment (Including Experimental Injections) Without Consent appeared first on The Truth About Covid Vaccines.

[This post contains video, click to play]

Dr. Alfred Johnson interviews Dr. Peter McCullough on what you need to know about Covid-19 and early treatment.

The latest information about:
the Delta variant;
asymptomatic transmission and testing;
natural immunity from having a covid-19 infection vs vaccination;
what to do if you have symptoms;
testing;
the use of nutraceuticals;
treatment protocols;
the use of hydroxychloroquine and ivermectin;
putting to rest the question of hydroxychloroquine and adverse cardiological effects;
gastrointestinal symptoms of Delta;
being aware of our state of health;
oral and dental hygiene;
the use of monoclonal antibodies including Regeneron, Remdesivir and full dose blood thinners;
outpatient followup;
long hauler Covid;
myocarditis;
the commencement of early treatment;
the role of fever in the disease process;
the use of NSAIDs;
obesity as a risk factor;
talking to your physician;
the failure of vaccines.

US Vaccine Adverse Event Reporting System (VAERS) COVID Vaccine Data

Data from Israel shows very high number of COVID-19 cases in double jabbed. Vaccines not stopping transmission.

CRAIG KELLY – Bill to Parliament: No Requirement for Medical Treatment (Including Experimental Injections) Without Consent

Independent Lab Tests Reveal At Least 62% of mRNA Vaccine Recipients Are Experiencing Capillary Clotting: Canada

The post Demand Early Treatment! – All questions Covid with Dr. Al Johnson and Dr. Peter McCullough appeared first on The Truth About Covid Vaccines.

https://datadashboard.health.gov.il/COVID-19/general

Referring to publicly available data from Israel ministry of health and the Israel Government gives us a clear indication that the vaccines do not stop transmission of COVID-19.

Media are suggesting that efficacy in Pfizer has dropped to 39%

The post Data from Israel shows very high number of COVID-19 cases in double jabbed. Vaccines not stopping transmission. appeared first on The Truth About Covid Vaccines.

Dear members,   

You may have read in the media overnight about Clive Palmer’s letter to both the Western Australian Premier and Chief Health Officer.   

The letter, which you can read in full below, details Mr Palmer’s intention to launch a class action on behalf of West Australian citizens should the WA Government decide to make COVID-19 vaccination mandatory, coerce people into getting vaccinated when their normal choice would be not to do so, or in some way incentivise vaccination, thereby altering what would be their normal choice.    

The letter references a recent CDC (Centers for Disease Control and Prevention) study that showed 74% of people in the study were infected with COVID-19 despite being fully vaccinated.

The majority of those displayed symptoms, such as cough, sore throat, fever, etc, and four of those fully vaccinated people were hospitalised.  

…………………………………………………       

Dear Chief Health Officer,      

Australia’s COVID-19 Vaccination Program 

1. I act for Mr. Clive F Palmer.   

2. I enclose, for your attention, a copy of the study entitled: “Outbreak of SARS-CoV-2 Infections, Including COVID-19 Vaccine Breakthrough Infections, Associated with Large Public Gatherings — Barnstable County, Massachusetts, July 2021” (CDC Study) published 30 July 2021 by the Centers for Disease Control and Prevention (CDC).   

3. The CDC Study is also accessible HERE

4. I am instructed by Mr Palmer that:     

A) the CDC Study found: 

• During July 2021, 469 cases of COVID-19 associated with multiple summer events and large public gatherings in a town in Barnstable County, Massachusetts, were identified among Massachusetts residents; vaccination coverage among eligible Massachusetts residents was 69%. 

• Approximately three quarters (346; 74%) of cases occurred in fully vaccinated persons (those who had completed a 2-dose course of mRNA vaccine [Pfizer-BioNTech or Moderna] or had received a single dose of Janssen [Johnson & Johnson] vaccine ≥14days before exposure). 
  
• Overall, 274 (79%) vaccinated patients with breakthrough infection were symptomatic, with the most common symptoms being cough, headache, sore throat, myalgia and fever. 

• Among five COVID-19 patients who were hospitalised, four were fully vaccinated; no deaths were reported. The four vaccinated patients who were hospitalised were aged between 20 and 70.

• Vaccine products received by persons experiencing breakthrough infections were Pfizer-BioNTech (159; 46%), Moderna (131; 38%), and Janssen (56; 16%); among fully vaccinated persons in the Massachusetts general population, 56% had received Pfizer-BioNTech, 38% had received Moderna, and 7% had received Janssen vaccine products.  

• Genomic sequencing of specimens from 133 patients identified the B.1.617.2 (Delta)variant of SARS-CoV-2, the virus that causes COVID-19, in 119 (89%) and the DeltaAY.3 sublineage in one (1%).    

B) the function of a vaccine, properly so-called and as understood by the public, is to:   

i) stop the vaccinated person from becoming infected with a human disease caused by the relevant virus, and to provide immunity against that disease in due course;    

ii) prevent a vaccinated person from developing symptoms of the disease caused by the relevant virus;

and iii) stop transmission of the relevant disease by a vaccinated person.   

C) his view is that:

i) it is clear from the CDC Study that the COVID-19 vaccines do not successfully carry out any of these functions. The COVID-19 vaccines fail on all three criteria.   

ii) the COVID-19 vaccines have failed and are not fit to be regarded as vaccines at all.   

D) further: 

i) there is no safety data for one, three or five-year safety data for the use of these vaccines;   

ii) there is no data regarding the safety of the vaccine for children and pregnant women.   

5. Mr Palmer’s view is that:

A) the CDC Study shows statistically significant numbers of people said to be vaccinated against COVID-19 are:    i) becoming infected with COVID-19 or its variants; ii) becoming symptomatic; iii) transmitting the disease; and iv) being admitted to hospital.   

B) people are being injected with the COVID-19 vaccines, risking their health and their lives, for no good reason.   

C) as a member of the Western Australian public service, under the Public Sector Management Act 1994 (WA)¸ you are obliged to: i) act in a way that protects and promotes the interests of the WA health system; ii) make decisions based on fair and objective processes; and iii) ensure your decisions are not influenced by self-interest, considerations of personal gain or other improper motives  

D) as it stands, you continue to roll out the COVID-19 vaccines despite: 
i) a lack of data supporting the efficacy and safety of the vaccines; 
ii) clear safety issues, which are known and quantified;
and iii) data from the leading diseases peak body internationally, the CDC, which demonstrates that the vaccines, for the reasons above, are ineffective against COVID-19 and its variants and therefore do not fulfil their purpose.   

6. Mr Palmer’s position is that:   

A) you are providing the public with incomplete, incorrect and misleading information regarding the COVID-19 vaccines;   

B) you are advocating for the vaccination of the Australian public on the basis of this incomplete, incorrect and misleading information;   

C) if you or your Government cause to be implemented legislation, regulations, policies or make declarations which:
i) require or coerce individuals to be vaccinated with a COVID-19 vaccine;
and ii) incentivise vaccination with a COVID-19 vaccine, then that will cause economic loss to be caused to businesses and individuals who decide not to be vaccinated (“the Class”) and Mr Palmer intends to fund a class action seeking:   
iii) an injunction in respect of the introduction of those measures;
and iv. damages for the economic loss caused, and/or likely to be caused, to the Class;   

D) it is unconscionable for you to: 
i) perpetuate the falsehood that the COVID-19 vaccines prevent a person from becoming infected with the disease and prevent a person from infecting others;
and ii) support measures which require or coerce individuals to be vaccinated, or otherwise incentivise vaccination, and Mr Palmer may also bring an action against you personally.   

7. I look forward to receiving your response as soon as possible and, in any event, within 7 days.   

ENDS

Most Covid patients at Israeli hospital fully vaccinated? What does this mean for Australia?

Outbreak of SARS-CoV-2 Infections, Including COVID-19 Vaccine Breakthrough Infections, Associated with Large Public Gatherings — Barnstable County, Massachusetts, July 2021

Independent Lab Tests Reveal At Least 62% of mRNA Vaccine Recipients Are Experiencing Capillary Clotting: Canada

Ex-Pfizer VP Yeadon Warns: Children 50 Times More Likely to Die From Vaccine Than Virus

The post Clive Palmer letter to WA Premier & CHO appeared first on The Truth About Covid Vaccines.

Israel has been held up as the “gold standard” of how to conduct the coronavirus vaccine rollout. It has seen approximately 70% of its population receive the jab. The Israelis have relied in the main on the Pfizer vaccine. 

However, recently the country’s Prime Minister, Naftali Bennett, stated that the Pfizer vaccine is ‘significantly less’ effective against the so-called Delta variant. This follows on from a statement last June by Ran Balicer, who leads an expert advisory panel for the Israeli government, in announcing that the country might end up in lockdown again. Balicer and other officials said that 90 per cent of the new cases were caused by the Delta variant.  

Now an Israeli doctor has revealed a bombshell during a television interview. In the interview on August 5 with Israel’s Chanel 13, Dr Kobi Haviv, medical director of Herzog Hospital in Jerusalem, stated that the majority of coronavirus patients in an Israeli hospital are fully vaccinated, including those with severe disease.  

Dr Haviv further specified that: “95% of the severe patients are vaccinated,” adding “85-90% of the hospitalizations are in fully vaccinated people” and the hospital is “opening more and more COVID wards.” This has led him to conclude that “the effectiveness of the vaccine is fading out.” 

Of the 72 hospitalized COVID-19 patients, 25 patients were in “critical condition”, 38 were in “moderate” condition, and 9 were in “mild” condition. There were two deaths reported at the time of the interview. 

Data from the Israeli Minister of Health released on July 22 declared that the effectiveness of the Pfizer-BioNTech vaccine at preventing COVID-19 has plummeted from 90 percent to only 39 percent, coinciding with the spread of the Delta variant in the country. 

All this begs a significant question as far as Australia is concerned. After National Cabinet on July 30, Prime Minister Scott Morrison announced that there will be “special rules” for people who are vaccinated because they present “less of a public health risk” However, in light of the above, why are our politicians and health officials insisting on this rhetoric, and that vaccinations are the way out of these ‘Delta’ induced lockdowns, when evidence is mounting to the contrary?  

A Covid-19 outbreak in a Massachusetts county in July primarily occurred among vaccinated people, sparking fears that a variant of the virus can impact that population more than other strains. 

Of the 469 cases detected in Barnstable County, 74 percent occurred among the fully vaccinated, according to a new study published by the CDC on 30 July. It also emerged last month that 49 fully vaccinated people in New Jersey died of coronavirus.   

Across the Atlantic, early analysis from Public Health England suggests vaccinated people infected with the Delta variant may be as infectious as their unvaccinated counterparts. The PHE technical briefing indicates that that “whilst vaccination may reduce an individual’s overall risk of becoming infected, once they are infected there is limited difference in viral load between those who are vaccinated and unvaccinated.” 

What is even more concerning is that, as alerted to by the Doctors for Covid Ethics, a Freedom of Information request to the Australian drugs regulator, the Therapeutic Goods Administration that granted provisional approval to the Pfizer vaccine, confirms that it has never seen the study data.

In other words, the TGA never saw or requested the patient data from Pfizer and simply accepted their reporting of their study as true.This means that when the head of the TGA John Skerritt said that “the safety evidence is pretty thorough” on February 6, his words would ring hollow to most Australians who have assumed, rightly or wrongly, that the TGA had actually looked at the patient data before granting any such approval. As noted by Doctors for Covid Ethics on its website, it is currently not known whether any of the major government agencies around the globe (FDA, MHRA or EMA) has independently verified, or attempted to verify, Pfizer’s data, before proceeding with provisional/emergency authorisation of Pfizer’s mRNA therapy vaccine. 

For any government, either by itself or via corporate proxy, to attempt to mandate vaccines in circumstances where there has not been adequate testing and analysis of risks as well as benefits would constitute not only a violation of the principle of informed consent (which Prime Minister Scott Morrison has stated he believes in – see this press conference as an example) — but a violation of Australia’s obligations under international law with respect to medical experimentation. 

Indeed, after National Cabinet on August 6, Scott Morrison indicated that mandatory vaccination could breach privacy laws, discrimination laws, and Australia’s policy remained that vaccines should be voluntary and free. In particular, he declared: “In our country, everyone has choices and they have choices that are supported by the rule of law and simply making the point that those choices have to be exercised, are consistent with the rule of law.” 

Let’s just see if these will simply be more hollow words from the hollow man.

Outbreak of SARS-CoV-2 Infections, Including COVID-19 Vaccine Breakthrough Infections, Associated with Large Public Gatherings — Barnstable County, Massachusetts, July 2021

Independent Lab Tests Reveal At Least 62% of mRNA Vaccine Recipients Are Experiencing Capillary Clotting: Canada

The Spike Protein is the Reason Why the Vaccines Might Kill You

Ex-Pfizer VP Yeadon Warns: Children 50 Times More Likely to Die From Vaccine Than Virus

The post Most Covid patients at Israeli hospital fully vaccinated? What does this mean for Australia? appeared first on The Truth About Covid Vaccines.

[This post contains video, click to play]

Over the weekend, tens of thousands rallied in Sydney to protest the ongoing and escalating NSW lockdown.

And like clockwork, the media demonised and vilified all who attended the Freedom Day March by focusing on a tiny minority misbehaving.

But we knew that was going to happen, so Rebel News sent a camera crew to bring you the other side of the story.

Watch and share what our camera crew captured, including the heartbreaking pleas from everyday Aussies of all backgrounds.

The post Powerful Sydney Freedom Day PROTEST VIDEO appeared first on The Truth About Covid Vaccines.

Early Release / July 30, 2021 / 70

Catherine M. Brown, DVM¹; Johanna Vostok, MPH¹; Hillary Johnson, MHS¹; Meagan Burns, MPH¹; Radhika Gharpure, DVM²; Samira Sami, DrPH²; Rebecca T. Sabo, MPH²; Noemi Hall, PhD²; Anne Foreman, PhD²; Petra L. Schubert, MPH¹; Glen R. Gallagher, PhD¹; Timelia Fink¹; Lawrence C. Madoff, MD¹; Stacey B. Gabriel, PhD³; Bronwyn MacInnis, PhD³; Daniel J. Park, PhD³; Katherine J. Siddle, PhD³; Vaira Harik, MS⁴; Deirdre Arvidson, MSN⁴; Taylor Brock-Fisher, MSc⁵; Molly Dunn, DVM⁵; Amanda Kearns⁵; A. Scott Laney, PhD² (View author affiliations)

http://dx.doi.org/10.15585/mmwr.mm7031e2external icon

Summary

What is already known about this topic?
Variants of SARS-CoV-2 continue to emerge. The B.1.617.2 (Delta) variant is highly transmissible.

What is added by this report?
In July 2021, following multiple large public events in a Barnstable County, Massachusetts, town, 469 COVID-19 cases were identified among Massachusetts residents who had traveled to the town during July 3–17; 346 (74%) occurred in fully vaccinated persons. Testing identified the Delta variant in 90% of specimens from 133 patients. Cycle threshold values were similar among specimens from patients who were fully vaccinated and those who were not.

What are the implications for public health practice?
Jurisdictions might consider expanded prevention strategies, including universal masking in indoor public settings, particularly for large public gatherings that include travelers from many areas with differing levels of SARS-CoV-2 transmission.

During July 2021, 469 cases of COVID-19 associated with multiple summer events and large public gatherings in a town in Barnstable County, Massachusetts, were identified among Massachusetts residents; vaccination coverage among eligible Massachusetts residents was 69%.

Approximately three quarters (346; 74%) of cases occurred in fully vaccinated persons (those who had completed a 2-dose course of mRNA vaccine [Pfizer-BioNTech or Moderna] or had received a single dose of Janssen [Johnson & Johnson] vaccine ≥14 days before exposure). Genomic sequencing of specimens from 133 patients identified the B.1.617.2 (Delta) variant of SARS-CoV-2, the virus that causes COVID-19, in 119 (89%) and the Delta AY.3 sublineage in one (1%). Overall, 274 (79%) vaccinated patients with breakthrough infection were symptomatic. Among five COVID-19 patients who were hospitalized, four were fully vaccinated; no deaths were reported.

Real-time reverse transcription–polymerase chain reaction (RT-PCR) cycle threshold (Ct) values in specimens from 127 vaccinated persons with breakthrough cases were similar to those from 84 persons who were unvaccinated, not fully vaccinated, or whose vaccination status was unknown (median = 22.77 and 21.54, respectively).

The Delta variant of SARS-CoV-2 is highly transmissible (1); vaccination is the most important strategy to prevent severe illness and death. On July 27, CDC recommended that all persons, including those who are fully vaccinated, should wear masks in indoor public settings in areas where COVID-19 transmission is high or substantial.* Findings from this investigation suggest that even jurisdictions without substantial or high COVID-19 transmission might consider expanding prevention strategies, including masking in indoor public settings regardless of vaccination status, given the potential risk of infection during attendance at large public gatherings that include travelers from many areas with differing levels of transmission.

During July 3–17, 2021, multiple summer events and large public gatherings were held in a town in Barnstable County, Massachusetts, that attracted thousands of tourists from across the United States. Beginning July 10, the Massachusetts Department of Public Health (MA DPH) received reports of an increase in COVID-19 cases among persons who reside in or recently visited Barnstable County, including in fully vaccinated persons. Persons with COVID-19 reported attending densely packed indoor and outdoor events at venues that included bars, restaurants, guest houses, and rental homes. On July 3, MA DPH had reported a 14-day average COVID-19 incidence of zero cases per 100,000 persons per day in residents of the town in Barnstable County; by July 17, the 14-day average incidence increased to 177 cases per 100,000 persons per day in residents of the town (2).

During July 10–26, using travel history data from the state COVID-19 surveillance system, MA DPH identified a cluster of cases among Massachusetts residents. Additional cases were identified by local health jurisdictions through case investigation. COVID-19 cases were matched with the state immunization registry. A cluster-associated case was defined as receipt of a positive SARS-CoV-2 test (nucleic acid amplification or antigen) result ≤14 days after travel to or residence in the town in Barnstable County since July 3. COVID-19 vaccine breakthrough cases were those in fully vaccinated Massachusetts residents (those with documentation from the state immunization registry of completion of COVID-19 vaccination as recommended by the Advisory Committee on Immunization Practices,^† ≥14 days before exposure).

Specimens were submitted for whole genome sequencing^§ to either the Massachusetts State Public Health Laboratory or the Broad Institute of the Massachusetts Institute of Technology and Harvard University. Ct values were obtained for 211 specimens tested using a noncommercial real-time RT-PCR panel for SARS-CoV-2 performed under Emergency Use Authorization at the Broad Institute Clinical Research Sequencing Platform. On July 15, MA DPH issued the first of two Epidemic Information Exchange notifications to identify additional cases among residents of U.S. jurisdictions outside Massachusetts associated with recent travel to the town in Barnstable County during July 2021. This activity was reviewed by CDC and was conducted consistent with applicable federal law and CDC policy.^¶

By July 26, a total of 469 COVID-19 cases were identified among Massachusetts residents; dates of positive specimen collection ranged from July 6 through July 25 (Figure 1). Most cases occurred in males (85%); median age was 40 years (range = <1–76 years). Nearly one half (199; 42%) reported residence in the town in Barnstable County. Overall, 346 (74%) persons with COVID-19 reported symptoms consistent with COVID-19.** Five were hospitalized; as of July 27, no deaths were reported. One hospitalized patient (age range = 50–59 years) was not vaccinated and had multiple underlying medical conditions.^†† Four additional, fully vaccinated patients^§§ aged 20–70 years were also hospitalized, two of whom had underlying medical conditions. Initial genomic sequencing of specimens from 133 patients identified the Delta variant in 119 (89%) cases and the Delta AY.3 sublineage in one (1%) case; genomic sequencing was not successful for 13 (10%) specimens.

Among the 469 cases in Massachusetts residents, 346 (74%) occurred in persons who were fully vaccinated; of these, 301 (87%) were male, with a median age of 42 years. Vaccine products received by persons experiencing breakthrough infections were Pfizer-BioNTech (159; 46%), Moderna (131; 38%), and Janssen (56; 16%); among fully vaccinated persons in the Massachusetts general population, 56% had received Pfizer-BioNTech, 38% had received Moderna, and 7% had received Janssen vaccine products. Among persons with breakthrough infection, 274 (79%) reported signs or symptoms, with the most common being cough, headache, sore throat, myalgia, and fever. Among fully vaccinated symptomatic persons, the median interval from completion of ≥14 days after the final vaccine dose to symptom onset was 86 days (range = 6–178 days). Among persons with breakthrough infection, four (1.2%) were hospitalized, and no deaths were reported. Real-time RT-PCR Ct values in specimens from 127 fully vaccinated patients (median = 22.77) were similar to those among 84 patients who were unvaccinated, not fully vaccinated, or whose vaccination status was unknown (median = 21.54) (Figure 2).

Transmission mitigation measures included broadening testing recommendations for persons with travel or close contact with a cluster-associated case, irrespective of vaccination status; local recommendations for mask use in indoor settings, irrespective of vaccination status; deployment of state-funded mobile testing and vaccination units in the town in Barnstable County; and informational outreach to visitors and residents. In this tourism-focused community, the Community Tracing Collaborative^¶¶ conducted outreach to hospitality workers, an international workforce requiring messaging in multiple languages.

The call from MA DPH for cases resulted in additional reports of cases among residents of 22 other states who had traveled to the town in Barnstable County during July 3–17, as well as reports of secondary transmission; further analyses are ongoing. As of July 3, estimated COVID-19 vaccination coverage among the eligible population in Massachusetts was 69% (3). Further investigations and characterization of breakthrough infections and vaccine effectiveness among this highly vaccinated population are ongoing.

Discussion

The SARS-CoV-2 Delta variant is highly transmissible (1), and understanding determinants of transmission, including human behavior and vaccine effectiveness, is critical to developing prevention strategies. Multipronged prevention strategies are needed to reduce COVID-19–related morbidity and mortality (4).

The findings in this report are subject to at least four limitations. First, data from this report are insufficient to draw conclusions about the effectiveness of COVID-19 vaccines against SARS-CoV-2, including the Delta variant, during this outbreak. As population-level vaccination coverage increases, vaccinated persons are likely to represent a larger proportion of COVID-19 cases. Second, asymptomatic breakthrough infections might be underrepresented because of detection bias. Third, demographics of cases likely reflect those of attendees at the public gatherings, as events were marketed to adult male participants; further study is underway to identify other population characteristics among cases, such as additional demographic characteristics and underlying health conditions including immunocompromising conditions.*** MA DPH, CDC, and affected jurisdictions are collaborating in this response; MA DPH is conducting additional case investigations, obtaining samples for genomic sequencing, and linking case information with laboratory data and vaccination history. Finally, Ct values obtained with SARS-CoV-2 qualitative RT-PCR diagnostic tests might provide a crude correlation to the amount of virus present in a sample and can also be affected by factors other than viral load.^††† Although the assay used in this investigation was not validated to provide quantitative results, there was no significant difference between the Ct values of samples collected from breakthrough cases and the other cases. This might mean that the viral load of vaccinated and unvaccinated persons infected with SARS-CoV-2 is also similar. However, microbiological studies are required to confirm these findings.

Event organizers and local health jurisdictions should continually assess the need for additional measures, including limiting capacity at gatherings or event postponement, based on current rates of COVID-19 transmission, population vaccination coverage, and other factors.^§§§ On July 27, CDC released recommendations that all persons, including those who are fully vaccinated, should wear masks in indoor public settings in areas where COVID-19 transmission is high or substantial. Findings from this investigation suggest that even jurisdictions without substantial or high COVID-19 transmission might consider expanding prevention strategies, including masking in indoor public settings regardless of vaccination status, given the potential risk of infection during attendance at large public gatherings that include travelers from many areas with differing levels of transmission.

Acknowledgments

Hanna Shephard, Geena Chiumento, Nicole Medina, Juliana Jacoboski, Julie Coco, Andrew Lang, Matthew Doucette, Sandra Smole, Patricia Kludt, Natalie Morgenstern, Kevin Cranston, Ryan J. Burke, Massachusetts Department of Public Health; Sean O’Brien, Theresa Covell, Barnstable County Department of Health and the Environment; Marguerite M. Clougherty, John C. Welch, Community Tracing Collaborative; Jacob Lemieux, Christine Loreth, Stephen Schaffner, Chris Tomkins-Tinch, Lydia Krasilnikova, Pardis Sabeti, Broad Institute; Sari Sanchez, Boston Public Health Commission; Mark Anderson, Vance Brown, Ben Brumfield, Anna Llewellyn, Jessica Ricaldi, Julie Villanueva, CDC COVID-19 Response Team.

Corresponding author: Catherine Brown, catherine.brown@mass.gov.

¹Massachusetts Department of Public Health; ²CDC COVID-19 Response Team; ³Broad Institute, Cambridge, Massachusetts; ⁴Barnstable County Department of Health and the Environment, Massachusetts; ⁵Community Tracing Collaborative, Commonwealth of Massachusetts.

All authors have completed and submitted the International Committee of Medical Journal Editors form for disclosure of potential conflicts of interest. Stacey B. Gabriel reports receiving grants from CDC. Bronwyn MacInnis, Katherine Siddle, and Daniel Park report receiving grants from CDC and the National Institutes of Health. Taylor Brock-Fisher reports receiving a grant from the Community Tracing Collaborative. No other potential conflicts of interest were disclosed.

* https://www.cdc.gov/coronavirus/2019-ncov/vaccines/fully-vaccinated.html

^† As of May 2021, ACIP recommended that all adults aged ≥18 years receive any of the three COVID-19 vaccines available in the United States via Emergency Use Authorization from the Food and Drug Administration, including Pfizer-BioNTech, Moderna, and Janssen; persons aged ≥12 years are eligible to receive the Pfizer-BioNTech COVID-19 vaccine. Full vaccination is defined as receipt of 2 doses of the Pfizer-BioNTech or Moderna COVID-19 vaccines or 1 dose of Janssen COVID-19 vaccine ≥14 days before exposure.

^§ Genomic sequencing was performed using Illumina NovaSeq using the NEB LunaScript RT ARTIC SARS-CoV-2 Kit. Novel mutations were not identified in the spike protein of the cluster-associated genomes compared with genomes collected during the same period from ongoing genomic surveillance efforts at Broad Institute. Raw and assembled genomic data are publicly available under NCBI BioProject PRJNA715749.

^¶ 45 C.F.R. part 46, 21 C.F.R. part 56; 42 U.S.C. Sect.241(d); 5 U.S.C. Sect.552a; 44 U.S.C. Sect.3501 et seq.

** COVID-like symptoms were based on the Council of State and Territorial Epidemiologists surveillance case definition for COVID-19. https://ndc.services.cdc.gov/case-definitions/coronavirus-disease-2019-2020-08-05/

^†† https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people-with-medical-conditions.html

^§§ One vaccinated, hospitalized COVID-19 patient had received the Pfizer-BioNTech vaccine and three had received the Janssen vaccine.

^¶¶ The Community Tracing Collaborative is a multiorganization partnership that has supported COVID contact tracing and outbreak investigation in Massachusetts. https://www.mass.gov/info-details/learn-about-the-community-tracing-collaborativeexternal icon

*** A preliminary analysis matching cluster-associated COVID-19 cases with the state HIV case surveillance data identified 30 (6%) cases with verified HIV infection; all were virally suppressed, and none were hospitalized as a result of infection with SARS-CoV-2.

^††† https://www.cdc.gov/coronavirus/2019-ncov/lab/faqs.html

^§§§ https://www.cdc.gov/coronavirus/2019-ncov/community/large-events/considerations-for-events-gatherings.html

References

1. CDC. COVID-19: SARS-CoV-2 variant classifications and definitions. Atlanta, GA: US Department of Health and Human Services, CDC; 2021. Accessed July 25, 2021. https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/variant-surveillance/variant-info.html
2. Massachusetts Department of Public Health. COVID-19 response reporting. Boston, MA: Massachusetts Department of Public Health; 2021. Accessed July 25, 2021. https://www.mass.gov/info-details/covid-19-response-reportingexternal icon
3. Massachusetts Department of Public Health. Massachusetts COVID-19 vaccination data and updates. Boston, MA: Massachusetts Department of Public Health; 2021. Accessed July 25, 2021. https://www.mass.gov/info-details/massachusetts-covid-19-vaccination-data-and-updates#daily-covid-19-vaccine-report-external icon
4. Christie A, Brooks JT, Hicks LA, Sauber-Schatz EK, Yoder JS, Honein MA. Guidance for implementing COVID-19 prevention strategies in the context of varying community transmission levels and vaccination coverage. MMWR Morb Mortal Wkly Rep 2021;70:1044–7. https://doi.org/10.15585/mmwr.mm7030e2external icon

FIGURE 1. SARS-CoV-2 infections (N = 469) associated with large public gatherings, by date of specimen collection and vaccination status* — Barnstable County, Massachusetts, July 2021

Abbreviation: MA DPH = Massachusetts Department of Public Health.

* Fully vaccinated was defined as ≥14 days after completion of state immunization registry–documented COVID-19 vaccination as recommended by the Advisory Committee on Immunization Practices.

FIGURE 2. SARS-CoV-2 real-time reverse transcription–polymerase chain reaction cycle threshold values* for specimens from patients with infections associated with large public gatherings, by vaccination status^† — Barnstable County, Massachusetts, July 2021^§

Abbreviations: Ct = cycle threshold; RT-PCR = reverse transcription–polymerase chain reaction.

* Specimens were analyzed using a noncommercial real-time RT-PCR panel for SARS-CoV-2 performed under Emergency Use Authorization at the Clinical Research Sequencing Platform, Broad Institute of the Massachusetts Institute of Technology and Harvard University.

^† Fully vaccinated was defined as ≥14 days after completion of state immunization registry–documented COVID-19 vaccination as recommended by the Advisory Committee on Immunization Practices.

^§ Whiskers represent minimum and maximum observations; top of box represents the third quartile (Q3), bottom represents the first quartile (Q1), and box height represents the interquartile range. Midline is the median; “x” is the mean.

Independent Lab Tests Reveal At Least 62% of mRNA Vaccine Recipients Are Experiencing Capillary Clotting: Canada

Ex-Pfizer VP Yeadon Warns: Children 50 Times More Likely to Die From Vaccine Than Virus

The Spike Protein is the Reason Why the Vaccines Might Kill You

Clive Palmer responds to TGA head, Professor Skerritt over COVID ad campaign

The post Outbreak of SARS-CoV-2 Infections, Including COVID-19 Vaccine Breakthrough Infections, Associated with Large Public Gatherings — Barnstable County, Massachusetts, July 2021 appeared first on The Truth About Covid Vaccines.

[This post contains video, click to play]

In the Canadian town of Lytton, Dr. Charles Hoffe is seeing many cases of severe vaccine injury from Covid-19 shots. Further investigation revealed a distressing 62% of his mRNA vaccine recipient patients are now experiencing capillary clotting as a result. He explains the mechanism behind the vaccine and what’s going wrong.

Canada: Moderna Vaccine Wrecks Havoc on Lytton BC

Texas Senate Committee Throws Out Mandatory COVID Vaccination

If You Get Sick, You’re Stuffed

No Vaccine Data for Pregnancy

Thrombosis Out of the Blue

Thousands of Adverse Reactions

Vaccine Manufacturers Indemnified

Don’t Tell the Public

The post Independent Lab Tests Reveal At Least 62% of mRNA Vaccine Recipients Are Experiencing Capillary Clotting: Canada appeared first on The Truth About Covid Vaccines.

Trust the Scientists

How many times have you heard the phrase ‘Trust the Scientists’ but never seen anyone’s name mentioned. Below are several doctors and scientists that warn against the vaccines.

Dr. Robert Malone – Inventor of mRNA Technology – in June, 2021 made a 3 hour video in which he says in great detail why the Covid vaccine is so dangerous.

Dr. Micheal Yeadon – Worked for Pfizer for 16+ years reaching the position of Vice President – says these vaccines are dangerous.

Dr. Geert Vanden Bossche – Worked in the vaccine industry his entire career – says injecting millions of people during an ongoing pandemic is dangerous.

Professor Dolores Cahill – from University College Dublin School of Medicine – Expects those that get injected to start dying or get very sick within the next few years.

More Doctors that have spoken up about the dangers of the vaccines that you can look up:
Dr. Roger Hodkinson
Dr. Byram Brindle
Dr. Peter McCullough
Dr. Zev Zelenko
Dr. Carrie Madej
Dr Sherri Tenpenny
Dr. Stephanie Seneff
Dr. Lee Merritt
Dr. Vernon Coleman
Professor Sucharit Bhakdi

Related: 
Australian Covid Vaccine Data
If You Get Sick, You’re Stuffed
No Vaccine Data for Pregnancy
Thrombosis Out of the Blue
Thousands of Adverse Reactions
Vaccine Manufacturers Indemnified
Don’t Tell the Public
Texas Senate Committee Throws Out Mandatory COVID Vaccination
Professor Dolores Cahill Discusses Covid Vaccination Effects
Canada: Moderna Vaccine Wrecks Havoc on Lytton BC

The post The Spike Protein is the Reason Why the Vaccines Might Kill You appeared first on The Truth About Covid Vaccines.

In a letter sent to Prof Skerritt today, Mr Palmer strongly defended the campaign saying all of the advertisements quoted TGA reported facts.

“The first fact being that there has only been one COVID death in Australia this year. The second fact being that your organisation, the TGA, reported that there have been over 300 deaths in Australia following the administration of the COVID vaccine,’’ Mr Palmer said.

“I’m interested to see the autopsy data which confirms that these deaths haven’t been caused by the vaccine.

“I believe it is prima facie a reasonable assumption that if people are vaccinated and then they die prima facie the vaccine may have been the cause of their deaths,’’ he said.

Mr Palmer said it was Prof Skerritt’s responsibility in his public role to ensure that those matters are properly investigated and autopsies carried out to see if this prima facie conclusion can be disregarded.

“It is a simple fact that the TGA – according to TGA reporting – has received over 24,000 adverse reports. Over 24,000 adverse reports would indicate that any public servant responsible for regulating such a medicine should exercise what power he or she has in the public interest and cease the administration and roll out of such a medicine.

“Otherwise, it could be inferred that he or she is committing a serious malfeasance in public office and will bear a personal responsibility for the outcomes,’’ he said.

Mr Palmer said the CDC website in the United States confirmed that their vaccine program had caused over 5,000 deaths, 3,900 disabilities, 571 miscarriages, 1,500 Bell’s palsy cases and 1,900 heart attacks.

“Why doesn’t the TGA publish Australian equivalent figures in these categories?

“I note Prof Skerritt’s comments in respect of the transparency however, it is disappointing that the TGA reports have now stopped reporting the number of people that have died following their COVID-19 vaccination,’’ Mr Palmer said.

“Such a number of deaths caused over such a small portion of the Australians who have had the vaccines over such a compressed period of time should be a matter of concern. Normally a medicine that was responsible for even one death would be suspended.

“I understand there have been over 10,000 deaths reported in Europe in respect of the vaccine. The combination of the forgoing matters means it’s beyond belief that the TGA does not take immediate action.

“The facts of the matter are clear on the CDC website in the United States that over 50% of animals died in the animal trials of these vaccines, which would normally indicate that such vaccines are not suitable for human consumption.

“I do not understand why the Australian Government has bought over 180,000,000 doses of the vaccines when there are less than 25,000,000 Australians.  Prima facie it looks a serious case of enrichment for pharma companies at the public’s expense,’’ Mr Palmer said.

“In respect to the 3.7 million deaths alleged to be caused by COVID in the world; you need to take stock of the number of deaths that occur in the world each year.

“I am concerned about Australia and Australians and there has only been one COVID death in Australia this year. Moreover, serious concerns need to be expressed about Doctor Fauci in the US and the revelations that have come to light in recent times.

“I know from previous dealing with the TGA that in many instances the TGA relies on his group to advise it.

“The facts are that we have no safety data for 1, 3, 5, or 7 years for these vaccines. Nor do we have data on the effects on pregnant women or children.

“The TGA has no idea of the long-term outcomes of giving this vaccine to the Australian population. It is also a great concern that the Government has given the pharmaceutical companies an indemnity for any claims related to the injuries and deaths their vaccines may cause.

“It would seem that those same pharmaceutical companies do not have faith and confidence in their products to market them as part of their business without such Government indemnity.”

Mr Palmer said he found it personally disappointing that Prof Skerritt, as head of the TGA, had a responsibility to properly regulate medicines and vaccines in this country.

“I find it extraordinary to see Prof Skerritt on television in paid commercials promoting a commercial product that is both the TGA’s and his own responsibility to regulate.

“This is a serious conflict of interest. The Hight Court of Australia has reconfirmed the implied term in our constitution of political free speech. I am a former member of the House of Representatives and a chairman of a registered political party under the electoral act.

“I will continue to exercise my constitutional rights in this matter and if necessary, I am happy to meet any challenge in court in that regard,’’ he said.

Mr Palmer has advised Prof Skerritt to obtain proper legal advice to ensure he is protected against any claims that may be made personally against him in the future.

“He needs to advise the government of what the Attorney General’s department knows already – that the Biosecurity Act is unconstitutional and could not survive a challenge in the High Court of Australia.

“History has shown that governments have often been wrong. That propaganda and coverups have often taken place. That millions have died because people in authority lack the courage and the proprietary to follow through with the principles and ethics of their calling,’’ Mr Palmer said.

“There is no pandemic in Australia – only one person has died of COVID this year. The TGA and the government has started spreading misleading information, designed to create fear in the population.

“The only information that was published by me is that there has been one COVID death this year, that the TGA have reported that over 300 people have died after receiving the vaccination and that there were over 24,000 adverse reports received by the TGA.  All of that comes from TGA releases.”

Mr Palmer said he regarded Prof Skerritt’s statements about him as defamatory and was considering them before taking legal advice.

“It seemed all of those facts and statements in our advertisements are absolutely true and confirmed by the TGA. Australians have the right to be fully informed. Informed consent is a fundamental pre-requisite for any medical treatment,’’ Mr Palmer said.

“Australia has signed international conventions guaranteeing such consent. There are serious questions to be answered over the financial and other interests of the TGA’s so-called expert committees.

“I am sure in the future that those committees will be shown not to be as independent as they should be and not to contain experts from all States and all relevant universities,” Mr Palmer said.

Related: 
Australian Covid Vaccine Data
If You Get Sick, You’re Stuffed
No Vaccine Data for Pregnancy
Thrombosis Out of the Blue
Thousands of Adverse Reactions
Vaccine Manufacturers Indemnified
Don’t Tell the Public
Texas Senate Committee Throws Out Mandatory COVID Vaccination
Professor Dolores Cahill Discusses Covid Vaccination Effects
Canada: Moderna Vaccine Wrecks Havoc on Lytton BC

The post Clive Palmer responds to TGA head, Professor Skerritt over COVID ad campaign appeared first on The Truth About Covid Vaccines.

[This post contains video, click to play]

Mr CRAIG KELLY (Hughes) (10:05): I move:

That this bill be now read a second time.

The principle behind the No Domestic COVID Vaccine Passports Bill 2021 is quite simple: COVID vaccines in this country should be freely available to all, with informed consent of course, but they should be mandatory to nobody. Already, there are 16 US states that have introduced similar legislation to that which I am introducing today. This bill has been modelled on Florida’s bill, introduced by Governor DeSantis, which has been widely accepted by the Florida electorate. I hope that this parliament will move forward and bring this bill on for debate and a vote as soon as possible. This bill is simply about the type of country that we want. Do we want a country where government officials and petty bureaucrats demand that you show your medical papers? That is not the country that I want. Your medical records should be something between you and your doctor.

The entire concept of a vaccine passport is itself inherently misleading. There is little evidence to show that these novel experimental COVID genetic vaccines actually prevent someone from contracting COVID or prevent someone from spreading COVID or prevent someone from being hospitalised with COVID. For the education of the member at the desk, I have the latest data from the US on what they call ‘vaccine breakthrough cases’. These are cases where someone has been injected twice and, after a period of 14 days, still contracts COVID. The number is so many that they no longer count them, but they do count the number of hospitalisations. As at 14 June, the number of so-called breakthrough cases—that is, people who have been vaccinated twice and have ended up in hospital with COVID—stands at 2,622, and the number of deaths of people who have been vaccinated twice in the US and have passed away from COVID stands at 549. However, these numbers, the CDC says, are ‘likely a substantial undercount’ of all SARS infections among so-called fully vaccinated persons, and this surveillance relies upon ‘passive and voluntary reporting’. So we don’t actually know what the true number of breakthrough cases are.

There is also growing concern over vaccine safety. The highly respected and highly credentialed Dr Tess Lawrie recently stated in submission she made that, ‘There is more than enough evidence to declare that the COVID vaccines are unsafe for use in humans.’ This is also a great concern, as we also have data from VAERS in the USA that shows that, as at 4 June, there have been 5,888 deaths that have occurred in people after the vaccine. Now it is true that this VAERS data is questionable. Dr Peter McCullough suggested that the number is more like 50,000 rather than 5,888. But the fact is that we just do not know. Again, this VAERS data is based on voluntary reporting. So we simply have no idea about what the true rate of deaths are after COVID injections and we have no idea whether they were related to them or just a mere coincidence.

I’d say that’s the entire problem, because we have to admit that this is still one giant medical experiment. I’d liked to quote Dr Damian Wojcik of New Zealand. Talking about having his patients injected, he said: ‘Not on my watch. Not with my patients. My patients are living persons with names and families, not laboratory rats to be sacrificed in a global experiment.’ Dr Roger Hodkinson—a doctor from Canada—said recently: ‘This experimental vaccine should never have been released. Mass vaccination is so transparently stupid; medical idiocy of a grotesque degree. The bottom line is that mass vaccination of everybody should stop immediately. And when it comes to injecting this stuff into the arms of children, I call this “state sanctioned child abuse”.’ Dr Peter McCullough has recently stated, ‘I can no longer recommend the vaccines’.

Therefore, as this is a medical experiment, the idea of having a vaccine passport is coercive. It is to coerce people into participating in a medical experiment, of which we simply do not know what the end result will be. We’ve even seen here in Australia how our medical bureaucrats have got it wrong time and time again. Firstly, when it came to the AstraZeneca vaccine, they said that there was no evidence of a relationship with blood clots. They were dangerously wrong. Then it was clear from the data out of Europe, from the European Medicines Agency, that the AstraZeneca should be suspended and most European countries elected for a cut-off date of 60 years of age. So, if you were under 60, in most European countries they did not give you the AstraZeneca vaccine.

But our medical bureaucrats decided that the Europeans didn’t know what they were doing and that we would have the cut-off at 50. Only last week they admitted that they were wrong again, and the result of their error has been that 800,000 Australians have been injected with a substance which our Chief Medical Officer now says has a greater risk than any benefit. This was 800,000 Australians injected, where the risk was greater to them than any benefit because of a mistake by our medical bureaucrats.

The thing is that we should look at that risk-benefit analysis. But we’ve seen that the short-term risks have been grossly underestimated by health officials around the world. That’s why there have been suspensions and recalls. But we have no idea of the medium-term risks, we have no idea of the long-term risks and we have no idea of the intergenerational risks. Therefore, for anyone to stand up and say that they know that the benefits outweigh the risks, well, they simply cannot say that. If you cannot quantify medium-, long-term and intergenerational risks then you simply cannot make that assessment—the data is not there. We’re flying blind into this experiment.

That’s also why we do not need a domestic vaccine passport in this country. It would also be a complete violation of human rights. The UN Economic and Social Council has said, ‘The right to health contains freedoms such as “the right to control one’s health and body, including sexual and reproductive freedom, and the right to be free from interference, such as the right to be free from torture, non-consensual medical treatment and experimentation.’

I’d also like to make special mention of our Paralympic squad. We have bureaucrats there running that Paralympic squad that have decided to discriminate against Paralympians. So we have a situation where athletes are playing the same sport, going to the same country, going to the same city, going to the same Olympic facilities and playing at the same stadiums. If they are a Paralympian they are forced into this experiment—otherwise they are not picked. If they are in the normal Olympics, that does not apply. That is discrimination. That is contrary to the principles of this bill. I would call on Paralympic Australia to end their discrimination against athletes going to the Paralympics. With that, I commend this bill to the House, and I also congratulate my good friend the member for Dawson on being the seconder for this bill.

The SPEAKER: Is the motion seconded?

Mr Christensen: Seconded.

Debate adjourned.

CRAIG KELLY – Bill to Parliament: No Requirement for Medical Treatment (Including Experimental Injections) Without Consent

Data from Israel shows very high number of COVID-19 cases in double jabbed. Vaccines not stopping transmission.

Worse Than the Disease? Reviewing Some Possible Unintended Consequences of the mRNA Vaccines Against COVID-19

Most Covid patients at Israeli hospital fully vaccinated? What does this mean for Australia?

The post CRAIG KELLY – Bill to Parliament: No Domestic COVID Vaccine Passports Bill 2021 appeared first on The Truth About Covid Vaccines.

Men and Women of Australia,
I feel duty-bound to bring the following to your attention.
The Australian Government’s Therapeutic Goods Administration report confirms 210 deaths and 24,000 adverse reactions after the COVID-19 vaccines. There are over 5,000 deaths in the USA attributed to the Covid Vaccines including Pfizer.
While I support the use of vaccines that have approval for general use, I am very concerned by the use of this vaccine on the general population.
My understanding is that emergency use of a medicine is only authorised in the US if the person receiving the treatment is in immediate danger of dying. This is not the case with millions of Australians who are not ill. The simple fact is that we don’t have one-year safety data, three-year safety data, or five-year safety data for the use of the COVID-19 vaccine on humans or animals. Over 50% of animals in the animal trials have died.
I do not understand why it is that millions of Australians should be subject to a medical treatment that has not complied with normal practices.
There is no pandemic in Australia – only one person has died of COVID in 2021. The TGA and the government have spread misleading information designed to create fear in the population. TheCenter for Disease Control website in the United States confirms the following effects that their vaccine program has had using the same vaccines that the TGA has approved in Australia – over5,000 deaths, 3,900 disabled, 571 miscarriages, 1,500 Bell’s Palsy, and 1,900 heart attacks.
The Governments around Australia have done a great job in protecting all Australians from COVID-19 and for healthy Australians to receive such a treatment is, as I understand it, unprecedented.
I don’t understand why Australians need to rush or take risks with their lives.
And I don’t understand why the Australian Government has granted the pharmaceutical companies a complete indemnity should their COVID-19 vaccines cause illness or death. It would appear that these pharmaceutical companies lack confidence in their own products, which makes them ask for such an indemnity. No one will be successful in court if the government has indemnified the pharmaceutical companies.
We need to maintain the very high standards Australia has set for itself in the approvals of vaccines.
The COVID 19 Vaccine doesn’t stop you from getting COVID and it doesn’t stop you from passing it on. Does it serve any real purpose?

For the TGA report and more information go to: thetruthaboutcovidvaccines.com

God bless Australia, Clive Palmer

New TGA Safety update – Now 24,402 adverse reactions.

Death data REMOVED
Guillain-Barre syndrome added as an adverse event of interest.

Adverse events of special interest that we are monitoring for both vaccines include:

• clotting disorders without thrombocytopenia (low platelets) including stroke, pulmonary embolism, and deep vein thrombosis
• anaphylaxis
• thrombocytopenia without thrombosis
• seizures
• acute cardiac injury, for example myocarditis and pericarditis, heart failure and cardiogenic shock, arrhythmia
• facial weakness or paralysis, for example Bell’s palsy
• loss of sense of taste or smell (also called ageusia or anosmia)
• Guillain-Barre syndrome.

Related: Australian Covid Vaccine Data

If You Get Sick, You’re Stuffed

No Vaccine Data for Pregnancy

Thrombosis Out of the Blue

Thousands of Adverse Reactions

Vaccine Manufacturers Indemnified

Don’t Tell the Public

Texas Senate Committee Throws Out Mandatory COVID Vaccination

Professor Dolores Cahill Discusses Covid Vaccination Effects

Canada: Moderna Vaccine Wrecks Havoc on Lytton BC

The post A Message from Clive Palmer appeared first on The Truth About Covid Vaccines.

[This post contains video, click to play]

Related: Texas Senate Committee Throws Out Mandatory COVID Vaccination

Professor Dolores Cahill Discusses Covid Vaccination Effects

Canada: Moderna Vaccine Wrecks Havoc on Lytton BC

If You Get Sick, You’re Stuffed

No Vaccine Data for Pregnancy

Thrombosis Out of the Blue

Thousands of Adverse Reactions

Vaccine Manufacturers Indemnified

Don’t Tell the Public

The post Australian Covid Vaccine Data appeared first on The Truth About Covid Vaccines.

[This post contains video, click to play]

And yet we still continue with the experiment! Who would subject their child to this if they know the truth?

Bannen: Walk us through your thoughts about this vaccine, particularly for adolescents and school aged children and younger.

Yeadon: Certainly. Just to reiterate, I’m of the industry, my whole career, and I’m generally pro-vaccine, but I’m pro safety, and these Covid-19 vaccines are not safe. Very briefly, they’re not safe, because the gene-based design makes your body manufacture virus spike protein, and we know, and we’ve known for years, the virus spike proteins trigger blood clots. So there’s plenty of literature, no one can fault the statement that I’ve just made. Dr. Wodarg and I wrote to the European Medicines Agency in December, pointing that out. So that’s a fundamental problem. About 75% of the adverse events that occur after vaccination, which are very much higher than usual, relate to thromboembolic events, that is, blood clots and bleeding, so what I’ve just said about the design, and the property of spike protein, exactly matches these serious events that are emerging.

Now here’s the real problem I’ve got, and I’m a father and a grandfather, young people are not susceptible to Covid-19. If they acquire the virus, they usually have no symptoms and they shrug it off very easily. So they’re not at risk. It’s a crazy thing then, to vaccinate them with something that is actually 50 times more likely to kill them, than the virus itself.

Related: 
Australian Covid Vaccine Data
If You Get Sick, You’re Stuffed
No Vaccine Data for Pregnancy
Thrombosis Out of the Blue
Thousands of Adverse Reactions
Vaccine Manufacturers Indemnified
Don’t Tell the Public
Texas Senate Committee Throws Out Mandatory COVID Vaccination
Professor Dolores Cahill Discusses Covid Vaccination Effects
Canada: Moderna Vaccine Wrecks Havoc on Lytton BC

The post Ex-Pfizer VP Yeadon Warns: Children 50 Times More Likely to Die From Vaccine Than Virus appeared first on The Truth About Covid Vaccines.

[This post contains video, click to play]

Sixth of 6 revealing moments with information about the Covid-19 vaccines, as discussed in the Australian Federal Senate hearing of April 21, 2021.

John Skerritt: The safety… the efficacy of the vaccine wasn’t assessed during clinical trials in pregnant women.

Brendan Murphy: The Commonwealth has provided certain indemnities to the vaccine manufacturers to protect that.

Senator Jacqui Lambie: If something goes wrong, you’re stuffed. The government isn’t going to look after you and you’re not getting compensation.

Brendan Murphy: I would hope you wouldn’t say to the public that if something goes wrong, you’re stuffed, Senator, that would not be good…

Senator Jacqui Lambie (interjecting): Well that’s the truth Mr. Murphy… it takes years to get through a court system!

Related: If You Get Sick, You’re Stuffed

No Vaccine Data for Pregnancy

Thrombosis Out of the Blue

Thousands of Adverse Reactions

Vaccine Manufacturers Indemnified

The post Don’t Tell the Public appeared first on The Truth About Covid Vaccines.

[This post contains video, click to play]

Fifth of 6 revealing moments with information about the Covid-19 vaccines, as discussed in the Australian Federal Senate hearing of April 21, 2021.

John Skerritt: The safety… the efficacy of the vaccine wasn’t assessed during clinical trials in pregnant women.

Brendan Murphy: The Commonwealth has provided certain indemnities to the vaccine manufacturers to protect that.

Related: If You Get Sick, You’re Stuffed

No Vaccine Data for Pregnancy

Thrombosis Out of the Blue

Thousands of Adverse Reactions

Don’t Tell the Public

The post Vaccine Manufacturers Indemnified appeared first on The Truth About Covid Vaccines.

[This post contains video, click to play]

Fourth of 6 revealing moments with information about the Covid-19 vaccines, as discussed in the Australian Federal Senate hearing of April 21, 2021.

John Skerritt: And it has contributed to a significant increase in adverse event reports. We currently have about 11,000 adverse event reports for the two … covid vaccines in front of the TGA.

Update: Over 24,000 adverse events were reported to the TGA by the 30th May 2021.

Related: If You Get Sick, You’re Stuffed

No Vaccine Data for Pregnancy

Thrombosis Out of the Blue

Vaccine Manufacturers Indemnified

Don’t Tell the Public

The post Thousands of Adverse Reactions appeared first on The Truth About Covid Vaccines.

[This post contains video, click to play]

Third of 6 revealing moments with information about the Covid-19 vaccines, as discussed in the Australian Federal Senate hearing of April 21, 2021.

Brendan Murphy: Thrombosis, it appears out of the blue, whether you have an underlying medical condition or not.

John Skerritt: Currently we have about 11,000 adverse event reports for the two covid vaccines in front of the TGA.

Update: Over 24,000 adverse events were reported to the TGA by the 30th May 2021.

Related: If You Get Sick, You’re Stuffed

No Vaccine Data for Pregnancy

Thousands of Adverse Reactions

Vaccine Manufacturers Indemnified

Don’t Tell the Public

The post Thrombosis Out of the Blue appeared first on The Truth About Covid Vaccines.

[This post contains video, click to play]

Second of 6 revealing moments with information about the Covid-19 vaccines, as discussed in the Australian Federal Senate hearing of April 21, 2021.

John Skerritt: The specific advice from the TGA is that the safety… the efficacy of the vaccine wasn’t assessed during clinical trials in pregnant women.

Brendan Murphy: In the absence of any studies, specific studies, in pregnant women, the advice has been that at this stage, people should have a discussion with their doctor.

Senator Jacqui Lambie: If something goes wrong, you’re stuffed. The government isn’t going to look after you, and you’re not getting compensation.

Related: If You Get Sick, You’re Stuffed

Thrombosis Out of the Blue

Thousands of Adverse Reactions

Vaccine Manufacturers Indemnified

Don’t Tell the Public

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[This post contains video, click to play]

First of 6 revealing moments with information about the Covid-19 vaccines, as discussed in the Australian Federal Senate hearing of April 21, 2021.

Brendan Murphy: Early on, when this clotting, thrombosis issue was first identified, there were… people didn’t understand it, there were some suggestions that people with, er, underlying clotting tendencies should not have the vaccine. There’s no evidence that… any underlying medical conditions predispose to this… reaction, rare reaction. It appears out of the blue, whether you have an underlying medical condition or not.

John Skerritt: And there’s no er, formal… what we call contraindications – in other words, you must not have this vaccine if you have X.

Brendan Murphy: The Commonwealth has provided certain indemnities to the vaccine manufacturers to protect that.

Senator Jacqui Lambie: If something goes wrong, you’re stuffed. The government isn’t going to look after you, and you’re not getting compensation.

Brendan Murphy: I would hope you wouldn’t… say to the public that if something goes wrong, you’re stuffed, Senator, that would not be good…

Senator Jacqui Lambie: If you do get sick from this stuff, you will get sick. I’m not going to sit here and pretend that’s not happening. Or that it won’t happen.

Related: No Vaccine Data for Pregnancy

Thrombosis Out of the Blue

Thousands of Adverse Reactions

Vaccine Manufacturers Indemnified

Don’t Tell the Public

The post If You Get Sick, You’re Stuffed appeared first on The Truth About Covid Vaccines.

[This post contains video, click to play]

Related: If You Get Sick, You’re Stuffed

No Vaccine Data for Pregnancy

Thrombosis Out of the Blue

Thousands of Adverse Reactions

Vaccine Manufacturers Indemnified

Don’t Tell the Public

The post Texas Senate Committee Throws Out Mandatory COVID Vaccination appeared first on The Truth About Covid Vaccines.

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‘Not on my watch’ says Dr Damian Wojcik. ‘And not in my patients. My patients are living persons, with names and families. Not laboratory rats.’

Related: VAERS COVID Vaccine Data

Don’t Tell the Public

Texas Senate Committee Throws Out Mandatory COVID Vaccination

Professor Dolores Cahill Discusses Covid Vaccination Effects

Canada: Moderna Vaccine Wrecks Havoc on Lytton BC

The post New Zealand Doctor – My Patients Are Not Lab Rats to be Sacrificed in a Global Vaccine Experiment appeared first on The Truth About Covid Vaccines.

[This post contains video, click to play]

Related: Texas Senate Committee Throws Out Mandatory COVID Vaccination

Canada: Moderna Vaccine Wrecks Havoc on Lytton BC

If You Get Sick, You’re Stuffed

No Vaccine Data for Pregnancy

Thrombosis Out of the Blue

Thousands of Adverse Reactions

Vaccine Manufacturers Indemnified

Don’t Tell the Public

The post Professor Dolores Cahill Discusses Covid Vaccination Effects appeared first on The Truth About Covid Vaccines.

[This post contains video, click to play]

Professor Dolores Cahill Discusses Covid Vaccination Effects

If You Get Sick, You’re Stuffed

No Vaccine Data for Pregnancy

Thrombosis Out of the Blue

Thousands of Adverse Reactions

Vaccine Manufacturers Indemnified

Don’t Tell the Public

The post Canada: Moderna Vaccine Wreaks Havoc on Lytton BC appeared first on The Truth About Covid Vaccines.

[This post contains video, click to play]

Source: Reuters

Demonstrators walk towards Trafalgar Square as they participate in an anti-lockdown and vaccine concern protest amid the coronavirus in London, Britain, May 29, 2021.

The post Vaccine concerned and anti-lockdown protestors march through central London on Saturday. appeared first on The Truth About Covid Vaccines.

Stephanie Seneff¹ and Greg Nigh²

¹Computer Science and Artificial Intelligence Laboratory, MIT, Cambridge MA, 02139, USA, E-mail: seneff@csail.mit.edu

²Naturopathic Oncology, Immersion Health, Portland, OR 97214, USA

ABSTRACT

Operation Warp Speed brought to market in the United States two mRNA vaccines, produced by Pfizer and Moderna. Interim data suggested high efficacy for both of these vaccines, which helped legitimize Emergency Use Authorization (EUA) by the FDA.

However, the exceptionally rapid movement of these vaccines through controlled trials and into mass deployment raises multiple safety concerns.

In this review we first describe the technology underlying these vaccines in detail. We then review both components of and the intended biological response to these vaccines, including production of the spike protein itself, and their potential relationship to a wide range of both acute and long-term induced pathologies, such as blood disorders, neurodegenerative diseases and autoimmune diseases.

Among these potential induced pathologies, we discuss the relevance of prion-protein-related amino acid sequences within the spike protein. We also present a brief review of studies supporting the potential for spike protein “shedding”, transmission of the protein from a vaccinated to an unvaccinated person, resulting in symptoms induced in the latter.

We finish by addressing a common point of debate, namely, whether or not these vaccines could modify the DNA of those receiving the vaccination. While there are no studies demonstrating definitively that this is happening, we provide a plausible scenario, supported by previously established pathways for transformation and transport of genetic material, whereby injected mRNA could ultimately be incorporated into germ cell DNA for transgenerational transmission.

We conclude with our recommendations regarding surveillance that will help to clarify the long-term effects of these experimental drugs and allow us to better assess the true risk/benefit ratio of these novel technologies.

Keywords: antibody dependent enhancement, autoimmune diseases, gene editing, lipid nanoparticles, messenger RNA, prion diseases, reverse transcription, SARS-CoV-2 vaccines

Introduction

Unprecedented.

This word has defined so much about 2020 and the pandemic related to SARS-CoV-2.

In addition to an unprecedented disease and its global response, COVID-19 also initiated an unprecedented process of vaccine research, production, testing, and public distribution (Shaw, 2021).

The sense of urgency around combatting the virus led to the creation, in March 2020, of Operation Warp Speed (OWS), then-President Donald Trump’s program to bring a vaccine against COVID-19 to market as quickly as possible(Jacobs and Armstrong, 2020).

OWS established a few more unprecedented aspects of COVID-19.

First, it brought the US Department of Defense into direct collaboration with US health departments with respect to vaccine distribution (Bonsell, 2021).

Second, the National Institutes of Health (NIH) collaborated with the biotechnology company Moderna in bringing an unprecedented type of vaccine against infectious disease to market, one utilizing a technology based on messenger RNA (mRNA) (National Institutes of Health, 2020).

The confluence of these unprecedented events has rapidly brought to public awareness the promise and potential of mRNA vaccines as a new weapon against infectious diseases into the future.

At the same time, events without precedent are, by definition, without a history and context against which to fully assess risks, hoped-for benefits, safety, and long-term viability as a positive contribution to public health.

In this paper, we will be briefly reviewing one particular aspect of these unprecedented events, namely the development and deployment of mRNA vaccines against the targeted class of infectious diseases under the umbrella of “SARS-CoV-2.”

We believe many of the issues we raise here will be applicable to any future mRNA vaccine that might be produced against other infectious agents, or in applications related to cancer and genetic diseases, while others seem specifically relevant to mRNA vaccines currently being implemented against the subclass of coronaviruses.

While the promises of this technology have been widely heralded, the objectively assessed risks and safety concerns have received far less detailed attention.

It is our intention to review several highly concerning molecular aspects of infectious disease-related mRNA technology, and to correlate these with both documented and potential pathological effects.

Unprecedented

Many aspects of Covid-19 and subsequent vaccine development are unprecedented for a vaccine deployed for use in the general population. Some of these includes the following.

1. First to use PEG (polyethylene glycol) in an injection (see text)

2. First to use mRNAvaccine technology against an infectious agent

3. First time Moderna has brought any product to market

4. First to have public health officials telling those receiving the vaccination to expect an adverse reaction

5. First to be implemented publicly with nothing more than preliminary efficacy data (see text)

6. First vaccine to make no clear claims about reducing infections, transmissibility, or deaths

7. First coronavirus vaccine ever attempted in humans

8. First injection of genetically modified polynucleotides in the general populatio

Vaccine Development

Development of mRNA vaccines against infectious disease is unprecedented in many ways.

In a 2018 publication sponsored by the Bill and Melinda Gates Foundation, vaccines were divided into three categories: Simple, Complex, and Unprecedented (Young et al., 2018).

Simple and Complex vaccines represented standard and modified applications of existing vaccine technologies.

Unprecedented represents a category of vaccine against a disease for which there has never before been a suitable vaccine.

Vaccines against HIV and malaria are examples. As their analysis indicates, depicted in Figure 1, unprecedented vaccines are expected to take 12.5 years to develop.

Even more ominously, they have a 5% estimated chance of making it through Phase II trials (assessing efficacy) and, of that 5%, a 40% chance of making it through Phase III trials (assessing population benefit).

In other words, an unprecedented vaccine was predicted to have a 2% probability of success at the stage of a Phase III clinical trial.

As the authors bluntly put it, there is a “low probability of success, especially for unprecedented vaccines.” (Young et al., 2018)

Figure 1. Launching innovative vaccines is costly and time-consuming, with a low probability of success, especially for unprecedented vaccines (adapted from Young et al, 2018).

With that in mind, two years later we have an unprecedented vaccine with reports of 90-95% efficacy (Baden et al. 2020).

In fact, these reports of efficacy are the primary motivation behind public support of vaccination adoption (U.S. Department of Health and Human Services, 2020).

This defies not only predictions, but also expectations. The British Medical Journal(BMJ) may be the only prominent conventional medical publication that has given a platform to voices calling attention to concerns around the efficacy of the COVID-19 vaccines.

There are indeed reasons to believe that estimations of efficacy are in need of re-evaluation. Peter Doshi, an associate editor of the BMJ, has published two important analyses (Doshi 2021a, 2021b) of the raw data released to the FDA by the vaccine makers, data that are the basis for the claim of high efficacy.

Unfortunately, these were published to the BMJ’s blog and not in its peer-reviewed content. Doshi, though, has published a study regarding vaccine efficacy and the questionable utility of vaccine trial endpoints in BMJ’s peer reviewed content (Doshi 2020).

A central aspect of Doshi’s critique of the preliminary efficacy data is the exclusion of over 3400 “suspected COVID-19 cases” that were not included in the interim analysis of the Pfizer vaccine data submitted to the FDA.

Further, a low-but-non-trivial percent of individuals in both Moderna and Pfizer trials were deemed to be SARS-CoV-1-positive at baseline despite prior infection being grounds for exclusion.

For these and other reasons the interim efficacy estimate of around 95% for both vaccines is suspect.

A more recent analysis looked specifically at the issue of relative vs. absolute risk reduction. While the high estimates of risk reduction are based upon relative risks, absolute risk reduction is a more appropriate metric for a member of the general public to determine whether a vaccination provides a meaningful risk reduction personally.

In that analysis, utilizing data supplied by the vaccine makers to the FDA, the Moderna vaccine at the time of interim analysis demonstrated an absolute risk reduction of 1.1% (p= 0.004), while the Pfizer vaccine absolute risk reduction was 0.7% (p<0.000) (Brown 2021).

Others have brought up important additional questions regarding COVID-19 vaccine development, questions with direct relevance to the mRNA vaccines reviewed here.

For example, Haidere, et. al. (2021) identify four “critical questions” related to development of these vaccines, questions that are germane to both their safety and their efficacy:
•Will Vaccines Stimulate the Immune Response?
•Will Vaccines Provide Sustainable Immune Endurance?
•How Will SARS-CoV-2 Mutate?
•Are We Prepared for Vaccine Backfires?

Lack of standard and extended preclinical and clinical trials of the two implemented mRNA vaccines leaves each of these questions to be answered over time.

It is now only through observation of pertinent physiological and epidemiological data generated by widescale delivery of the vaccines to the general public that these questions will be resolved.

And this is only possible if there is free access to unbiased reporting of outcomes –something that seems unlikely given the widespread censorship of vaccine-related information because of the perceived need to declare success at all cost.

The two mRNA vaccines that have made it through phase 3 trials and are now being delivered to the general population are the Moderna vaccine and the Pfizer-BioNTech vaccine.

The vaccines have much in common. Both are based on mRNA encoding the spike protein of the SARS-CoV-2 virus. Both demonstrated a relative efficacy rate of 94-95%.

Preliminary indications are that antibodies are still present after three months. Both recommend two doses spaced by three or four weeks, and recently there are reports of annual booster injections being necessary (Mahose, 2021).

Both are delivered through muscle injection, and both require deep-freeze storage to keep the RNA from breaking down.

This is because, unlike double-stranded DNA which is very stable, single-strand RNA products are apt to be damaged or rendered powerless at warm temperatures and must be kept extremely cold to retain their potential efficacy (Pushparajah et al., 2021).

It is claimed by the manufacturers that the Pfizer vaccine requires storage at -94 degrees Fahrenheit (-70 degrees Celsius), which makes it very challenging to transport it and keep it cold during the interim before it is finally administered.

The Moderna vaccine can be stored for 6 months at -4 degrees Fahrenheit (-20 degrees Celsius), and it can be stored safely in the refrigerator for 30 days following thawing (Zimmer et al., 2021).

Two other vaccines that are now being administered under emergency use are the Johnson & Johnson vaccine and the AstraZeneca vaccine.

Both are based on a vector DNA technology that is very different from the technology used in the mRNA vaccines. While these vaccines were also rushed to market with insufficient evaluation, they are not the subject of this paper so we will just describe briefly how they are developed.

These vaccines are based on a defective version of an adenovirus, a double-stranded DNA virus that causes the common cold.

The adenovirus has been genetically modified in two ways, such that it cannot replicate due to critical missing genes, and its genome has been augmented with the DNA code for the SARS-CoV-2 spike protein.

AstraZeneca’s production involves an immortalized human cell line called Human Embryonic Kidney (HEK) 293, which is grown in culture along with the defective viruses (Dicks et al., 2012). The HEK cell line was genetically modified back in the 1970s by augmenting its DNA with segments from an adenovirus that supply the missing genes needed for replication of the defective virus (Louis et al., 1997). Johnson & Johnson uses a similar technique based on a fetal retinal cell line.

Because the manufacture of these vaccines requires genetically modified human tumor cell lines, there is the potential for human DNA contamination as well as many other potential contaminants.

The media has generated a great deal of excitement about this revolutionary technology, but there are also concerns that we may not be realizing the complexity of the body’s potential for reactions to foreign mRNA and other ingredients in these vaccines that go far beyond the simple goal of tricking the body into producing antibodies to the spike protein.

In the remainder of this paper, we will first describe in more detail the technology behind mRNA vaccines. We devote several sections to specific aspects of the mRNA vaccines that concern us with regard to the potential for both predictable and unpredictable negative consequences.

We conclude with a plea to governments and the pharmaceutical industry to consider exercising greater caution in the current undertaking to vaccinate as many people as possible against SARS-CoV-2.

Technology of mRNA Vaccines

In the early phase of nucleotide-based gene therapy development, there was considerably more effort invested in gene delivery through DNA plasmids rather than through mRNA technology.

Two major obstacles for mRNA are its transient nature due to its susceptibility to breakdown by RNAses, as well as its known power to invoke a strong immune response, which interferes with its transcription into protein.

Plasmid DNA has been shown to persist in muscle up to six months, whereas mRNA almost certainly disappears much sooner.

For vaccine applications, it was originally thought that the immunogenic nature of RNA could work to an advantage, as the mRNA could double as an adjuvant for the vaccine, eliminating the arguments in favor of a toxic additive like aluminum.

However, the immune response results not only in an inflammatory response but also the rapid clearance of the RNA and suppression of transcription. So this idea turned out not to be practical.

There was an extensive period of time over which various ideas were explored to try to keep the mRNA from breaking down before it could produce protein. A major advance was the realization that substituting methyl-pseudouridine for all the uridine nucleotides would stabilize RNA against degradation, allowing it to survive long enough to produce adequate amounts of protein antigen needed for immunogenesis (Liu, 2019).

This form of mRNA delivered in the vaccine is never seen in nature, and therefore has the potential for unknown consequences.

The Pfizer-BioNTech and Moderna mRNA vaccines are based on very similar technologies, where a lipid nanoparticle encloses an RNA sequence coding for the full-length SARS-CoV-2 spike protein.

In the manufacturing process, the first step is to assemble a DNA molecule encoding the spike protein. This process has now been commoditized, so it’s relatively straightforward to obtain a DNA molecule from a specification of the sequence of nucleotides (Corbett et al., 2020).

Following a cell-free in vitro transcription from DNA, utilizing an enzymatic reaction catalyzed by RNA polymerase, the single-stranded RNA is stabilized through specific nucleoside modifications, and highly purified.

The company Moderna, in Cambridge, MA, is one of the developers of deployed mRNA vaccines for SARS-CoV-2. Moderna executives have a grand vision of extending the technology for many applications where the body can be directed to produce therapeutic proteins not just for antibody production but also to treat genetic diseases and cancer, among others.

They are developing a generic platform where DNA is the storage element, messenger RNA is the “software” and the proteins that the RNA codes for represent diverse application domains.

The vision is grandiose and the theoretical potential applications are vast (Moderna, 2020). The technology is impressive, but manipulation of the code of life could lead to completely unanticipated negative effects, potentially long term or even permanent.

SARS-CoV-2 is a member of the class of positive-strand RNA viruses, which means that they code directly for the proteins that the RNA encodes, rather than requiring a copy to an antisense strand prior to translation into protein.

The virus consists primarily of the single-strand RNA molecule packaged up inside a protein coat, consisting of the virus’s structural proteins, most notably the spike protein, which facilitates both viral binding to a receptor (in the case of SARS-CoV-2 this is the ACE2 receptor) and virus fusion with the host cell membrane. The SARS-CoV-2 spike protein is the primary target for neutralizing antibodies.

It is a class I fusion glycoprotein, and it is analogous to haemagglutinin produced by influenza viruses and the fusion glycoprotein produced by syncytial viruses, as well as gp160 produced by human immunodeficiency virus (HIV) (Corbett et al., 2020).

The mRNA vaccines are the culmination of years of research in exploring the possibility of using RNA encapsulated in a lipid particle as a messenger. The host cell’s existing biological machinery is co-opted to facilitate the natural production of protein from the mRNA.

The field has blossomed in part because of the ease with which specific oligonucleotide DNA sequences can be synthesized in the laboratory without the direct involvement of living organisms.

This technology has become commoditized and can be done at large-scale, with relatively low cost. Enzymatic conversion of DNA to RNA is also straightforward, and it is feasible to isolate essentially pure single-strand RNA from the reaction soup (Kosuri and Church, 2014).

1. Considerations in mRNA Selection and Modification

While the process is simple in principle, the manufacturers of mRNA vaccines do face some considerable technical challenges.

The first, as we’ve discussed, is that extracellular mRNA itself can induce an immune response which would result in its rapid clearance before it is even taken up by cells. So, the mRNA needs to be encased in a nanoparticle that will keep it hidden from the immune system.

The second issue is getting the cells to take up the nanoparticles. This can be solved in part by incorporating phospholipids into the nanoparticle to take advantage of natural pathways of lipid particle endocytosis.

The third problem is to activate the machinery that is involved in translating RNA into protein. In the case of SARS-CoV-2, the protein that is produced is the spike protein.

Following spike protein synthesis, antigen-presenting cells need to present the spike protein to T cells, which will ultimately produce protective memory antibodies (Moderna, 2020).

This step is not particularly straightforward, because the nanoparticles are mostly taken up by muscle cells, which, being immobile, are not necessarily equipped to launch an immune response.

As we will see, the likely scenario is that the spike protein is synthesized by muscle cells and then handed over to macrophages acting as antigen-presenting cells, which then launch the standard B-cell-based antibody-generating cascade response.

The mRNA that is enclosed in the vaccines undergoes several modification steps following its synthesis from a DNA template. Some of these steps involve preparing it to look exactly like a human mRNA sequence appropriately modified to support ribosomal translation into protein. Other modifications have the goal of protecting it from breakdown, so that sufficient protein can be produced to elicit an antibody response.

Unmodified mRNA induces an immune response that leads to high serum levels of interferon-α (IF-α), which is considered an undesirable response. However, researchers have found that replacing all of the uridines in the mRNA with N-methyl-pseudouridine enhances stability of the molecule while reducing its immunogenicity (Karikó et al. 2008; Corbett et al., 2020).

This step is part of the preparation of the mRNA in the vaccines, but, in addition, a 7-methylguanosine “cap” is added to the 5’ end of the molecule and a poly-adenine (poly-A) tail, consisting of 100 or more adenine nucleotides, is added to the 3’ end. The cap and tail are essential in maintaining the stability of the mRNA within the cytosol and promoting translation into protein (Schlake et al., 2012; Gallie, 1991).

Normally, the spike protein flips very easily from a pre-fusion configuration to a post-fusion configuration. The spike protein that is in these vaccines has been tweaked to encourage it to favor a stable configuration in its prefusion state, as this state provokes a stronger immune response (Jackson et al., 2020).

This was done via a “genetic mutation,” by replacing a critical two-residue segment with two proline residues at positions 986 and 987, at the top of the central helix of the S2 subunit (Wrapp et al., 2020).

Proline is a highly inflexible amino acid, so it interferes with the transition to the fusion state. This modification provides antibodies much better access to the critical site that supports fusion and subsequent cellular uptake.

But might this also mean that the genetically modified version of the spike protein produced by the human host cell following instructions from the vaccine mRNA lingers in the plasma membrane bound to ACE2 receptors because of impaired fusion capabilities? What might be the consequence of this? We don’t know.

Researchers in China published a report in Nature in August 2020 in which they presented data on several experimental mRNA vaccines where the mRNA coded for various fragments and proteins in the SARS-CoV-2 virus.

They tested three distinct vaccine formulations for their ability to induce an appropriate immune response in mice.

The three structural proteins, S (spike), M and E are minimal requirements to assemble a “virus-like particle” (VLP). Their hypothesis was that providing M and E as well as the S spike protein in the mRNA code would permit the assembly of VLPs that might elicit an improved immune response, because they more closely resemble the natural virus than S protein exposed on the surface of cells that have taken up only the S protein mRNA from the vaccine nanoparticles.

They were also hoping that critical fragments of the spike protein would be sufficient to induce immunity, rather than the entire spike protein, if viral-like particles could be produced through augmentation with M and E (Lu et al., 2020).

They confirmed experimentally that a vaccine containing the complete genes for all three proteins elicited a robust immune response that lasted for at least eight weeks following the second dose of the vaccine.

Its performance was far superior to that of a vaccine containing only the spike protein. Disappointingly, a vaccine that contained only critical components of the spike protein, augmented with the other two envelope proteins, elicited practically no response.

Moderna researchers have conducted similar studies with similar results. They concluded that the spike protein alone was clearly inferior to a formulation containing RNA encoding all three envelope proteins, and they hypothesized that this was due to the fact that all three proteins were needed to allow the cell to release intact virus-like particles, rather than to just post the spike protein in the plasma membrane.

The spike protein alone failed to initiate a T cell response in animal studies, whereas the formulation with all three proteins did (Corbett et al., 2020). The two emergency-approved vaccines only contain mRNA code for spike protein (without E or M), and there must have been a good reason for this decision, despite its observed poor performance.

It is possible that more sophisticated design of the lipid nanoparticle (see below) resulted in the ability to have the lipids serve as an adjuvant (similar to aluminum that is commonly added to traditional vaccines) while still protecting the RNA from degradation.

Another curious modification in the RNA code is that the developers have enriched the sequence in cytosines and guanines (Cs and Gs) at the expense of adenines and uracils (As and Us). They have been careful to replace only the third position in the codon in this way, and only when it does not alter the amino acid map (Hubert, 2020).

It has been demonstrated experimentally that GC-rich mRNA sequences are expressed (translated into protein) up to 100-fold more efficiently than GC-poor sequences (Kudla et al., 2006).

So this appears to be another modification to further assure synthesis of abundant copies of the spike protein. We do not know the unintended consequences of this maneuver. Intracellular pathogens, including viruses, tend to have low GC content compared to the host cell’s genome (Rocha and Danchin, 2020).

So, this modification may have been motivated in part by the desire to enhance the effectiveness of the deception that the protein is a human protein.

All of these various modifications to the RNA are designed to make it resist breakdown, appear more like a human messenger RNA protein-coding sequence, and efficiently translate into antigenic protein.

2. Lipid Nanoparticle Construction

Lipid nanoparticles (LNPs), also known as liposomes, can encapsulate RNA molecules, protecting them from enzymatic degradation by ribonucleases, and thus they form an essential ingredient of a successful delivery method (Wadhwa et al., 2020; Xu et al., 2020).

These artificial constructs closely resemble exosomes. Exosomes are extracellular vesicles secreted by cells and taken up by their neighbors, and they also often embed DNA or RNA. Thus, these nanoparticles can take advantage of natural endocytosis processes that normally internalize extracellular exosomes into endosomes.

As the endosome acidifies to become a lysosome, the mRNA is released into the cytoplasm, and this is where translation into protein takes place. Liposomes have actually been found to be more successful at enhancing antigen presentation and maturation of dendritic cells, when compared to fusion proteins that encapsulate virus-based vaccines (Norling et al., 2019).

The lipid nanoparticles (LNPs) in these vaccines are composed of ionizable cationic lipids, phospholipids, cholesterol and polyethylene glycol (PEG). Together, this mixture assembles into a stable lipid bilayer around the mRNA molecule.

The phospholipids in these experimental vaccines consist of a phosphatidylcholine headgroup connected to two saturated alkyl tails through a glycerol linker. The lipid used in these vaccines, named 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC), has 18 repeat carbon units. The relatively long chain tends to form a gel phase rather than a fluid phase.

Molecules with shorter chains (such as a 12-carbon chain) tend to stay in a fluid phase instead. Gel phase liposomes utilizing DSPC have been found to have superior performance in protecting RNA from degradation because the longer alkyl chains are much more constrained in their movements within the lipid domain.

They also appear to be more efficient as an adjuvant, increasing the release of the cytockines tumor necrosis factor-α (TNF-α), interleukin (IL)-6 and IL-1β from exposed cells (Norling et al., 2019).

However, their ability to induce an inflammatory response may be the cause of the many symptoms people are experiencing, such as pain, swelling, fever and sleepiness.

A study published in bioRxiv verified experimentally that these ionizable cationic lipids in lipid nanoparticles induce a strong inflammatory response in mice (Ndeupen et al., 2021).

The current mRNA vaccines are delivered through intramuscular injection. Muscles contain a large network of blood vessels where immune cells can be recruited to the injection site (Zeng et al., 2020). Muscle cells generally can enhance an immune reaction once immune cells infiltrate, in response to an adjuvant (Marino et al., 2011). Careful analysis of the response to an mRNA vaccine, administered to mice, revealed that antigen is expressed initially within muscle cells and then transferred to antigen-presenting cells, suggesting “cross-priming” as the primary path for initiating a CD8 Tcell response (Lazzaro et al., 2015).

One can speculate that muscle cells make use of an immune response that is normally used to deal with misfolded human proteins. Such proteins induce upregulation of major histocompatibility complex (MHC) class II proteins, which then bind to the misfolded proteins and transport them intact to the plasma membrane (Jiang et al., 2013).

The MHC-bound surface protein then induces an inflammatory response and subsequent infiltration of antigen-presenting cells (e.g., dendritic cells and macrophages) into the muscle tissue, which then take up the displayed proteins and carry them into the lymph system to present them to T-cells.

These T-cells can then finally launch the cascade that ultimately produces memory antibodies specific to the protein. Muscle cells do express MHC class II proteins (Cifuentes-Diaz et al., 1992).

As contrasted with class I, class II MHC proteins specialize in transporting intact proteins to the surface as opposed to small peptide sequences derived from the partial breakdown of the proteins (Jiang et al., 2013).

An in vitro study on non-human primates demonstrated that radiolabeled mRNA moved from the injection site into the draining lymph node and remained there for at least 28 hours.

Antigen-presenting cells (APCs) in both the muscle tissue as well as the draining lymph nodes were shown to contain radiolabeled mRNA (Lindsay et al., 2019).

Classical APCs include dendritic cells, macrophages, Langerhans cells (in the skin) and B cells. Many of the side effects associated with these vaccines involve pain and inflammation at the injection site, as would be expected given the rapid infiltration of immune cells.

Lymphadenopathy is an inflammatory state in the lymph system associated with swollen lymph nodes. Swollen lymph nodes in the arm pit (axillary lymphadenopathy) is a feature of metastatic breast cancer.

A paper published in 2021 described four cases of women who developed axillary lymphadenopathy following a SARS-CoV-2 vaccine (Mehta et al., 2021). The authors urged caution in misinterpreting this condition as an indicator requiring biopsy follow-up for possible breast cancer.

This symptom corroborates tracer studies showing that the mRNA vaccine is predominantly taken up by APCs that then presumably synthesize the antigen (spike protein) from the mRNA and migrate into the lymph system, displaying spike protein on their membranes.

A list of the most common adverse effects reportedby the FDA that were experienced during the Pfizer-BioNTech clinical trials include “injection site pain, fatigue, headache, muscle pain, chills, joint pain, fever, injection site swelling, injection site redness, nausea, malaise, and lymphadenopathy.” (US Food and Drug Administration, 2021).

We turn now to individual molecular and organ system concerns that arise with these mRNA vaccines.

Adjuvants, Polyethylene Glycol, and Anaphylaxis

Adjuvants are vaccine additives intended to “elicit distinctive immunological profiles with regard to the direction, duration, and strength of immune responses” from the vaccines to which they are added (Liang et al., 2020).

Alum or other aluminum compounds are most commonly utilized in traditional vaccines, and they elicit a wide range of systemic immune activation pathways as well as stromal cell activation at the site of the injection (Lambrecht et al., 2009; Danielsson & Eriksson, 2021).

An aluminum-based adjuvant was determined not to be optimal for a coronavirus vaccine, so other solutions were sought (Liang et. al., 2020).

A solution presented itself in the form of the widely used pharmaceutical ingredient polyethylene glycol, or PEG. A limiting factor in the use of nucleic-acid-based vaccines is the tendency for the nucleic acids to be quickly degraded by nuclease enzymes (Ho et al., 2021).

Regarding the RNAse enzymes targeting injected mRNA, these enzymes are widely distributed both intracellularly (primarily within the lysosomes) (Fujiwara et al., 2017) and extracellularly (Lu et al., 2018). To overcome this limitation, both mRNA vaccines currently deployed against COVID-19 utilize lipid-based nanoparticles as delivery vehicles.

The mRNA cargo is placed inside a shell composed of synthetic lipids and cholesterol, along with PEG to stabilize the mRNA molecule against degradation. The vaccine produced by Pfizer/BioNTech creates nanoparticles from 2-[(polyethylene glycol)-2000]-N,N-ditetradecylacetamide, or ALC-0159, commonly abbreviated simply as PEG (World Health Organization, 2021, January 14).

The Moderna vaccine contains another PEG variant, SM-102, 1,2-dimyristoyl-rac-glycero-3-methoxypolyethylene glycol2000 (World Health Organization, 2021, January 19).

For convenience we will abbreviate both PEG-modified lipids as PEG, and refer to the vaccines as PEGylated according to standard nomenclature.

The lipid shell plays a triple role. First, it protects the genetic material from degradation prior to cellular uptake. Second, the lipid shell, which also contains cholesterol, facilitates cellular uptake through fusion with the lipid membrane of the cell and subsequent endocytosis of the lipid particle, invoking naturally existing processes. And finally, it acts as an adjuvant (Ho et al., 2021).

It is in this latter role as immune stimulant that most concerns have been raised regarding the widespread use of PEG in an injection therapy.

In an article published in May 2019, prior to large clinical trials involving these PEGylated vaccines, Mohamed et. al. (2019) described a number of concerning findings regarding PEG and the immunological activation it had been shown to produce, which includes humoral, cell-mediated, and complement-based activation.

They note that, paradoxically, large injection doses of PEG cause no apparent allergic reaction. Small doses, though, can lead to dramatic pathological immune activation. l

Vaccines employing PEGylation utilize micromolar amounts of these lipids, constituting this potentially immunogenic low-dose exposure.

In animal studies it has been shown that complement activation is responsible for both anaphylaxis and cardiovascular collapse, and injected PEG activates multiple complement pathways in humans as well.

The authors of one study conclude by noting that “This cascade of secondary mediators substantially amplifies effector immune responses and may induce anaphylaxis in sensitive individuals. Indeed, recent studies in pigs have demonstrated that systemic complement activation (e.g., induced following intravenous injection of PEGylated liposomes) can underlie cardiac anaphylaxis where C5a played a causal role.” (Hamad et al., 2008)

It is also important to note that anaphylactoid shock in pigs occurred not with first injected exposure, but following second injected exposure (Kozma et al., 2019). The presence of antibodies against PEG is widespread in the population (Zhou et al., 2020). Yang and Lai (2015) found that around 42% of blood samples surveyed contained anti-PEG antibodies, and they warn that these could have important consequencesfor any PEG-based therapeutics introduced.

Hong et. al. (2020) found anti-PEG antibodies with a prevalence up to 72% in populations with no prior exposure to PEG-based medical therapy.

Lila et. al. (2018) note that the “existence of such anti-PEG antibodies has been intimately correlated with an impairment of therapeutic efficacy in tandem with the development of severe adverse effects in several clinical settings employing PEGylated-based therapeutics.”

Anaphylaxis to vaccines has previously been assumedto be rare based on the frequency of such events reported to VAERS, a database established by the Centers for Disease Control and Prevention in 1990 for reporting of adverse events related to vaccines (Centers for Disease Control and Prevention, 1990; Su et al., 2019).

While rare, anaphylaxis can be life-threatening, so it is important to monitor for the possibility in the short period following vaccination (McNeil et al., 2016).Sellaturay et. al., after reviewing 5 cases of anaphylaxis they link to PEG exposure, one near-fatal and involving cardiac arrest, write, “PEG is a high-risk ’hidden’ allergen, usually unsuspected and can cause frequent allergic reactions due to inadvertent re-exposure.

Allergy investigation carries the risk of anaphylaxis and should be undertaken only in specialist drug allergy centres.” (Sellaturay et al., 2020). In fact it has already been demonstrated that pre-existing antibodies to PEG are linked to more common and more severe reactions upon re-exposure (Ganson et al., 2016).

Is anaphylaxis upon exposure to PEG happening with a frequency relevant to public health? Numerous studies have now documented the phenomenon (Lee et al., 2015; Povsic et al., 2016; Wylon et al., 2016).

Anaphylactic reactions to the mRNA vaccines are widely reported in the media (Kelso, 2021) and, as noted above, have been frequently reported in the VAERS database (690 reports of anaphylaxis following SARS-CoV-2 vaccines up to January 29, 2021).

There are also some initial case studies published in the peer-reviewed literature (Garvey & Nasser, 2020; CDC COVID-19 Response Team, 2021, January 15). Anaphylaxis reactions to vaccines prior to these COVID-19 vaccines were generally reported at rates less than 2 cases per million vaccinations (McNeil et al., 2016), while the current rate with the COVID-19 vaccinations was reported by the CDC to be more than 11 cases per million (CDC COVID-19 Response Team, 2021, January 29).

However, a published prospective study on 64,900 medical employees, where their reactions to their first mRNA vaccination were carefully monitored, found that 2.1% of the subjects reported acute allergic reactions.

A more extreme reaction involving anaphylaxis occurred at a rate of 247 per million vaccinations (Blumenthal et al., 2021). This is more than 21 times as many as were initially reported by the CDC.

The second injection exposure is likely to cause even larger numbers of anaphylactic reactions.

mRNA Vaccines, Spike Proteins, and Antibody-Dependent Enhancement (ADE)

ADE is an immunological phenomenon first described in 1964 (Hawkes et al., 1964). In that publication Hawkes described a set of experiments in which cultures of flavivirus were incubated with avian sera containing high titers of antibodies against those viruses.

The unexpected finding was that, with increasingly high dilutions of the antibody-containing sera, cell infectivity was enhanced. Lack of an explanation for how this could happen is likely responsible for its being largely ignored for almost 20 years (Morens et al., 1994).

Multiple pathways have been proposed through which antibodies both directly and indirectly participate in the neutralization of infections (Lu et al., 2018b).

ADE is a special case of what can happen when low, non-neutralizing levels of either specific or cross-reactive antibodies against a virus are present at the time of infection. These antibodies might be present due to prior exposure to the virus, exposure to a related virus, or due to prior vaccination against the virus.

Upon reinfection, antibodies in insufficient numbers to neutralize the virus nevertheless bind to the virus. These antibodies then dock at the Fc receptor on cell surfaces, facilitating viral entry into the cell and subsequently enhancing the infectivity of the virus (Wan et. al.,2020).

ADE is believed to underlie the more severe dengue fever often observed in those with previous exposure (Beltramello et al., 2010), and might also play a role in more severe disease among those previously vaccinated against the disease (Shukla et al., 2020).

ADE is also believed to play a role in Ebola (Takada et al., 2003), zika virus infection (Bardina et al., 2017), and other flavivirus infections (Campos et al., 2020).

In an extended correspondence published in Nature Biotechnology, Eroshenko et. al. offer a comprehensive review of evidence suggesting that ADE could become manifest with any vaccinations employed against SARS-CoV-2.

Importantly, they note that ADE has been observed with coronavirus vaccines tested in both in Vitro and in Vivo models (Eroshenko et al., 2020). Others have warned about the same possibility with SARS-CoV-2 vaccines.

A theory for how ADE might occur in the case of a SARS-CoV-2 vaccine suggests that non-neutralizing antibodies form immune complexes with viral antigens to provoke excessive secretion of pro-inflammatory cytokines, and, in the extreme case, a cytokine storm causing widespread local tissue damage (Lee et al., 2020).

One extensive review of ADE potentially associated with SARS-CoV-2 vaccines noted, “At present, there are no known clinical findings, immunological assays or biomarkers that can differentiate any severe viral infection from immune-enhanced disease, whether by measuring antibodies, T cells or intrinsic host responses” (Arvin et al. 2020; Liu et al.,2019). We will return to this point again below.

Preexisting immunoglobulin G (IgG) antibodies, induced by prior vaccination, contribute to severe pulmonary damage by SARS-CoV in macaques (Liu et al., 2019).

Peron and Nakaya (2020) provide evidence suggesting that the much more diverse range of prior exposures to coronaviruses experienced by the elderly might predispose them to ADE upon exposure to SARS-CoV-2.

A concerning pre-print article reported that plasma from 76% of patients who had recovered from severe COVID-19 disease, when added to cultures of SARS-CoV-2 and susceptible cells, exhibited enhanced ability for SARS-CoV-2 viral infection of Raji cells (Wu et al., 2020).

The authors note that “the antibody titers [against the spike protein] were higher in elderly patients of COVID-19, and stronger antibody response was associated with delayed viral clearance and increased disease severity in patients. Hence it is reasonable to speculate that S protein-specific antibodies may contribute to disease severity during SARS-CoV-2 infection.” (Wu et al., 2020)

It has been reported that all three US vaccine manufacturers –Moderna, Pfizer, and Johnson & Johnson –are working to develop booster shots (Zaman 2021).With tens of millions of young adults and even children now with vaccine-induced coronavirus spike protein antibodies, there exists the possibility of triggering ADE related to either future SARS-CoV-2 infection or booster injection among this younger population. Time will tell.

The mRNA vaccines ultimately deliver the highly antigenic spike protein to antigen-presenting cells. As such, monoclonal antibodies against the spike protein are the expected outcome of the currently deployed mRNA vaccines.

Human spike protein monoclonal antibodies were found to produce high levels of cross-reactive antibodies against endogenous human proteins (Vojdani et. al., 2021; reviewed in more detail below).

Given evidence only partially reviewed here, there is sufficient reason to suspect that antibodies to the spike protein will contribute to ADE provoked by prior SARS-CoV-2 infection or vaccination, which may manifest as either acute or chronic autoimmune and inflammatory conditions.

We have noted above that it is not possible to distinguish an ADE manifestation of disease from a true, non-ADE viral infection. In this light, it is important to recognize that, when diseases and deaths occur shortly after vaccination with an mRNA vaccine, it can never be definitively determined, even with a full investigation, that the vaccine reaction was not a proximal cause.

Pathogenic Priming, Multisystem Inflammatory Disease, and Autoimmunity

Pathogenic priming is a concept that is similar in outcome to ADE, but different in the underlying mechanism. We discuss it here as a unique mechanism through which the mRNA vaccines could provoke associated pathologies.

In April 2020 an important paper was published regarding the potential for self-reactive antibodies to be generated following exposure to the spike protein and other antigenic epitopes spread over the length of SARS-CoV-2.

Lyons-Weiler (2020) coined the phrase “pathogen priming” because he believed the more commonly used “immune enhancement” fails to capture the severity of the condition and its consequences.

In his in silico analysis, Lyons-Weiler compared all antigenic SARS-CoV-2 protein epitopes flagged in the SVMTriP database (http://sysbio.unl.edu/SVMTriP/) and searched the p-BLAST database (https://blast.ncbi.nlm.nih.gov/Blast.cgi) for homology between those epitopes and endogenous human proteins.

Of the 37 SARS-CoV-2 proteins analyzed, 29 had antigenic regions. All but one of these 29 had homology with human proteins (putative self-antigens)and were predicted to be autoreactogenic.

The largest number of homologies were associated with the spike (S) protein and the NS3 protein, both having 6 homologous human proteins.

Functional analysis of the endogenous human proteins homologous with viral proteins found that over 1/3 of them are associated with the adaptive immune system.

The author speculates that prior virus exposure or prior vaccination, either of which could initiate antibody production that targets these endogenous proteins, may be playing a role in the development of more severe disease in the elderly in particular.

In this case, the pre-existing antibodies act to suppress the adaptive immune system and lead to more severe disease.

Another group (Ehrenfeld et. al., 2020), in a paper predominantly about the wide range of autoimmune diseases found in association with a prior SARS-CoV-2 infection, also investigated how the spike protein could trigger such a range of diseases.

They report, in Table 1 of that reference, strings of heptapeptides within the human proteome that overlap with the spike protein generated by SARS-CoV-2. They identified 26 heptapeptides found in humans and in the spike protein.

It is interesting to note that 2 of the 26 overlapping heptapeptides were found to be sequential, a strikingly long string of identical peptides to be found in common between endogenous human proteins and the spike protein.

Commenting on the overlapping peptides they had discovered and the potential for this to drive many types of autoimmunity simultaneously, they comment, “The clinical scenario that emerges is upsetting.” Indeed, it is.

In May of 2020, another important paper in this regard was published by Vojdani and Kharrazian (2020). The authors used both mouse and rabbit monoclonal antibodies against the 2003 SARS spike protein to test for reactivity against not only the spike protein of SARS-CoV-2, but also against several endogenous human proteins.

They discovered that there was a high level of binding not only with the SARS-CoV-2 spike protein, but against a wide range of endogenous proteins. “[W]e found that the strongest reactions were with transglutaminase 3 (tTG3), transglutaminase 2 (tTG2), ENA, myelin basic protein (MBP), mitochondria, nuclear antigen (NA), α-myosin, thyroid peroxidase (TPO), collagen, claudin 5+6, and S100B.” (Vojdani and Kharrazian, 2020).

These important findings need to be emphasized.

Antibodies with a high binding affinity to SARS-CoV-2 spike and other proteins also have a high binding affinity with tTG (associated with Celiac Disease), TPO (Hashimoto’s thyroiditis), myelin basic protein (multiple sclerosis), and several endogenous proteins.

Unlike the autoimmune process associated with pathogen priming, these autoimmune diseases typically take years to manifest symptomatically.

The autoantibodies generated by the spike protein predicted by Lyons-Weiler (2020) and described above were confirmed with an in vitro study published more recently. In this follow-on paper, Vojdani et. al., (2021) looked again at the issue of cross-reactivity of antibodies, this time using human monoclonal antibodies (mAbs) against the SARS-CoV-2 spike protein rather than mouse and rabbit mAbs.

Their results confirmed and extended their prior findings. “At a cutoff of 0.32 OD [optical density], SARS-CoV-2 membrane protein antibody reacted with 18 out of the 55 tested antigens.” These 18 endogenous antigens encompass reactivity to tissue in liver, mitochondria, the nervous and digestive system, the pancreas, and elsewhere in the body.

In a report on multisystem inflammatory syndrome in children (MIS-C), Carter et. al. (2020) studied 23 cases. Seventeen of 23 (68%) patients had serological evidence of prior SARS-CoV-2 infection.

Of the three antibodies assessed in the patient population (nucleocapsid, RBD, and spike), IgG spike protein antibody optical density (which quantifies antibody concentrations against a standardized curve (Wikipedia, 2021)), was highest (see Figure 1d in Carter et al., 2020).

MIS-C is now commonly speculated to be an example of immune priming by prior exposure to SARS-CoV-2 or to other coronaviruses. Buonsenso et. al. (2020) reviewed multiple immunologic similarities between MIS-C and disease related to prior β-hemolytic Group A streptococcal infection (GAS).

The authors write, “We can speculate that children’s multiple exposition to SARS-CoV-2 with parents with COVID-19 can work as a priming of the immune system, as happens with GAS infection and, in genetically predisposed children, lead to [MIS-C] development.

Anotherhypothesis is that previous infections with other coronaviruses, much more frequent in the pediatric population, may have primed the child immune system to SARS-CoV-2 virus.”

In June 2019 Galeotti and Bayry (2020) reviewed the occurrence of both autoimmune and inflammatory diseases in patients with COVID-19. They focus their analysis on MIS-C. After reviewing several previously published reports of a temporal link between COVID-19 and onset of MIS-C and describing a number of possible mechanistic connections between the two, the authors noted that no causal link had been established.

In a somewhat prescient recommendation, they wrote, “A fine analysis of homology between various antigens of SARS-CoV-2 and self-antigens, by use of in silico approaches and validation in experimental models, should be considered in order to confirm this hypothesis.”

It is precisely this type of in silico analysis carried out by Lyons-Weiler (2020) and by Ehrenfeld et. al. (2020) described in the opening paragraphs of this section which found the tight homology between viral antigens and self-antigens. While this may not definitively confirm the causal link hypothesized by Galeotti and Bayry, it is strong supporting evidence.

Autoimmunity is becoming much more widely recognized as a sequela of COVID-19.

There are multiple reports of previously healthy individuals who developed diseases such as idiopathic thrombocytopenic purpura, Guillain-Barré syndrome and autoimmune haemolytic anaemia (Galeotti and Bayry, 2020).

There are three independent case reports of systemic lupus erythemosus (SLE) with cutaneous manifestations following symptomatic COVID-19. In one case a 39-year-old male had SLE onset two months following outpatient treatment for COVID-19 (Zamani et.al., 2021).

Another striking case of rapidly progressing and fatal SLE with cutaneous manifestations is described by Slimani et.al. (2021). Autoantibodies are very commonly found in COVID-19 patients, including antibodies found in blood (Vlachoyiannopoulos et. al., 2020) and cerebrospinal fluid (CFS) (Franke et. al., 2021).

Though SARS-CoV-2 is not found in the CSF, it is theorized that the autoantibodies created in response to SARS-CoV-2 exposure may lead to at least some portion of the neurological complications documented in COVID-19 patients.

One important Letter to the Editor submitted to the journal Arthritis & Rheumatologyby Bertin et. al. (2020) noted the high prevalence and strong association (p=0.009) of autoantibodies against cardiolipin in COVID-19 patients with severe disease.

Zuo et. al. (2020) found anti-phospholipid autoantibodies in 52% of hospitalized COVID-19 patients and speculated that these antibodies contribute to the high incidence of coagulopathies in these patients.

Schiaffino et. al. (2020) reported that serum from a high percentage of hospitalized COVID-19 patients contained autoantibodies reactive to the plasma membrane of hepatocytes and gastric cells.

One patient with Guillain-Barre Syndrome was found to have antibody reactivity in cerebrospinal fluid (CFS), leading the authors to suggest that cross-reactivity with proteins in the CFS could lead to neurological complications seen in some COVID-19 patients.

In a more recent review, Gao et. al. (2021) noted high levels of autoantibodies in COVID-19 patients across multiple studies. They conclude, “[O]ne of the potential side effects of giving a mass vaccine could be an mergence [sic] of autoimmune diseases especially in individuals who are genetically prone for autoimmunity.”

A recent publication compiles a great deal of evidence that autoantibodies against a broad range of receptors and tissue can be found in individuals who have had previous SARS-CoV-2 infection. “All 31 former COVID-19 patients had between 2 and 7 different GPCR-fAABs [G-protein coupled receptor functional autoantibodies] that acted as receptor agonists.”(Wallukat et. al. 2021)

The diversity of GPCR-fAABs identified, encompassing both agonist and antagonist activity on target receptors, strongly correlated with a range of post-COVID-19 symptoms, including tachycardia, bradycardia, alopecia, attention deficit, PoTS, neuropathies, and others.

The same study, referencing the autoantibodies predicted by Lyons-Weiler (2020) mentioned above, notes with obvious grave concern: “The Sars-CoV-2 spike protein is a potential epitopic target for biomimicry-induced autoimmunological processes [25]. Therefore, we feel it will be extremely important to investigate whether GPCR-fAABs will also become detectable after immunisation by vaccination against the virus.”

We have reviewed the evidence here that the spike protein of SARS-CoV-2 has extensive sequence homology with multiple endogenous human proteins and could prime the immune system toward development of both auto-inflammatory and autoimmune disease.

This is particularly concerning given that the protein has been redesigned with two extra proline residues to potentially impede its clearance from the circulation through membrane fusion.

These diseases could present acutely and over relatively short timespans such as with MIS-C or could potentially not manifest for months or years following exposure to the spike protein, whether via natural infection or via vaccination.

Many who test positive for COVID-19 express no symptoms. The number of asymptomatic, PCR-positive cases varies widely between studies, from a low of 1.6% to a high of 56.5% (Gao et. al., 2020).

Those who are insensitive to COVID-19 probably have a very strong innate immune system. The healthy mucosal barrier’s neutrophils and macrophages rapidly clear the viruses, often without the need for any antibodies to be produced by the adaptive system. However, the vaccine intentionally completely bypasses the mucosalimmune system, both through its injection past the natural mucosal barriers and its artificial configuration as an RNA-containing nanoparticle.

As noted in Carsetti (2020), those with a strong innate immune response almost universally experience either asymptomatic infection or only mild COVID-19 disease presentation. Nevertheless, they might face chronic autoimmune disease, as described previously, as a consequence of excessive antibody production in response to the vaccine, which was not necessary in the first place.

The Spleen, Platelets and Thrombocytopenia

Dr. Gregory Michael, an obstetrician in Miami Beach, died of a cerebral hemorrhage 16 days after receiving the first dose of the Pfizer/BioNTech COVID-19 vaccine. Within three days of the vaccine, he developed idiopathic thrombocytopenic purpura (ITP), an autoimmune disorder in which the immune cells attack and destroy the platelets. His platelet count dropped precipitously, and this caused an inability to stop internal bleeding, leading to the stroke, as described in an article in the New York Times (Grady and Mazzei, 2021).

The New York Times followed up with a second article that discussed several other cases of ITP following SARS-CoV-2 vaccination (Grady, 2021), and several other incidences ofprecipitous drop of platelets and thrombocytopenia following SARS-CoV-2 vaccination have been reported in the Vaccine Adverse Event Reporting System (VAERS).

1. Biodistribution of mRNA Vaccines

Several studies on mRNA-based vaccines have confirmed independently that the spleen is a major center of activity for the immune response. A study on an mRNA-based influenza virus vaccine is extremely relevant for answering the question of the biodistribution of the mRNA in the vaccine.

This vaccine, like the SARS-CoV-2 vaccines, was designed as lipid nanoparticles with modified RNA coding for hemagglutinin (the equivalent surface fusion protein to the spike protein in corona viruses), and was administered through muscular injection.

The concentration of mRNA was tracked over time in various tissue samples, and the maximum concentration observed at each site was recorded. Not surprisingly, the concentration was highest in the muscle at the injection site (5,680 ng/mL).

This level decreased slowly over time, reaching half the original value at 18.8 hours following injection. The next highest level was observed in the proximal lymph node, peaking at 2,120 ng/mL and not dropping to half this value until 25.4 hours later. Among organs, the highest levels by far were found in the spleen (86.69 ng/mL) and liver (47.2 ng/mL). Elsewhere in the body the concentration was at 100-to 1,000-fold lower levels. In particular, distal lymph nodes only had a peak concentration of 8 ng/mL.

They concluded that the mRNA distributes from the injection site to the liver and spleen via the lymphatic system, ultimately reaching the general circulation. This likely happens through its transport inside macrophages and other immune cells that take it up at the muscular injection site.

Disturbingly, it also reaches into the brain, although at much lower levels (Bahl et al., 2017).

The European Medicines Agency assessment report for the Moderna vaccine also noted that mRNA could be detected in the brain following intramuscular administration at about 2% of the level found in the plasma (European Medicines Agency, 2021).

In another experiment conducted to track the biodistribution pathway of RNA vaccines, a rabies RNA vaccine was administered intramuscularly to rats in a single dose. The vaccine included a code for an immunogenic rabies protein as well as the code for RNA polymerase and was formulated as an oil-in-water nanoemulsion.

Thus, it is not entirely representative of the SARS-CoV-2 mRNA vaccines. Nevertheless, its intramuscular administration and its dependence on RNA uptake by immune cells likely means that it would migrate through the tissues in a similar pathway as the SARS-CoV-2 vaccine.

The authors observed an enlargement of the draining lymph nodes, and tissue studies revealed that the rabies RNA appeared initially at the injection site and in the draining lymph nodes within one day, and was also found in blood, lungs, spleen and liver (Stokes et al., 2020).

These results are consistent with the above study on influenza mRNA vaccines.Finally, a study comparing luciferase-expressing mRNA nanoparticles with luciferase-expressing mRNA dendritic cells as an alternative approach to vaccination revealed that the luciferase signal reached a broader range of lymphoid sites with the nanoparticle delivery mechanism.

More importantly, the luciferase signal was concentrated in the spleen for the nanoparticles compared to dominance in the lungs for the dendritic cells (Firdessa-Fite and Creuso, 2020).

2.Immune Thrombocytopenia

Immune thrombocytopenia (ITP) has emerged as an important complication of COVID-19 (Bhattacharjee and Banerjee, 2020). In many cases, it emerges after full recovery from the disease, i.e, after the virus has been cleared, suggesting it is an autoimmune phenomenon.

A likelypathway by which ITP could occur following vaccination is through the migration of immune cells carrying a cargo of mRNA nanoparticles via the lymph system into the spleen. These immune cells would produce spike protein according to the code in the nanoparticles, and the spike protein would induce B cell generation of IgG antibodies to it.

ITP appears initially as petechiae or purpura on the skin, and/or bleeding from mucosal surfaces. It has a high risk of fatality through haemorrhaging and stroke. ITP is characterized by both increased platelet destruction and reduced platelet production, and autoantibodies play a pivotal role (Sun and Shan, 2019).

Platelets are coated by anti-platelet antibodies and immune complexes, and this induces their clearance by phagocytes. Particularly under conditions of impaired autophagy, the resulting signaling cascade can also result in suppression of production of megakaryocytes in the bone marrow, which are the precursor cells for platelet production (Sun and Shan, 2019).

A case study of a patient diagnosed with COVID-19 is revealing because he developed sudden onset thrombocytopenia a couple of days after he had been released from the hospital based on a negative COVID-19 nucleic acid test. Following this development, it was verified that the patient had a reduced number of platelet-producing megakaryocytes, while autoimmune antibodies were negative, suggesting a problem with platelet production rather than platelet destruction (Chen et al., 2020).

Platelets appear to play an important role in viral clearance. Within one minute after platelets were incubated together with influenza viruses, the viruses had already attached to the platelets. Subsequent internalization, possibly by phagocytosis, peaked at 30 minutes (Jansen et al., 2020).

The SARS-CoV-2 spike protein bindssialic acid, which means it could attach to glycoproteins in the platelet membranes (Baker et al., 2020). There is a structural similarity between the S1 spike protein in SARS CoV and neuraminidase expressed by the influenza virus, which might mean that the spike protein possesses neuraminidase activity (Zhang et al., 2004).

Several viruses express neuraminidase, and it generally acts enzymatically to catabolize the glycans in glycoproteins through desialylation. Thus, it seems plausible that a dangerous cascade leading to ITP could ensue following mRNA vaccination, even with no live virus present, particularly in the context of impaired autophagy.

Immune cells in the arm muscle take up the RNA particles and circulate within the lymph system, accumulating in the spleen. There, the immune cells produce abundant spike protein, which binds to the platelet glycoproteins and desialylates them. Platelet interaction with neutrophils causes NETosis and the launch of an inflammatory cascade.

The exposed glycoproteins become targets for autoimmune antibodies that then attack and remove the platelets, leading to a rapid drop in platelet counts, and a life-threatening event.

Activation of Latent Herpes Zoster

An observational study conducted at Tel Aviv Medical Center and the Carmel Medical Center in Haifa, Israel, found a significantly increased rate of herpes zoster following the Pfizer vaccination (Furer 2021). This observational study monitored patients with pre-existing autoimmune inflammatory rheumatic diseases (AIIRD). Among the 491 patients with AIIRD over the study period, 6 (1.2%) were diagnosed with herpes zoster as a first-ever diagnosis between 2 days and 2 weeks after either the first or second vaccination.

In the control group of 99 patients there were no herpes zoster cases identified. The CDC’s VAERS database, queried on April 19, 2021, contains 278 reports of herpes zoster following either the Moderna or Pfizer vaccinations.

Given the documented underreporting to VAERS (Lazarus et al. 2010), and given the associational nature of VAERS reports, it is not possible to prove any causal link between the vaccinations and the zoster reports.

However, we believe the occurrence of zoster is another important ‘signal’ in VAERS.This increased risk to shingles, if valid, may have important broader implications. Multiple studies have shown that patients with either primary or acquired immune deficiency are more susceptible to severe herpes zoster infection (Ansari et al., 2020).

This suggests that the mRNA vaccines may be suppressing the innate immune response. There is cross-talk between TNF-α and type I interferon in autoimmune disease, wherein each suppresses the other (Palucka et al., 2005). Type I interferon inhibits varicella-zoster virus replication (Ku et al., 2016). TNF-α is sharply upregulated in an inflammatory response, which is induced by the lipid nanoparticles in the vaccine. Its upregulation is also associated with the chronic inflammatory state of rheumatoid arthritis (Matsuno et al., 2002). Exuberant TNF-α expression following vaccination may be interfering with the dendritic cell INF-α response that keeps latent herpes zoster in check.

Spike Protein Toxicity

The picture is now emerging that SARS-CoV-2 has serious effects on the vasculature in multiple organs, including the brain vasculature. As mentioned earlier, the spike protein facilitates entry of the virus into a host cell by binding to ACE2 in the plasma membrane. ACE2 is a type I integral membrane protein that cleaves angiotensin II into angiotensin(1-7), thus clearing angiotensin II and lowering blood pressure. In a series of papers, Yuichiro Suzuki in collaboration with other authors presented a strong argument that the spike protein by itself can cause a signaling response in the vasculature with potentially widespread consequences (Suzuki, 2020; Suzuki et al., 2020; Suzuki et al., 2021; Suzuki and Gychka, 2021).

These authors observed that, in severe cases of COVID-19, SARS-CoV-2 causes significant morphological changes to the pulmonary vasculature. Post-mortem analysis of the lungs of patients who died from COVID-19 revealed histological features showing vascular wall thickening, mainly due to hypertrophy of the tunica media.

Enlarged smooth muscle cells had become rounded, with swollen nuclei and cytoplasmic vacuoles (Suzuki et al., 2020). Furthermore, they showed that exposure of cultured human pulmonary artery smooth muscle cells to the SARS-CoV-2 spike protein S1 subunit was sufficient to promote cell signaling without the rest of the virus components.

Figure 2: A simple model for a process by which the spike protein produced through the mRNA vaccines could induce a pathological response distinct from the desirable induction of antibodies to suppress viral entry. Redrawn with permission from Suzuki and Gychka, 2021.

Follow-on papers (Suzuki et al., 2021, Suzuki and Gychka, 2021) showed that the spike protein S1 subunit suppresses ACE2, causing a condition resembling pulmonary arterial hypertension (PAH), a severe lung disease with very high mortality. Their model is depicted here in Figure 2.

Ominously, Suzuki and Gychka (2021) wrote: “Thus, these in vivo studies demonstrated that the spike protein of SARS-CoV-1 (without the rest of the virus) reduces the ACE2 expression, increases the level of angiotensin II, and exacerbates the lung injury.”

The “in vivo studies” they referred to here (Kuba et al., 2005) had shown that SARS coronavirus-induced lung injury was primarily due to inhibition of ACE2 by the SARS-CoV spike protein, causing a large increase in angiotensin-II.

Suzuki et al. (2021) went on to demonstrate experimentally that the S1 component of the SARS-CoV-2 virus, at a low concentration of 130 pM, activated the MEK/ERK/MAPK signaling pathway to promote cell growth. They speculated that these effects would not be restricted to the lung vasculature.

The signaling cascade triggered in the heart vasculature would cause coronary artery disease, and activation in the brain could lead to stroke. Systemic hypertension would also be predicted. They hypothesized that this ability of the spike protein to promote pulmonary arterial hypertension could predispose patients who recover from SARS-CoV-2 to later develop right ventricular heart failure.

Furthermore, they suggested that a similar effect could happen inresponse to the mRNA vaccines, and they warned of potential long-term consequences to both children and adults who received COVID-19 vaccines based on the spike protein (Suzuki and Gychka, 2021).

An interesting study by Lei et. al. (2021) found that pseudovirus —spheres decorated with the SARS-CoV-2 S1 protein but lacking any viral DNA in theircore —caused inflammation and damage in both the arteries and lungs of mice exposed intratracheally.

They then exposed healthy human endothelial cells to the samepseudovirus particles. Binding of these particles to endothelial ACE2 receptors led to mitochondrial damage and fragmentation in those endothelial cells, leading to the characteristic pathological changes in the associated tissue.

This study makes it clear that spike protein alone, unassociated with the rest of the viral genome, is sufficient to cause the endothelial damage associated with COVID-19.

The implications for vaccines intended to cause cells to manufacture the spike protein are clear and are an obvious cause for concern.

Neurological symptoms associated with COVID-19, such as headache, nausea and dizziness, encephalitis and fatal brain blood clots are all indicators of damaging viral effects on the brain.

Buzhdygan et al. (2020) proposed that primary human brain microvascular endothelial cells could cause these symptoms. ACE2 is ubiquitously expressed in the endothelial cells in the brain capillaries. ACE2 expression is upregulated in the brain vasculature in association with dementia and hypertension, both of which are risk factors for bad outcomes from COVID-19.

In an in vitro study of the blood-brain barrier, the S1 component of the spike protein promoted loss of barrier integrity, suggesting that the spike protein acting alone triggers a pro-inflammatory response in brain endothelial cells, which could explain the neurological consequences of the disease (Buzhdygan et al., 2020).

The implications of this observation are disturbing because the mRNA vaccines induce synthesis of the spike protein, which could theoretically act in a similar way to harm the brain.

The spike protein generated endogenously by the vaccine could also negatively impact the male testes, as the ACE2 receptor is highly expressed in Leydig cells in the testes (Verma et al., 2020). Several studies have now shown that the coronavirus spike protein is able to gain access to cells in the testes via the ACE2 receptor, and disrupt male reproduction (Navarra et al., 2020; Wang and Xu, 2020). A paper involving postmortem examination of testicles of six male COVID-19 patients found microscopic evidence of spike protein in interstitial cells in the testes of patients with damaged testicles (Achua et al., 2021).

A Possible Link to Prion Diseases and Neurodegeneration

Prion diseases are a collection of neurodegenerative diseases that are induced through the misfolding of important bodily proteins, which form toxic oligomers that eventually precipitate out as fibrils causing widespread damage to neurons.

Stanley Prusiner first coined the name `prion’ to describe these misfolded proteins (Prusiner, 1982). The best-known prion disease is MADCOW disease (bovine spongiform encephalopathy), which became an epidemic in European cattle beginning in the 1980s.

The CDC web site on prion diseases states that “prion diseases are usually rapidly progressive and always fatal.”(Centers for Disease Control and Prevention, 2018). It is now believed that many neurodegenerative diseases, including Alzheimer’s, Parkinson’s disease, and amyotrophic lateral sclerosis (ALS) may be prion diseases, and researchers have identified specific proteinaceous infectious particles linked to these diseases (Weickenmeier et al., 2019).

Furthermore, researchers have identified a signature motif linked to susceptibility to misfolding into toxic oligomers, called the glycine zipper motif. It is characterized by a pattern of two glycine residues spaced by three intervening amino acids, represented as GxxxG.

The bovine prion linked to MADCOW has a spectacular sequence of ten GxxxGs in a row (see uniprot.org/uniprot/P10279).

More generally, the GxxxG motif is a common feature of transmembrane proteins, and the glycines play an essential role in cross-linking α-helices in the protein (Mueller et al., 2014).

Prion proteins become toxic when the α-helices misfold as β-sheets, and the protein is then impaired in its ability to enter the membrane (Prusiner, 1982).

Glycines within the glycine zipper transmembrane motifs in the amyloid-β precursor protein (APP) play a central role in the misfolding of amyloid-β linked to Alzheimer’s disease (Decock et al., 2016).

APP contains a total of four GxxxG motifs. When considering that the SARS-CoV-2 spike protein is a transmembrane protein, and that it contains fiveGxxxG motifs in its sequence (see uniprot.org/uniprot/P0DTC2), it becomes extremely plausible that it could behave as a prion.

One of the GxxxG sequences is present within its membrane fusion domain. Recall that the mRNA vaccines are designed with an altered sequencethat replaces two adjacent amino acids in the fusion domain with a pair of prolines.

This is done intentionally in order to force the protein to remain in its open state and make it harder for it to fuse with the membrane. This seems to us like a dangerous step towards misfolding potentially leading to prion disease.

A paper published by J. Bart Classen (2021) proposed that the spike protein in the mRNA vaccines could cause prion-like diseases, in part through its ability to bind to many known proteins andinduce their misfolding into potential prions. Idrees and Kumar (2021) have proposed that the spike protein’s S1 component is prone to act as a functional amyloid and form toxic aggregates.

These authors wrote that S1 has the ability “to form amyloid and toxic aggregates that can act as seeds to aggregate many of the misfolded brain proteins and can ultimately lead to neurodegeneration.”According to Tetz and Tetz (2020), the form of the spike protein in SARS-CoV-2 has prion regions that are not present inthe spike proteins for other coronaviruses. While this was reported in a non-peer-reviewed article, the authors had published a previous paper in 2018 identifying prion-like regions in multiple eukaryotic viruses, so they have considerable expertise in this area (Tetz and Tetz, 2018).

A final point here relates to information about the Pfizer vaccine in particular. The European Medicines Agency (EMA) Public Assessment Report is a document submitted to gain approval to market the vaccine in Europe. It describes in detail a review of the manufacturing process as well as a wide range of associated testing data.

One concerning revelation is the presence of “fragmented species” of RNA in the injection solution. These are RNA fragments resulting from early termination of the process of transcription from the DNA template. These fragments, if translated by the cell following injection, would generate incomplete spike proteins, again resulting in altered and unpredictable three-dimensional structure and a physiological impact that is at best neutral and at worst detrimental to cellular functioning.

There were considerably more of these fragmented forms of RNA found in the commercially manufactured products than in the products used in clinical trials. The latter were produced via a much more tightly controlled manufacturing process.

Pfizer claims the RNA fragments “likely… will not result in expressed proteins” due to their assumed rapid degradation within the cell. No data was presented to rule out protein expression, though, leaving the reviewers to comment, “These [fragmented RNA] forms are poorly characterised, and the limited data provided for protein expression do not fully address the uncertainties relating to the risk of translating proteins/peptides other than the intended spike protein” (EMA 2020).

To our knowledge no data has been forthcoming since that time. While we are not asserting that non-spike proteins generated from fragmented RNA would be misfolded or otherwise pathological, we believe they would at least contribute to the cellular stress that promotes prion-associated conformational changes in the spike protein that is present.

1.Lessons from Parkinson’s Disease

Parkinson’s disease is a neurodegenerative disease associated with Lewy body deposits in the brain, and the main protein found in these Lewy bodies is α-synuclein. That protein, α-Synuclein, is certainly prion-like insofar as under certain conditions it aggregates into toxic soluble oligomers and fibrils (Lema Tomé et al., 2013).

Research has shown that misfolded α-synuclein can form first in the gut and then travel from there to the brain along the vagus nerve, probably in the form of exosomes released from dying cells where the misfolded protein originated (Kakarla et al., 2020; Steiner et al., 2011).

The cellular conditions that promote misfolding include both an acidic pH and high expression of inflammatory cytokines.

It is clear that the vagus nerve is critical for transmission of misfolded proteins to the brain, because severance of the vagus nerve protects from Parkinson’s. Vagus nerve atrophy in association with Parkinson’s disease provides further evidence of the involvement of the vagus nerve in transport of misfolded α-synuclein oligomers from the gut to the brain (Walter et al., 2018).

Another pathway is through the olfactory nerve, and a loss of a sense of smell is an early sign of Parkinson’s disease. Ominously, diminution or loss of the sense of smell is also a common symptom of SARS-CoV-2 infection. There are many parallels between α-synuclein and the spike protein, suggesting the possibility of prion-like disease following vaccination.

We have already shown that the mRNA in the vaccine ends up in high concentrations in the liver and spleen, two organs that are well connected to the vagus nerve.

The cationic lipids in the vaccine create an acidic pH conducive to misfolding, and they also induce a strong inflammatory response, another predisposing condition.

Germinal centers are structures within the spleen and other secondary lymphoid organs where follicular dendritic cells present antigens to Bcells, which in turn perfect their antibody response. Researchers have shown that mRNA vaccines, in contrast with recombinant protein vaccines, elicit a robust development of neutralizing antibodies at these germinal centers in the spleen (Lederer et al., 2020).

However, this also means that mRNA vaccines induce an ideal situation for prion formation from the spike protein, and its transport via exosomes along the vagus nerve to the brain.

Studies have shown that prion spread from one animal to another first appears in the lymphoid tissues, particularly the spleen. Differentiated follicular dendritic cells are central to the process, as they accumulate misfolded prion proteins (Al-Dybiat et al., 2019).

An inflammatory response upregulates synthesis of α-synuclein in these dendritic cells, increasing the risk of prion formation. Prions that accumulate in the cytoplasm are packaged up into lipid bodies that are released as exosomes (Liu et al., 2017).

These exosomes eventually travel to the brain, causing disease. 2.Vaccine SheddingThere has been considerable chatter on the Internet about the possibility of vaccinated people causing disease in unvaccinated people in close proximity. While this may seem hard to believe, there is a plausible process by which it could occur through the release of exosomes from dendritic cells in the spleen containing misfolded spike proteins, in complex with other prion reconformed proteins. These exosomescan travel to distant places. It is not impossible to imagine that they are being released from the lungs and inhaled by a nearby person. Extracellular vesicles, including exosomes, have been detected in sputum, mucus, epithelial lining fluid, and bronchoalveolar lavage fluid in association with respiratory diseases (Lucchetti et al., 2021).

A Phase 1/2/3 study undertaken by BioNTech on the Pfizer mRNA vaccine implied in their study protocol that they anticipated the possibility of secondary exposure to the vaccine (BioNTech, 2020).

The protocol included the requirement that “exposure during pregnancy” should be reported by the study participants. They then gave examples of “environmental exposure during pregnancy” which included exposure “to the study intervention by inhalation or skin contact.” They even suggested two levels of indirect exposure: “A male family member or healthcare provider who has been exposed to the study intervention by inhalation or skin contact then exposes his female partner prior toor around the time of conception.”

Emergence of Novel Variants of SARS-CoV-2

An interesting hypothesis has been proposed in a paper published in Nature, which described a case of serious COVID-19 disease in a cancer patient who was taking immune-suppressing cancer chemotherapy drugs (Kemp et al., 2021).

The patient survived for 101 days after admission to the hospital, finally succumbing in the battle against the virus. The patient constantly shed viruses over the entire 101 days, and therefore he was moved to a negative-pressure high air-change infectious disease isolation room, to prevent contagious spread.

During the course of the hospital stay, the patient was treated with Remdesivir and subsequently with two rounds of antibody-containing plasma taken from individuals who had recovered from COVID-19 (convalescent plasma).

It was only after the plasma treatments that the virus began to rapidly mutate, and a dominant new strain eventually emerged, verified from samples taken from the nose and throat of the patient.

An immune-compromised patient offers little support from cytotoxic T cells to clear the virus. An in vitro experiment demonstrated that this mutant strain had reduced sensitivity to multiple units of convalescent plasma taken from several recovered patients.

The authors proposed that the administered antibodies had actually accelerated the mutation rate in the virus, because the patient was unable to fully clear the virus due to their weak immune response. This allowed a “survival of the fittest” program to set in, ultimately populating the patient’s body with a novel antibody-resistant strain. Prolonged viral replication in this patient led to “viral immune escape,” and similar resistant strains could potentially spread very quickly within an exposed population (Kemp et al., 2021).

Indeed, a similar process might plausibly be at work to produce the highly contagious new strains that are now appearing in the United Kingdom, South Africa and Brazil. There are at least two concerns that we have regarding this experiment, in relation to the mRNA vaccines.

The first is that, via continued infection of immune-compromised patients, we can expect continued emergence of more novel strains that are resistant to the antibodies induced by the vaccine, such that the vaccine may quickly become obsolete, and there may well be demands for the population to undergo another mass vaccination campaign.

Already a published study by researchers from Pfizer has shown that vaccine effectiveness is reduced for many of these variant strains. The vaccine was only 2/3 as effective against the South African strain as against the original strain (Liu et al., 2021).

The second more ominous consideration is to ponder what will happen with an immune-compromised patient following vaccination. It is conceivable that they will respond to the vaccine by producing antibodies, but those antibodies will be unable to contain the disease following exposure to COVID-19 due to impaired function of cytotoxic T cells.

This scenario is not much different from the administration of convalescent plasma to immune-compromised patients, and so it might engender the evolution of antibody-resistant strains in the same way, only on a much grander scale. This possibility will surely be used to argue for repeated rounds of vaccines every few months, with increasing numbers of viral variants coded into the vaccines. This is an arms race that we will probably lose.

Potential for Permanent Incorporation of Spike Protein Gene into human DNA

It has been claimed that mRNA-based vaccines are safer than DNA-vectored vaccines that work by incorporating the genetic code for the target antigenic protein into a DNA virus, because the RNA cannot become inadvertently incorporated into the human genome.

However, it is not at all clear that this is true. The classic model of DNA → RNA → protein is now known to be false. It is now indisputable that there is a large class of viruses called retroviruses that carry genes that reverse transcribe RNA back into complementary DNA (cDNA).

In 1975, Howard Temin, Renato Dulbecco, and David Baltimore shared the Nobel Prize in Physiology or Medicine in 1975 for their discovery of reverse transcriptase and its synthesis by retroviruses (such as human immunodeficiency virus (HIV)) to derive DNA from RNA (Temin and Mizutani, 1970, Baltimore, 1970).

Much later, it was discovered that reverse transcriptase is not unique to retroviruses. More than a third of the human genome is devoted to mysterious mobile DNA elements called SINEs and LINEs (short and long interspersed nuclear elements, respectively).

LINEs provide reverse transcriptase capabilities to convert RNA into DNA, and SINEs provide support for integrating the DNA into the genome. Thus, these elements provide the tools needed to convert RNA into DNA and incorporate it into the genome so as to maintain the new gene through future generations (Weiner, 2002).

SINEs and LINEs are members of a larger class of genetic elements called retrotransposons. Retrotransposons can copy and paste their DNA to a new site in the genome via an RNA intermediate, while possibly introducing genetic alterations in the process (Pray, 2008).

Retrotransposons, also known as “jumping genes,” were first identified by the geneticist Barbara McClintock of ColdSpring Harbor Laboratory in New York, over 50 years ago (McClintock, 1965).

Much later, in 1983, she was recognized with a Nobel prize for this work. Remarkably, retrotransposons seem to be able to expand their domain from generation to generation. LINEs and SINEs collaborate to invade new genomic sites through translation of their DNA to RNA and back to a fresh copy of DNA, which is then inserted at an AT-rich region of the genome.

These LINEs and SINEs had long been considered to be “junk” DNA, an absurd idea that has now been dispelled, as awareness of their critical functions has grown.

In particular, it has now become clear that they can also import RNA from an exogenous source into a mammalian host’s DNA. Retroviral-like repeat elements found in the mouse genome called intracisternal A particles (IAPs) have been shown to be capable of incorporating viral RNA into the mouse genome.

Recombination between an exogenous nonretroviral RNA virus and an IAP retrotansposon resulted in reverse transcription of the viral RNA and integration into the host’s genome (Geuking et al., 2009).

Furthermore, as we shall see later, the mRNA in the new SARS-CoV-2 vaccines could also get passed on from generation to generation, with the help of LINEs expressed in sperm, vianon-integrated cDNA encapsulated in plasmids. The implications of this predictable phenomenon are unclear, but potentially far-reaching.

1. Exogenous and Endogenous Retroviruses

There is also a concern that the RNA in the mRNA vaccines could be transferred into the human genome with assistance from retroviruses.

Retroviruses are a class of viruses that maintain their genomic information in the form of RNA, but that possess the enzymes needed to reverse transcribe their RNA into DNA and insert it into a host genome. They then rely on existing natural tools from the host to produce copies of the virus through translation of DNA back into RNA and to produce the proteins that the viral RNA codes for and assemble them into a fresh viral particle (Lesbats et al., 2016).

Human endogenous retroviruses (HERVs) are benign sections in the DNA of humans that closely resemble retroviruses, and that are believed to have become permanent sequences in the human genome through a process of integration from what was originally an exogenous retrovirus.

Endogenous retroviruses are abundant in all jawed vertebrates and are estimated to occupy 5-8% of the human genome. The protein syncytin, which has become essential for placental fusion with the uterine wall and for the fusion step between the sperm and the egg at fertilization, is a good example of an endogenous retroviral protein.

Syncytin is the envelope gene of a recently identified human endogenous defective retrovirus, HERV-W (Mi et al., 2000). During gestation, the fetus expresses high levels of another endogenous retrovirus, HERV-R, and it appears to protect the fetus from immune attack from the mother (Luganini and Gribaudo, 2020).

Endogenous retroviral elements closely resemble retrotransposons. Their reverse transcriptase, when expressed, has the theoretical capability to convert spike protein RNA from the mRNA vaccines into DNA.

2. Permanent DNA integration of Exogenous Retrovirus Genes

Humans are colonized by a large collection of exogenous retroviruses that in many cases cause no harm to the host, and may even be symbiotic (Luganini and Gribaudo, 2020).

Exogenous viruses can be converted to endogenous viruses (permanently incorporated into host DNA) in the laboratory, as demonstrated by Rudolf Jaenisch (Jaenisch, 1976), who infected preimplantation mouse embryos with the Moloney murine leukemia virus (M-MuLV).

The mice generated from these infected embryos developed leukemia, and the viral DNA was integrated into their germ line and transmitted to their offspring. Besides the incorporation of viral DNA into the host genome, it was also shown as early as 1980 that DNA plasmids could be microinjected into the nuclei of mouse embryos to produce transgenic mice that breed true (Gordon et al., 1980).

The plasmid DNA was incorporated into the nuclear genome of the mice through existing natural processes, thus preserving the newly acquired genetic information in the offspring’s genome. This discovery has been the basis for many genetic engineering experiments on transgenic mice engineered to express newly acquired human genes since then (Bouabe and Okkenhaug, 2013).

3. LINE-1 is Widely Expressed

LINEs alone make up over 20% of the human genome. The most common LINE is LINE-1, which encodes a reverse transcriptase that regulates fundamental biological processes. LINE-1 is expressed in many cell types, but at especially high levels in sperm.

Sperm cells can be used as vectors of both exogenous DNA and exogenous RNA molecules through sperm-mediated gene transfer assays. Sperm can reverse transcribe exogenous RNA directly into cDNA and can deliver plasmids packaging up this cDNA to the fertilized egg.

These plasmids are able to propagate themselves within the developing embryo and to populate many tissues in the fetus. In fact, they survive into adulthood as extrachromosomal structures and are capable of being passed on to progeny.

These plasmids are transcriptionally competent, meaning that they can be used to synthesize proteins encoded by the DNA they contain (Pittoggi et al., 2006).

In addition to sperm, embryos also express reverse transcriptase prior to implantation, and its inhibition causes developmental arrest. LINE-1 is also expressed by cancer cells, and RNA interference-mediated silencing of human LINE-1 induces differentiation in many cancer cell lines.

Reverse-transcriptase machinery is implicated in the genesis of new genetic information, both in cancer cells and in germ cells. Many tumor tissues have been found to express high levels of LINE-1, and to contain many extrachromosomal plasmids in their nucleus.

Malignant gliomas are the primary tumors of the central nervous system. It has beenshown experimentally that these tumors release exosomes containing DNA, RNA and proteins, that end up in the general circulation (Vaidya and Sugaya, 2020).

LINE-1 is also highly expressed in immune cells in several autoimmune diseases such as systemic lupus erythematosus, Sjögrens and psoriasis (Zhang et al., 2020).

4. Integrating Spike Protein Gene into Human Genome

Remarkably, it has been demonstrated that neurons from the brain of Alzheimer’s patients harbor multiple variants of the gene for amyloid precursor protein APP, incorporated into the genome, which are created through a process called somatic gene recombination (SGR) (Kaeser et al., 2020).

SGR requires gene transcription, DNA strand-breaks, and reverse transcriptase activity, all of which may be promoted by well-known Alzheimer’s disease risk factors.

The DNA coding for APP is reverse transcribed into RNA and then transcribed back into DNA and incorporated into the genome at a strand break site. Since RNA is more susceptible to mutations, the DNA in these mosaic copies contains many mutant variants of the gene, so the cell becomes a mosaic, capable of producing multiple variants of APP.

Neurons from Alzheimer’s patients contained as many as 500 million base pairs of excess DNA in their chromosomes (Bushman et al., 2015).

Researchers from MIT and Harvard published a disturbing paper in 2021, where they provided strong evidence that the SARS-CoV-2 RNA can be reverse transcribed into DNA and integrated into human DNA (Zhang et al., 2021).

They were led to investigate this idea after having observed that many patients continue to test positive for COVID-19 after the virus has already been cleared from their body. The authors found chimeric transcripts that contained viral DNA sequences fused to cellularDNA sequences in patients who had recovered from COVID-19.

Since COVID-19 often induces a cytokine storm in severe cases, they confirmed the possibility of enhanced reverse transcriptase activity through an in vitro study using cytokine-containing conditioned media in cell cultures. They found a 2-3-fold upregulation of endogenous LINE-1 expression in response to cytokines. The exogenous RNA from the virus incorporated into human DNA could produce fragments of viral proteins indefinitely after the infection has been cleared, and this yields a false-positive on a PCR test.

5. Bovine Viral Diarrhea: A Disturbing Model

Bovine Viral Diarrhea (BVD) is an infectious viral disease that affects cattle throughout the world. It is a member of the class of pestiviruses, which are small, spherical, single-stranded, enveloped RNA viruses.

The disease is associated with gastrointestinal, respiratory and reproductive diseases. A unique characteristic of BVD is that the virus can cross the placenta of an infected pregnant dam. This can result in the birth of a calf which carries intra-cellular viral particles which it mistakes as `self.’ Its immune system refuses to recognize the virus as a foreign invasion, and, as a result, the calf sheds the virus in large quantities throughout its life, potentially infecting the entire herd.

It has become a widespread practice to identify such carrier calves and cull them from the herd in an attempt to curtail infection (Khodakaram-Tafti & Farjanikish, 2017).

It seems plausible that a dangerous situation may arise in the future where a woman receives an mRNA vaccine for SARS-CoV-2 and then conceives a child shortly thereafter. The sperm would be free to take up RNA-embedded liposomes from the vaccine and convert them to DNA using LINE-1.

They would then produce plasmids containing the code for the spike protein which would be taken up by the fertilized egg through the process described above. The infant that is born is then potentially unable to mount antibodies to the spike protein because their immune system considers it to be `self.’

Should that infant get infected with SARS-CoV-2 at any time in its lifespan, its immune system would not mount a defense against the virus, and the virus would presumably be free to multiply in the infant’s body without restraint. The infant would logically become a super-spreader in such a situation.

Admittedly, this is speculation at this time, but there is evidence from what we know about retrotransposons, sperm, fertilization, the immune system and viruses, that such a scenario cannot be ruled out.

It has already been demonstrated in mouse experiments that the genetic elements in DNA vector vaccines, which are essentially plasmids, can integrate into the host genome (Wang et al., 2004). In fact, such a process has been suggested as a basis for Lamarckian evolution defined as the inheritance of acquired traits (Steele, 1980).

The realization that what was formerly called “junk DNA” is not junk, is just one of the results coming out of the new philosophical paradigm in human language, biology and genetics that is based on fractal genomics (Pellionisz, 2012) —a paradigm that Pellionisz has linked to the involvement of “true narrative representations” (TNRs; Oller, 2010), realized as “iterations of a fractal template” in the highly repetitive processes of normal development of the many branching structures of the human body.

These processes are numerous in the lungs, kidneys, veins and arteries, and most importantly in the brain. The mRNA vaccines are an experimental gene therapy with the potential to incorporate the code for the SARS-CoV-2 spike protein into human DNA.

This DNA code could instruct the synthesis of large numbers of copies of proteinaceous infectious particles, and this has the potential to insert multiple false signals into the unfolding narrative, resulting in unpredictable outcomes.

Conclusion

Experimental mRNA vaccines have been heralded as having the potential for great benefits, but they also harbor the possibility of potentially tragic and even catastrophic unforeseen consequences.

The mRNA vaccines against SARS-CoV-2 have been implemented with great fanfare, but there are many aspects of their widespread utilization that merit concern. We have reviewed some, but not all, of those concerns here, and we want to emphasize that these concerns are potentially serious and might not be evident for years or even transgenerationally.

In order to adequately rule out the adverse potentialities described in this paper, we recommend, at a minimum, that the following research and surveillance practices be adopted:

•A national effort to collect detailed data on adverse events associated with the mRNA vaccines with abundant funding allocation, tracked well beyond the first couple of weeks after vaccination.

•Repeated autoantibody testing of the vaccine-recipient population. The autoantibodies tested could be standardized and should be based upon previously documented antibodies and autoantibodies potentially elicited by the spike protein. These include autoantibodies against phospholipids, collagen, actin, thyroperoxidase (TPO), myelin basic protein, tissue transglutaminase, and perhaps others.

•Immunological profiling related to cytokine balance and related biological effects. Tests should include, at a minimum, IL-6, INF-α, D-dimer, fibrinogen, and C-reactive protein.

•Studies comparing populations who were vaccinated with the mRNA vaccines and those who were not to confirm the expected decreased infection rate and milder symptoms of the vaccinated group, while at the same time comparing the rates of various autoimmune diseases and prion diseases in the same two populations.

•Studies to assess whether it is possible for an unvaccinated person to acquire vaccine-specific forms of the spike proteins from a vaccinated person in close proximity.

•In vitro studies to assess whether the mRNA nanoparticles can be taken up by sperm and converted into cDNA plasmids.

•Animal studies to determine whether vaccination shortly before conception can result in offspring carrying spike-protein-encoding plasmids in their tissues, possibly integrated into their genome.

•In vitro studies aimed to better understand the toxicity of the spike protein to the brain, heart, testes, etc. Public policy around mass vaccination has generally proceeded on the assumption that the risk/benefit ratio for the novel mRNA vaccines is a “slam dunk.” With the massive vaccination campaign well underway in response to the declared international emergency of COVID-19, we have rushed into vaccine experiments on a worldwide scale. At the very least, we should take advantage of the data that are available from these experiments to learn more about this new and previously untested technology. And, in the future, we urge governments to proceed with more caution in the face of new biotechnologies.

Finally, as an obvious but tragically ignored suggestion, the government should also be encouraging the population to take safe and affordable steps to boost their immune systems naturally, such as getting out in the sunlight to raise vitamin D levels (Ali, 2020), and eating mainly organic whole foods rather than chemical-laden processed foods (Rico-Campà et al., 2019).

Also, eating foods that are good sources of vitamin A, vitamin C and vitamin K2 should be encouraged, as deficiencies in these vitamins are linked to bad outcomes from COVID-19 (Goddek, 2020; Sarohan, 2020).

Acknowledgements

This research was funded in part by Quanta Computers, Inc., Taiwan, under the auspices of the Qmulus project.

Competing interests

The authors have no competing interests or conflicts to declare.

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