Informed Consent

November 2021

COVID-19: stigmatising the unvaccinated is not justified thelancet.com

Abstract 10712: mRNA COVID Vaccines Dramatically Increase Endothelial Inflammatory Markers and ACS Risk as Measured by the PULS Cardiac Test: A Warning ahajournals.org

OSHA suspends enforcement of COVID-19 vaccine mandate for large businesses foxnews.com

Wait what? FDA wants 55 years to process FOIA request over vaccine data reuters.com

Hospitalizations rising among fully vaccinated in U.S., Fauci says nbcnews.com

“…fully vaccinated but not boosted.” But the booster is a replica of the original vaccine; it is not variant-specific.

New Orleans-based US Court of Appeals for the 5th Circuit stalls implementation of mandate

US Department of Labor issues emergency temporary standard to protect workers from coronavirus osha.gov

The “state of emergency” is being abused. This is unjustified circumvention of the democratic process. It is completely illogical to mandate an experimental treatment that is unable to prevent transmission of a virus that is not a threat to most people. It is also stunningly hypocritical to expect unvaccinated U.S. citizens to be subjected to ongoing testing when there are thousands of illegal immigrants crossing U.S. borders who are not required to test.

Covid-19: Researcher blows the whistle on data integrity issues in Pfizer’s vaccine trial bmj.com

Senior NIH expert pushes back on growing vaccine mandates thehill.com

Age-and Sex-Specific Incidence of Cerebral Venous Sinus Thrombosis Associated With Ad26.COV2.S (Johnson & Johnson/Janssen) COVID-19 Vaccination jamanetwork.com

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October 2021

Vaccine Safety Update cdc.gov

Why would anyone subject their children to an experimental treatment that has no long term studies on side effects?

The FDA approved an oral blood thinning medication (for the treatment of blood clots) for children just months before the youth vaccine rollout.

Alert: Severe Concerns Regarding the Reliability and Legality of Data from Israel in light of the Planned Discussion on the Administration of COVID-19 Vaccines to Children Aged 5 – 11 doctorsforcovidethics.org

The First General Federal Vaccination Requirement: The OSHA Emergency Temporary Standard for COVID-19 Vaccinations ssrn.com article

The text below is quoted from the reissued EUA letter from the FDA to Pfizer Inc. dated Oct. 20, 2021, page 7:

Although COMIRNATY (COVID-19 Vaccine, mRNA) is approved to prevent COVID-19 in individuals 16 years of age and older, there is not sufficient approved vaccine available for distribution to this population in its entirety at the time of reissuance of this EUA. Additionally, there are no COVID-19 vaccines that are approved to provide: COVID-19 vaccination in individuals age 12 through 15; a third primary series dose to certain immunocompromised populations described in this EUA; a homologous booster dose to the authorized population described in this EUA; or a heterologous booster dose following completion of primary vaccination with another authorized COVID-19 vaccine.

In addition to Comirnaty not being available, the announcement by Pfizer on its “FDA approval” is not straightforward. The Pfizer vaccine marketed as Comirnaty will be distributed under an approved Biologics License Application AND under Emergency Use Authorization. Both standards are only covered under CICP should an individual be harmed by the vaccine. There are distinct differences between CICP and VICP (for licensed vaccines) which affect legal liability and compensation. 

A ‘black hole’ for COVID vaccine injury claims reuters.com

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The text below is quoted from “Q & A for Comirnaty (COVID-19 Vaccine mRNA)” from fda.gov:

The FDA-approved Comirnaty (COVID-19 Vaccine, mRNA), made by Pfizer for BioNTech and the FDA-authorized Pfizer-BioNTech COVID-19 Vaccine under EUA have the same formulation and can be used interchangeably to provide the COVID-19 vaccination series without presenting any safety or effectiveness concerns. Therefore, providers can use doses distributed under EUA to administer the vaccination series as if the doses were the licensed vaccine. For purposes of administration, doses distributed under the EUA are interchangeable with the licensed doses. The Vaccine Information Fact Sheet for Recipients and Caregivers provides additional information about both the approved and authorized vaccines.

“AS IF” the doses were the licensed vaccine???” BUT THEY ARE NOT!!! And where is the “licensed” vaccine?

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September 2021

“The bottom line: We’re going to protect vaccinated workers from unvaccinated co-workers.” —Joe Biden, Sept. 9, 2021.

Yes, Biden actually said that, promoting deliberate division of U.S. citizens over a personal health decision regarding experimental vaccines that may not be as effective as reported.

“susceptibility to infection increases with time as soon as 2–3 months after vaccination—consistent with waning protective immunity. This potentially important observation is consistent with recent large-scale data and requires further investigation.” thelancet.com

Increases in COVID-19 are unrelated to levels of vaccination across 68 countries and 2947 counties in the United States European Journal of Epidemiology

40% of local COVID-19 cases in Syracuse, New York, are in the vaccinated cdc.gov

The Department of Defense program named “Project Salus” run in cooperation with the JAIC has analyzed data on 5.6 million Medicare beneficiaries aged 65 and older, and found that “the vast majority of COVID hospitalizations are occurring among fully-vaccinated individuals and that outcomes among the fully vaccinated are growing worse with each passing week.” 

The ‘Covid-19 Vaccine Surveillance Report – Week 43’ published by the UK Health Security Agency (formerly Public Health England) on Thursday, October 28, 2021 showed that the vast majority of Covid-19 hospitalizations between September 27th and October 24th were among the fully vaccinated population.

95% of hospitalized Victoria Australia covid patients are vaccinated thefallingdarkness.com

Most COVID-19 Patients at Israel Hospital Fully Vaccinated, Doctor Calls Mandates ‘Diabolic’ visiontimes.com

Joe Biden’s 100 Employees Vaccine Rule Means 98 Percent of Companies Unaffected newsweek.comHow does this square with preserving individual liberty, fairness, and equality under the law? This sort of under inclusiveness belies the premise that any of this is truly an emergency.

“We do see—after six to eight months—more rapid waning concerning infections and mild to moderate symptoms,” Dr. Mikhail Dolsten, Pfizer’s chief scientific officer marketwatch.com

What You Need to Know About A Potential “COVID Pill” Pfizer and Merck Are Each Developing prevention.com

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AUGUST 2021

The announcement by Pfizer regarding “full FDA approval” of their COVID-19 vaccine IS NOT STRAIGHTFORWARD. See officially released documents below.

Comirnaty and Pfizer-BioNTech COVID-19 Vaccine fda.gov

PFIZER-BIONTECH COVID-19 VACCINE COMIRNATY® RECEIVES FULL U.S. FDA APPROVAL FOR INDIVIDUALS 16 YEARS AND OLDER pfizer.com

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PAGE 1

*originally published Feb., 2021

The accuracy of information regarding COVID-19 vaccines can vary in the marketing of the vaccines and at vaccine administration sites. Please review the most updated vaccine fact sheets carefully before choosing to be inoculated.

The purpose of this post is to provide information because all information is necessary for informed consent. More information, more education, more dialogue, more transparency, and less censorship is the solution to misinformation.

Please see Additional Information and Sources on page 3 for important links.

This post may be updated periodically with possible changes, omissions or additions.

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The decision to receive a COVID-19 vaccine or any medical intervention is a private decision between an individual and their healthcare provider based on individual risks and benefits.

The decision not to receive a COVID-19 vaccine does not make an individual “anti-vax.” “Anti-vax” is a scathing pejorative used to intentionally divide. In fact, it is smart to be cautious about mRNA technology. The public should be encouraged to make informed medical decisions, including complete transparency regarding benefits and risks of vaccines. Open and honest public discussion is not being conducted to address the ethical issues of COVID-19 vaccines, including evidence for very legitimate concerns and fears. No one should hand off matters pertaining to their own health and/or personal autonomy to people who do not know them or their health history.

No one should be bribed, shamed, coerced, segregated, stigmatized, discriminated against, or mandated to take an investigational COVID-19 vaccine released under an emergency use authorization. Consent” is being manufactured by the media, using deliberate, deceptive coercion through FEAR.

The marketing campaign for these vaccines is unprecedented. Why?

It is unconscionable to suggest that COVID-19 injections be mandated for anyone when the vaccine is a new medical product undergoing its first year of study. It is impossible to give fully-informed consent without long-term, unbiased data. Where there is risk there must be choice.

• Under the PREP Act, companies like Pfizer and Moderna have total immunity from liability if something unintentionally goes wrong with their vaccines.

Naturally-acquired immunity from previous infection counts toward herd or population immunity! The suggestion to vaccinate everyone will NOT gain herd immunity, but WILL cause more variants.

There is no long-term safety data from the use of mRNA vaccines which interact with the immune system in a novel way. Reported safety and efficacy data is extremely short-term.

• When someone says “the science is settled, it’s safe and effective” they don’t know what they’re talking about. Science is never settled, it’s about probabilities and the weight of evidence gathered over time.

Natural immunity confers longer lasting and stronger protection against infection, symptomatic disease and hospitalization caused by the Delta variant of SARS-CoV-2, compared to the BNT162b2 two-dose vaccine-induced immunity. Individuals who were both previously infected with SARS-CoV-2 and given a single dose of the vaccine gained additional protection against the Delta variant.

• Do COVID-19 vaccines qualify as a public health measure capable of providing collective benefit that supersedes individual risk? In other words, is it your “civic or patriotic duty” to receive one of these vaccines? COVID-19 vaccines do not prevent infection and do not block transmission because they do not provide sterilizing immunity in the mucosa, but may confer systemic immunity (in the circulation) with reported protection from severe disease for the vaccine recipient only lasting about 6 months. (Immunizations that prevent disease without actually preventing infections are called leaky vaccines.)

• Vaccine “breakthrough” or vaccine failure?

Vaccine-driven virulence evolution should be addressed with the public, not as an argument against vaccination or its value, but as a consequence that needs to be considered, and one that can be potentially avoided. 

• There is insufficient evidence to support the need for mass vaccination campaigns of populations considered low risk, including children and the naturally immune. Individuals are not and have never been at equal risk for severe disease or death from COVID-19 if infected, both young and old. Research has found that about 81 percent of people with COVID-19 have mild or moderate illness. According to the Centers for Disease Control, most people with mild to moderate COVID-19 can recover at home.

• There is not enough large-scale clinical trial data to assure well-informed unvaccinated people that their risk of experiencing vaccine side effects is lower than their chance of being hospitalized.

• What percentage of the population has been infected/recovered from COVID-19? What percentage of those individuals have also been vaccinated? The fact these two critical pieces of data are not being tracked and/or published is incompetence bordering on corruption. 

• The risks for adverse outcomes for young individuals may be higher with the vaccine in the short term than the negligible risk with the virus itself.

There is no epidemiological benefit for children to get a COVID-19 vaccine, IT IS ALL RISK.

• Masking Children: Tragic, Unscientific, and Damaging aier.org

• Positive RT-PCR test results do not equate to symptom presentation or infection with SARS-CoV-2. Positive RT-PCR test results do not rule out bacterial infection or co-infection with other viral pathogens. The agent detected may not be the definitive cause of disease. There is no standardized CT (cycle threshold) being used for the RT-PCR, which could be why there are so many false positives as well as cases of missed diagnosis. There should be a standard that is used for equivalence in measurement. The standard should be used on vaccinated and unvaccinated individuals alike. RT-PCR reported case data is unclear in determining the current status of infections and may also show exposure at some point in the past. The indiscriminate use of this test with the absence of ANY clinical diagnosis is questionable. Constant testing of HEALTHY people will only prolong the “pandemic.” Inflated case numbers as well as death misclassifications have driven hysteria and fear. Test results from the emergency use of RT-PCR tests have proven to be highly fallible.

• COVID-19 deaths were identified using a new ICD–10 code in 2020. When COVID-19 was reported as a cause of death, or when it was listed as a “probable” or “presumed” cause, the death was coded as U07.1. This included “cases” with or without laboratory confirmation. It is important to be familiar with the broader information regarding deaths from COVID-19 such as whether or not an individual died from or with the disease. How many deaths were falsely attributed to COVID-19? In addition, there is a distinction between virus deaths and lockdown/restrictions deaths. Deaths due to the suppression of alternative treatments, suicides, limited access to healthcare due to mistrust and fear, and alcohol/drug use are NOT due to a virus, but due to lockdowns/restrictions.

• There were 646 deaths relating to the flu among adults reported in 2020, whereas in 2019 the CDC estimated that between 24,000 and 62,000 people died from influenza-related illnesses. rochesterregional.org

• COVID-19 is one of thousands of health threats. Other critical health matters are not receiving much needed attention during the pandemic. The media’s hysterical coverage of the pandemic has dissuaded patients from seeking essential care.

• The behavior of epidemics, both infections and death statistics, follow a bell-shaped curve which rises, crests and descends per Farr’s Law which has existed since 1840.

• There is no FDA-approved vaccine to prevent COVID-19 as stated on the vaccine fact sheets.

• The duration of protection against COVID-19 is currently unknown as stated on the vaccine fact sheets.

• COVID-19 vaccines may not protect everyone as stated on the vaccine fact sheets.

• Immune function is a strong determinant of an individual’s risk of and complications from pathogens. There is a high degree of individual variability in antibody responses to a pathogen in the amount, type, and quality of antibodies made, including the components of immune memory.

• COVID-19 vaccines are not yet licensed. They have been released under an Emergency Use Authorization by the FDA.

“In general, FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities.”

• Under an EUA, COVID-19 vaccines cannot be made mandatory for any individual.

Federal law: Title 21 U.S.C. § 360bbb-3(e)(1)(A)(ii)(I-III) of the Federal Food, Drug, and Cosmetic Act states: Individuals to whom the product is administered are informed—

(I) that the Secretary has authorized the emergency use of the product;
(II) of the significant known and potential benefits and risks of such use, and
of the extent to which such benefits and risks are unknown; and
(III) of the option to accept or refuse administration of the product, of the consequences, if any, of refusing administration of the product, and of the alternatives to the product that are available and of their benefits and risks.

Per the COVID-19 Vaccine Tracker, there are presently 135 vaccine candidates and 20 “approved” vaccines. This post includes links to vaccine fact sheets/information for four (4) COVID-19 vaccines.

COVID-19 vaccine fact sheets and websites

Pfizer-BioNTech Covid-19 Fact Sheet

Pfizer-BioNTech Covid-19 vaccine website

Pfizer-BioNTech Covid-19 vaccine fact sheet language translations

Pfizer-BioNTech Covid-19 vaccine short term efficacy and safety data

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Moderna Covid-19 Fact Sheet

Moderna Covid-19 vaccine website

Moderna Covid-19 vaccine fact sheet language translations

Moderna Covid-19 vaccine short term efficacy and safety data

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COVID-19 Vaccine Information Sheet for AstraZeneca/COVISHIELD

AstraZeneca Covid-19 Information Hub

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Janssen COVID-19 vaccine fact sheet (manufacturer Janssen Biotech Inc., a Janssen Pharmaceutical Company of Johnson & Johnson)

*The FDA’s EUA now includes a warning that rare clotting events might occur after vaccination, primarily among women ages 18–49 years.

 Johnson and Johnson Covid-19 Media Hub

Janssen Covid-19 vaccine short term efficacy and safety data