The Missing Pages of Our COVID-19 Vaccine Informed Consent Document

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I was recently considered old enough to be eligible to book an appointment for a Covid-19 vaccination. After working in the health field virtually all my adult life, I’ve developed deep respect and trust in my body’s ability to keep me healthy as long as I treat it well. But I thought I should check into these Covid-19 vaccines to see if a new, “Emergency Use” vaccine would somehow serve me better than risking getting SARS-CoV-2 itself. I must admit I was curious about how our health authorities thought a vaccine would provide better protection than my own immune system when data shows we have a mean survival rate of over 99% without a vaccine (95% if you are over 70). But I was willing to hear what they had in mind.

I started by researching the 4 front-runner vaccines (Pfizer, Moderna, AstraZeneca and Johnson and Johnson). I read the Pfizer and Moderna submissions to the FDA for “Emergency Use” approval. Then I listened to countless researchers who work in the fields of immunology, vaccines, and virology. When it finally became available, I looked at the Informed Consent documents that my own (Ontario) and other provincial health authorities presented as information you should consider before taking the vaccine.

I was shocked by what information was not there. The consent forms seemed to be far more focused on information-gathering for the practitioner than on information-providing so the public could fully weigh the benefits and risks of taking this vaccine. The Ontario form did refer to a “COVID-19 Vaccine Information Sheet”, which everyone was to read, but it was not included with the consent package.

Having already done considerable research at this point, I found the government information to be misleading and incomplete. For example, on page 3 of the Information Sheet, it’s implied that these vaccines work like “all vaccines. . .” by “. . . presenting our body with something that looks like the infection . . .” when in fact, these vaccines work entirely differently. They use new gene therapy technology to get your body to produce a foreign spike protein that is intended to make your body create an immune response. The document says “This piece of the virus cannot hurt you, . . .”, but they cannot know that. First, it’s a synthetic piece of mRNA in the case of Pfizer and Moderna, and foreign DNA in the other two. A corona vaccine has never been successfully developed before. They don’t know if the genetic message will shut off before creating a full immune response. They don’t know how this genetic information will influence other genes. The trials to find answers are still going on; the pre-“emergency use” approval trials were too short to be able to gather long-term data concerning the outcomes of this novel gene therapy. If you take these vaccines, you become a subject in Stage 3 and 4 of the ongoing experiment.

I didn’t find these and other important points made clear in the Informed Consent Form. So, I decided to make a list of what I would like to have known to make a fully informed choice to consent or decline a Covid-19 vaccine. Following is the list that evolved from my research.

Background Information of Interest

• Your Rights. The Nuremberg Code, the UN Declaration of Human Rights and the UNESCO Universal Declaration on Bioethics and Human Rights are agreements that give citizens the right to choose to consent to any biological intervention after being fully informed about the intention, risks and benefits of the procedure, and being free from coercion in any form to consent. This means that neither our government, an employer, a nursing home, a school nor an airline should be trying to force you to consent to an experimental medical treatment, especially a non-FDA approved treatment, in order to work, play or live your life as you wish. These international laws were put in place to protect us from being used as medical guinea pigs by some over-zealous pharmaceutical company, agency or government without our knowledge and without our agreeing to accept the risks associated with the treatment, such as what was perpetrated on the Jews and the infirmed under the Nazis. It was also designed to prevent segregation (e.g. privileges for the vaccinated vs the un-vaccinated), hence the “coercion” rider. The Informed Consent document you are asked to sign before you receive a vaccination, or any other medical procedure, is to confirm that you know what you are getting into and you do so of your own free will with the understanding that there is no penalty for refusing.

• There are no “FDA approved” vaccines. All vaccines currently available that are intend to protect you from SARS CoV-2 are authorized for temporary “emergency use” (USA) or “interim order” (Canada) only. That means that the research behind them is incomplete, in this case, “fast tracked”, which means many aspects of the vaccine’s effects remain unknown, such as its effect on pregnancy, or special groups, like the very old or the very young, people who already have immunity from having had Covid-19, people who had a flu shot, or the long-term effects of the vaccine, autoimmune challenges, etc. The work just hasn’t yet been done. Anyone who tells you these vaccines are “safe and effective” is either ignorant or lying. They cannot know what hasn’t been tested.

• Covid-19 vaccines are experimental “vaccines.” Many scientists say that, by definition, these are not actually “vaccines.” They do, however, match the traditional definition of “gene therapies.” As experiments, Phase 3 and 4 of the trials are scheduled to go at least another year or more; Pfizer’s trials go until January 31, 2023 and Moderna’s to October 27, 2022.

Because Pfizer and Moderna’s original trials did not include proper, long-term animal testing, humans are the test subjects for what animal trials may have revealed. In past development trials for coronavirus vaccines, the animal trials revealed an issue, for example, of Antibody Dependent Enhancement (ADE) in which those who were vaccinated responded well regarding antibodies, but when subsequently exposed to the wild virus, suffered severe cases of the disease and often death. This issue was not addressed in many of the current vaccines. Similarly, long-term effects of the new mRNA gene technologies are unknown. RNA gene therapy products have never been approved for prior use in vaccines nor has this science been verified by independent researchers and been published in peer-reviewed journals. The experiment continues.

• These vaccines do not prevent you from getting the disease nor do they prevent you from transmitting the disease. The current vaccine trials were designed to establish that the vaccines could reduce symptoms in mild- to moderate cases of SARS CoV-2. They were NOT designed to prevent the disease nor to prevent transmission. While it is arguable whether the criterion of reducing symptoms was met scientifically, it is absolutely clear that these vaccines do not prevent you or anyone from getting SARS-CoV-2. Recent evidence finds significant numbers of fully vaccinated people are getting Covid-19 (“Breakthrough” cases) and a shocking number are dying (US VAERS reports 5,165 deaths between December 14, 2020 and May 28, 2021 following vaccination). The vaccines do not stop you from transmitting the disease to Granny. That’s why vaccinated people are told to continue wearing masks. That leaves you having to protect yourself and others from getting SARS-CoV-2 just as people have protected themselves for the past few hundred years of coronaviruses (as opposed to using the ineffective and totally destructive practices that were assigned this time). Bottom line: these vaccines do not give you your normal life back, as Pharma, the media, government and many medical and health “authorities” imply.

• Vaccine companies have immunity from liability and a poor track record for integrity. The US government gave vaccine companies immunity from prosecution if their products caused personal injury in 1986. To compensate for this self-regulation freedom, the industry was to submit bi-annual reports of their work on safety and efficacy of all new vaccines to the US Senate and the House. A court-ordered (filed 07092018) access to information request by the Informed Consent Action Network (ICAN) resulted in the revelation that no safety and efficacy reports for new vaccines had been submitted since being granted immunity from prosecution. That means that there has been no industry vaccine safety and efficacy data made public since 1986. The mantra that vaccines are “safe and effective” is just industry say- so. These same companies have also paid out billions in court settlements for knowingly creating false and misleading advertising regarding drugs, lying to physicians, producing fraudulent research studies and other legal breeches of integrity during that same period.

Moderna cannot be painted with the same brush, having only joined the “vaccine companies” list when Covid arrived. They were previously a failed gene therapy company. These are the companies that our government and health authorities want us to trust with a “Warp Speed” rollout of an experimental gene product as a “vaccine” for a coronavirus that over 99% of people survive without a vaccine.

Risk vs Benefit Considerations of Not Vaccinating

• Most people already have powerful immune protection. Your immune system has been adapting to protect you from viruses for thousands of years. It knows what it’s doing. Firstly, understand that Covid presents a high risk of mortality predominately to elderly people and those who have more than 2 co-morbidities and who have blood Vitamin D levels below 20 mg/mL. For people under 50, the infection survival rate is greater than 99.98%. For those over 70, it’s 94.6% according to Dr. Stephen Malthouse, the CDC, and many others. The death rate for immune-normal children is less than for the flu, statistically zero.

• There are highly effective prevention and treatment protocols for SARS-CoV-2 available. Long proven therapies like Hydroxychloroquine, Ivermectin, high-dose Vitamine C and Vitamin D were deliberately downplayed in the early going of covid so that Emergency Use vaccines could be developed. There’s obviously no need for a vaccine if there are safe, effective treatments available. For example, studies show that survival, and probable prevention, are made easier by keeping blood Vitamin D levels between 40 and 60 ng/mL (some scientists advise 60 – 80 ng.) When Covid symptoms come on (e.g. a scratchy throat, stuffed sinuses, unusual fatigue, headache, etc.), immediate high dosing with Vitamin C, Hydroxychloroquine (HCQ) with Zinc protocol, or an Ivermectin Protocol (I-MASK) have all shown to be effective tratments. An early start (within 5 days of symptom onset) is critical for an early resolution. There are other effective treatments, such as nebulized hydrogen peroxide or Budesonide, but the research is less extensive on these. Dr. P. McCullough and many other scientists confirm that, had HCQ and Ivermectin for early treatments not been suppressed, 85% of COVID-19 deaths would have been avoided.

Photo caption: all meta-analyses to date show Ivermectin to be effective against COVID-19, yet Health Canada and the FDA have still not approved this treatment, not even for “emergency use authorization” or “interim order authorization.”

• Natural immunity provides more complete immunity than artificially-induced immunity. Evidence indicates that natural immunity (from getting and recovering from a virus) is better than artificially-induced immunity because your immune system learns to deal with the whole virus in natural immunity, rather than just one protein, segment, or modified form of the virus like happens in vaccine-induced immunity. Your immune system responds on more levels. There is also evidence (Jorge Dominguez-Andres, et al) that applying vaccine-induced immunity to someone who already has natural immunity to the virus actually interferes with the long-term effectiveness of innate and adaptive immune responses. Thus, there may be added risk to those who previously had covid getting a vaccine. Recent UK data indicates that people with prior infection have the most intense vaccine-related adverse reactions. An added benefit of natural immunity recently confirmed by a study by Andrew Redd was that T- cells created by natural immunity fully recognize “variants” (which appear to be normal mutations) to date. Vaccines are not so effective, as is suggested by recent British data that 29% of Brits who died from the India variant had received their second vaccination. Vaccine-makers are indicating that you will need boosters or annual vaccinations to deal with these variations if you choose to vaccinate.

Emerging Adverse Event Data

Now that a number of months have gone by since the rollout of the Covid-19 vaccines, monitoring systems are beginning to identify some of the long-term adverse events that might be associated with the vaccines that were not possible to see in the short, preliminary Phase 3 trials of the vaccines and because significant animal studies were not done. Note that the US and Canadian Adverse Events (AE) monitoring systems are passive, meaning that it is up to the vaccine-injured or their healthcare practitioner to file a report. This appears to create an underreporting problem.

Canada’s AE numbers are low when compared to rates of injuries noted by more vigorous reporting systems in the UK and Europe and even compared to the passive US VAERS (Vaccine Adverse Event Reporting System) which, in a study out of Harvard, found to receive reports of less than 1% of vaccine injuries.

That means that, if Canada has a similarly low reporting rate due to its passive system, the June 11, 2021 report of 6,864 Total Adverse Events with 1,391 being Serious, could actually mean that well over 100,000 Canadians have had serious adverse events following being vaccinated. If Health Canada is not rigorously collecting these injury reports, Canadians are not getting good data on the actual safety of these vaccines. This lack of precise monitoring is inexcusably poor scientific method for a new technology, “Emergency Use,” experimental injection that is still in Phase 3 of the experiment.

Following is a list of Adverse Events that are showing up with some frequency after vaccination in countries around the world. Understand that, for some of these injuries, direct cause and effect has not been proven; it’s that the incidence of the injuries are higher than would be expected in normal populations, or that a causal mechanism is not yet understood. More study is essential. If some of these issues concern you, search out the latest scientific evidence directly from the scientists who work in the field (not from Google, outlets that use “fact-checkers” or pharmaceutical industry-dependent “experts”).

• Reproductive issues – Unusual and heavy bleeding with menstruation, breast and scrotum swelling, erectile dysfunction, miscarriages and premature births are being reported. The UK Yellow Card system reported an increase of 475% in the 6 weeks (vaccine rollout) up to March 7, 2021 in the number of women who lost their unborn child. The spike protein from the vaccine has appeared in the breast milk of mothers and subsequently in their babies. At least one baby suffered a bleeding disorder and died. Recent Kirsch data suggests that miscarriage rates for women who get vaccinated in the first 20 weeks of pregnancies are 82% compared to the normal 10%. Remember that the vaccine trials did not include pregnant or soon-to-be pregnant women, so effects on women and their babies are unknown until now.

• Cardiovascular issues – Heart failure, heart attacks and Myocarditis/Pericarditis (inflammation or the heart or lining around the heart) are occurring often within days of vaccination. Myocarditis is particularly affecting younger males (18 – 40 years old) within 5 days of their 2^nd shot, though not exclusively. Data out of Israel shows that vaccinated 16 – 24 year old males have 25 times the rate of myocarditis than normal. Scientists generally agree that it is the spike protein itself that is almost entirely responsible for the damage to the cardiovascular system when it gets into circulation (Brindle, Seneff, Whelan and others). As of mid-June, the CDC has had reports of 475 cases of Myocarditis in the US in under 30-year-olds and is scheduled to have an emergency meeting June 18, 2021 because of these excessive heart inflammation cases.

• Neurological issues – Bell’s Palsy (facial paralysis), Guillain-Barre Syndrome (rapid onset muscle weakness and loss of sensation), Transverse Myelitis (spinal cord inflammation) and other seizure, tremor and loss of sensation/control issues have occurred post vaccination. Symptoms may resolve in time, but many do not.

• Breakthrough cases – Fully vaccinated people are testing positive for covid. There have been so many of these “Breakthrough cases” in the US that the CDC changed the monitoring system to only record those that require hospitalization or that result in death and only those that test positive with a much less sensitive PCR test. These changes will make it almost impossible to determine what protection the vaccine is actually providing against infection.

• Deaths from vaccination – The CDC’s VAERS system reported 4057 deaths following a covid vaccination between December 14, 2020 and May 7, 2021. 13 of 23 post- vaccination deaths in Norway were autopsied and concluded that common side effects from the vaccine were likely the cause. Israel posted an article on February 11, 2021 based on Pfizer vaccine data following their 5-week vaccination period which concluded that, for the elderly, about 40 times more people were killed following the vaccine than by COVID itself, and about 260 times more people than the disease in younger people. Post-vaccination deaths are occurring in previously healthy ,as well as compromised people, usually within 3 or 4 days of being vaccinated and up to 14 days.

• Pending long-term adverse events – Some fully expected long term AEs have yet to evolve. Specifically, Antibody Dependent Enhancement, which caused previous coronavirus vaccine efforts to fail when animals and people who showed good antibody response got more severe forms of the disease or died when exposed to the live virus. There is a possibility this problem may surface with the coming Fall coronavirus season. Secondly, Autoimmune diseases are expected because of the level of inflammation that may be created by the spike proteins, but they often take a year and more to develop into recognizable symptoms.

• Calls for a vaccination moratorium – A UK report based on their Yellow Card monitoring system has been submitted to the Medicines and Healthcare Products Regulatory Agency stating that “the MHRA now has more than enough evidence on the Yellow Card system to declare the COVID-19 vaccines unsafe for use in humans.” They suggest that “an immediate halt to the vaccination program is required whilst a full and independent safety analysis is undertaken to investigate the full extent of the harms, . . .” Similar requests, some legal, have been put forward in European countries by doctors and scientists. In addition, many scientists, doctors and legal experts are advising that children under 18 years old should not be vaccinated until much more is known about long term adverse events. US VAERS currently reports 271 serious AEs in 12 – 17 year olds and 7 deaths. This is totally avoidable. Childrens’ Health Defense has requested that the FDA revoke Emergency Use Authorizations and refrain from vaccinating all demographic groups and specifically children, “. . . because the current risks of serious adverse events or deaths outweigh the benefits, and because existing, approved drugs provide highly effective prophylaxis and treatment against COVID, . . .”

My intention in presenting these pages is that this document broadens your perspective and helps you make a more fully informed choice regarding whether to get the Covid-19 vaccine at this time or not. Stay healthy.

by Gail Reynolds, Exercise Physiologist