COVID-19 Vaccine is experimental and your choice

The COVID vaccine is experimental—and will be until final Phase 3 clinical trial results are statistically analyzed, sometime in 2022, then peer-reviewed by unbiased experts, then presented to the FDA to begin a final approval process. Under international laws of informed consent, healthcare professional or their staff are required to provide effectiveness, safety, contraindications (situations where the medication, vaccine, or other, are inappropriate due to another health condition) and, in the case of the COVID vaccine, clearly state the vaccine is experimental and that we really don’t know anything about efficacy or safety as those trials remain incomplete.

I’m not pro- or anti- Vaxx. I do want to help educate so all of us can make informed choices. It’s all about YOU.

Under the U.S. constitution, vaccines cannot be mandated

Your personal choice to get the SARS-COVID-19 vaccine (or any medical procedure) remains your choice:

• The Ninth Amendment reads “The enumeration in the Constitution, of certain rights, shall not be construed to deny or disparage others retained by the people.” The Ninth Amendment – and indeed the entire Bill of Rights – originally concerned restrictions upon Federal power.
• Subsequently the Fourteenth Amendment prohibits States from making or enforcing any law that deprives any person of life, liberty, or property, without due process of law; nor deny to any person within its jurisdiction the equal protection of the laws.
• While these laws may be lessened during designated pandemics, there have only been four actual pandemics in the last 2 centuries—including H1N1 swine flu and now COVID. Looking at the CDC graph, what do you see?

Would a mandate that everyone get a vaccine deprive certain of us of life or good health? Please consider these questions and answer them for yourselves:

1. On one side is “get the vaccine to protect me from you” (The idea here is the vaccine prevents an uninfected person from getting COVID—we don’t know and won’t know until the end of clinical trials in 2022);
2. On another side is “get the vaccine to stop symptoms.” Again, we do not know. Current clinical trials are not designed to measure this.
3. Can employers require vaccination? No. All employees in the U.S. have exemptions from mandatory vaccination requirements. Under Title VII of the Civil Rights Act of 1964, once an employer receives notice that an “employee’s sincerely held religious belief, practice, or observance prevents him from taking the influenza vaccine, the employer must provide a reasonable accommodation unless it would pose an undue hardship”. This has been ratified by the Supreme Court to include all vaccines. Medical exemption includes past adverse reactions to other vaccines, autoimmune disease, and other. Masks, social distancing, working remotely… are commonplace now and considered “reasonable accommodations”.
4. Should the vaccine include a tracker or other method of identifying who did and did not receive the vaccine? Please see your Bill of Rights under the Constitution. Doing so violates your rights as a U.S. Citizen.
5. Should the vaccine be mandatory for travel? Or to remain employed if you are an otherwise responsible and productive employee? No. Under all U.S. laws. Other countries have different laws.

Clinical trial results to date:

1. After only 2-months of trials, both the Pfizer and Moderna vaccines were granted Emergency Use Authorization (EUA) by the FDA in December 2020.
2. Johnson and Johnson (Janssen) received experimental approval Early 2021
3. None of these vaccines have authorization for children aged under 16 or aged adults over 60.
4. Emergency use does NOT mean they were approved by the FDA. Why? We’re still awaiting clinical trial data. During a time when viruses impact multiple countries, the World Health Organization can declare a pandemic. If a pandemic is declared then emergency procedures come into play. Is this right? Please see the number of cases and scenario below—decide for yourself.
5. We’ll know far more after the safety and efficacy studies complete in 2022. More to learn.

There is more to know—did you have COVID? Allergies? Autoimmune? Should you get the COVID 19 vaccine?

https://www.cdc.gov/flu/weekly/index.htm#ILIActivityMap Documented Seasonal flu declined substantially and was relabeled COVID because symptoms are near identical.

Let’s do some math (sorry):

As of March 24, 2021, in our country of 326.7 million people, there were 29.8 million COVID cases. That is a 9 percent infection rate based on either symptoms or actual testing for travel or testing due to symptoms. Let’s assume this is a correct number although many were “diagnosed” based on symptoms and not positive tests.

Of the 29.8 million infected, there were 543 thousand deaths assigned to COVID. That is a 1.8 percent death rate.

Compare that to H1N1 swine flu:

In 2009 H1N1 was declared a pandemic. By 2018 (the last data available and health care providers are not required to report infections), another 9 percent infection rate according to the CDC.

Healthcare providers are not required to report swine flu deaths; the CDC states:

“While flu deaths in children are reported to CDC, flu deaths in adults are not nationally notifiable.”

How effective were the Flu Vaccines? According to the CDC:

The overall vaccine effectiveness (VE) of the 2017-2018 flu vaccine against both influenza A and B viruses is estimated to be 40%. This means the flu vaccine reduced a person’s overall risk of having to seek medical care at a doctor’s office for flu illness by 40%. If 200 people had the H1N1 flu, even if all of them went to their doctor for symptoms, then 8 of them would have been better off by receiving the vaccine. The average number of patients who need to be treated to prevent one additional bad outcome (i.e. the number of patients that need to be treated for one to benefit compared with a control is):  125  and the Absolute risk reduction as noted above is: 0.8 %

This does not take into account unwanted vaccine effects. Would you take a medication or vaccine that would only benefit 1 out of 125 patients without knowing the other effects? Risk vs benefits?

Are they even safe? We will not know until the clinical trials end.

1. The Pfizer study of 43,000 individuals, the authors data show: “Severe local and systemic adverse reactions (grade ≥3, defined as interfering with daily activity) occurred more commonly in vaccine recipients than in placebo recipients.” (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7745957/) In fact, this fairly readable paper shows no difference in (death rates) mortality between those who received the vaccine and those who didn’t—just more unwanted effects.
2. During December 14–23, 2020, monitoring by the Vaccine Adverse Event Reporting System detected 21 cases of anaphylaxis within 24 hours of receiving the vaccine. Published in Morbidity and Mortality Weekly Report, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7808711/, individuals who had allergic responses more than 24 hours later were not included in the analysis because the authors decided it could only be questionably related to the vaccine.
3. December 2020, only two months into clinical trials that will complete late 2022, vaccine manufacturers Pfizer and Moderna used media channels to promote a “95% reduction in cases among those immunized”. Not only is this very preliminary, where did these numbers come from? In the Pfizer study, 21,500 healthy individuals received an injection that did not contain the active COVID RNA (placebo). Of these, 128 (~ 0.7 percent) tested positive for COVID-19 while only 8 in the group that received the active vaccine developed the virus. While “95 percent” might look impressive, let’s dig deeper:
   1. Is a change of 128 to 8 people out of 43,000 in the study meaningful? Time might tell. I’m waiting for the trials and the peer review to complete.
   2. According to the Pfizer clinical trials, if ~0.7 percent of 21,500 healthy people get COVID-19, does this constitute an emergency? (note the very different percentage from guestimates. These individual were nasally tested for positive COVID—not based on symptoms alone).
   3. Between now and mid-2022, the 43,000 individuals enrolled in Pfizer’s clinical trial will be monitored to calculate efficacy. How many still get sick or have an adverse reaction; numbers may change. https://www.nejm.org/doi/full/10.1056/NEJMoa2034577.
4. Efficacy is what happens under strictly controlled clinical trial settings with a high level of compliance monitoring; effectiveness is what happens under “real world conditions” e.g. going out to dinner with friends, to the gym, gathering for Holiday’s or Church, etc. We have no idea whether or not the vaccine will return us to social freedom.
5. We don’t have enough information to know whether or not the vaccine prevents contracting the disease, experiencing symptoms, and/or spreading the disease. It may still be possible to contract it and spread it if you are exposed—and you may remain asymptomatic and never know you are a source. Again, we’ll know more by the end of the clinical trials (at least a year away).

This is all why after getting a vaccine, twice, you will still be wearing a mask and cautioned not to hug your loved ones.

What about vaccine safety?

1. The CDC describes minor adverse effects as pain where they got the shot, fatigue, headache, chills, fever, and joint and muscle pain. Sounds like the same symptoms of COVID for most of us—2% of us sail through as long as we’ve kept ourselves healthy.
2. The CDC is cautioning anyone with allergies to any of the vaccine ingredients to avoid the vaccine (ingredients include eggs, Polyethylene glycol, preservatives…); a table of prior allergies that cause adverse effects that can be found at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7808711/table/T1/?report=objectonly.
3. We do need to understand whether or not vaccines are appropriate for people who have predispositions for autoimmune disease, allergies, GI disorders, or previously were diagnosed with COVID. We just don’t know—individuals with autoimmune diseases (or were otherwise unhealthy) were excluded from vaccine trials yet are being heavily told to get the vaccine before the trials are complete.
4. The COVID vaccine is the first of its kind RNA vaccine that uses nanoparticle technology to get the RNA into your cells. The code for the SARS spike protein is inserted into your DNA so your cells begin to produce the spike protein. This is not the complete viral particle but enough of it to kick your immune system in gear, theoretically, to make antibodies that help your immune system recognize and control COVID exposure. We don’t yet know if the vaccine actually creates antibodies, how long any immunity might last… Might the vaccine create a false sense of security? Will you have antibodies? You are still expected to wear masks, stay home, social distance, and get your COVID test(s) if you travel.

What about special populations? Pregnant women, individuals who have already had COVID-19 (and may have antibodies to it), individuals with other health situations (particularly heart disease and diabetes).

1. In the clinical trials to date, individuals were excluded if they had COVID previously, are pregnant, –no one knows what happens if the vaccine is given to individuals in these groups. Many questions https://pubmed.ncbi.nlm.nih.gov/32584464/
   • If you already have COVID antibodies due to prior exposure, would you need additional immunization or is your immune system already protecting you?
   • Consider a SARS-COVID-19 antibody test. In Alaska, you can make an appointment with LabCorp for the blood draw at https://patient.labcorp.com/covid-19-antibody-test (outside Alaska, Quest also offers a COVID antibody test). You do not need a doctor’s requisition. Long-lasting immunity is “IgG”; the more immediate response type is “IgM”. Currently available tests explore both. https://pubmed.ncbi.nlm.nih.gov/32584464/
   • If you already have antibodies due to prior exposure, what is the safety, effectiveness, or necessity of being vaccinated? No data is available.
   • Could the vaccine now trigger an over-reactive immune system if you already have been exposed to COVID-19?
   • Research suggests that if you have had COVID (with or without symptoms) donating your blood may help others develop immunity. We need to know more about this interesting possibility.
2. If you choose to receive the COVID vaccination and have unwanted effects, the CDC encourages reporting these. Again, this is an experimental vaccine and we are still trying to understand the risks and benefits. Do report these here: https://www.cdc.gov/vaccinesafety/ensuringsafety/monitoring/vaers/index.html. For further assistance with reporting to VAERS, call 1-800-822-7967
3. Under EUA, if you experience adverse events, you may not sue the vaccine manufacturer: On 4 February 2020, US Secretary of Health and Human Services Alex Azar published a notice of declaration under the Public Readiness and Emergency Preparedness Act for medical countermeasures against COVID‑19 stating “any vaccine, used to treat, diagnose, cure, prevent, or mitigate COVID‑19, or the transmission of SARS-CoV-2” … precludes “liability claims alleging negligence by a manufacturer in creating a vaccine, or negligence by a health care provider in prescribing the wrong dose, absent willful misconduct”. The declaration is effective in the United States through 1 October 2024. Please report your adverse events so they can be known; don’t expect any compensation if the testing was inaccurate or your vaccine caused a problem. Note the date. COVID acknowledgement and shutdowns were announced in March 2020.

How bad is COVID-19 anyway?

In 2018 (the last year we have verified information from the CDC) https://www.who.int/data/global-health-estimates 17.9 million lives worldwide were lost to cardiovascular disease, 9.6 million to cancer…

In 2020, 29.8 cases were assigned to COVID-19, most of whom had cardiovascular and diabetes complications—healthcare professionals agree that metabolic syndrome, including high cholesterol being overweight, and high blood pressure, are problems of the Standard American Diet.

Many individuals were diagnosed based only on symptoms and not a valid COVID test. Over more than 95 percent have recovered according to John’s Hopkins University. As of March 24, 2021 there are 29.8 million COVID cases in the US and the curve has substantially declined. This is a 9 percent infection rate. Of those, nearly half a million deaths (none of us want deaths) which is a 1.8 death rate.

Of the four real pandemics in the last 2 centuries, each has resulted in death rates (up to 50%) rather than under 1 percent. Don’t get me wrong, I do honestly feel awful when a loved one is lost. Shouldn’t we focus more on the root cause?

• Metabolic syndrome
• Generally unhealthy lifestyles
• Running ourselves down

Let’s not run in fear just because the media promotes fear. Let’s please think. And let’s please keep ourselves healthy by increasing genuine building blocks and being responsible.

Absolutely there are options beyond a vaccine!

Please read these other research-backed summaries:

Melatonin is proven protective against COVID, Flu, and balances the immune system

Natural remedies for COVID, Flu, and…

COVID: What should we really do?

Hugs and Health!

Marie