October 15, 2021 from Marilyn Singleton, MD JD

FACTS AND STATS ON COVID (10/21/21)
curated by Marilyn M. Singleton

What is Immunity?

  • Innate immunity. White cells – polys, macrophages are nonspecific. They call in other cells if they can’t handle the infection.
  • Adaptive immune responses include antibodies. A major goal of antibodies is to bind to the pathogen and prevent it from infecting, or entering, a cell. Antibodies that prevent entry into cells are called neutralizing antibodies.
    • An epitope, also known as antigenic determinant, is the part of an antigen that is recognized by theimmune system specifically by antibodies, B cells, or T cells. The epitope is the specific piece of the antigen to which an antibody binds.
    • Difference between neutralizing antibodies and binding antibodies: Not all antibodies that bind a pathogenic particle are neutralizing. Non-neutralizing antibodies, or binding antibodies, bind specifically to the pathogen, but do not interfere with their infectivity. That might be because they do not bind to the right region. In some cases, non-neutralizing antibodies or insufficient amounts of neutralizing antibodies binding to virus particles can make it easier for the virus to get into the cell. This is called antibody dependent enhancement.
  • T cells – T cell lymphocytes develop from stem cells in bone marrow. These immature T cells migrate to the thymus. The thymus is a lymphatic system gland that functions mainly to promote the development of mature T cells. They work with macrophages. But T cells are specific to a virus. They are a major source of cytokines.
    • Killer T cells find and destroy infected cells that have been turned into virus-making factories.
    • Helper T cells – (CD4) These cells don’t make toxins or fight invaders themselves. They use chemical messages to give instructions to the other immune system cells. (i.e., make cytokines). These instructions help Killer T cells and B cells make a lot more of themselves so they can fight the infection and make sure the fight stays under control.
    • This subset can be further subdivided into Th1 and Th2, and the cytokines they produce are known as Th1-type cytokines (pro-inflammatory response, kill intracellular parasites, and perpetuate autoimmune response); and Th2-type cytokines counteract the response, also give eosinophilic response. In excess, Th2 responses will counteract the Th1 mediated microbicidal action.
    • B-cells – (Named after the place they were discovered, the Bursa of Fabricius, an organ only found in birds.) B cells don’t kill viruses themselves. The B-cell sweeps up the leftover viruses after the T cell attack. And they make antibodies. Prior infection creates memory B cells that patrol the blood looking for reinfection and the bone marrow plasma cells stay in the bones trickling out antibodies for decades. People who recover from mild COVID-19 have bone marrow cells that can churn out antibodies for decades, although viral variants could dampen some of the protection they offer.
  • An important difference between T cells and B cells is that B cells can connect to antigens right on the surface of the invading virus or bacteria. This is different from T cells, which can only connect to virus antigens on the outside of infected cells.

What Is RNA?

DNA (deoxyribonucleic acid) is a double-stranded molecule that stores the genetic instructions your body’s cells need to make proteins. (adenine, cytosine, guanine, and thymine) Proteins are the ‘workhorses’ that carry out the functions of the human body.

RNA (ribonucleic acid), a single-stranded molecule, also carries genetic information. There are several types of RNA. (adenine, cytosine, guanine, and uracil). Messenger RNA, or mRNA for short, carries a copy of the genetic information from the DNA for each protein to a cell’s ribosomes, the “machinery” that makes proteins.

What Is the Coronavirus?

Coronaviruses (CoVs) are a big family of RNA viruses. RNA viruses are divided into 4 genera: alpha, beta, delta, and gamma. Alpha and beta CoVs infect humans and four of these cause the common cold. The “spike” protein is what gives the coronavirus family of viruses their name. The spikes jut out from the surface of the spherical virus, giving it a crown-like halo, or “corona.” The beta-coronavirus that causes COVID-19 is called SARS-CoV-2.

Coronaviruses (CoVs) are enveloped viruses with positive-sense single-stranded RNA genomes. They are widespread in animals and can cause mild to severe respiratory or enteric disease in humans. There are currently seven CoVs known to infect humans, which include the four “seasonal” human CoVs: OC43, 229E, NL63, and HKU1, which can cause mild cold-like symptoms and three highly pathogenic CoVs: SARS-CoV, MERS-CoV, and SARS-CoV-2. SARS-CoV emerged in 2002 and resulted in more than 8,000 human infections with a case fatality rate of approximately 10%. This was followed by the discovery of MERS-CoV in 2012, which has resulted in more than 2000 human infections and over 800 lethal cases with ongoing sporadic outbreaks in the Middle East. More recently, the outbreak of SARS-CoV-2 has caused unprecedented social and economic damage around the world. Since it was first reported in Wuhan, China in December 2019, SARS-CoV-2 has resulted in over 164 million infections and more than 3.4 million deaths as of 20th May 2021, according to WHO.

What Is COVID-19?

The name COVID-19 stands for COrona VIrus Disease – 2019.

What Is the “Spike Protein” and Its Relationship to COVID-19?

The spike protein is the part of the virus that latches onto and enters the cells that it infects. Once inside the cell, the virus injects its RNA and hijacks the cell and it becomes part of the cell’s protein production machinery (ribosome). If the virus replicates, the disease spreads. When the body’s immune system detects viral damage, it reacts with inflammation.

 What Is an ACE2 Receptor and Its Relationship to COVID-19?

ACE2 (Angiotensin Converting Enzyme) is present in many tissues including the lungs, heart, blood vessels, kidneys, liver and gastrointestinal tract, both male and female reproductive systems, nose, and mouth. One of the roles of ACE2 is to modulate the body’s response to inflammation. The virus enters the cells through the ACE2 receptor on the cell’s surface and then interferes with ACE2’s job of modulating the inflammatory response.

The spike protein binds to the ACE2 receptor on cells, particularly the lungs that have lots of ACE2 receptors. This causes damage to the cells that line lung tissue and blood vessels. This disrupts the exchange of oxygen and carbon dioxide between the lungs and blood.

While initially we thought of COVID-19 as a respiratory illness, it is primarily a blood vessel disease. It affects the lungs, but also affects other organs in the body, and can cause strokes and blood clots.

What Is a Cytokine Storm?

Cytokines are small molecules that help direct the immune response to invaders, e.g., a virus. When the process of fighting off invaders “storms out of control” the blood vessels leak, the blood clotting process is disturbed, and the result can be organ failure and death.

What Are Comorbidities and Risk Factors for COVID-19?

A comorbidity is a medical condition that you are already experiencing. Comorbidities may affect the severity of COVID-19.

  • Age over 80 years old — #1 factor. Any age catches it, but age increases likelihood of serious symptoms, death. 80% of deaths are over 65 yrs.
  • High blood pressure
  • Diabetes
  • Obesity
  • Chronic kidney disease
  • Liver cirrhosis
  • Asthma/emphysema/smoking
  • Heart disease – CHF, CAD, cardiomyopathy, congenital
  • Malignancy/immune suppression – transplants, HIV, long-term use of steroids
  • Down syndrome – more physical problems, may be in group home

CDC: For 6% of the deaths, COVID-19 was the only cause mentioned. For deaths with conditions or causes in addition to COVID-19, on average, there were 2.9 additional conditions or causes per death. The number of deaths with each condition or cause is shown for all deaths and by age groups. Values in the table represent number of deaths that mention the condition listed and 94% of deaths mention more than one condition.

Italian study – But the Italian data show: 2.1% of the deceased had no comorbidity factor. The assumption that the healthy and the unhealthy have an equal chance of dying is clearly wrong. Those with comorbidity conditions are actually about 10.5 times as likely to die as those who are healthy.

What is the PCR Test (Reverse transcription polymerase chain reaction)

This is under Emergency Use Authorization (EUA). Results are for the identification of SARS-CoV-2 RNA.  The more the cycles, the more the virus is amplified, picking up fragments and dead virus. Cycles went as high as 40. Dr. Kary Mullis, the inventor of the process, who won the Nobel Prize in Chemistry in 1993 said that the PCR test cannot diagnose disease.

  • Positive results are indicative of active infection with SARS-CoV-2 but do not rule out bacterial infection or co-infection with other viruses. (SARS = severe acute respiratory syndrome).
  • Detection of viral RNA may not indicate the presence of infectious virus or that SARS-CoV-2 is the causative agent for clinical symptoms.
  • The performance of this test has not been established for monitoring treatment of SARS-CoV-2 infection.
  • The performance of this test has not been established for screening of blood or blood products for the presence of SARS-CoV-2.
  • This test cannot rule out diseases caused by other bacterial or viral pathogens (p.38).
  • Since no quantified virus isolates of the SARS-CoV-2 were available for CDC use at the time the test was developed and this study conducted, assays designed for detection of the SARS-CoV-2 RNA were tested with characterized stocks of in vitro transcribed full length RNA. 40, CDC 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel (7/21/21).

What Do All These Numbers Mean?

  • Case vs infection – “Case” should be someone with symptoms. But reports call mere infections a “case.”
  • Change in PCR – After the vaccinations progressed, to define a breakthrough case, CDC is accepting only positives tests at less than 24 cycles.
  • Change in counting cases post May 2021 – only report hospitalization or death.
  • Unvaccinated = up to 2 weeks after last dose so adverse effects are listed as unvaccinated.
  • Milder cases are now being hospitalized.

What Are the Survivability Rates for COVID-19?

COVID-19 does not kill all age-groups equally and is focused on elderly persons with comorbidities, younger persons with medical conditions, obese persons, and diabetics.

  • Ages 0-19 years, the infection survival rate is 99.9973%.
  • Ages 20-29, the infection survival rate is 99.986%.
  • Ages 30-39, the infection survival rate is 99.969%.
  • Ages 40-49, the infection survival rate is 99.918%.
  • Ages 50-59, the survivability rate is 99.73%.
  • Ages 60-69, the survivability rate is 99.41%.
  • For ages 70+, the survivability rate is 97.6%. (non-institutionalized)
  • For ages 70+, the survivability rate is 94.5%. (all)
  • The average age of death from COVID-19 is 73 years; 50% of deaths are over age 80 years.
  • The average COVID-19 death has 2.5 comorbidities.

What is a Variant?

All viruses have millions of variants. Viruses ‘mutate’ as part of their existence. The
SARS-CoV-2 Delta (India) variant is more transmissible than earlier versions of the virus, but it is weaker, less deadly. Side note: when you hear bureaucrats talk about “eliminating” COVID-19, this maybe code word for spending more money on costly treatments and vaccines. Consider this: we have not eliminated the annual flu or the common cold. We continue to learn to live with many types of viruses and let our natural immunity do its job.

Six months ago, we had 14 variants. Vaccines cause nonlethal evolutionary pressure, allowing the dominant variant to move forward.  Now Delta is dominant. And the vaccinated are spreaders.

Variants of Concern: Alpha (UK), Beta (S. America), Delta (India), Eta (UK), Gamma (Brazil), Kappa (India), Theta (Philippines), Lambda (Peru), Mu (Columbia, Ecuador, Los Angeles), Iota (New York)

What is Gain-Of-Function?

Gain-of-function is a term that describes any type of virology research that results in the gain of a certain function. Regarding SARS-CoV-2 (the virus that causes COVID-19), this research causes a pathogen to be more infectious or deadly, particularly to humans.

What Is the Origin of the SARS-CoV-2 Virus That Causes COVID-19?

There are two theories of the origin SARS-CoV-2.

The first theory is “natural emergence.” According to the Chinese government, the virus jumped from a pangolin sold at a “wet” market (where wild animals are sold for meat) in Wuhan. This was similar to the 2002 Chinese SARS-1 epidemic in which a bat virus spread to a civet and then to humans; and the 2012 Middle East MERS epidemic in which a bat virus spread to camels and then to humans. This 2019 novel coronavirus (SARS-CoV-2) was in the same family as the SARS-1 and MERS viruses. However, Chinese authorities have failed to identify the original species that allegedly spread the virus to humans.

The second theory is that the virus escaped from a lab in Wuhan, China.

  • Viruses have long been known to escape from labs.
  • The Wuhan Institute of Virology, is a leading world center for research on coronaviruses.
  • According to the House Intelligence investigation in May 2021, there were warnings from U.S. diplomats in China as early as 2017 that the Wuhan lab was conducting dangerous research on coronaviruses without following necessary safety protocols, risking the accidental outbreak of a pandemic.
  • Anthony Fauci’s recently released emails from February 2020 reveal that scientists raised the possibility of a lab leak and also expressed concern the virus appeared to be engineered.
  • Zhengli Shi, the “Bat Lady,” organized frequent expeditions to the bat-infested caves of Yunnan in southern China and collected around a hundred different bat coronaviruses.
  • Three researchers from the Wuhan lab became ill with symptoms consistent with COVID-19 and sought hospital care in October-November 2019.
  • Shi worked with Dr. Ralph S. Baric at the University of North Carolina. Their work focused on (1) enhancing the ability of bat viruses to infect humans and (2) “gain-of-function” research which created viruses more infectious and deadly than those that exist in nature. This was presumably to predict the cross-over of viruses from animals to humans.
  • In 2015, the scientists acknowledged the risks involved with gain-of-function research but proceeded anyway.
  • From June 2014 to May 2019, the EcoHealth Alliance of New York headed by Dr. Peter Dazak, had a grant from the National Institute of Allergy and Infectious Diseases (NIAID). EcoHealth Alliance then funneled the grant money to the Wuhan Institute of Virology.

 The scientists working in Wuhan took a natural coronavirus found in bats. They spliced this onto a new spike, and as a result of this, they made it into the highly transmissible SARS-Cov-2. This virus binds more strongly to human ACE-2 enzymes than any other species, including bats. This binding to ACE-2 is a possible explanation for the clinical symptoms infected people develop. It may also be an explanation for the complications we see after receiving an mRNA vaccine that reproduces the spike protein. SARS-Cov-2 has a mutated gene similar to that found in HIV and Ebola. This section of mutated gene did not exist in SARS. This mutation makes the virus have a binding ability to the human cell, which is up to 1000 times stronger than the SARS virus. This makes it extremely infectious.

What Are Symptoms of COVID-19?

  • Fever or chills
  • Cough
  • Shortness of breath or difficulty breathing
  • Fatigue
  • Muscle or body aches
  • Headache***
  • New loss of taste or smell** (esp. post vax)
  • Sore throat***
  • Congestion or runny nose***
  • Sneezing***
  • Nausea or vomiting
  • Diarrhea
  • Some have reported chest pain, delirium, red fingers and toes, skin rash

It is important to note that it is rare for people without symptoms (asymptomatic) to spread the SARS-CoV-2 virus.

Treatments

Treatments for COVID are classified into several categories: (1) antibody therapies, which use lab-produced antibodies to help stop viral replication; (2) antivirals, which specifically target and kill viral particles; and (3) corticosteroids, which can help reduce the body’s inflammatory response to the infection; (4) anti-clotting medications.

Early Treatment Options for COVID-19

(This is a list of available options and are not meant to be taken together, but under the protocols of a trusted doctor. These products are not a cure but can improve the path to recovery. See Appendix A and B for sample protocols.)

  • Zinc blocks virus replication, as first discovered by world-leading SARS virologist Ralph Baric in 2010.
  • Ivermectin (an antiparasitic drug) has strong anti-viral and anti-inflammatory Early treatment is most successful.
  • Quercetin (a plant polyphenol) supports the cellular absorption of zinc and has anti-viral properties, as first discovered during the SARS-1 epidemic in 2003.
  • Bromhexine (a mucolytic cough medication) inhibits entry of the virus into the cell, whether or not you have a cough.
  • Vitamins C and D support and improve the immune system response to infections.
  • Aspirin may help prevent infection-related thrombosis (blood clots) and embolisms (blood clots that travel in the body) in patients at risk.
  • Azithromycin (an antibiotic) prevents bacterial superinfections of the lung.
  • Prednisone (a corticosteroid) reduces COVID-related systemic inflammation.
  • Hydroxychloroquine (HCQ) has known anti-thrombotic, anti-inflammatory, and possibly anti-viral Has been used safety for malaria for over 50 years.
  • Inhaled Budesonide (Pulmacort) – local steroid with some systemic action.
  • Other treatments fenofibrate, an existing cholesterol drug, and fluvoxamine, an antidepressant, Olumiant, a cytokine inhibitor (Rheum Arthritis)
  • Monoclonal antibodies are man-made proteins that act like human antibodies in the immune system. There are 4 different ways they can be made and are named based on what they are made of.
    • Murine: These are made from mouse proteins and the names of the treatments end in -omab.
    • Chimeric: These proteins are a combination of part mouse and part human and the names of the treatments end in -ximab.
    • Humanized: These are made from small parts of mouse proteins attached to human proteins and the names of the treatments end in -zumab.
    • Human: These are fully human proteins and the names of the treatments end in -umab.
  • Regeneron – Combination of casirivimab and imdevimab; also for post exposure prophylaxis.
  • Combination of bamlanivimab and etesevimab, which is authorized for patients aged 12 years or older, and sotrovimab, which received an emergency use authorization for mild-to-moderate COVID-19 in patients at risk for progressing to severe disease and Regeneron’s antibody cocktail as a postexposure prophylaxis. (600 mg of casirivimab and 600 mg of imdevimab — half the dose that was authorized under the original EUA.
  • New Anti-viral pills – Merck & Co. and Ridgeback Biotherapeutics called molnupiravir; Pfizer, PF-07321332; and Roche and Atea Pharmaceuticals, AT-527.
  • See Treatment Protocols at Appendix A and B at the end of this document and on these websites:

 What is a Vaccine?

The CDC’s specific definition says vaccines are “a product that stimulates a person’s immune system to produce immunity to a specific disease, protecting the person from that disease. Vaccines are usually administered through needle injections, but can also be administered by mouth or sprayed into the nose.”

The HHS says on its vaccines.gov website that a vaccine “is made from very small amounts of weak or dead germs that can cause diseases — for example, viruses, bacteria, or toxins. It prepares your body to fight the disease faster and more effectively so you won’t get sick.”

Vaccines are preventive “and a preventative vaccine is something you give to your body that stimulates an immune response, so when you’re exposed to the natural infection, your body will already be prepared to respond. COVID vaccines fall into that category of being preventative vaccines.

 Vaccine Authorization Process

A manufacturer must conduct various studies, including clinical trials, to prove that the vaccine is safe for use and is effective. These trials must be complete before an application can be submitted. Approval of vaccinations typically have 4 phases. First, the drug is given to a small number of people; second, to a few hundred people; third, to a large scale trial of generally 3,000 people. This stage takes 1 to 4 years. The phase 4 is the continued monitoring of an approved drug looking for problems that were missed (such as birth defects with thalidomide and heart problems with Vioxx.)  The mumps vaccine had been the quickest approval; it took 5 years.

Emergency Use Authorization (EUA) Fastrack Vaccine Authorization Process

The current vaccines for COVID-19 in the United States underwent the Emergency Use Authorization process (EUA) based on The Project BioShield Act of 2004 passed after an anthrax scare. In this process, once the Secretary of Health and Human Services determines that there is a public health emergency, an EUA may be issued if based on available data the benefits outweigh the risks of the drug and there is no adequate, approved, and available alternative.

An EUA allows a manufacturer to apply using interim clinical trial data. For an EUA, the manufacturer may submit its safety data based on a median two-months follow-up (since this is when most side effects tend to happen) for every individual who completed the vaccine regimen. For the FDA to authorize a vaccine under an EUA, a pharmaceutical company needs to show that it’s safe and effective at preventing the disease. As part of the EUA application process, the FDA reviews available phase 3 clinical trial data (final or interim) to determine if the vaccine’s known benefits outweigh the known risks.

Compared to conventional medications, vaccines are approved and regulated differently. When pharmaceutical companies pursue vaccine approval, they submit a Biologics License Application (BLA) instead of a New Drug Application (NDA). This is because vaccines are considered to be biological products— products made from living cells, proteins, etc. — and the process to make them is more complex than conventional medications approved through an NDA.

Vaccines available through an EUA can only be used in the way they’ve been authorized. In other words, the EUAs need to be amended for things like booster doses, new age groups, and other changes if new supporting data becomes available.

But once a vaccine is fully approved, healthcare providers can use their clinical judgment to prescribe it as medically appropriate for their patients — which may be outside of its approved labeling (called off-label).

Currently Available Vaccines in the United States and Their Ingredients

Pfizer-BioNTech, Moderna, and Johnson & Johnson/Janssen are being used in the United States. These are “non-sterilizing vaccines, meaning they cannot stop getting an infection or stop the spread. The Pfizer CEO and the CDC Director publicly stated that his vaccine does not prevent transmission and spread of the virus. The vaccines only promise that you will get a milder case of COVID-19. There is uncertainty regarding their effectiveness against the variants.

The Moderna (modified RNA, 2008) and Pfizer-BioNTech (2010) vaccines use messenger RNA (mRNA). mRNA vaccines do not contain a live virus — they give our bodies “instructions” for how to make and fight the harmless spike-shaped proteins that will protect against a COVID-19 infection. While these vaccines use new technology, researchers have been studying them for decades. 1990s cancer therapy.

Forty-two days after the genetic code for SARS-CoV-2 was released, Moderna had the vaccine.

(Some history from Wikipedia: The first successful transfection of mRNA packaged within a liposomal nanoparticle into a cell was published in 1989. “Naked” (or unprotected) mRNA was injected a year later into the muscle of mice. These studies were the first evidence that in vitro transcribed mRNA could deliver the genetic information to produce proteins within living cell tissue[ and led to the concept proposal of messenger RNA vaccines.

Liposome-encapsulated mRNA was shown in 1993 to stimulate T cells in mice, and mRNA proved useful two years later to elicit both humoral (e.g., antibodies) and cellular immune (phagocytes, antigen-specific killer lymphocytes, cytokines) response against a pathogen.

Successful application of modified nucleosides as a medium to get mRNA inside cells without setting off the body’s defense system was reported in 2005. The companies, BioNTech in 2008 and Moderna in 2010, were started to develop mRNA biotechnologies.

US government agency DARPA (Defense Advanced Research Projects Agency) launched in 2010 a biotech research program called ADEPT as part of its mission to develop emerging technologies for the US military. DARPA recognized a year later the potential of nucleic acid technology for defense against pandemics and began to invest in the field through ADEPT. DARPA’s grants were seen as a vote of confidence which in turn encouraged other government agencies and private investors to also invest in mRNA technology. In 2013, DARPA awarded a $25 million grant to Moderna.

There are mRNA drugs for cardiovascular, metabolic and renal diseases, and selected targets for cancer were initially linked to serious side effects. mRNA vaccines for human use have been studied for rabies, Zika virus disease, cytomegalovirus, and influenza.)

Moderna Ingredients (www.modernatx.com/patents Revised: 12/2020); https://www.fda.gov/media/144638/download#page=2

  • Messenger ribonucleic acid (mRNA).
  • Lipids: SM-102, Polyethylene glycol (PEG), 2000 dimyristoyl glycerol (DMG), cholesterol, 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC)
  • Salts, sugars, buffers: tromethamine, tromethamine hydrochloride, acetic acid, sodium acetate, sucrose.
  • The vaccine does not contain eggs, preservatives, or latex.
  • Fetal Cells: The vaccine does not contain any aborted fetal cells and does not use them in the manufacture of the vaccine. However, such a cell line was used to test the efficacy of the vaccine in the lab.

The Pfizer-BioNTech Ingredients (Pfizer Inc., New York, NY 10017, BioNTech Manufacturing GmbH An der Goldgrube 12 55131 Mainz, Germany LAB-1451-0.7 Rev. Dec. 2020); https://www.fda.gov/media/144414/download#page=2)

  • Messenger ribonucleic acid (mRNA).
  • Lipids: 4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate), 2 [(polyethylene glycol)-2000]-N,N-ditetradecylacetamide, 1,2-Distearoyl-sn-glycero-3- phosphocholine, and cholesterol.
  • Salts, sugars, buffers: potassium chloride, monobasic potassium phosphate, sodium chloride, dibasic sodium phosphate dihydrate, sucrose.
  • The vaccine does not contain eggs, preservatives, or latex.
  • Fetal Cells: The vaccine does not contain any aborted fetal cells and does not use them in the manufacture of the vaccine. However, such a cell line was used to test the efficacy of the vaccine in the lab. On October 6, 2021, a video was released with a whistleblower who revealed a corporate email stating “one or more cell lines with an origin that can be traced back to human fetal tissue has been used in laboratory tests associated with the vaccine program.” Pfizer vice presidents wrote that Pfizer did not want that information revealed unless absolutely necessary. Cell line: HEK [human embryo kidney] 293 T cells.

 The Johnson & Johnson/Janssen vaccine is a non-replicating viral vector vaccine and does not contain a live virus, produced by a technique that has been around since the 1970s. It uses a harmless adenovirus to create a spike protein that the immune system responds to, creating antibodies to protect against COVID-19.

Johnson & Johnson Ingredients

(https://www.fda.gov/media/146305/download#page=2)

  • Recombinant, replication-incompetent adenovirus type 26 expressing the
    SARS-CoV-2 spike protein, citric acid monohydrate, trisodium citrate dihydrate, ethanol, 2 hydroxypropyl-β-cyclodextrin (HBCD), polysorbate-80, sodium chloride.
  • Fetal Cells: The vaccine did require the use of fetal cell cultures, specifically PER.C6 (a retinal cell line that was isolated from an aborted fetus in 1985), in order to produce and manufacture the vaccine.

 Approval of BioNTech Vaccine

There was no committee of academic and statistical experts to review the results. Instead, a meeting was held between the pharmaceutical companies and the FDA, and data, preceding the Delta outbreak was reviewed giving the meeting participants a knowingly false impression of high vaccine efficacy which clearly has been lost as the SARS-CoV-2 had mutated.

1) Pfizer was not granted full approval, but instead was given continuance of the EUA for 16 and older “for logistical reasons.” According to the FDA:

FN8 of approval letter: “The licensed vaccine has the same formulation as the EUA-authorized vaccine and the products can be used interchangeably to provide the vaccination series without presenting any safety or effectiveness concerns. The products are legally distinct with certain differences that do not impact safety or effectiveness.”

Why need EUA?  FN12 of approval letter:  “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.” (Comirnaty, is not currently produced, distributed, or marketed, and for Americans fundamentally will not exist as a distinct product for years.)

FN9 of approval letter: There is an EUA for the Pfizer-BioNTech COVID-19 Vaccine in individuals 12 years of age and older. The more recent authorizations — adolescents (ages 12 to 15) and the administration of a third dose to certain immunocompromised (Aug. 12th  EUA) individuals 12 years of age and older (Aug. 23rd EUA). (This was not part of the original BLA submission.)

2) According to the FDA: FDA has approved COMIRNATY (COVID-19 Vaccine, mRNA; tozinameran) for use in individuals 16 years of age and older (the original Dec. 11th EUA). The EUA (May 10th) will continue to cover adolescents (ages 12 to 15) and the administration of a third dose to certain immunocompromised (Aug. 12th EUA)individuals 12 years of age and older (Aug. 23rd EUA). (This was not part of the original BLA submission)

***BioNTech was granted conditional approval, but is required by statute to do post-marketing studies on myocarditis until 2025; and pregnancy and infant outcomes (2023).

How is Comirnaty related to the PFIZER-BIONTECH COVID-19 VACCINE?

The FDA-approved Pfizer-BioNTech product Comirnaty (COVID-19 Vaccine, mRNA) 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 vaccine.

Comirnaty has one more ingredient than the Pfizer – unnamed. (Now they are saying its saline).

The Comirnaty letter blanks out where it will be manufactured. Some say it is Shanghai.

The FDA-approved package insert reads: “13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility. COMIRNATY has not been evaluated for the potential to cause carcinogenicity, genotoxicity, or impairment of male fertility.” It mentions one study in female rats.

The package insert warns of myocarditis, but omits mention of Guillain-Barré syndrome, thrombotic complications, and other serious events.

FDA Factsheet: WHAT IF I DECIDE NOT TO GET COMIRNATY (COVID-19 VACCINE, mRNA) OR THE PFIZER-BIONTECH COVID-19 VACCINE? (p.6)

“Under the EUA, it is your choice to receive or not receive the vaccine. Should you decide not to receive it, it will not change your standard of medical care.”

CDC’s List of Possible Adverse Reactions (Side Effects) (https://www.fda.gov/media/143557/download. Vaccines and Related Biological Products Advisory Committee October 22, 2020 Meeting Presentation)

Short-term adverse events

  • Guillain Barré syndrome
  • acute disseminated encephalomyelitis
  • transverse myelitis
  • convulsions/seizures
  • stroke
  • narcolepsy and cataplexy
  • anaphylaxis, acute myocardial infarction, myocarditis/pericarditis
  • autoimmune disease
  • deaths
  • effects on pregnancy and birth outcomes
  • acute demyelinating diseases
  • non-anaphylactic allergic reactions
  • thrombocytopenia
  • disseminated intravascular coagulation
  • venous thromboembolism
  • arthritis and arthralgia/joint pain
  • Kawasaki disease
  • multisystem Inflammatory Syndrome in children
  • vaccine enhanced disease.

Note: ARE YOU TAKING OTHER MEDICATIONS? Be aware that anyone of these vaccinations may adversely interact with your medications. You have to discuss this with your doctor.  For example: birth control pills, blood thinners, immunosuppressive drugs, etc

Long-term adverse effects

  • Immune disorders
  • Guillain Barré syndrome
  • Cardiac effects
  • Cancers
  • Neurologic conditions

Problems with the Vaccines

(from Dr. Peter McCullough)

  1. COVID-19 vaccination is voluntary research. No person can receive pressure, coercion, or threat of reprisal on their free choice of participation. Violation of this principle constitutes reckless endangerment.
  2. COVID-19 vaccines do not work well enough. The current COVID-19 vaccines are not sufficiently protective against contracting COVID-19 to support its use beyond a voluntary clinical trial. A total of 10,262 SARS-CoV-2 vaccine breakthrough infections had been reported from 46 U.S. states and territories as of April 30, 2021. In response to these numerous reports, the CDC announced on May 1, 2021, that community breakthrough cases would no longer be reported to the public and only those vaccine failure cases requiring hospitalization will be reported. (https://www.cdc.gov/mmwr/volumes/70/wr/mm7021e3.htm).
  3. The COVID-19 vaccines do not protect against the increasingly prevalent Delta (India) variant. In the UK, as of June 25, 2021, of 92,056 cases of Delta, 42% were vaccinated. Fortunately, among all Delta cases, there was a 0.3% mortality as compared to the alpha (UK) variant at 1.9%.
  4. COVID-19 vaccines have a dangerous mechanism of action. The Pfizer and Moderna vaccines are considered “genetic vaccines” or vaccines produced from gene therapy molecular platforms. They cause the body to make an uncontrolled and unpredictable quantity of the pathogenic spike protein from the SARS-CoV-2 virus. The injected vaccine is supposed to stay in the area of the injection. But if these proteins land in vital organs such as the brain, heart, lungs, or reproductive organs, the reaction may cause the body’s immune system to attack these organs. The proteins land in the blood vessels and directly cause blood clots.
  5. COVID-19 vaccines have a safety problem. In 1990, the Vaccine Adverse Event Reporting Systems (“VAERS”) was established as a national early warning system to detect possible safety problems in U.S. licensed vaccines. It collects voluntary reports.
    1. The total reports in VAERS for all vaccines per year up to 2019 was 16,320.
    2. The total reports in VAERS for COVID vaccines alone through July 7, 2021 is 438,440.

These are actual events reported to Vaccine Adverse Event Reporting Systems (www.OpenVAERS.com) include:

  • Persistent malaise
  • Extreme exhaustion
  • Multisystem inflammatory syndrome
  • Myocarditis
  • Chronic seizures
  • Paralysis
  • Loss of hearing
  • Psychological effects: mood changes, anxiety, confusion, difficulty finding words, recent memory loss, and bizarre, frightening thoughts
  • Bell’s palsy
  • Swollen, painful lymph nodes
  • Thrombocytopenia
  • Miscarriages and premature births among vaccinated pregnant women
  • Severe headaches, migraines that do not respond to medications
  • Cardiac problems—heart arrhythmias, tachycardia, and sudden heart failure
  • Strokes
  • Visual problems and blindness
  • Encephalitis/encephalomyelitis and brain stem encephalitis
  • Narcolepsy
  • Autoimmune diseases
  • Arthritis/joint pains
  • Venous thromboembolism

Deaths and Hospitalizations: As of July 16, 2021, there were 11,405 COVID-19 vaccine deaths reported and over 36,015 hospitalizations reported for the COVID-19 vaccines (Pfizer, Moderna, J&J). By historical comparison, from 1999, until December 31, 2019, VAERS received 3,167 death reports (158 per year) adult death reports for all vaccines combined. COVID-19 vaccine deaths are 57 times more than previous years. COVID-19 vaccine adverse events account for 99% of all vaccine-related adverse events from Dec 2020 through present in VAERS. (For current stats, see: https://vaersanalysis.info).

Comparison of Flu and COVID-19 Vaccines: Between the years 2019 and 2020 about 170 million Americans took the flu vaccine. Of this number, there were 45 deaths associated with the flu vaccine. As of July 23, 2021, about 330 million doses of COVID-19 have been given with 11,405 deaths reported to VAERS. COVID-19 vaccine reports 115 times more deaths than the flu vaccine.

  1. There are growing number of cases of myocarditis (heart inflammation) among individuals below age 30 years to the point that the CDC has issued a warning. Myocarditis causes injury to heart muscle cells and may result in permanent heart damage leading to heart failure, abnormal rhythms, and cardiac death. People in this age group should not take the vaccine.
  2. The FDA has given an update on the J&J vaccine concerning the risk of cerebral venous sinus thrombosis (blood clot in the central vein in the brain) in women ages 18-48 associated with low platelet counts. No woman under age 48 should take the vaccine.
  3. Possible viral shedding after vaccination. These are “leaky” vaccines, meaning they only lessen the disease, but the virus survives long enough to transmit to others. Viral shedding (or sometimes “vaccine shedding”), is where the body releases viral particles from a vaccine, hypothetically creating a risk of infection to others. This has been known to happen with vaccines using weakened live viruses (like mumps, measles, chicken pox, shingles). The currently available COVID-19 vaccines from Pfizer/BioNTech, Moderna, and Johnson & Johnson do not contain the live SARS-CoV-2 virus – just the spike protein portion.

Presumably, the mRNA and adenovirus-vector vaccines are processed near the injection site and degrade after 10 to 14 days, so the spike protein never circulates throughout the body and could get to an area where it could be shed, such as the nose.

Whether the spike protein portion of the SARS-CoV-2 virus can cause disease even if it is found in other parts of the body is being debated. There are reports of positive COVID tests after close contact with vaccinated persons and a report that it may have been transmitted through breast milk. The Pfizer-BioNTech on the Pfizer mRNA vaccine implied in their study protocol that they anticipated the possibility of secondary exposure to the vaccine exposure “to the study intervention by inhalation or skin contact.

  1. Antibody dependent enhancement (ADE) – A potentially fatal risk of coronavirus vaccines has been known for decades. Sometimes antibodies (non-neutralizing) recognize and bind to the pathogen, but they can’t prevent the entry into the cell (and infection). They may actually increase the ability of a virus to enter cells So virus gets into the cell and causes an exaggerated immune response.

This is the reason why there has never been a coronavirus vaccine before. When they tried developing coronavirus vaccines in the past, the test animals seemed to develop robust antibodies but when they were challenged with the wild virus, they got sick and died. This stopped the vaccine development in its tracks. This adverse reaction has been also seen with Dengue Virus, Ebola Virus, HIV, and RSV vaccines well.

Exemptions

  • Medical
    • Previous allergy to a vaccine or its ingredients
    • Allergy to ingredients – PEG (polyethylene glycol)
    • Not Guillian Barre, Bell’s Palsy, autoimmune disease
    • Lawsuit – Prior COVID-19 infection with positive antibodies to SARS-CoV-2
  • Religious – genuinely held belief
  • Other
    • Children, due to lack of testing
    • Pregnant women (possibly), due to reports miscarriage after vaccination

Natural Immunity

  • 91 studies now confirm that prior infection with the SARS-CoV-2 virus confers lasting immunity. https://brownstone.org/articles/79-research-studies-affirm-naturally-acquired-immunity-to-covid-19-documented-linked-and-quoted/.
  • They have found that natural infection induces the immune cells that migrate to the bone marrow and sit there for the rest of your life, 1918 flu left immunity still active >100 years later. SARS1 immunity still active currently (and cross-reactive with Covid). The default is that infection = indefinite immunity until proven otherwise, consistent with standard medical practice from before Covid (B cell lasts lifetime).
  • The researchers assumed there are usually 10 times more cases than are being reported, although that may drop to 5 times in regions that have more testing.
  • In May 2021, CDC estimated 35% were infected.; Dr. Marty Makary of Johns Hopkins thinks it is 80%.
  • Benefits of vaccines should be considered in light of resistant strains waning immunity, and development of natural immunity.
  • We should say immune and non-immune instead of vaccinated
  • When you get infected with COVID, your body’s immune system develops antibodies to the entire surface of the virus, not just the slight protein that the vaccines give you, but the entire surface. So you get a more diverse antibody portfolio in your system.
  • One study showed B cell memory active after a year.
  • Some say the vax gives T cell reactivity to all variants.
  • The safety and efficacy data are on the old strain. Efficacy fell from 95% to 42% in 6 months – Israel
  • The large Israeli study demonstrated that 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 Pfizer two-dose vaccine-induced immunity.” Over 700,000 people were included in the study.
    • The study examined the risk for additional infection – either a breakthrough infection in vaccinated individuals or reinfection in previously infected unvaxxed (or single dose) ones.
    • SARS-CoV-2-naïve vaccinees had a 13.06-fold increased risk for breakthrough infection with the Delta variant compared to those unvaxxed previously infected [with natural immunity].
    • Vaccinees were also at a 8 times greater risk for COVID-19-related-hospitalizations compared to those that were previously infected.
    • After adjusting for comorbidities, the study found a 27.02-fold increased risk for symptomatic breakthrough infection in the vaccinated as opposed to symptomatic reinfection for those with natural immunity.
  • Despite the assertion that vaccine gives T-cell reactivity to all variants, many reports show that new cases are mostly vaccinated.
    • Duke Univ – 364 cases – only 8 were unvaxxed – minor symptoms, no hospital
    • Pittsburg – 30% are vaccinated; in hospital – 7 – 40% depending on pre-existing conditions
    • Massachusetts = About three-fourths of people infected in a Massachusetts Covid-19 outbreak were fully vaccinated
  • CDC found that fully vaccinated people who get infected carry as much of the virus in their nose as unvaccinated people. 

Breakthrough Cases

Therefore, it is not accurate to say it is a “pandemic of the unvaccinated” without acknowledging the data was during a time period where most of the American public was unvaccinated.

As of Jan. 1, 2021, only 0.5 percent of the U.S. population had been fully vaccinated. By Mar. 1, it was 7.6 percent. By Apr. 1, it was 16.8 percent. By May 1, it was 30.9 percent. On June 1, 40.6 percent. By the end of June, it was 46.3 percent.

In the state of Hawaii 1 percent of COVID-19 deaths occurred in the vaccinated. However, the 1 percent figure was based on data from March 2020-August 2021.

It is misleading to include deaths during 2020 because the vaccine program didn’t begin until January 2021 and even then less than half of the country was vaccinated by the end of June 2021.

 Warning

The investigational, genetic COVID-19 vaccines are not safe for general use. Given the lack of, and erroneous, “science” regarding the genetically engineered messenger-RNA vaccines, it is impossible for anyone to be able to give ethically and legally required informed consent to take them, or prepare for the possible long term adverse effects.

The available evidence and science indicate that COVID-19 vaccines are unnecessary, ineffective and unsafe. First, low risk groups, those who have had COVID-19 are protected by natural immunity. Treatments are available for the higher-risk groups, thus vaccination is unnecessary. Second, none of the vaccine trials have provided any evidence that vaccination prevents transmission of the infection by vaccinated individuals. Third, the vaccines are dangerous to both healthy individuals and those with pre-existing chronic diseases. The risk-benefit analysis does not weigh in favor of vaccines.

Masks, social distancing, and lockdowns were ineffective in taming COVID-19. The World Health Organization 2019 guidance stated that only hand washing and isolation of sick/symptomatic persons to be used for pandemics.

Choosing Your Doctor

Your choice of doctor in this battle against COVID-19 may be a life and death decision. Many doctors have not read all the studies and may not be fully informed of all treatment options, particularly early treatment or prevention of COVID. Demand (politely) full informed consent. Be sure to read carefully the pre-vaccine questionnaire and note any allergies, including PEG.

Compensation and Medical Treatment in Event of Injury

The Countermeasures Injury Compensation Program (CICP) is the source of redress for injury to pay for medical care. Need willful misconduct. Generally, a claim must be submitted to the CICP within one (1) year from the date of receiving the vaccine. To learn more about this program, visit www.hrsa.gov/cicp/ or call 1-855-266-2427.

Even though Comirnaty is licensed, it is still considered a covered countermeasure under the Prep Act (Public Readiness and Emergency Preparedness Act, 2005, amended 2020, 2021; 42 U.S.C. § 247d-6d. ) until October 2024. “The countermeasure was administered or used during the effective period of the declaration.”

“Covered countermeasure” means— (A) a qualified pandemic or epidemic product (designed to treat, cure, mitigate pandemic) (B) a security countermeasure (C) a drug (D) biological product, or device that is authorized for emergency use. (42 USC 247d-6b(c)(1)(B), 42 USC 247d-6d(i)(1) and (7)).

Covered Countermeasures are any antiviral, any other drug, any biologic, any diagnostic, any other device, or any vaccine, used to treat, diagnose, cure, prevent, or mitigate COVID-19, or the transmission of SARS-CoV-2 or a virus mutating therefrom, or any device used in the administration of any such product, and all components and constituent materials of any such product. https://www.federalregister.gov/documents/2020/03/17/2020-05484/declaration-under-the-public-readiness-and-emergency-preparedness-act-for-medical-countermeasures

The liability waiver may not hinge on EUA status.  The fact that an EUA exists for something essentially means the drug/product is a “Covered Countermeasure.” But drugs with “full approval” can also be a “Covered Countermeasure” even if they don’t have an EUA.  So even if the EUA for the Pfizer drug was ended it would still be a “Covered Countermeasure” and shielded from liability.

Ask your employer if they will compensate you for any vaccine side effects if they have required you to get the shot.

Conclusion

COVID-19 isn’t going to be eradicated, and that was the reality before Delta came around. The hope is that our bodies will recognize it and fight it off. Eventually (and hopefully despite its likely man-made nature), SARS-CoV-2 will become another mild virus like the common cold.

Prevention (CDC, WHO suggestions)

If you haven’t had the COVID-19 vaccine, you can take many steps to reduce your risk of infection. The World Health Organization (WHO) and the U.S. Centers for Disease Control and Prevention (CDC) recommend following these precautions for avoiding COVID-19:

  • Avoid large events and mass gatherings.
  • Avoid close contact (within 6 feet, or about 2 meters) with others. Avoid anyone who is sick.
  • Stay home when possible and keep distance between yourself and others if COVID-19 is spreading in your community, especially if you have a higher risk of serious illness.
  • Wash your hands often with soap and water for at least 20 seconds, or use an alcohol-based hand sanitizer that contains at least 60% alcohol.
  • Wear a face mask in indoor public spaces and outdoors where there is a high risk of COVID-19 transmission, such as at a crowded event or large gathering. Further mask guidance differs depending on whether you are fully vaccinated or unvaccinated. Surgical masks may be used if available. N95 respirators should be reserved for health care providers.
  • Cover your mouth and nose with your elbow or a tissue when you cough or sneeze. Throw away the used tissue. Wash your hands right away.
  • Avoid touching your eyes, nose and mouth.
  • Avoid sharing dishes, glasses, towels, bedding and other household items if you’re sick.
  • Clean and disinfect high-touch surfaces, such as doorknobs, light switches, electronics and counters, daily.
  • Stay home from work, school and public areas if you’re sick, unless you’re going to get medical care. Avoid taking public transportation, taxis and ride-sharing if you’re sick.

In addition to these everyday precautions, if you are at higher risk of infection or of developing serious COVID-19 symptoms, you might also want to:

  • Make sure you have at least a 30-day supply of your regular prescription and over-the-counter medications.
  • Check to see if your vaccinations are up to date, particularly for influenza and pneumonia. These vaccines won’t prevent COVID-19, but becoming ill with influenza or pneumonia may worsen your outcome if you also catch COVID-19.
  • Establish an alternate way of communicating with your doctor if you have to stay at home for a few weeks. Some doctors are doing appointments via phone or video conference.
  • If possible, arrange for social visits to be held outside with friends and family, while keeping 6 feet (2 meters) apart. Keep the group small to reduce the risk of the COVID-19 virus spreading. The virus is more likely to spread in larger groups, especially when people are close together and for a longer period of time.
  • Arrange for delivery orders of restaurant meals, groceries or medications so you don’t have to leave your home.
  • Call your doctor if you have questions about your medical conditions and COVID-19 or if you’re ill. If you need emergency care, call your local emergency number or go to your local emergency department.
  • Call your doctor if you have questions about non-critical medical appointments. He or she will advise you whether a virtual visit, in-person visit, delaying the appointment or other options are appropriate.

Resources

Exemptions, Research, and More

www.LCAction/vaccine

Vaccine Fact Sheets

https://physiciansforinformedconsent.org/covid-19-vaccines/

Employment

https://www.eeoc.gov/laws/guidance/questions-and-answers-religious-discrimination-workplace

https://avoiceforchoiceadvocacy.org/wp-content/uploads/2020/08/Federal-and-CA-State-Employment-law-Vaccine-mandates.pdf

https://pandemic.solari.com/form-for-employees-whose-employers-are-requiring-covid-19-injections/

 Disclaimer: This information is provided as an educational service. It is not intended as a substitute for diagnosis, treatment, or advice from a qualified professional. Patients should consult their physicians for individual medical evaluation and treatment.

 Information is constantly evolving. We will try to keep you updated on significant changes to the information provided.

APPENDIX A

Over-the-counter Medicines & Nutraceuticals to Prevent/Reduce COVID Post-Vaccination Side Effects

These recommendations are based on the clinical experience of COVID-expert doctors surveyed. The recommendations are designed to address two concerns:

  1. Prevention or reduction of side effects and adverse events that may in some cases be severe. The schedule for each nutraceutical or medicine is designed to cover the time when various of the side effects have been reported.
  2. “Breakthrough” COVID infections are being reported during the approximately two weeks before immunity from the vaccine starts. The recommended antivirals and vitamin D help protect against these shortly-after-vaccine COVID infections. Vitamin D also helps protect against vaccine side effects.

All the therapeutics listed are available over the counter without prescription. However, for those with access to them, adding ivermectin or hydroxychloroquine enhances the anti-COVID protection.

  • Aspirin (anti-thrombotic)

325 mg/day for 4 weeks beginning the day before vaccination.

=== Article Snip - see Source Article for complete info! ===


Read Original Article
https://marilynsingletonmdjd.com/2021/10/15/covid-facts-and-stats/
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