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COVID-19, Current Events, Guest Column, What's New

COVID-19: Shall You Rush to Inject Your Toddler?

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Guest Column by Jane M. Orient, MD

        I hope you are staying well in these troubled times.

        Many parents are said to be relieved that they can now take their toddler or 6-month-old infant for their COVID shots. The federal advisory committee considering the shots voted 22 to zero to recommend Emergency Use Authorization (EUA) for both Pfizer and Moderna injections for children at least 6 months old, and FDA and CDC approved them with lightning speed. Thus, the shots that the federal government already bought and paid for won’t have to be wasted.

        The shots only have an EUA, not FDA approval, and you will need to sign a consent form. Some data you might like to consider: As of May, there had been 60,442 adverse events involving liver damage reported to the FDA’s Vaccine Adverse Event Reporting System (VAERS), including 204 in children under age 12. Some involved death or need for a liver transplant.

 

        Evidently, children under age 12 were being given unauthorized shots.

        Observers of the hearings pointed out:

  • The trials in young children enrolled 4,500 subjects, but 3,000 (67%) dropped out.
  • No actual health benefits were shown, so they used “immunobridging”—comparing antibody response to that of older subjects in a previous trial. A number of experts said that antibody response did not correlate well with immunity, especially against the new variants.
  • Committee members received risk: benefit documents (190 single-spaced pages) at most two days before the meeting, so they did not have adequate time to study them.
  • By fall of 2021, 26 high-quality studies from outside the U.S. showed a two- to seven-fold increased risk of myocarditis (inflammation of the heart) from mRNA shots.

        While the shots are “free,” children and their parents will pay the costs of any adverse reactions.

        Parents need to do due diligence. In particular, they need to be alert to mild symptoms that could warn of myocarditis. Doctors need to have a “high index of suspicion” for checking blood troponin levels and other indicators of heart damage to allow early diagnosis and treatment.

Jane Orient, M.D., Executive Director, Association of American Physicians and Surgeons, jane@aapsonline.org

COVID-19, Culture & Society, Guest Column, Politics, What's New

On Covid and Conscience

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Guest Column by Robert S. Emmons, MD

What has harmed you more, Covid-19 or loneliness? While daily we watched ominous dashboards of Covid deaths, delayed medical care, barriers to self-care, drug overdoses and suicides all made mortality rates rise. For my part, I have learned how to do my work via videoconference, and I have never been so busy with new referrals in my entire career as a psychiatrist.

As our preoccupation with all things Covid lets up, fear is loosening its grip on our minds. Now we can gain the perspective we need to recognize the outsized influence of unconscious moral impulses on personal and communal risk management.

We like to imagine that we regularly reason our ways through life’s problems, but most of our actions are driven by the unconscious algorithms that enable us to make daily decisions small and large, without expending undue mental energy in well-worn territory. The same is true for problems of conscience. Our unconscious moral algorithms are partly inherited. They also are profoundly shaped by institutional messages, popular culture, trauma and our earliest moral role models.

Various institutions, media and corporations know very well that moral responses drive many of our decisions, so when they have something to sell, they routinely provide us with a window-dressing of topical information, coupled with relentless, breathless calls to conscience as seemingly our only mode of motivation. For nearly two years now, we have been bombarded with the same kind of messaging around matters of medical science.

Well-intentioned appeals by public officials to conscience — “Do your part for your community!” — have, predictably, been appropriated as fodder for the moral outrage sales machine. Provisional scientific opinion on public health has too often been inflated to imperative in wildly punitive ways: “Comply, or you’ll kill Grandma!” “Don’t comply, or government will kill you!”

In my practice of motivating patients toward effective lifestyle behaviors, I deliver information about the links between today’s choices and tomorrow’s effects in carefully calibrated, nonjudgmental language. I teach my patients to self-reinforce small successes, rather than tally up the wages of failure. It only brings up resistance for me to imply, no matter how subtly or unintentionally, to a patient that they are bad if they do not follow my advice. Coercive pressure almost always backfires by undermining trust.

Exactly the same principles apply in the field of public health. A media milieu of algorithm-driven shaming and blackballing has hardly improved the quality of decision-making by elected officials, health officers, their audiences or doctors. We can have more confidence in health decisions taken in the private sphere where pressure tactics cannot reach.

Just like Covid, public health controversies are here with us to stay. As you devise your own personal risk management protocols, language that implies right and wrong can be your dependable guide to recognizing science information that is contaminated by the unconscious moral-emotional complex.

“Misinformation” and “disinformation” head the list of the words I ban from my professional lexicon. These necessarily elastic pieces of journalistic shorthand mainly encourage negative moral impulses toward sources rather than rational evaluation of evidence. I routinely discount medical information presented by sources that campaign aggressively against “misinformation” and “disinformation.” As a clinical scientist, I place my confidence in the experts, agencies, and publications that rigorously eschew browbeating and threats.

In our hearts, we know the difference between false trust based on idealization of celebrity, deference to authority and manufactured group affiliation as well as authentic trust based on the respect, care and reciprocity that can only happen at a one-to-one level. If you need help interpreting medical science, then, your personal physician is your best guide.

Each one of us can do our part for our communities, going forward, by abstaining from all morally charged language when speaking to public health topics. If you see a neighbor practicing their own medical risk management in ways different than yours, please give them the benefit of the doubt, not the finger.

This post is by Robert S. Emmons, M.D, of Moretown who has maintained a private psychiatric practice in Vermont for 33 years. He is a member of the volunteer clinical faculty at University of Vermont Larner College of Medicine, where he has taught the topics of professionalism, ethics and psychoanalytic psychotherapy. https://www.robertemmonsmd.us

Previously published in the VTdigger, https://vtdigger.org/2022/02/28/emmons-on-covid-and-conscience/

COVID-19, Culture & Society, Current Events, Doctors, Featured, Op-eds, Politics, What's New

It’s Black History Month: Let’s Get Real

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I knew we were turning the corner on Covidmania when I walked by two little girls, one black, one white, playing on their front lawn. They had cheerful, mask-free glowing smiles. They proudly showed me the twisty little creatures they made with pipe cleaners. What a welcomed sight!

As Covid fear was waning, unnerved by the thought that we might regain our happy lives, the government-media complex blared that our society is systemically infected with racism and white people must repent.

The deafening drumbeat of race, racism, and more race is leaving its mark. New York City is using race as a criterion allocating Covid-19 treatments. That will certainly erode trust in the medical system. President Biden is undermining the legitimacy of the Supreme Court by pledging to fill a vacancy, not with the best person, but a black female. The issue is not that black female bright legal scholars do not exist, but that the only stated criteria were gender and skin color. Of course, it didn’t matter that Bush nominee former California Supreme Court Justice Janice Rogers Brown was a black female when her confirmation for the U.S. Court of Appeals for D.C. was delayed for two years for the crime of not supporting affirmative action.

To prove their anti-racist creds schools, corporations, and government entities instituted diversity, equity, and inclusion (DEI) “training.” Is that like house-breaking a dog? Are white people to be figuratively rapped on the nose with an old newspaper? And if obedience school is unsuccessful, we can tax them into submission.

California’s year-old, “first-of-its-kind” Reparations Task Force has determined that reparations should be limited to descendants of slaves who were “kidnapped from their homeland.” Black immigrants are excluded because they have a country to which they can return if they are unhappy with the racist United States. Missing the irony, California’s black female slave descendant Secretary of State posited that Barack Obama had the gumption to run for president only because he was not a descendant of slaves. Thus, he was not—these many generations later—“stunted” by the psychological impact of slavery that left slaves with only enough energy to merely survive. Moreover, Obama did not have limitations “drilled in his psyche.” Exactly who is doing the drilling today? California elected officials? Television shows with black stars? Teachers? Homeboys in the ‘hood? Absentee parents?

Wow! So black people can’t aspire to greatness if they had a slave as an ancestor. Talk about the bigotry of low expectations. Show me the excuse for the success of slave descendant entrepreneur and philanthropist Madame C.J. Walker, considered the first female millionaire in the United States in 1910. And James Derham who went from slave to physician and treated patients of all colors in Louisiana in the 1700s.

Mr. Antiracism himself, Henry Rogers (aka Ibram X. Kendi) may have bamboozled corporate America into spreading the toxic instruction to find racism in every action and thought in every minute of one’s waking hours. Disturbingly, the American Medical Association as part of its Health Equity Plan aims to “excise the myth of meritocracy.”

With big money at stake, professional football players are chosen for their ability, not their skin color. Is winning games more important than saving patients’ lives? Should we not be teaching our students to be scientifically curious, compassionate, and have the health of individual patients as their prime concern? Should physicians not attain knowledge at the highest level possible?

Now it seems that political agendas, not patients have taken precedence. A medical school group called White Coats for Black Lives is making the rounds at medical schools. Its stated goals are (1) to “dismantle dominant, exploitative systems in the United States, which are largely reliant on anti-Black racism, colonialism, cisheteropatriarchy, white supremacy, and capitalism;” and (2) to rebuild a healthy future for marginalized communities by abolishing prisons, establishing federal universal health care, ensuring reproductive and environmental justice, and “queer and trans liberation.” Many of us want to improve health care for those who have poor access—black, white, and otherwise. But let’s not sacrifice quality care for individual patients for a broad political movement.

After two years of manufactured fear, negativity, and learned helplessness courtesy of loudmouthed ideologues fomenting unrest, we need a dose of reality. White people are not stamped with the mark of the devil. Every friendly gesture is not a feeble attempt at reparations. It’s just a fellow human being cheerful. Plenty of black and other persons of color have intelligence, strength and ingenuity. We are able to do more than merely survive.

As Ezra Pound said, “a slave is one who waits for someone to come and free him.” Don’t wait. Free yourselves.

 

COVID-19, Current Events, Featured, Op-eds, Politics, What's New

Covid 2022: A New Year, New Fears

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By now, Dr. Fauci’s Covid “fearspeak” has become background noise. Yes, the new “Omicron” variant is making its way around the world. Fortunately, reports from South Africa as well as other studies indicate that Omicron’s illness is milder than Delta. Even Fauci-friendly public health physicians have cautioned that there is “absolutely no reason to panic.”

In 2022, we should panic because opioid overdoses took the lives of 100,000 fellow Americans from April 2020 to April 2021—an increase of 28 percent from the same period the year before. The statistic is appalling but not surprising given the Covid lockdowns coupled with millions of doses of fentanyl and other illicit drugs flooding across a porous border.

We should panic because one in ten Americans has diabetes and one in three Americans has prediabetes. Moreover, 89 percent of the diabetics are overweight (Body Mass Index over 25). Just over 73 percent of the U.S. population are overweight and 42.5 percent are obese (BMI over 30). Worse yet, obesity among adults, age 18 to 25 years increased from 6.2 percent to 32.7 percent over the last 40 years. Instead of Dr. Fauci telling us we have to relinquish our individual choices when it comes to the increasingly ineffective current Covid vaccines, he should emphasize the effect of obesity on Covid outcomes. According to the CDC, about 78 percent of people who have been hospitalized, needed a ventilator or died from Covid-19 have been overweight or obese.

We should fear the loss scientific medical practice, when to avoid being stressed out, patients are demanding informed consent to be weighed in the doctor’s office. Yet curiously, informed consent is not required for experimental mRNA vaccines.

We should fear the blatant abuse of power by our public servants in the name of public health. We should be afraid when our top health bureaucrat, the Health and Human Services (HHS) Secretary declared “it is absolutely the government’s business” to know people’s vaccination status.” We should panic when elected representatives jump on the medical privacy-be-damned bandwagon. The House of Representatives handily approved the Immunization Infrastructure Modernization Act of 2021 which would establish yet another government database. This one is an “immunization information system,” that can share every vaccine dose with not only with other governmental but private entities.

We should be afraid when the FDA sends threatening letters to pharmacists, trying to limit the use of a safe drug shown to be 60 percent effective in improving outcomes of Covid. Why? It has side effects such as skin rash, nausea, vomiting, diarrhea, stomach pain, facial or limb swelling, neurologic adverse events (dizziness, seizures, confusion), sudden drop in blood pressure, severe skin rash potentially requiring hospitalization and liver injury. We’ve seen no such letters regarding molnupiravir, the new kid on the block for Covid treatment that can cause diarrhea, dizziness, headache, hives, itching, skin rash, nausea, redness of skin, vomiting, bone and cartilage damage in children, birth defects, cancer and is only 30 percent effective.

We should panic knowing that pharmaceutical companies spent $266,846,347 lobbying Congress, and the American Medical Association’s top corporate donors are pharmaceutical companies.

We should panic about the federal government establishing guidelines (future regulations?) for news and social media on suppression of health “misinformation.” We should worry that Meta, the company formerly known as Facebook engages in Soviet-style silencing certain political viewpoints.

We should fear social engineering and panic about the media becoming the new form of re-education camps. It’s hard to miss the oohing and aahing over the first transgender person to make it to the Jeopardy! Tournament of Champions. Did they fawn over the first male, the first black person, the first white person, the first Asian person? No. BTW, the first Tournament winner was a woman, and a black man won years before women and blacks knew they were inferior, weak-minded oppressed persons. Someone, please come forward and enlighten us as to why a transgender person answering questions on a game show is headline news. Viewed in the most favorable light, perhaps the media were providing welcomed distraction from Dr. Fauci and his smug and smarmy self.

We should fear misguided attempts to stop racism with racism. In the name of social justice, colleges, businesses, medical schools, and K-12 schools have fallen into the trap of promoting Marxist race warfare where students and employees can learn that minorities are permanent victims of the irredeemably racist white people.

We should fear becoming accustomed to a new socially acceptable apartheid: segregation by race, vaccination status, and mask-wearing.

Most of all, we should fear how readily our fellow Americans acquiesced to unreasonable, unscientific demands at the altar of Covid-19.

When it comes to Covid in 2022, opt for prudence, not panic. Eat well, get enough vitamin D, exercise, wash your hands, engage with your friends, cough or sneeze in your elbow, and stay home if you are feeling unwell. If you do get sick, seek medical care immediately.

Live your life. After all, there are 14 more letters after omicron in the Greek alphabet.

COVID-19, Culture & Society, Current Events, Featured, Medicine, Op-eds, What's New

A Constitutional Cure for Covid-19

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Covid, Covid, Covid. Variant, variant, variant. Trust me, I’m the government’s highest paid employee, and “I represent science.” Show your papers, wear a mask, take a shot or lose your job. And the beat goes on for an infection where 99.95 percent of infected persons under age 70 years recover. It’s becoming clear that Covid-19 is not merely a disease but an excuse to concentrate power in the government.

It’s time for the political histrionics to stop. Multiple studies have shown that the consequences far outweigh any potential (and illusory) benefits of masks, lockdowns, and school closures. The Centers for Disease Control and Prevention (CDC) Director admitted that the current Covid-19 mRNA vaccines, while helpful in reducing deaths and hospitalizations, do not stop transmission of the virus. “Breakthrough” cases in vaccinated persons are on the rise. Moreover, the current vaccines likely are not effective for the new, likely less lethal Omicron variant. Public health experts opine that the SARS-CoV-2 virus (that causes Covid-19) and its multiple variants are becoming endemic. That means SARS-CoV-2 and its infinite number of variants will not be eliminated, but become a manageable part of the human-viral ecosystem.

Sadly, our government is not responding in accordance with the scientific facts. Instead, federal and some local governments are mandating more vaccines, culminating in proof of vaccination to engage in society and continue living as a normal human being. This is not science. This is nascent totalitarianism.

Two lines from the 1990 Cold War era spy film, The Hunt for Red October foreshadowed our government’s warp speed trajectory to authoritarianism. “Privacy is not of major concern in the Soviet Union, comrade. It’s often contrary to the collective good.” And a White House official casually boasted, “I’m a politician that means I’m a cheat and a liar.”

It didn’t take long for President Biden to tell the big lie. As president-elect, Mr. Biden said there would be no vaccine mandates. Speaker of the House Nancy Pelosi (the third in line for the presidency) brilliantly illustrated the intersection of lying and privacy. As late as August 2021, Speaker Pelosi said, “We cannot require someone to be vaccinated. That’s just not what we can do. It is a matter of privacy to know who is or who isn’t.”

Without skipping a beat, the executive branch issued three separate vaccine mandates: all federal contractors (including remote workers), an Occupational Health & Safety Administration (OSHA) requirement for businesses with more than 100 employees, and a Centers for Medicare and Medicaid Services (CMS) requirement for employees, volunteers and third-party contractors of health care providers certified by CMS.

The judicial branch is fighting back against the President’s attempt to jettison the Constitution’s separation of powers clauses, a large chunk of the Bill of Rights, and Supreme Court precedents on bodily autonomy with these mandates. On November 9th, the Fifth Circuit Court of Appeals put the OSHA mandate on hold. The Court reasoned that the mandate “threatens to substantially burden the liberty interests of reluctant individual recipients put to a choice between their job(s) and their jab(s).” And “the loss of constitutional freedoms ‘for even minimal periods of time … unquestionably constitutes irreparable injury.”

Citing the lack of congressional authorization and harm to access to medical care, on November 29th aMissouri federal district court placed a temporary halt on the CMS health care workers “boundary-pushing”mandate. The government planned to enforce the mandate by imposing monetary penalties, denial of payment and termination from the Medicare and Medicaid program. The ruling covers providers in Kansas, Alaska, Arkansas, Iowa, Missouri, Nebraska, New Hampshire, North Dakota, South Dakota and Wyoming.

On November 30th, a Louisiana federal district court blocked the CMS mandate issuing a nationwide injunction in a lawsuit brought by 14 states (Arizona, Alabama, Georgia, Idaho, Indiana, Kentucky, Louisiana, Mississippi, Montana, Ohio, Oklahoma, South Carolina, Utah and West Virginia). “If the executive branch is allowed to usurp the power of the legislative branch to make laws, two of the three powers conferred by our Constitution would be in the same hands. … [C]ivil liberties face grave risks when governments proclaim indefinite states of emergency.”

That same day, a Kentucky federal district court issued a hold on the federal government contractors mandate, citing lack of authority of the executive branch—“even for a good cause”. The court reasoned that if a procurement statute could be used to mandate vaccination, it “could be used to enact virtually any measure at the president’s whim under the guise of economy and efficiency.” The ruling covers Kentucky, Ohio and Tennessee.

The mainstream media finally reported on the toxicity and poor results of Dr. Fauci’s “standard of care” treatment, remdesivir. This prompted families to use the courts rather than watch their relatives needlessly die. Victories for patients are growing. A Chicago area judge recently ordered a hospital to “step aside” and allow a physician to administer ivermectin in an effort to save a dying patient. It worked.

People are tired of lies. When Google employees are signing a “manifesto” to fight the mandates, you know the seeds of revolt have sprouted.

 

COVID-19, Culture & Society, Current Events, Featured, Op-eds, Politics, What's New

Sometimes It Takes a Puppy

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A few years back I returned from setting up our make-shift medical clinic in El Salvador after braving washed out roads and trying to stay on the right side of MS-13 to an “incident.” I had stored a banana in my purse to enjoy on the airplane. Upon arrival in San Francisco, I was approached by a Customs agent and his cute little beagle who had alerted him to the smell of contraband—my now-consumed banana.

I only hope the beagles who gave their lives for a perverted science experiment will similarly “bust” Dr. Fauci. We all know he has done much worse: suppressed possible life-saving treatment to AIDS patients, funded dangerous “gain of function” studies making viruses more deadly, suppressed early treatment of COVID-19, promoted ineffective, toxic remdesivir to treat hospitalized COVID-19 patients, and fanatically pushed for experimental mRNA “vaccines.”

Sometimes it takes a puppy.

But sometimes it takes all of us to turn back the clock from 1984. This story of a society held together by “thoughtcrimes” and “Newspeak” was supposed to be a cautionary tale to alert us to the insidious rise of totalitarianism. Sadly, apathy was the would-be overlords’ ally. Civil debate with exchange of facts and opinions based on those facts has all but disappeared. Many Americans became all too comfortable with silencing of views with which certain corners of society disagree.

Science was supposed to be the pursuit of knowledge through uncensored factual experimental or observable data. Now well-researched medical articles that challenge the party line have been “removed” from public view for unstated reasons.

The silver lining of COVID-19 is that the unscientific responses and public policies have exposed breaches of scientific integrity. It has also brought to light the assault on the patient-centered practice of medicine. This assault has been years in the making. First, the insurers called us providers. What a degrading term! We didn’t object. No matter what one’s health care skill is, we are healers, not mere service providers. Once we accepted being mere cogs, the insurers and Medicare could more easily insinuate themselves into the patient-physician relationship. Play by our rules or you don’t get paid. Purchase of physician practices by private equity firms, regulation of formularies, factory-like working conditions with patient over-bookings, dehumanizing electronic medical records have become routine rather than a source of outrage.

The last straw may be the AMA’s most recent foray into the world of pre-Marxist ideology. With a straight face in the pursuit of equity, the AMA has released a document filled with “Newspeak”. It wants to erase the “narratives grounded in white supremacy,” “meritocracy and individualism” and use “a rich tradition of work in health equity and related fields, including critical race theory” to guide our thoughts and speech. We can no longer use the term “white paper” which of course has nothing to do with racial identity. We can no longer say vulnerable because “people are not vulnerable; they are made vulnerable.” Minority is out and BIPOC is in. We are to avoid saying “target,” “tackle,” “combat” or other terms with violent connotation when  referring to people, groups or communities. Do they really think anyone is going to pay attention to such drivel?

I guess we should send this document to President Biden who said we have to keep punching at the problem of violence against women, or poor kids are just as bright as white kids or that Barack Obama was articulate and bright and clean.

The tide is turning. Toxic critical race theory and usurpation of parents’ rights was defeated in Virginia. Protests against medical tyranny are growing. States are filing lawsuits against vaccine mandates. The truth is coming out. The British Medical Journal has proudly published and spread through social media an article whose title speaks for itself: Covid-19: Researcher blows the whistle on data integrity issues in Pfizer’s vaccine trial. Some authorities are backing off on vaccine mandates (here and here).

And as for Dr. Fauci, he will be the next Greek mythical hero, felled by his hubris. Let’s all send him copy of Arthur Guiterman’s poem, On the Vanity of Earthly Greatness.

The tusks that clashed in mighty brawls
Of mastodons, are billiard balls.

The sword of Charlemagne the Just
Is ferric oxide, known as rust.

The grizzly bear whose potent hug
Was feared by all, is now a rug.

Great Caesar’s bust is on my shelf,
And I don’t feel so well myself.

His time is coming.

 

COVID-19, Guest Column, What's New

COVID-19: Should You Get Your Kids Jabbed ASAP?

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Guest column by Jane Orient, MD

On Oct 26, a panel of experts recommended 17 to 0 that FDA authorize the Pfizer vaccine at one-third dose, for 5-to-12 year-olds. Will you be rushing your child to the nearest vaccine center? Or worrying about mandates?

The issue is certainly controversial; more than 140,000 comments were received.

Vaccine proponents say that “rare” or “mild” adverse effects are a “small price to pay.” But parents may want to examine these graphs and decide for themselves:

image.png

Inflammation of the heart (myocarditis) is much more common in younger age groups. And the number of cases has increased sharply, as has the number of excess deaths (deaths above the expected or baseline number). Note that children have been receiving the jabs even before they have been authorized (ask people who work in pharmacies). What will happen when children are injected in greatly increased numbers?

The aggressive vaccination campaign has NOT reduced the death rate.

image.png

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Myocarditis is much more common after the second dose. Hence, parents might want to have their child checked for asymptomatic heart damage a few days after the first dose (e.g., by blood troponin levels, electrocardiogram, and echocardiogram).

image.png

 “Myocarditis in children is neither rare nor mild,” said cardiologist Peter McCullough, M.D., at an Oct 27 meeting in Phoenix, Arizona, with an extended Q&A period.

Additional information:

·         91 studies on natural immunity compiled by Paul Elias Alexander

·         Articles by Dr. Peter McCullough

·         Updated AAPS Guide to Home-Based COVID Treatment.

Jane Orient, M.D.

Executive Director

Association of American Physicians and Surgeons, jane@aapsonline.org

COVID-19, What's New

COVID Facts and Stats

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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.

  • Ibuprofen (anti-inflammatory)

Two 200 mg caplets 3 times/day the day before, day of and day after vaccination. Continue as needed if symptomatic (fever, muscle aches, headache, etc.)

  • Loratadine (Claritin or generic equivalent; H1 blocker, anti-inflammatory)

10 mg/day the day before, day of and day after vaccination.

  • Famotidine (Pepcid or generic equivalent; H2 blocker, anti-inflammatory)

20 mg twice per day the day before, day of and day after vaccination.

  • Vitamin D3 (potent anti-inflammatory effects at sufficient dosage; anti-viral immune enhancement)

One dose of 50,000 IU five to seven days before vaccination (serum levels peak on average at 7 days), Then daily 15,000 IU until 5 days after vaccination, Then continue with maintenance dosage of 5,000 – 10,000 IU/day.

For extra protection against breakthrough COVID infection during the approximately two-week window before immunity starts:

  • Zinc (anti-viral)

50 mg/day started as far ahead of vaccination as possible and continued three weeks or indefinitely.

  • Quercetin (zinc ionophore, to enhance zinc anti-viral effect; anti-inflammatory; anti-thrombotic)

250 mg twice per day for three weeks starting the day before vaccination.

  • Vitamin C (anti-viral; anti-inflammatory)

3,000 mg/day started as far ahead of vaccination as possible and continued three weeks or indefinitely.

DISCLAIMER: This information is for educational purposes only. It is not intended to serve as a substitute for diagnosis, treatment, or advice from a qualified, licensed medical professional. Any treatment you undertake should be discussed with your physician or other licensed medical professional.

APPENDIX B

Early At-home Covid Rx Protocol for Primary Care Providers

Prompt early initiation of sequenced multidrug therapy (SMDT) is a widely and currently available solution to stem the tide of hospitalizations and death. A multipronged therapeutic approach includes 1) adjuvant nutraceuticals, 2) combination intracellular anti-infective therapy (antivirals and antibiotics e.g. hydroxychloroquine, ivermectin, fluvoxamine, quercetin, doxycycline, azithromycin etc.), 3) inhaled/oral corticosteroids e.g. inhaled budesonide, dexamethasone etc., 4) antiplatelet agents/anticoagulants e.g. high-dose aspirin, enoxoparin, low molecular weight heparin etc., 5) supportive care including supplemental oxygen, monitoring, and telemedicine. Randomized trials of individual, novel oral therapies have not delivered tools for physicians to combat the pandemic in practice. No single therapeutic option thus far has been entirely effective and therefore a combination is required at this time.

 NEUTRACEUTICALS:

  • Vitamin D3 10,000 IU/day. After recovery, reduce to 5,000 IU/day and maintain long-term.
  • Zinc 50 mg/day elemental
  • Quercetin 500 mg bid
  • Vitamin C 3,000 mg/day
  • Melatonin 1 – 3 mg at bedtime (may be added PRN, as it can cause daytime drowsiness)
  1. A Guide to Home-Based Covid Treatment. https://aapsonline.org/covidpatientguide/
  2. Ramakrishnan S, Nicolau DV, Langford B, Mahdi M, Jeffers H, et al., Univ. of Oxford, Inhaled budesonide in the treatment of early COVID-19 illness: a randomised controlled trial. MedRxiv preprint. 2021 Jan 8. https://www.medrxiv.org/content/10.1101/2021.02.04.21251134v1 [Full Text PDF]
  3. Kory P, Meduri GU, Iglesias J, Varon J, Berkowitz K, et al. Review of the Emerging Evidence Demonstrating the Efficacy of Ivermectin in the Prophylaxis and Treatment of COVID-19. Front. Pharmacol. 2021 Jan. https://covid19criticalcare.com/wp-content/uploads/2020/11/FLCCC-Ivermectin-in-the-prophylaxis-and-treatment-of-COVID-19.pdf
  4. The Evidence-Based Medical Consultancy Ltd., Ivermectin reduces the risk of death from COVID-19 – a rapid review and meta-analysis in support of the recommendation of the Front Line COVID-19 Critical Care Alliance. Jan 3, 2021. https://b3d2650e-e929-4448-a527-4eeb59304c7f.filesusr.com/ugd/593c4f_8cb655bd21b1448ba6cf1f4c59f0d73d.pdf

COVID-19, Featured, Op-eds, Politics, What's New

Covid Coincidence

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“They” say there is no such thing as coincidence. They must have known about Covid-19, the political viral disease.

Is it a coincidence that the year of the Covid is also the year that scientific integrity died? Discourse is the lifeblood of science. I thought we had gotten past jailing or guillotining or dismissing as crackpots people whose scientific theories with which we disagreed. Many scientific mavericks were vilified: William Harvey describing the circulatory system, Ignaz Semmelweis’ advocating for simple hand-washing, Barry Marshall determining that H. pylori, not spicy foods caused peptic ulcers, to name a few. We have a modern day version of public humiliation and worse. Data that does not fit the “official story” is removed from popular social media sites, not reported on mainstream television channels, and hidden from easily accessed public websites.

Was it a coincidence that an all-out campaign to debunk the effectiveness of hydroxychloroquine as an early treatment for Covid-19 occurred after President Trump had good words to say about it in an election year? The denigration was relentless, despite 60 years of use in autoimmune diseases for its anti-inflammatory effects. Hydroxychloroquine was also found to have anti-blood clot effects. And with several viruses it was shown to inhibit viral entry into cells and viral replication. All of these properties would be effective in treating Covid-19 symptoms.

Another anti-parasitic medication, ivermectin, has 20 possible mechanisms of action against the SARS-CoV-2 virus, including interrupting viral entry into cells and anti-inflammatory action. Significantly, ivermectin is a protease inhibitor, that is, a substance that blocks proteins that allow viruses to reproduce themselves.

Is it a coincidence that Pfizer’s new anti-Covid pill, PF-07321332 is also a protease inhibitor? Notably, Pfizer’s drug would have to be given early after the onset Covid symptoms. This is also the recommendation for hydroxychloroquine and ivermectin—a recommendation that many studies ignored when dismissing the value of these anti-parasitic medications.

Is it a coincidence that Merck, who distributes ivermectin, is seeking fast-track approval for molnupiravir, an antiviral agent to treat Covid-19? How convenient that the U.S. government will purchase $1.2 billion worth of the yet-to-be-approved drug. And how predictable that vaccine maker Moderna’s stock fell 11 percentafter the announcement. Vaccines are yesterday’s cash cow. Is it a coincidence that ivermectin costs no more than $100 dollars per treatment course and molnupirivir costs $700 per 10-day course of treatment?

Is it a coincidence that the pharmaceutical and health products industry, to keep their seat at the table, has spent $171,262,239 so far this year in lobbying and that Pfizer and Merck were among the top five clients?

Is it a coincidence that Dr. Fauci, in dismissing hydroxychloroquine and ivermectin, resurrected his same excuses for not using a drug that frontline physicians found effective for AIDS patients? Physicians begged Dr. Fauci to publicize the use of the sulfa drug, Bactrim, as prevention and treatment for PCP (Pneumocystis carinii pneumonia) in AIDS patients. According to investigative author Sean Strub, “Fauci refused to acknowledge the evidence and … even encouraged people with AIDS to stop taking treatments, like Bactrim, that weren’t specifically approved for use in people with AIDS.” Dr. Fauci told activists there was “no data to suggest PCP prophylaxis was beneficial and that it may, in fact be dangerous.” Thousands of deaths could have been avoided. This sounds chillingly familiar to his position on Covid treatments. Damn the clinical success. I don’t care if the drugs work; I’m waiting for my pet drugs with high price tags!

Is it a coincidence that Dr. Fauci’s personal favorite AIDS drug, AZT (zidovudine), was ramrodded through the FDA? And that it was toxic, didn’t work, and in fact killed people, like his favorite anti-Covid drug, remdesivir? Remdesivir’s toxic effects were known when it was tested against Ebola virus disease in 2019. By April 2020, it was known that 60 percent of Covid patients given remdesivir had adverse effects, including liver and kidney injury. Worse yet, remdesivir did not improve survival. Indeed, a few months later the World Health Organization recommended against its use, but Fauci’s National Institutes of Health (NIH) still has it on its treatment protocol at $3,120 per treatment course.

I have a broader question about why diversity of thought is squelched. Tyrants despise free thinkers. It is not coincidence that President Biden, who wants to exert more federal government control over our lives through vaccine mandates, bought all of Regeneron’s monoclonal antibody treatments that were not in short supply but were being successfully used by “red states.” He vowed that “if governors won’t help us beat the pandemic, I’ll use my power as president to get them out of the way.”

Health and Human Services framed the sequestration more kindly: “This system will help maintain equitable distribution, both geographically and temporally, across the country.” Is it a coincidence that “governmental ownership and administration of the means of production and distribution of goods” sounds like socialism?

 

COVID-19, Guest Column, What's New

Asymptomatic Spread of Covid Is Rare

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by Paul Alexander, PhD

Asymptomatic spread is virtually non-existent, and if this does occur, it is less than 1%. It is very rare and we have very limited evidence (and questionable) of this happening at all. We have no documented proof, no documented evidence of this occurring in any appreciable manner. Spread of pathogen will occur more surely when the persons are ill/sick with symptoms, especially if the symptoms function to expel the pathogen into the surrounding air. Having no symptoms or very mild symptoms reduces risk of spread and with no symptoms, spread is basically removed. This is the same for SARS-CoV-2 virus and a recent BMJ publication pretty much sums it up that asymptomatic are rarely the drivers as it was thought to be. This is basic immunology and should not be changed for SARS-CoV-2 (COVID-19). We are being emphatic in saying there is no evidence of asymptomatic spread. We also recognize that one must be careful not to claim ‘zero’ as the evidence changes daily and rapidly and absence of documented evidence is also not a reason. It may just have not been studied yet or documented optimally. But we are confident enough based on the existing literature to also agree that ‘it is a dangerous assumption to believe that there is persuasive, scientific evidence of asymptomatic transmission’.

The basis for the societal lockdowns was that 40% to 50% of persons infected with SARS-CoV-2 could potentially spread it due to being asymptomatic. “But fears that the virus may be spread to a significant degree by asymptomatic carriers soon led government leaders to issue broad and lengthy stay-at-home orders and mask mandates out of concerns that anyone could be a silent spreader”. However, the evidence in support of common asymptomatic spread remains largely non-existent and we argue, was overstated and potentially was made with no basis.

A high-quality review study by Madewell published in JAMA sought to estimate the secondary attack rate of SARS-CoV-2 in households and determine factors that modify this parameter. In addition, researchers sought to estimate the proportion of households with index cases that had any secondary transmission, and also compared the SARS-CoV-2 household secondary attack rate with that of other severe viruses and with that to close contacts for studies that reported the secondary attack rate for both close and household contacts. The study was a meta-analysis of 54 studies with 77 758 participants. Secondary attack rates represented the spread to additional persons and researchers found a 25-fold increased risk within households between symptomatic positive infected index persons versus asymptomatic infected index persons. “Household secondary attack rates were increased from symptomatic index cases (18.0%; 95% CI, 14.2%-22.1%) than from asymptomatic index cases (0.7%; 95% CI, 0%-4.9%)”. This study showed just how rare asymptomatic spread was within a confined household environment.

From the nearly 2 million children that were followed in school in Sweden, it was reported that with no mask mandates, there were zero deaths from Covid and a few instances of transmission and minimal hospitalization.

In the UK, the ‘Scientific Advisory Group for Emergencies’ recommended that “Prioritizing rapid testing of symptomatic people is likely to have a greater impact on identifying positive cases and reducing transmission than frequent testing of asymptomatic people in an outbreak area”.

A study published in Nature found no instances of asymptomatic spread from positive asymptomatic cases among all 1,174 close contacts of the cases, based on a base sample of 10 million persons. “There were no positive tests amongst 1,174 close contacts of asymptomatic cases”. AIER’s Zucker responded this way “The conclusion is not that asymptomatic spread is rare or that the science is uncertain. The study revealed something that hardly ever happens in these kinds of studies. There was not one documented case. Forget rare. Forget even Fauci’s previous suggestion that asymptomatic transmission exists but not does drive the spread. Replace all that with: never. At least not in this study for 10,000,000”. Haynes of Life site news reported similarly.

A study on infectivity of asymptomatic SARS-CoV-2 carriers was carried out by Goa at al. Researchers looked at the 455 contacts who were exposed to the asymptomatic COVID-19 virus carrier. They were divided into three groups: 35 patients, 196 family members and 224 hospital staffs. “No severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections was detected in 455 contacts by nucleic acid test”.

In this regard, the World Health Organization (WHO) also made this claim that asymptomatic spread/transmission is rare. This issue of asymptomatic spread is the key issue being used to force vaccination in children. The science, however, remains contrary to this proposed policy mandate. Even Dr. Fauci said asymptomatic transmission is rare, and an epidemic is not driven by asymptomatic carriers.

As an update that we say clearly is 16 months too late, the WHO on June 29th 2021 has now recommended no testing of asymptomatic persons. This is after trillions of $ have been sucked out of economies and many lives lost due to lost jobs and closures of societies and schools. Many people killed themselves due to the unscientific and illogical testing policy of asymptomatic persons.

Additionally, a high-quality robust study in the French Alps examined the spread of Covid-19 virus via a cluster of Covid-19. They followed one infected child who visited three different schools and interacted with other children, teachers, and various adults. They reported no instance of secondary transmission despite close interactions. These data have been available to the CDC and other health experts for over a year. As mentioned earlier, Ludvigsson published a seminal paper in the New England Journal of Medicine on Covid-19 among children 1 to 16 years of age and their teachers in Sweden.

A recent June 10th 2021 op-ed sheds more confirmatory light that asymptomatic spread was more a myth that a reality. Ballan and Tindall wrote “People presenting with symptoms of Covid-19 are almost exclusively responsible for transmitting SARS-CoV-2. Serious infection usually results from frequent exposure to high doses of SARS-CoV-2, such as health care workers caring for sick Covid-19 patients in hospitals or nursing homes and people living in the same household.

Paul Elias Alexander, PhD, has expertise in the teaching of epidemiology (clinical epidemiology), evidence-based medicine, and research methodology. He is a former professor at McMaster University in evidence-based medicine; a former COVID pandemic advisor to WHO-PAHO in Washington, D.C. (2020); and a former senior advisor on COVID pandemic policy at the U.S. government’s Department of Health and Human Services (HHS) in Washington, D.C. He did graduate studies at Oxford University in England, the University of Toronto in Canada, McMaster University in Canada, and York University in Canada. He is currently an independent academic scientist and consultant.

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