Health & Fitness

On March 11, 2022, CDC researchers released results of a small study in children 5 to 15 years old, who had received two doses of the Pfizer mRNA COVID vaccine. The study’s conclusion, which included many caveats, was that there was reduction of COVID disease in just 31% of children aged 5 to 11 years compared to 59% in children 12 to 15 years old.

Despite questionable disease risk reduction from their own data, the recommendation was that all children as young as 5 years old should get the vaccine.¹

Even though fathers are spending more time sharing the raising of children with mothers today,² national surveys show that women with minor children still remain the primary child care givers in America.^3,4

The ones who usually take children to doctors, mothers on the front line are soon expected to make decisions about giving babies as young as 6 months old the new genetically engineered Pfizer COVID-19 vaccine when the FDA predictably approves it for emergency use this spring.^5,6

Public health officials want doctors to give the mRNA vaccine, which forces the body’s cells to manufacture the SARS-CoV-2 spike protein, to the most vulnerable age group,⁷ the tiny babies and young children under 5 years old, whose immune systems and brains are not yet fully developed.^8,9,10 It is an age group that mothers historically have been the most responsible for nurturing and protecting from harm.

Fastest Development of An Experimental Shot in History

The targeting of infants and toddlers for COVID vaccination comes two years after the U.S. government declared a coronavirus public health emergency in January 2020¹¹ and then gave Pfizer and six other drug companies $9 billion to manufacture a coronavirus vaccine at warp speed.¹²

Most vaccines take at least 10 years to go through the development and testing licensing process before being approved by the U.S. Food and Drug Administration for distribution.¹³

Pfizer spent just 248 days testing their experimental COVID vaccine using a never-before licensed technology, which injects synthetic mRNA encapsulated in lipid nanoparticles into the body to induce cells to make the SARS-CoV-2 spike protein and become — in the words of the World Economic Forum — “vaccine production plants.”^14,15

In December 2020, the FDA granted Pfizer and its German corporation partner BioNTech, an Emergency Use Authorization — or EUA — to release the unlicensed mRNA vaccine for use by every person over 16 years old.^16,17 That EUA was quickly followed six months later by one for children as young as 12,¹⁸ then five months later with authorization for children as young as 5.¹⁹

It is the fastest development and mass administration of an experimental vaccine to healthy humans in history,²⁰ and the first vaccine to be distributed and recommended for mass use under an Emergency Use Authorization.²¹ Although the FDA fully licensed Pfizer’s Comirnaty vaccine in August 2021 as “safe, pure and potent” for 16-year-olds,²² it still is not officially licensed for children younger than that.

FDA’s Emergency Use Authorization Comes With Big Assumptions

By February 2022, only about 55% of children over age 12 in America had gotten two doses of the Pfizer COVID vaccine, while just 30% of 5- to 11-year-olds had received at least one dose.²³

Perhaps mothers are not impressed with the dodgy rationale FDA officials used to justify handing Pfizer an EUA using vague language with large assumptions like it is “reasonable to believe” the vaccine “may be effective” and “reasonable to conclude based on the totality of the scientific evidence available” that the “known and potential benefits ... outweigh the known and potential risks of the vaccine.”²⁴

Those kinds of sweeping caveats clearly demonstrate that an EUA allows a lower standard for scientific evidence of the product’s safety and effectiveness than full licensure.²⁵ In fact, it is not unreasonable to conclude that the Pfizer COVID vaccine is still an investigational product, still experimental whenever it is given to a child under 16 years old.^26,27

So far, parents in America are split down the middle when it comes to the idea of giving young children Pfizer’s new COVID-19 vaccine. Half of parents²⁸ are uncomfortable with injecting synthetic mRNA coated in lipid nanoparticles into the cells of their child’s body, which is supposed to prevent a bad case of COVID disease — but not necessarily prevent their child from being infected with the virus and transmitting it to others.^29,30

With researchers finding that many SARS-CoV-2 infections in young children are asymptomatic and go undetected,³¹ and with evidence that natural immunity from infection is broad and persistent,^32,33 parents are asking legitimate questions about why their young children are candidates for this vaccine.

A recent survey found that half of parents were worried about (1) whether the vaccine has been studied long enough in children; (2) whether there are long term side effects; (3) whether the vaccine’s experimental mRNA technology is safe; (4) whether the vaccines work, and (5) the effect of short-term side effects.³⁴

Research published in February 2022 revealed that one-third of parents say they will “wait and see” before vaccinating a child under 5 years old and 26% say they will “definitely not” allow their infant or toddler to receive the COVID vaccine.³⁵

With the majority of parents worried about whether Pfizer’s COVID vaccine carries unacceptable risks, is effective, or is necessary for their child, what kind of information about COVID disease and the vaccine is being given to mothers taking children to pediatricians around the country?

Are Moms Being Given Complete Information About COVID Shots?

Is the information accurate and complete? Are pediatricians treating mothers with respect and allowing them to exercise voluntary informed consent to COVID vaccination on behalf of a minor child, or are mothers being threatened and punished if they say, “no thanks?”³⁶ How many doctors plan to deny medical care to children when their mothers decline the COVID vaccine?

A 2020 study reported that more than half of U.S. pediatricians refuse to care for a child if their mothers decline to give the child even one of the four dozen doses of other vaccines CDC officials insist all children must get before age 6.^37,38,39,40

To stop mothers from being able to exercise informed consent to vaccination on behalf of their children, medical trade associations have lobbied state legislatures to pass laws giving doctors permission to extract consent for any type of vaccination from children as young as 11 years old without the knowledge of their parents⁴¹ and, in 2020, the District of Columbia was the first to pass that kind of law.^42,43

Five states (Alabama, Oregon, South Carolina, North Carolina and Rhode Island) have passed laws to give doctors the power to persuade children between 14 and 16 years old to get COVID vaccine without telling parents.⁴⁴

If you cringe thinking about whether your 11-year-old or teenager is intellectually, psychologically and emotionally equipped to accurately weigh the potential benefits and risks of a vaccine and resist the pressure from a doctor telling them what to do,⁴⁵ you are not alone.

As a co-founder of the charitable National Vaccine Information Center established in 1982 to prevent vaccine injuries and deaths through public education,⁴⁶ I have never been more concerned about a new vaccine the government wants doctors to give to every infant and child.

As a mother of three and now a grandmother, as a college-educated woman who completely trusted my pediatrician when I took my healthy 2.5-year-old son for a DPT shot in 1980 and then watched him suffer a convulsion, collapse and brain inflammation reaction that put him in a special education classroom,⁴⁷ I urge all mothers to become fully informed about the SARS-CoV-2 infection and the COVID-19 vaccine before making a vaccination decision for a child of any age.

All Vaccines Come With Two Risks

Vaccines are pharmaceutical products that come with two risks: a risk the vaccine will cause a reaction that could cause harm, and a risk the vaccine will fail to protect against infection and transmission of a disease that could cause harm.

Because we are all individuals born with different genes and environmental influences, the risks for disease complications or vaccine complications can be greater for some, depending upon genetic, epigenetic, environmental and other biological factors unique to the individual.^48,49,50,51

If the risks of COVID vaccination turn out to be 100% for your child — whether it is because the vaccine causes a severe reaction or fails to prevent severe complications of the disease — you should know that in June 2020, Congress completely shielded vaccine manufacturers and anyone administering the COVID vaccine from product liability and malpractice lawsuits in civil court.^52,53 So whatever happens, you will be on your own.

At the National Vaccine information Center, we do not make vaccine use recommendations, but we do defend without compromise the human right to exercise voluntary, informed consent to medical risk-taking.⁵⁴ You have the moral right and should have the legal right to accept or refuse a vaccine for yourself or your minor child without being sanctioned in any way.⁵⁵

This commentary offers an overview of COVID disease and the vaccine, with a focus on the genetically engineered messenger mRNA COVID vaccine manufactured by Pfizer being recommended for children by federal government officials and medical trade associations in the U.S. I encourage you to check out the library of over 200 live-linked references anchoring this commentary on NVIC.org to verify the content and do your own research.

Most Coronaviruses Cause Mild Symptoms Like the Common Cold

Coronaviruses are a group of diverse, single stranded RNA viruses that have been around for thousands of years and infect animals, as well as humans.

Coronaviruses usually cause mild respiratory and gastrointestinal symptoms like those of the common cold,⁵⁶ with the exception of Severe Acute Respiratory Syndrome (SARS) that emerged in China in 2002, and the coronavirus causing Middle East Respiratory Syndrome (MERS) identified in Jordan and Saudi Arabia in 2012 - both of which had high mortality rates.⁵⁷

About 20% of cold or flu-like upper respiratory infections each year are caused by coronaviruses and there is evidence that many people already have at least partial natural immunity to common coronavirus infections.

Some researchers think this may be one reason why the current SARS-CoV-2 infection is asymptomatic or mild for most healthy children and many adults,⁵⁸ and why COVID-19 tests can generate false positive results because the tests pick up evidence of previous coronavirus infections.^59,60

Controversy Over Origins of COVID, Shot Effectiveness, Safety

Since early 2020, public health officials have insisted that the SARS-CoV-2 virus spontaneously jumped into a human out of a bat at a wet food market in China and the only way to end the pandemic is to lock down, mask up, and require everyone to be vaccinated.^{61,62,63,64,65,66} There are prominent scientists, doctors, ethicists, attorneys, lawmakers and journalists around the world, who disagree with that view. They point out there is compelling evidence:

• that the SARS-CoV-2 virus was created in a lab and top health officials did not want the public to know about it;^67,68,69,70
• that fast tracked mRNA COVID vaccines have not been thoroughly tested by drug companies, which have failed to release all the clinical trial data, and both the companies and public health officials are downplaying serious vaccine-related reactions and deaths;^{71,72,73,74,75,76,77}
• that the most widely-used mRNA COVID manufactured by Pfizer and Moderna may prevent serious disease complications, but vaccinated people can still get infected with and transmit the new coronavirus to other people,⁷⁸ and any temporary protection from COVID disease wanes quickly after vaccination;⁷⁹
• that the SARS-CoV-2 infection is mostly asymptomatic or mild in healthy children and young adults⁸⁰ and that naturally acquired immunity is equal to or broader and longer lasting than COVID vaccine acquired artificial immunity;^81,82,83,84 and
• that governments have done more harm than good by locking down societies and creating masking and vaccine mandates;^{85,86,87,88,89,90,91}

Here are four questions you need to keep in mind when you are making a COVID-19 vaccine decision for your minor child:

1. HOW SERIOUS IS COVID-19 DISEASE IN CHILDREN?

By February 2022, the new coronavirus had evolved from the original alpha variant that human populations had no immunological experience with, to the more transmissible and severe Delta variant that emerged in the summer of 2021, to the Omicron variant that became dominant in late 2021.⁹²

Omicron is highly contagious but causes fewer complications and hospitalizations than Delta,⁹³ and there is speculation that the fact so many people have developed various degrees of natural immunity to SARS-CoV-2 is one reason why hospitalizations and deaths are coming down in the U.S.^94,95

As of February 14, 2022, COVID-19 death rates reported by states in the previous seven days ranged from 0.26 to about 1.5 deaths per 100,000 people.⁹⁶

To put the worst case 1.5 COVID-related deaths per 100,000 people rate into perspective, the annual death rate for some of the leading causes of death in the U.S. in 2014 were: 193 deaths per 100,000 for heart disease; 186 per 100,000 for cancer; 46 per 100,000 for chronic respiratory disease; 24 per 100,000 for diabetes; 15 per 100,000 for drug overdoses.⁹⁷

Severe COVID Most Likely in Chronically Ill People Over 65

At the outset of the coronavirus pandemic, it became obvious that most of the serious complications of COVID-19 disease leading to hospitalizations and death do not occur in children or healthy young adults, but in people over age 65, especially if they have one or more chronic health problems.

In 2020, researchers projected that about 45 percent of the U.S. adult population was at increased risk for complications from SARS-CoV-2 infections because of underlying heart or respiratory disease, diabetes, hypertension and cancer.⁹⁸

One big study sponsored by the CDC looked at the connection between underlying medical conditions and severe illness among more than 500,000 adults with COVID-19 admitted to 800 US hospitals in 2020 and 2021. Researchers found that 95 percent of adult COVID patients had at least one underlying poor health condition like high blood pressure and obesity.⁹⁹ The strongest risk factors for death were obesity, anxiety and fear disorders, and diabetes with complications.

Children with chronic health problems are also at risk for COVID disease complications. The CDC states on its website that, “In the United States, more than 40% of school-aged children and adolescents have at least one chronic health condition, such as asthma, obesity, other physical conditions, and behavior/learning problems.”¹⁰⁰

Most Serious COVID-19 Occurs in Chronically Ill Children

A large cross-sectional study funded by the CDC examined the health records of more than 43,000 patients under the age of 18 with a COVID diagnosis who visited the emergency room or were admitted to 900 US hospitals in 2020 or January 2021.¹⁰¹

The median age of child COVID patients was 12 years old. Researchers found that about 29 percent of the child COVID patients had underlying chronic conditions like asthma; obesity; and neurodevelopmental, depressive, anxiety and fear-related disorders.

The strongest risk factors for hospitalization were type 1 diabetes and obesity. The strongest risk factors for severe COVID illness were type 1 diabetes and congenital cardiac and circulatory problems. Prematurity was a risk factor for severe COVID illness in children under two years old.¹⁰² Those with a COVID diagnosis represented only about 1% of all children who visited an emergency room or were admitted to the hospital.

More than 81% of COVID related deaths in the U.S. have occurred in seniors over age 65 and deaths in that age group are 80 times higher than for people between 18 and 29.¹⁰³ The COVID case fatality rate for children by February 2022 was measured at less than one percent in the U.S.¹⁰⁴

Healthy Infants and Children Usually Have No or Mild Symptoms

Studies have shown that most healthy infants and children with COVID disease either have no symptoms or much milder symptoms than adults, which last about a week.¹⁰⁵ COVID disease symptoms in the majority of healthy children are similar to a cold or flu-like illness and range from fever, sore throat, fatigue and body aches to runny nose and congestion, headache, cough, nausea and diarrhea.

As with most respiratory diseases, pneumonia is always a risk and, clearly, risks for COVID complications are higher for children with certain types of underlying chronic disease.¹⁰⁶

Severe complications of COVID-19 disease in some individuals appear to involve a hyper-inflammatory response by the immune system to infection with SARS-CoV-2. This can lead to cytokine storm involving elevated levels of circulating cytokines and immune-cell hyperactivation that can lead to severe respiratory distress and death if the inflammation does not resolve.¹⁰⁷

There is a condition called Multisystem Inflammatory Syndrome in Children (MIS-C) that has been reported rarely, and obese children are most at risk. Symptoms include a prolonged fever, unusual fatigue, vomiting and diarrhea, red skin rash, abdominal pain, red lips and eyes and swollen hands or feet.¹⁰⁸

Children With COVID at Very Low Risk of Hospitalization, Death

While the majority of people diagnosed with COVID disease have mild to moderate symptoms, about 10 to 15% become severely ill and five percent become critically ill. Most recover in two to three weeks, but researchers estimate about one in five may have symptoms for five or more weeks and one in 10 people will have symptoms that last for 12 weeks or longer.¹⁰⁹

Symptoms of “long Covid,” can include fatigue, shortness of breath, muscle pain, joint pain, headache, cough, chest pain, altered smell and taste, diarrhea, difficulty thinking clearly, memory loss, anxiety and sleep disorders. About four percent of children may experience “long Covid” symptoms like fatigue, headache and loss of smell and the majority recover within eight weeks.¹¹⁰

If infected with the SARS-CoV-2 virus, healthy children have a very low risk of being hospitalized or dying. A U.S. state data report published by the American Academy of Pediatrics on February 3, 2022 found that out of about 1.2 million COVID-related hospitalizations, only 3% were children. Out of 821,369 reported COVID deaths in the U.S., 828 of those deaths or .01% were in children.¹¹¹

2. ARE THERE WAYS TO PREVENT OR TREAT COVID COMPLICATIONS?

One of the great tragedies of the coronavirus pandemic over the past two years has been that very few drugs and effective medical protocols have been approved by the government to help people prevent or recover from the SARS-CoV-2 infection.

About 95 percent of the public funds appropriated by the U.S. and other governments to fund the global response to the coronavirus pandemic were given to multi-national drug companies to develop and deliver vaccines, while only five percent was spent on exploring therapies to treat COVID disease.¹¹² There are still very few FDA-approved drugs or therapies available for doctors to treat COVID disease.

Most of the anti-viral COVID drugs approved by the FDA under an EUA are very expensive,^113,114,115 and there are unanswered questions about risks and whether they work very well.^{116,117,118,119} In early 2020, practicing physicians searching for ways to help people with COVID began repurposing already licensed drugs for off-label use, a common practice that has been allowed under FDA law for many years.¹²⁰

Some Doctors Use Repurposed Licensed Drugs to Treat COVID

Some of the more affordable licensed drugs that have been repurposed by physicians to treat COVID over the past two years include the Nobel award winning anti-parasitic, anti-viral and anti-inflammatory drug Ivermectin.^{121,122,123,124,125,126}

Vitamins, minerals and supplements that have been used to help prevent or address COVID complications include the Vitamins D,^127,128 C,¹²⁹ and B complex;¹³⁰ magnesium;¹³¹ quercetin;^132,133 melatonin,¹³⁴ curcumin,¹³⁵ zinc,¹³⁶ NAC,¹³⁷ probiotics,¹³⁸ Omega 3s,¹³⁹ glutathione¹⁴⁰ and aspirin.¹⁴¹

As with all drugs and supplements, it is important to have a knowledgeable doctor direct treatment in the appropriate doses and for the right length of time, because what may work and is safe at one stage of the disease may not be during another stage.

The Front Line Covid-19 Critical Care Alliance (FLCCCA)¹⁴² and World Council for Health¹⁴³ are two groups of doctors who have developed COVID-19 treatment protocols that are not endorsed by government health officials but are being used by a number of health professionals around the world to treat adults and children with COVID.

High Mortality Rate for COVID Patients Hospitalized in US

With an average 38 percent mortality rate for seriously ill COVID patients admitted to U.S. hospitals in 2020,¹⁴⁴ and with COVID patients who are put on a ventilator experiencing a 45 to 85 percent mortality rate,^145,146,147 it is no wonder independent doctors have been exploring options for reducing COVID complications and keeping patients out of hospitals.

Yet, these doctors are being criticized by public health officials discouraging the use of repurposed licensed drugs like ivermectin¹⁴⁸ and over-the-counter supplements¹⁴⁹ that peer reviewed studies have shown either prevent severe disease and improve, or have the potential to improve, survival.¹⁵⁰

Medical boards in some states are trying remove the medical licenses from those doctors,¹⁵¹ and it can be difficult to find a doctor in the U.S. willing to depart from the few government approved medical protocols for treating COVID.¹⁵² The National Institutes of Health warns that:¹⁵³

“Research hasn’t clearly shown that any dietary supplement helps prevent COVID-19 or can decrease the severity of COVID-19 symptoms. Only vaccines and medications can prevent COVID-19 and treat its symptoms.”

No Drugs Specifically Approved to Treat Children With COVID

The only guidelines published by the Centers for Disease Control for treatment of children with COVID are dated December 2020 and state, “Currently, there are no drugs specifically approved by the FDA for treatment of COVID-19 in children.”¹⁵⁴

NIH has a child treatment guide, which states that “Most children with SARS-CoV-2 infection will not require any specific therapy” and “There are limited data on the pathogenesis and clinical spectrum of COVID-19 disease in children.” It goes on to say that:

“There are no pediatric data from placebo-controlled randomized clinical trials and limited data from observational studies to inform the development of pediatric-specific recommendations for the treatment of COVID-19.”¹⁵⁵

After lockdowns and forced masking and a year that saw many Americans subjected to mandatory COVID vaccination to enter public spaces and keep their jobs, it is very sad that government officials have done so little to investigate and approve therapies to address COVID disease.

One political explanation is that under FDA regulations, drug companies cannot receive emergency use authorization to distribute fast tracked experimental vaccines (or drugs) if there are “adequate, approved, and available alternatives.”¹⁵⁶

3. HOW EFFECTIVE IS PFIZER’S COVID VACCINE?

After the coronavirus pandemic was declared by public health officials in early 2020 and governments asked drug companies to fast track development of experimental COVID vaccines, the FDA issued guidelines assuring the companies that vaccine trials would only have to demonstrate “at least 50%” efficacy in preventing severe COVID-19 disease.

There was no requirement for companies to prove their COVID vaccines prevent infection and transmission of the SARS-CoV-2 virus.^157,158 Perhaps that is one reason why the vaccines are called COVID vaccines and not SARS-CoV-2 vaccines.

But the general public did not and still does not understand the difference. That is because for more than a century, people have been carefully taught to believe that a vaccine produces artificial immunity in the body to prevent transmission of contagious diseases to other people.¹⁵⁹

CDC Changed Definition of ‘Vaccine’ and ‘Vaccination’

CDC officials frequently have referred to vaccines as “immunizations.”¹⁶⁰ But in 2021, the CDC suddenly changed its definition of “vaccine” from “a product that stimulates a person’s immune system to produce immunity to a specific disease” to “a preparation that is used to stimulate the body’s immune response against diseases.”¹⁶¹

The Merriam Webster Dictionary also changed its definition of “vaccine” to eliminate the concept that a vaccine stimulates “immunity” and replaced it with the concept that vaccines create an “immune response.”¹⁶²

Up until now, the words “vaccine” and “vaccination” have been synonymous with creating “artificial immunity” in humans and animals.¹⁶³

The rewriting of that definition to admit that vaccines cannot be presumed to confer immunity — only modify the person’s immune response — is stunning because mandatory vaccination laws historically have been based on the common belief that all infants and children must get vaccinated to create “herd immunity” and prevent the transmission of contagious diseases within a community.^164,165

If the definition of “vaccine” and “vaccination” no longer includes the concept of immunity,¹⁶⁶ then the definitions of vaccine “efficacy” and “effectiveness” have been forever changed as well.^167,168

Public Misled That Shots Prevent Infection and Transmission

To obtain the EUA in late 2020, Pfizer published clinical trial data involving about 43,000 participants over age 16, with more than 21,000 of them injected with the company’s experimental mRNA COVID vaccine. Pfizer said the data showed that two doses of the vaccine achieved a 95% efficacy for preventing severe COVID disease.^169,170

Most mainstream media reports publicizing the Pfizer clinical trial results misled the public into believing that a 95 percent “efficacy” rate meant the vaccine reliably prevented SARS-CoV-2 infection.¹⁷¹ Americans obeying mask mandates put into place before the vaccine was released, assumed that they would be able to ditch the mask and stop social distancing once they got vaccinated.¹⁷²

But in early 2021 when CDC officials did not back away from mask mandates for vaccinated persons, people started suspecting something was wrong about that assumption. Fully vaccinated people were told to keep the masks on and socially distance like unvaccinated people.¹⁷³

The logical question was: Why do fully vaccinated people have to worry about getting infected or infecting other people?

The answer to that question became obvious when study after study published in the medical literature since December 2020 showed that two or three doses of Pfizer’s mRNA COVID vaccine do not reliably prevent symptomatic or asymptomatic infection and transmission of SARS-CoV-2 virus, and the vaccine has a very short shelf life for protection against COVID disease, waning within a few months of vaccination.^174,175,176

While that reality sets in, studies are revealing that naturally acquired immunity from the new coronavirus infection is broad and long-lasting,^{177,178,179,180,181} perhaps two years or more.¹⁸²

More COVID Booster Shots or Annual Re-Vaccination?

In fact, within four months of Pfizer’s COVID vaccine being approved by FDA for distribution, in April 2021 the company’s CEO called for a third shot — a booster dose — and suggested it was possible vaccinated people would have to get revaccinated every year.¹⁸³

Seven months later, the FDA dutifully approved the Pfizer booster shot for emergency use by everyone over 18 years old,¹⁸⁴ and on January 3, 2022, expanded the EUA to allow a third booster shot for children as young as 12 years old.¹⁸⁵ Now there is talk about a fourth booster shot.¹⁸⁶ And the Pfizer CEO is once again calling for annual COVID vaccinations in the future.¹⁸⁷

On February 1, 2022, Pfizer applied for an EUA to give its COVID vaccine to infants and young children between 6 months and 5 years old.¹⁸⁸

But, within 10 days, the request was suddenly withdrawn after indications that two 3-microgram doses of the vaccine did not prevent COVID disease symptoms in that age group and a third dose would be required to demonstrate efficacy.^189,190

4. HOW REACTIVE IS THE VACCINE AND ARE THERE SERIOUS RISKS?

After the FDA gave emergency use permission to Pfizer in December 2020 to distribute their COVID vaccine, the nonprofit group Public Health and Medical Professionals for Transparency filed a Freedom of Information Act (FOIA) request for the FDA to immediately release 450,000 pages of Pfizer vaccine testing data that the agency relied upon to grant the EUA.

FDA officials refused the request, claiming it would take them 75 years to release all the trial data to the public. A lawsuit was filed and, on Jan 6, 2022, a Texas federal judge ordered the FDA to release 55,000 pages every 30 days until all the requested pages were made public.¹⁹¹

The need for full public disclosure was reinforced by an allegation by a whistleblower, who had worked for a subcontractor involved in the first COVID vaccine clinical trial Pfizer conducted in 2020. She charged that there were serious irregularities in the trial, including falsification of data, lack of monitoring of trial participants after vaccination and failure to immediately follow up of patients who experienced adverse events.¹⁹²

Questions About Vaccine Safety Testing, Lack of Transparency

Pfizer has been haunted by questions about what it does and does not know about the reactivity and long-term side effects of its COVID vaccine ever since the FDA granted emergency use authorization after only nine months of testing.^193,194,195

To demonstrate safety, drug companies historically have been required to first test the experimental vaccine for toxicity in animals, followed up by Phase 1 and 2 human clinical trials to test the vaccine on a few hundred volunteers for detection of common side effects; then progress to Phase 3 trials that involve thousands of people to further identify potential serious reactions.¹⁹⁶

Although Pfizer did publish a few small animal studies testing its mRNA COVID vaccine on mice, rats and monkeys, most of the focus was on showing the vaccine was effective, not that it was safe.^{197,198,199,200}

To speed up the COVID vaccine testing process, FDA allowed Pfizer and other drug companies to conduct some of the animal and human clinical studies simultaneously, instead of sequentially.^201,202

To further accelerate approval, FDA also allowed companies to provide testing data from previous research on other types of experimental mRNA vaccines as preliminary proof that COVID mRNA vaccines were effective and safe, even though those other mRNA vaccines were never licensed.²⁰³

Majority in Pfizer Clinical Trials Had Adverse Events

In December 2020, Pfizer published results of a Phase 2/3 randomized saline placebo controlled human clinical trial in a bid to be the first company to obtain Emergency Use Authorization from the FDA to distribute a COVID vaccine for mass use.

The company tested two 30 microgram doses of the vaccine given 21 days apart to about 21,700 healthy volunteers aged 16 and older who had not been previously diagnosed with COVID, and followed them up for between seven days and several months after the second dose to identify common and serious adverse events.²⁰⁴

The majority of vaccinated participants experienced a local or systemic reaction, with younger people more often reporting side effects like pain at the injection site, headache, fatigue, fever and swollen lymph glands that occurred more often after the second dose and lasted for several days but then resolved, according to Pfizer.

The few serious adverse events recorded after vaccination in the trial, such as cardiac arrythmia and a death from cardiac arrest, were dismissed by investigators as unrelated to the vaccine.²⁰⁵

In 2021, Pfizer published results of Phase 2/3 clinical trials testing two 30 microgram doses of its COVID vaccine on about 1,100 healthy 12- to 15-year-olds,²⁰⁶ and another one that tested two 10 microgram doses on about 1,500 healthy 5- to 11-year-olds, who had never been diagnosed with COVID.²⁰⁷

The children were followed up for seven days, one month and six months. For the 5- to 11-year-old children in the Phase 2/3 clinical trial who got the Pfizer COVID vaccine, researchers reduced the dose from 30 micrograms to 10 micrograms in an effort to lower the incidence of systemic reactions like fever.

On the CDC website in a summary of Pfizer/BioNTech COVID-19 vaccine reactions and adverse events, the CDC states that within seven days of vaccination over 90% of study participants aged 12 to 15 years reported at least one local or systemic reaction and among child study participants aged 5 to 11 years old, about 86% reported at least one local reaction and about 66% reported at least one systemic reaction like fever, chills, fatigue, headache, new or worsened muscle pain or swollen lymph nodes.²⁰⁸

Pfizer Unblinded Shot Trials, Vaccinated Placebo Participants

Although Pfizer says it plans to follow up clinical trial participants of all ages for two years, by March 2021 the company had unblinded the study and offered the COVID vaccine to placebo participants, which scientifically compromises evaluations and comparisons of long-term health problems in vaccinated versus unvaccinated participants.^209,210 The unblinding of a clinical trial while follow up of participants is ongoing has never been done before — it is unprecedented.²¹¹

In those Phase 2/3 trials, including a six-month follow-up trial,²¹² and from anecdotal experiences reported by those who have gotten the Pfizer vaccine,²¹³ it is obvious that the mRNA COVID vaccine is quite reactive.

The majority of vaccinated people, especially if they are younger and after receiving a second dose,²¹⁴ experience acute reactions like injection site pain, fever, headache, fatigue, swollen lymph glands and body discomfort sometimes severe enough to require a day or two of recovery, which can include needing to stay home from work.²¹⁵

One CDC official commented early on that, “People should be prepared to have pain” following vaccination, suggesting that pain is a sign that “It’s your body building an immune response to the protein that is mimicking the disease."²¹⁶

Other doctors point out that strong reaction symptoms like high fevers, chills, headache, joint and muscle aching, and disabling fatigue are evidence of an inflammatory response mounted by the innate immune system and that antibodies are later generated by the adaptive part of the immune system.^217,218 It has long been recognized that strong reactions to pharmaceutical products can be a reason to exercise caution, especially with repeat doses.^{219,220,221,222,223}

Blood, Cardiac and Brain Disorders After Pfizer COVID Shots

Since the Pfizer vaccine was released under an EUA, there have been serious blood, cardiac and brain disorders reported in the medical literature, and also by people who have received the vaccine.^{224,225,226,227}

Among the more serious are immune thrombocytopenic purpura,²²⁸ which causes internal bleeding because the immune system attacks platelets and the blood cannot clot; heart inflammation that can cause a variety of cardiac problems;²²⁹ and immune mediated inflammatory neurological disorders^230,231 like Guillain Barre Syndrome,²³² Bell’s Palsy²³³ and Acute Disseminated Encephalomyelitis.^234,235

CDC officials have acknowledged only two major serious reactions related to Comirnaty vaccine: (1) anaphylaxis, a severe allergic reaction also known as shock that has symptoms like trouble breathing, swelling of the tongue and throat, hives and drop in blood pressure;^236,237 and (2) heart inflammation, which is commonly diagnosed as myocarditis or pericarditis with symptoms like chest pain, fast beating, fluttering or pounding heart and shortness of breath.²³⁸

Inflammation of the Heart Reported After Pfizer COVID Shots

Inflammation of the heart is not a trivial complication, whether it is caused by an infection or a vaccine. Myocarditis is inflammation of the cardiac muscle and is more often seen in infants and teenagers, but can occur at any age, especially after a viral infection.²³⁹

Myocarditis and pericarditis, which is inflammation of the tissue surrounding the heart, are thought to be largely immune-mediated and in serious cases, can lead to heart rhythm disorders, heart damage, heart failure and death.

Every year, heart disease kills nearly 660,000 Americans — 1 in 4. It is the leading cause of death in the United States among men and women of all races, costing the nation $363 billion a year.²⁴⁰ Myocarditis is a known complication of smallpox vaccine²⁴¹ and has been reported after influenza vaccine²⁴² and now is being reported after the Pfizer and Moderna mRNA vaccines.^243,244

A controlled study using large national healthcare databases from the US Department of Veterans Affairs found that individuals who had acute COVID-19 disease are at increased risk of many types of cardiovascular problems, including myocarditis and pericarditis; heart rhythm disorders; heart failure; ischemic and non-ischemic heart disease that can cause stroke and thromboembolic disease, or deep vein thrombosis involving blood clots.²⁴⁵

Although researchers said the greatest risk for COVID-related heart inflammation was in unvaccinated persons, the myocarditis risks were increased even for vaccinated people who got COVID.

A descriptive study conducted by CDC researchers analyzed reports to the federal Vaccine Adverse Event Reporting System (VAERS) database from December 2020 to August 2021 and found that crude reporting rates of myocarditis within seven days of mRNA vaccinations were higher than expected across multiple age groups and in both women and men.²⁴⁶

The rates of myocarditis cases were highest after the second dose in adolescent males, with about 70 cases of myocarditis reported per million doses of the Pfizer COVID vaccine in 12 to 15 year old males and about 106 myocarditis cases per million doses in males 16 to 17 years old. Most myocarditis symptoms appeared to occur and resolve more quickly after vaccination than after viral illness.

Still, the researchers admitted that, “the risks and outcomes of myocarditis after COVID-19 vaccination are unclear.”

Blood Clotting and Blood Vessel Disorders After Shots

Blood clotting and blood vessel disorders have also been reported after receiving Pfizer’s mRNA vaccine. One self-controlled case series study looked at patient records of 29 million people vaccinated in England and hospitalized between December 2020 and April 2021.

Nine million patients in the health records database got the Pfizer vaccine and researchers discovered an increased risk for blood clotting and blood vessel disorders within 15 to 21 days of vaccination that can lead to death.²⁴⁷

The conclusion was that after receiving the Pfizer COVID mRNA vaccine, there are increased risks for arterial thromboembolism, which is a blood clot in an artery that stops the flow of blood to an organ or another part of the body;²⁴⁸ and for ischemic stroke, which is when a blood clot cuts off blood supply to the brain and brain cells begin to die within minutes;²⁴⁹ and for cerebral venous sinus thrombosis (CVST), which is when a blood clot forms in the brain’s venous sinuses and prevents blood from draining out of the brain.²⁵⁰

The researchers pointed out that these blood clotting and blood vessel disorders also are complications of SARS-CoV-2 infections and occur more frequently in seriously ill patients testing positive for COVID than after COVID vaccination.

Over 1 Million COVID Vaccine Reaction Reports Filed

As of February 4, 2022, there were over 1.1 million adverse event reports following COVID-19 vaccinations filed with the U.S. Vaccine Adverse Event Reporting System known as VAERS that was created under the National Childhood Vaccine Injury Act of 1986.^{251,252,253,254}

COVID vaccine-related reaction reports represent more than 50 percent of the nearly two million total adverse event reports that have been made to VAERS for all federally recommended vaccines since the vaccine reaction reporting system became operational in 1990. It is estimated that only between one and 10% of vaccine adverse events that occur in the U.S. are reported to VAERS.^255,256

Using MedAlerts, an independent search engine for VAERS established in 2003, I conducted a search the first week in February 2022 and found that about 624,000 of the COVID vaccine adverse event reports were associated with the Pfizer Comirnaty vaccine,²⁵⁷ including over 130,000 events categorized as “serious,”²⁵⁸ and about 15,500 deaths.^259,260

A portion of these reports have been filed by residents of other countries who have received the Pfizer COVID vaccine, and federal health officials warn that there is no proof of causation for any given vaccine adverse event report filed with VAERS.²⁶¹

If your doctor refuses to report a serious health problem following vaccination to VAERS that you or your child have suffered, go to NVIC.org to learn how you can report it yourself.

Strong Inflammatory Responses Associated With mRNA Shots

What is it about the Pfizer mRNA vaccine that makes it so reactive? Because the Comirnaty vaccine was fast-tracked to licensure and all animal and human clinical trial data have not been fully released to the public, there has been speculation about the potential biological mechanisms for vaccine induced inflammatory disorders affecting the heart vessels and brain and other parts of the body.

The main concern about the Comirnaty vaccine’s reactivity is centered on the fact it uses a new mRNA technology platform that pushes synthetic mRNA coated with lipid nanoparticles into the body’s cells to force cells to produce the SARS-CoV-2 spike protein. This is the first mRNA vaccine injected into humans on a mass basis and the first one using a lipid nanoparticle delivery system.²⁶²

A search of the medical literature and mainstream media articles quickly reveals that two years before Pfizer and Moderna got an EUA to distribute their mRNA vaccines, academic researchers warned of potential safety issues with the platform, like local and systemic inflammation; stimulation of hyper-inflammatory immune responses causing chronic inflammation and autoimmunity;²⁶³ and the presence of extracellular RNA that may cause edema and the formation of blood clots.²⁶⁴

The lipid nanoparticles that coat the synthetic mRNA in COVID vaccines can be highly inflammatory, as one recent study in mice demonstrated.^265,266 This is the first human vaccine to include lipid nanoparticles and there are outstanding questions about biodistribution in the body and if they can accumulate in different organs of the body like the liver, spleen, lungs, kidneys and perhaps crosses the blood brain barrier.^{267,268,269,270,271}

There has been a debate about whether lipid nanoparticle coated mRNA that provokes cells to generate the SARS-CoV-2 spike protein ends up in the ovaries and could potentially affect fertility, with one of the inventors of mRNA technology and other scientists saying it could happen and other scientists saying it cannot.^272,273

At the same time there is an investigation going on in Europe about menstrual irregularities and spontaneous bleeding in menopausal women who have gotten mRNA vaccines.^274,275

There are also questions about antibody dependent enhancement (ADE),^276,277 which could make certain people who already have coronavirus antibodies because they got vaccinated or had a previous infection more susceptible to severe COVID disease if they are infected or re-infected with SARS-CoV-2.

Public health officials disagree that COVID vaccine can cause antibody dependent enhancement, maintaining that vaccinated people who get COVID have milder, not more severe, disease.²⁷⁸

Questions About Few Contraindications, Long Term Safety

There are questions about the almost total absence of contraindications, which means reasons not to give the Comirnaty vaccine, and recommendations to give another dose after a previous reaction.²⁷⁹ Then there is the lack of published evidence for the blanket recommendation that it is safe to give Comirnaty vaccine at the same time with all other government recommended vaccines.^280,281

At the end of the day, the biggest safety concern about Pfizer’s mRNA vaccine being given to children is that it just has not been studied long enough to determine if it will negatively affect the long term health of children.

Eminent scientists and doctors in the U.S. and around the world have been challenging official narratives about COVID and COVID-19 vaccines and asking all the right questions.^282,283 A U.S. senator has held panel discussions on Capitol Hill to give a voice to these scientists and to those who have been injured by COVID vaccines or have had their informed consent rights violated.²⁸⁴

Americans all across the country have been defending civil liberties and informed consent rights in many different kinds of public forums, even as they face censorship and abuse from those who are trying to silence the public conversation about vaccination, health and autonomy.^285,286

Concern About COVID Vaccine Mandates for Infants and Children

In closing, it is important to remember that the COVID-19 vaccine is the 17th vaccine U.S. health officials now direct doctors to give to children as young as five years old.²⁸⁷ When the FDA gives Pfizer the green light to distribute Comirnaty to children younger than that, the vaccine will be given to six-month old babies.

After 40 years of monitoring the science, policy, law and ethics of vaccination, my greatest concern is that this new vaccine eventually will be mandated for all infants and children, just like almost all vaccines that industry has created in the past century have been mandated.

We are responsible for protecting our children from harm, our children, who are now the most chronically ill and disabled children in the history of our nation.

Two in five children between six and 17 years old suffer with some kind of inflammatory immune or brain disorder like asthma, diabetes and epilepsy,²⁸⁸ and 1 child in 6 is developmentally delayed,²⁸⁹ but there are no credible explanations coming from public health officials for why so many of our children are growing up sick and disabled and face a lifetime of chronic poor health.

Debate About Vaccination Is More Than 200 Years Old

Before the current public debate about COVID vaccine, there have been public debates about the wisdom of giving children many other vaccines that were very reactive. I joined with parents of DPT vaccine injured children to launch the modern vaccine safety and informed consent movement in 1982 because we wanted the toxic, highly inflammatory whole cell pertussis vaccine that had harmed our children taken off the market.^290,291

We followed mothers and fathers in the 19th century, who protested the reactivity of the smallpox vaccine.^292,293

Our activism in the late 20th century was followed by parents speaking out in the early 1990s about what happened to their children after being given the first genetically engineered vaccine for hepatitis B,^294,295,296 followed by young mothers and fathers in the early 21st century once again asking government, industry and the medical establishment to expand knowledge about vaccine side effects and who is at highest risk.^297,298,299

The charged debates about flawed vaccine science and the violation of the human rights inherent in mandatory vaccination laws have not changed in two hundred years. The fact that the debate about vaccination will not go away — no matter how much money and political power is thrown at it to make it go away — only confirms the universal need for it.

Moral and Legal Right to Make Voluntary Vaccination Decisions

As a mother, you have the moral right and must have the legal right to gather as much information as you can about COVID disease and the COVID vaccine, consult with a trusted health professional, and then follow your conscience and your gut instincts when making a decision about whether or not your child should get vaccinated — without being coerced or sanctioned by anyone for the decision you make.³⁰⁰

If you want to work in your state to protect your legal right to make a voluntary decision about vaccination, go to NVICAdvocacy.org and become a registered user of the free NVIC Advocacy Portal so you can stay informed about good or bad vaccine bills moving in your state and take action.

Last year, after NVIC worked with families across the country to successfully hold back state COVID vaccine mandates after the federal government issued strict vaccine mandates for both federal and private company employees, about 20 states passed laws in some way prohibiting COVID vaccine mandates or vaccine passports.

Not one state legislature passed a law mandating the COVID vaccine, even as Governors and local state officials in a few states enacted COVID vaccine mandates without getting legislature approval.³⁰¹

Sign up for NVIC’s texting service and get NVIC’s weekly journal newspaper — The Vaccine Reaction — in your email box to stay up to date on breaking news.³⁰² Read and download vaccine education information from NVIC.org and share it with your friends, family, legislators and thought leaders in your community.

Be the one who never has to say you did not do today what you could have done to change tomorrow. It’s your health, your family, your choice. And our mission continues: No forced vaccination. Not in America.

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This article was previously published July 7, 2019, and has been updated with new information.

Dr. Paul Saladino¹ trained at the University of Arizona with a focus on integrative medicine. He completed his residency in psychiatry at the University of Washington in 2019, and is a certified functional medicine practitioner through the Institute for Functional Medicine. In this interview, Saladino discusses the surprising benefits of the carnivore diet, especially for those struggling with autoimmune disease.

Initially, I was skeptical of the carnivore diet, but once I listened to Saladino’s detailed analysis and justification for this approach, I changed my position and believe it is appropriate for a large number of individuals.

While at the time of this interview, Saladino was still a resident-in-training, he's developed profound expertise in this area by attending medical school twice, and diving deep into the medical literature.

"I graduated from college in 1999. I went to the College of William and Mary, studied chemistry and biology and did a whole bunch of molecular biology research there. My dad's a doctor, so I [was] steeped in medicine throughout my pre-career years and throughout my childhood …

I've always been interested in the way that health and disease affected quality of life and the way that food affected the way that I felt as a human being," Saladino says.

"I've been an athlete for most of my life, running and backcountry skiing and climbing mountains and so on. I was always kind of tuned into connections between food and health and disease. But when I got out of college … I took six years off and just spent the time in the mountains, exploring and adventuring.

Perhaps I already had this sort of seed within me of just questioning norms and asking interesting questions or being very curious. But that time certainly fed that. I hiked the Pacific Crest Trail … 2,700 miles. I climbed mountains throughout the Pacific Northwest, the Rockies in Colorado. I got into mountaineering and backcountry skiing.

Eventually, I realized that I really loved biology. I was really curious about some of these health questions. I wanted to go back to school. My dad is … an internist, an incredible man who spent so much of his life caring for patients. But I also saw him spend a lot of time working and not a lot of time being able to achieve balance and real self-work …

I went to physician assistant (PA) school at the George Washington University, and then started working in cardiology with a group of cardiologists in Bend, Oregon. Cardiology originally was a good fit for me because I thought I was a runner at the time … This is what maybe is unique about my training … I went to medical school twice."

Looking for the Root of Disease

A PA can be likened to an accelerated shortcut to being a physician. They have nearly identical practicing privileges, although a PA works under the authority of a supervising physician.

So, Saladino went through two years of basic clinical science twice, which helps explain his deep understanding and appreciation of the biological sciences. He admits that while his initial interest was primarily determining the benefits and drawbacks of various drug treatments, he quickly developed an interest in understanding the actual root of disease.

"I wanted to know how to change the course of a disease, how to get to the root cause of the disease. I know this is what you're fascinated by too. It unites a lot of us in these fields. It's, 'What is causing a disease?' This is the most interesting question to me and medicine.

That birthed my second career in medicine … Because I realized very quickly into my career as a PA that I was going to want to go back to medical school to get an M.D., to get a doctoral degree, to continue my training, to have the ability to practice as a physician, and to do that practice from a perspective of someone looking for root causes of diseases.

That's really been my focus. I ended up working as a PA in cardiology for four years. At that point, I went back to medical school at the University of Arizona in Tucson, which has a pretty strong history of integrative medicine … They have the Center for Integrative Medicine there …

As I looked at medicine differently, food seemed to be such a huge part. The things that we are putting into our body really seem to be a big part of what created health and disease …

Right now, I'm in my last month of my four years of residency at the University of Washington. I've got one month left to finish residency. But it was really the first seven years of my medical training after being a PA that kind of set the stage for this next sort of exploration, curiosity, realization for me …

I had this incredible privilege to see medicine through the eyes of someone who had been in the trenches. I thought, 'OK. Now I'm learning medicine again. What is going on here?' Every time I learned something, I thought, 'What is the root cause here? What is going on?'

What happened for me was this constant kind of disappointment, this constant sort of struggle realizing, 'The pharmaceuticals are incredible, but they're not treating the root cause. People don't often get better' … I was looking for tools that worked … I had the suspicion that it was diet. What I'm learning is that there may be an ideal diet for everyone, or it might be individualized. It might be some of both in there."

The Carnivore Diet

When Saladino discovered the carnivore diet, he'd already been contemplating ancestral norms and evolutionary ideas, asking questions such as: "Where have humans come from? How do we eat? What is the most congruent way of eating for humans that is going to give us optimal health?"

He admits the idea of the carnivore diet is “super radical.” He first heard of the carnivore diet from Jordan Peterson on a Joe Rogan podcast. He talked about his daughter Mikhaila, who had a bad case of juvenile rheumatoid arthritis (JRA), which is an autoimmune inflammatory disease.

She had multiple joint replacements at a young age, which crippled her. "She discovered this way of eating only animal meat," Saladino says, and over time, her symptoms improved.

"In medicine, we talk about case reports. I love case reports because I want to see how things actually work at a real level," Saladino says. "It was so striking to me that someone like Mikhaila could essentially reverse and completely heal from JRA and then the depression that was connected with it, probably because of the concomitant immunologic and inflammatory mechanisms with this radical dietary change.

I thought, 'That is really striking. I want to study that.' Then Jordan Peterson talks about the fact that he had anxiety and sleep apnea and other issues himself. They improved when he started eating an animal-based diet."

Might Plant Diets Trigger Autoimmune Problems in Some People?

Now, why would an animal-only diet be more effective than a plant-only diet? Everyone "knows" plant foods are good for you and a crucial part of a healthy diet. Saladino continues:

"I love that this notion just turned it all on its head. It just tipped everything over and I thought, 'Wait a minute. It kind of makes sense. Maybe plants don't want to get eaten. Maybe plants aren't good for humans?' At the beginning, I was very skeptical and I thought, 'I really need to dig into this,' and so I did …

This fundamental premise, this idea that plants and humans, plants and herbivores or plants and animals have coevolved, and every life form really has one goal. That's to push its DNA into the next species and to continue the lineage of that species.

A mustard plant wants the mustard plant to continue. An oak tree wants the oak tree to continue. Life and ecology is this beautiful intermingling of all these species working together but fighting and eating each other and trying to kill each other, but sometimes being symbiotic.

This concept that 'Maybe plants don't want to get eaten after all,' maybe this unconditional narrative that all plants are good for you all the time, maybe we should question that. That's a pretty radical concept, because I think even within the functional medicine sphere, there's this notion that all plants are good for you and the more plants you eat, the better.

But this counterculture, disruptive concept that for some people — perhaps for all of us, perhaps just for some people — plants can trigger autoimmunity through a variety of mechanisms is really intriguing."

The Plant Paradox

I’ve previously highlighted the work of Dr. Steven Gundry, who wrote the book “The Plant Paradox.” In it, he succinctly explains why and how plants, which we expect to be beneficial for us, can be harmful at times. Gundry’s premise is based on the harmful effects of lectins — plant proteins, sometimes called sticky proteins or glyca-binding proteins — because they seek out and bind to certain sugar molecules on the surface of cells.

Some — including wheat germ agglutinin (WGA), found in wheat and other grass-family seeds — bind to specific receptor sites on your intestinal mucosal cells and interfere with the absorption of nutrients across your intestinal wall. As such, they act as "antinutrients," and can have a detrimental effect on your gut microbiome by shifting the balance of your bacterial flora. Saladino had already investigated lectins as a means to improve his own eczema.

"I think one of the ways that I differ greatly from mainstream medicine in my conceptualization … is I don't believe in 76,000 diseases. I believe in like five diseases. Everybody manifests them a little differently. I kind of knew that my autoimmune disease was probably the same as almost everybody else's autoimmune disease.

If I could understand what was triggering my autoimmune disease, maybe that will be the first start of this journey, this first thread that I could pull on to understand what was causing other people's autoimmune diseases, because autoimmunity, inflammation, these are almost synonyms. If we can understand that, we can help a lot of people.

I was just going through this process. Gundry's work was a part of it. I think that now I would disagree with him on many issues … [He] has some great ideas about lectins …

I think … he's tried to create the lowest lectin, plant-based diet that he can with a small amount of meat … But I think that he and many others are misunderstanding a series of studies done in the '60s and '70s with rodents and methionine overfeeding that suggested excess levels of methionine would shorten the lives of these rodents.

Gundry and some other people have said, 'Animal protein shortens lives of humans' … I was actually a vegan 13 or 14 years ago. I explored that … My impression is that most of the plant-based physicians, when they're saying the animal protein shortens lives, they're referring to these methionine studies."

Imbalance of Methionine-Glycine Ratio Is the Problem

As noted by Saladino, in studies where rodents are given very high amounts of methionine, a sulfur-containing amino acid found in animal protein, a shortening of lifespan is observed. However, rodent diets are quite different from human diets. Mice and rats are not eating salad and steak. They're given chow to which certain nutrient ratios have been added or subtracted.

When the amount of methionine in the rat or mouse diet is increased by about 2%, lifespan starts to dwindle. The original conclusion was that excess methionine might shorten human lives as well, and some human biochemistry research suggest that might be the case. However, if you look at subsequent studies, you find there's more to the story.

"[W]hen they did the next study, they took the methionine out of the diet a little bit. They did methionine restriction. What did they see? They saw lengthening of the life of the rats … That was further strengthening their first hypothesis. But then the magical thing happened.

They gave them a large amount of methionine or the same amount of methionine, 2% of the diet with more glycine. What did they see? They saw extension of the lifespan. Then they realized — and this is what I think everybody's leaving out — that it's not about the excess methionine. It's about the imbalance and the methionine-glycine ratio.

We know this from human biochemistry. If you look at the folate cycle, if you look at methylation, if you look at the way we handle methyl groups, methionine is a methyl-containing amino acid. We know that homocysteine is converted to methionine by a series of enzymes. This involves the methylenetetrahydrofolate (MTHFR) gene, which makes L-5-methylfolate.

Your body uses L-5-methylfolate with homocysteine and the enzymes methionine synthase (MTR) and methionine synthase reductase (MTRR) … to add a methyl group to homocysteine to make methionine. Methionine is the precursor for S-adenosyl methionine (SAM-e). SAM-e does all these methylation reactions in the body.

But what we know is that excess methionine is buffered by glycine. Our body will use glycine to buffer methionine. If we get too many methyl groups and we don't have the corresponding amino acids to buffer them, the biochemistry can get kind of messed up.

Then the hypothesis, which I think is fairly compelling, is that too many sulfur-containing amino acids can create oxidative stress. Homocysteine is a sulfur-containing amino acid. I think there's good evidence that too much homocysteine probably causes oxidative stress by the same mechanism.

What we're looking at is a balance between sulfur- and nonsulfur-containing amino acids. We need the glycine, which doesn't have any sulfur, to sort of balance and buffer the methionine. There is this interesting concept that if we eat too much methionine, we will imbalance glycine.

Glycine is such a crucial amino acid. If we use up all of our glycine to buffer methionine, we won't have enough glycine to make two very critical proteins: collagen and glutathione."

Can a Carnivore Diet Provide All the Nutrients You Need?

Glycine is the smallest and simplest of the amino acids. Methionine and glycine are found in muscle meat at a ratio of about 2% methionine and about 7% to 8% glycine. In connective tissue, you find about 0.9% methionine and about 23% to 24% glycine, which isn't surprising because connective tissue consists mostly of collagen.

Collagen is typically constructed from three amino acids: glycine, proline and hydroxyproline, at a 1-to-1-to-1 ratio. So, there's a significant difference between collagenous tissue and muscle meat.

"When we are thinking about eating a carnivorous diet, I am a strong advocate for this concept of nose-to-tail eating, this idea that evolutionarily, our ancestors were certainly eating the whole animal, both from a spiritual perspective or a respective perspective for the animal and from a functional pragmatic perspective. They wanted all the calories and all the nutrients," Saladino says.

"If you look at an animal, there are unique nutrients in the muscle meat. There's a whole unique set of nutrients in the liver, and … unique amino acid composition in the connective tissue. There are unique nutrients in the bones. There are unique nutrients in the bone marrow and the fatty tissues. You can see this animal as this sort of fascinating partitioning of nutrients.

The idea of a carnivore diet or a whole-foods, animal-based diet became much more viable for me when I realized … studying anthropology that our ancestors were in fact eating the whole animal. Every indigenous culture that I'm aware of on the planet that's living now eats the whole animal.

Then you think, 'Now it makes sense.' It's not just about eating steak. You're really getting this incredibly diverse array of nutrients in the whole animal … You can get every single thing that we need. It's really interesting to kind of break it down and say, 'You're getting calcium in the bones. You're getting copper to balance the zinc in the liver. You're getting this B vitamin in the liver. You're getting this B vitamin in the muscle meat.'

But what we find is that we have to eat the whole animal. If we just eat the muscle meat, we're really going to be missing out on nutrients. But that's such an incredible postulate to say, 'Wait a minute. I can get all the nutrients that I need as a human by eating an animal nose-to-tail?' That's incredible. It's like the best multivitamin ever.

I would argue further that animal-based nutrients are much more bioavailable than plant-based nutrients. They're in the right ratio, which are incredible if you look at zinc, copper, calcium and magnesium. Then it kind of makes sense when you think about it from an evolutionary perspective. A deer or an elephant is a mammal. They're much more similar to a human operating system, to a human physiology, than a plant is.

We can get some nutrients from plants, but an animal looks so much more like us, that it's so much more compatible with our biochemistry when we take it in. The last part of the equation is that we can do all that, eating animals nose-to-tail without any of the antinutrients … that might be present in plants.

It appears that some people may be uniquely sensitive to those anti-nutrients. My hypothesis … is that may be the root cause for a lot of autoimmunity."

Organ Meats in a Pill

If you struggle with the idea of eating organ meats, you could consider a whole food supplement. There are now a few companies that provide desiccated organ tablets. Some of the better ones are sourcing grass fed animals from New Zealand, allowing you to get desiccated brain, liver, pancreas and spleen.

"A lot of people are finding improvements in histamine issues with kidney," Saladino says. "The best thing would be to eat kidney, because it has diamine oxidase (DAO) …

But a lot of people are taking the desiccated organ complex with kidney from Ancestral Supplements or another manufacturer and getting improvements in histamine issues because of the DAO that's in that."

What About mTOR Activation?

One of my initial concerns, and one of the reasons why I seriously doubted the carnivore diet would be a good idea, is the chronic activation of mammalian target of rapamycin (mTOR), a protein-sensing pathway involved in aging. When mTOR is activated then autophagy is inhibited, and that is the last thing you want to do on a long-term basis, as it is a prescription for metabolic disaster.

However, as I listened to Saladino's presentations, it became clear that it was a no-carb diet and would clearly put people into ketosis. And if they further restricted their eating window to six hours and did a one-day-a-week fast, there should be more than enough time to inhibit mTOR and activate autophagy.

For quite some time I was overly fearful of eating too much protein and over activating mTOR activation as it can speed aging and decreases life span. Some people are even taking rapamycin supplements to continually suppress it. But you do need to activate mTOR now and then, especially if you want to have any hope of ever increasing your muscle mass.

What I also came to realize is that activating mTOR and increasing muscle mass is even more important as you age. Sarcopenia or loss of muscle mass as you age can dramatically contribute to frailty. So, it is a fine balance.

Insulin Is Primary mTOR Activator When in Ketosis

As noted by Saladino, there's an important distinction to be made here, and that is that when you are in a ketogenic state, insulin is a far more profound activator of mTOR than leucine.

Needless to say, a carnivore diet is about as low-carb (ketogenic) as you get. There's virtually no carbohydrates. You're going to be generating massive amounts of ketones as a result, and you'll already be in ketosis.

The question is, can these two approaches — the carnivore diet and partial fasting to trigger autophagy — be successfully integrated? Based on Saladino's explanation of how the carnivore diet affects mTOR, it appears they might make for an excellent hybrid program.

"In a gross oversimplification, [mTOR] is kind of like the anabolic lever. It's the 'build your body up' side of your metabolism. It's balanced by 5' adenosine monophosphate-activated protein kinase (AMPK), which is the more catabolic. When we're eating … we're sort of activating mTOR … When we're not eating, we're generally triggering AMPK …

There has to be a balance … What's fascinating to me about the mTOR story is that when I really dug into this, the literature would suggest there are two ways to activate mTOR. There are different mechanisms, but they both do it. One of them is proteins, specifically leucine. One of them is insulin …

In terms of insulin and leucine, if we compare those … insulin had a much greater effect on mTOR, turning it on. The insulin effect also acted much longer, on the order of three to four hours. Leucine certainly will turn mTOR on, but it has a lesser effect. I think, relatively speaking, at the risk of putting a number on it, it was about 30% less, and then it did it for only about 45 minutes to one hour.

What we're seeing here is we can activate mTOR with protein, specifically leucine load … But if we activate mTOR with leucine, it's kind of on and then off about an hour later. If we activate mTOR with insulin, then it's going to be on for three to four hours. People can leverage this in whatever direction they want.

But with regard to a carnivore diet, some of the interesting discussion is around the question, 'Will eating … nose to tail … over-activate mTOR?' I think what's interesting is it probably won't, if we look at the molecular mechanisms, because it will primarily be a leucine switch of mTOR that we're turning on. It'll be on-off, on-off, rather than the insulin switch of mTOR.

Relatively speaking here, I think there's an interesting possibility that if we're eating carbohydrates, we're going to trigger more mTOR through the actions of insulin and the insulin-glucagon ratio than we are with protein. The carnivore diet is kind of like a unique example, because there's essentially no carbohydrate.

When we look at ketogenic diets, like a carnivore diet, we know that insulin is very low … When we eat food, insulin is going to rise. But in a ketogenic state, we know that insulin and glucagon are going to rise together. That ratio is not really going to change.

This comes up a lot in discussions with people. They say, 'Isn't eating a lot of protein going to spike my insulin? Isn't eating a lot of protein going to turn on gluconeogenesis? My blood sugar is going to spike.' That's not what we see at all, especially on a carnivore diet, because the insulin and the glucagon are going to rise a little bit, and they rise concomitantly, so then the insulin-glucagon ratio doesn't change.

When the insulin-glucagon ratio stays consistent, you're not really activating mTOR through insulin. You're not getting a big insulin spike at all … If someone's not in ketosis, if they're not fat-adapted and you eat a bunch of protein, yes, you're going to get a big spike in your insulin. That insulin-glucagon ratio is going to change drastically. But this is in stark contradistinction to the way that insulin responds when you're in a ketogenic state."

Carnivore Diet May Work Well With Partial Fasting Regimen

In summary, Saladino believes there's little risk of overactivating mTOR with leucine on a nose-to-tail carnivore diet along with appropriate time restricted eating and fasting.

So, the answer to the question "can these two approaches — the carnivore diet and partial fasting to trigger autophagy — be successfully integrated?" the answer seems to be yes. From an evolutionary perspective, it seems clear humans have hunted animals for meat (although not necessarily exclusively). Mankind also fasted for periods of time.

"I think there's absolutely a role for intermittent fasting, time-restricted eating, longer fasts — 24, 48, 72 hours — where you really shut everything off and you turn on AMPK," Saladino says. "You shut mTOR down permanently for a little while, and then turn it back on with protein and meat …

I would argue that the meat or the animal foods are a little bit more of a precise switch for mTOR. You can just be like, 'On, off, on, off.' Like I said, you can exercise, turn it on, get anabolic, work out, build muscle, regrow and then do other phases where you're breaking down, doing autophagy or apoptosis and totally recycling your cells."

I've previously written many articles detailing the ins and outs of intermittent fasting and cyclical partial fasting. This is also the topic of my latest book, "KetoFast." I've also written about the importance of eating your last meal at least three hours before bedtime.

Aside from preventing the deterioration of your mitochondria, avoiding late-night eating will also help inhibit fat accumulation. NADPH creates fatty acids. If you eat food before you go to bed, thereby providing your body with energy that you're not using, then something must be done with that energy. Since you're not moving, your body stores it away for later use.

To store the energy as fat, your body uses NADPH to make fatty acids. As a result of that creation, your NADPH levels plummet, thus reducing your body's ability to recharge your antioxidant structure. I think this may be one of the most important justifications for not eating three or four hours before bedtime.

Other Topics Covered in This Interview

Saladino covers a lot of ground in this interview — more than can be included in this written summary, so I encourage you to listen to the interview in its entirety. In it, we also cover the following topics, and consider the following questions:

More Information

By the time this interview airs, Saladino will have completed his residency and opened his private practice focusing on functional medicine for the treatment of psychiatric and nonpsychiatric ailments. You can learn more about Saladino and his practice on Paulsaladinomd.com.

He plans on doing virtual consultations as well, so you may benefit from his experience even if you're in another state. To schedule a virtual or in-person consultation, email him at PaulSaladinoMD@gmail.com.

Saladino is also writing a book, and is starting to speak at various conferences. He'll be at KetoCon in Austin, in June 2019. He also has a podcast called "Fundamental Health With Paul Saladino M.D.," which you can find on iTunes, Stitcher, Spotify and YouTube. In closing, Saladino says:

"I think this is one of the conversations that I really like having … It's saying, 'Hey. This is a radical thing. We really need to examine this carefully and do blood testing and make sure it's safe for people, because it seems to help people with autoimmune disease.'

I've seen people with Crohn's and ulcerative colitis and eczema and psoriasis resolve, which is just mind-boggling … But the flipside is you need to make sure [it's safe] … 'Are people going to get deficiencies?' I don't think so. I think there's an evolutionary basis for this. But how do we show this is safe and get some pilot studies going?

Because it's my strengthening suspicion that this is going to be a very useful tool for us in the medical world moving forward … What I've learned about functional medicine is that it all starts in the gut. Every functional medicine doctor has to be a gastroenterologist …

I'm going to be treating patients in my practice who are psychiatric and non-psychiatric because I really think it's all connected … I'll be treating people with all sorts of conditions, from GI to autoimmune … I really believe that a lot of psychiatric illness is autoimmune in nature and that a big part of improving that in the future is going to be treating people from that perspective, in a very holistic way."

Editor's Note: This article was updated July 29, 2019, to correct an error on how to mediate against oxalate toxicity.

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