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DNA and mRNA Vaccines – FDA Guidance and Regulations

Guidelines and Safety Concerns with DNA and mRNA Vaccines

While DNA and mRNA vaccines have been under development for decades, they are new to the market and human bodies. We are seeing more data and information on safety, regulation, and longer-term effects. However, there continue to be unanswered questions. 

Today’s article reviews what we know about DNA and mRNA vaccines and provides you with information so you can feel empowered when making medical decisions for yourself and your family. 

Keep reading to learn more about: 

What are DNA and mRNA vaccines?

First, the basic biology to know the difference between DNA and RNA. 

DNA is the double helix structured genetic code inside every cell’s nucleus. It is the blueprint for life. RNA is a copy of that DNA and is a single strand instead of a double. The “m” in mRNA stands for messenger. 

In transcription, the DNA is copied to the mRNA. In the next step, called translation, the blueprint is read and turned into a protein. This process happens inside cells.  

Both DNA and mRNA vaccines use the genetic material, or code, from the virus or other pathogen. The foreign genetic material uses the body’s cells to make the protein, which elicits an immune response that produces antibodies that protect against that part of the pathogen. 

Conventional  vaccines contain an inactivated virus, live virus, or parts of a virus. DNA and mRNA vaccines don’t contain the virus itself, just part of the genetic code for the virus. 

DNA vaccines are stable at room temperature and mRNA vaccines require cold temperature storage. Both gene-based vaccines have been researched and developed for decades but have only been used on a large scale in the last couple of years as a response to the Covid-19 pandemic, because they were never to the point of being able to be approved in the normal vaccine evaluation process of evaluating safety and effectiveness. 

The first (Covid19) DNA vaccine to come to market is ZyCoV-D, a DNA vaccine against SARS-CoV-2 (the virus that causes Covid-19), was developed in India. The vaccine is applied to the skin, not injected. The DNA enters cells in the body where mRNA copies are made, eliciting an immune response and antibody production against the foreign DNA. 

The first mRNA vaccines brought to market are the mRNA Covid-19 vaccines developed by Pfizer and Moderna, the primary vaccines available in the United States. The vaccines contain the mRNA code for the spike protein portion of SARS-VoV-2. When injected, the cells use the mRNA code to make the viral spike protein, which then triggers the body’s immune response. 

FDA Regulatory Guidelines and Emergency Use Authorization

In the United States, the U.S. Food and Drug Administration (FDA) regulates vaccines. Both Covid mRNA vaccines available have received an emergency use authorization (EUA) from the FDA in the rush to find a solution during the pandemic. The EUA allows a fast-track to bring new vaccines to the public in an emergency. 

These mRNA vaccines have been tested in large clinical trials but have not been granted full authorization by the FDA. 

The World Health Organization (WHO) developed safety guidelines for DNA vaccines in 2007 and updated guidelines in 2019. These guidelines discuss the possible health and toxicity risks of this technology.

It recommends investigating organs, tissues, endocrine glands, and reproductive health to uncover any unintended consequences of vaccination. In addition, the updates discuss emergency use of the technology where the risk for the disease may outweigh the risk of the vaccines for the population. 

From the document:

“As with all vaccines, the intended clinical use factors into the benefit/risk decision-making, with extremely low tolerance of risk for vaccines to be used routinely for children vs. a greater tolerance of risk for vaccines against priority pathogens of vaccine emergency ranking that would be used in an outbreak setting where the risk of the disease exceeds the risk from the vaccine. All prophylactic vaccines are held to high expectations of safety”.

The WHO has established similar guidelines for mRNA vaccines with a new draft released in December of 2020. These guidelines are meant as scientific advisory to inform vaccine safety, manufacturing, and vaccine approval globally. 

While the WHO guidelines for DNA vaccines were established in 2007, it wasn’t until the Covid pandemic in 2020 that guidelines for mRNA vaccines were established, despite mRNA vaccines already in development.

The DNA vaccine guidelines discuss safety concerns and possible long-term effects that need to be researched and understood, but the mRNA guidelines don’t express the same concerns. Perhaps the guidelines were rushed given the nature of the pandemic. 

Potential Vaccine Safety Concerns 

As with all medical interventions, side effects and risks are possible. Let’s look at some of them for DNA and mRNA vaccines. 

Common vaccine side effects 

Side effects of vaccination may be due to the body’s fast and intense immune response to the genetic material. For the mRNA Covid vaccines, around 65% experience at least one of the following side effects from the first dose:

Potential adverse reactions

Unlike the manageable side effects listed above, a small percentage of people may experience an allergic reaction to a vaccine. In the vaccine clinical trials, 0.6% of Pfizer vaccine recipients and 1.5% of Moderna vaccine recipients reported hypersensitivity reactions, compared to 0.51% and 1.1% of those who received a placebo injection.  

Under the FDA emergency authorization guidance, vaccines shouldn’t be administered to those with a known history of anaphylaxis to any vaccine component. Everyone receiving an mRNA vaccine is required to wait 15 minutes after vaccination to monitor for any allergic reaction, and those at a greater risk must be monitored for 30 minutes. 

Some propose that allergic reactions may occur to ingredients in the vaccine other than the genetic component. The mRNA vaccines don’t contain milk, egg, or other common allergens like previous vaccine technologies.

Polyethylene glycol, or PEG, is used as part of the delivery system for some of the vaccines. PEG is also referred to as the lipid nanoparticle (LPN) delivery system. Some people can have anaphylactic reactions to PEG. 

Not all severe reactions to a vaccine are anaphylaxis. Out of the first 1.8 million Americans to receive the Pfizer vaccine in December of 2020, there were 175 cases of a severe reaction, 21 of which were anaphylaxis.

Myocarditis

Myocarditis, or inflammation of the heart muscle, may be triggered by mRNA vaccines in some. These cases have primarily been in young men after receiving the second vaccine dose. Symptoms include:

There were 1226 cases of myocarditis between December 2020 and June 2021. Those followed in the study recovered quite well from myocarditis with supportive interventions, such as anti-inflammatory medications. Some were hospitalized, but the study reported no deaths. 

Unknown risks

Because of the EUA and rapid vaccination in a large population, we only have safety data since the vaccines were introduced around two years ago. We don’t have long-term safety data. And we won’t have it until time passes and more data is collected. 

There are many questions to answer regarding DNA and mRNA vaccines on health over the long term, such as their impact on human DNA, fertility, and all body systems.

Dendrimers 

Dendrimers are synthetic nanoparticles used as an adjuvant in mRNA vaccines to stimulate the immune system. Dendrimers are known to cause localized toxicity to the cells they encounter.

However, other vaccine ingredients are meant to mitigate these concerns. Dendrimers are a vaccine ingredient that we need more research on in terms of health risks, especially over the long-term. 

To learn more about dendrimers, please read Toxicity of Dendrimers.

Vaccination vs. infection 

With all vaccination decisions, it’s important to weigh the risks of the disease itself alongside the potential risks of vaccination. In the case of Covid-19, most people will likely be infected because the virus is highly contagious.

Unlike older vaccines against other viruses, most people who’ve been vaccinated against Covid-19 will still get the disease. Recent data indicates that the vaccine does not protect against the severe form of the disease and death. (SUSAN added STUDIES to end of doc)

Vaccine Recovery Action Steps 

Considering the possible risks of vaccines, it’s important to be informed. Information is empowerment! 

Here are some considerations for recovering from vaccine side effects: 

 

DNA and mRNA vaccines will likely become the new vaccine standard. It’s helpful to understand what they are, how they work, and what to expect. Functional Medicine offers many tools for supporting the immune system and body when exposed to vaccines.  

This website is dedicated to being a trusted resource for supporting the body through vaccine recovery. 

 

References

  1. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7938284/
  2. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6631684/
  3. https://www.nature.com/articles/d41586-021-02385-x
  4. https://www.fda.gov/vaccines-blood-biologics/vaccines/emergency-use-authorization-vaccines-explained
  5. https://cdn.who.int/media/docs/default-source/biologicals/vaccine-quality/guidelines-for-assuring-the-quality-and-non-clinical-safety-evaluation-of-dna-vaccines70ee1b3e-88a6-40af-8989-fbff8304a377.pdf?sfvrsn=521ee591_1&download=true
  6. https://www.who.int/docs/default-source/biologicals/ecbs/reg-considerations-on-rna-vaccines_1st-draft_pc_tz_22122020.pdf?sfvrsn=c13e1e20_3
  7. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7745181/
  8. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8049195/
  9. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7948517/
  10. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8441754/
  11. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7862013/
  12. https://pubmed.ncbi.nlm.nih.gov/34237049/
  13. (UK) COVID-19 vaccine surveillance report Week 51- https://www.medrxiv.org/content/10.1101/2022.07.04.22277225v1.full.pdf
  14. https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1043608/Vaccine_surveillance_report_-_week_51.pdf
  15. Waning of SARS-CoV-2 vaccine-induced immunity: A systematic 2 review and secondary data analysis
  16. https://www.mercurynews.com/2022/03/06/covid-19-deaths-among-vaccinated-rose-sharply-with-omicron/
  17. https://expose-news.com/2022/03/01/russia-distraction-uk-gov-revealed-triple-vaccinated-account-9-in-10-covid-deaths/
  18. https://www.ahajournals.org/doi/abs/10.1161/circ.144.suppl_1.10712

 

 

Use of Dendrimers in mRNA Vaccines – Side Effects and Reactions

Toxicity of Dendrimers

There continue to be so many unknowns when it comes to mRNA vaccines and why some people develop mild symptoms or more adverse reactions to vaccinations while others seem to tolerate them okay.

Dendrimers are synthetic substances added to this type of vaccine that may have toxic properties to cells.

Other types of vaccines have toxic ingredients like mercury, aluminum, or formaldehyde which may account for some of the adverse reactions that people experience.

mRNA vaccines don’t contain these ingredients, but they do contain dendrimers. While we don’t know for sure, we are curious if dendrimers play a role in vaccine toxicity.

This article will dive into dendrimers, what they are, how they work, and what we know about toxicity. We will also discuss and review strategies to support vaccine recovery.

Keep reading to learn more about: 

What Are Dendrimers?  

Dendrimers are microscopic synthetic particles known as nanoparticles. They have a central core and symmetrical branches moving outward to make a spherical shape.

The repeated units of the dendrimers put them in the category of polymers. However, dendrimers are a new type of polymer and a very new and growing area of chemistry.

Dendrimers were discovered in the late 1970s and early 1980s by independent researchers. These molecules are highly desirable in the biomedical field for many applications, including:

Dendrimers And Vaccines 

Dendrimers are attractive to companies that develop and manufacture vaccines for two reasons. First, dendrimers have immune-stimulating properties, which increase the efficacy of vaccines. Dendrimers are an adjuvant, meaning they help create a more robust immune response to help the body produce antibodies. Second, dendrimers act as a carrier for the antigens the vaccines deliver to the body.

Dendrimers are used in the newer mRNA vaccines, including those developed for Covid-19, because of their nano size and ability to interact with cell membranes, proteins, and DNA.

Many mRNA vaccines for infectious diseases have been developed or are being developed using dendrimers as an ingredient. These include vaccines for the following:

mRNA vaccines have been researched and developed for nearly 30 years but only first came to market for the approved Covid-19 mRNA vaccines. As you can see from this list, many more are expected to become available as this technology becomes dominant in the vaccine industry.

Dendrimer Toxicity 

While dendrimers certainly have many applications in healthcare, they may not be without risks. Dendrimers are inherently toxic.

The toxicity is due to the interaction between the dendrimer and cells, where the cell membranes become disrupted. This may cause nanoholes (microscopic holes) and the thinning and erosion of the cell membrane, causing toxicity to the cells.

Because of the degradation of the cell membranes that dendrimers cause, their use is associated with a condition called membrane thinning and structural disorder, which is dependent on the size, type, and dose of the dendrimer.

Dendrimers in vaccines may have other unintended consequences and adverse effects. We’ve discussed how dendrimers in vaccines are designed to stimulate the immune system, but they may also have immune suppressive properties that interfere with the normal functioning of the immune system, such as by increasing inflammation.

Another issue is the breakdown of nanoparticles. Once the dendrimers are in the cell, the route out of the cell and out of the body isn’t so clear. Some evidence suggests the ability of dendrimers and nanoparticles to accumulate, stimulating further inflammation.

The possible accumulation of dendrimers raises questions about long-term consequences of the dendrimers, as well as mRNA vaccines.

As clinical trials continue, more information needs to be gathered to understand the implications of this technology.

Because the toxicity of dendrimers is known, scientists continue to study ways to make dendrimers more biocompatible.

Currently, mRNA vaccines also contain other ingredients such as polyethylene glycol (PEG), acetate, carbohydrates, or peptides to help mitigate cell damage. Oligonucleotides, short DNA or RNA molecules, may also be incorporated into the dendrimer via complexation.

The bottom line is that dendrimers are artificial ingredients that the body doesn’t recognize. The immune system needs to identify the nanoparticles and detoxify them.

Although we don’t know for sure, dendrimers may play a role in the symptoms experienced after receiving an mRNA vaccine, such as fever, body aches, and more.

Vaccine Recovery Action Steps

Each person needs to decide the pros and cons for themselves regarding vaccines. Some  sectors of the population may not be good candidates for these vaccines given their health status.

Some people may be more at risk for vaccine side effects or require additional support in recovering from vaccines. It may be helpful to work with your provider or a Functional Medicine doctor for guidance and support through the process.

Here are some Functional Medicine recovery tools to consider:

Support your immune system before and after a vaccine.

Dendrimers are an important aspect of mRNA technology but one that may not be without risks.

Our aim is to empower and educate with information so you can be fully informed about vaccines and vaccine recovery.

References

  1. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4074873/
  2. https://pubmed.ncbi.nlm.nih.gov/34871877/
  3. https://pubmed.ncbi.nlm.nih.gov/19886668/
  4. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8668227/
  5. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4961123/
  6. https://pubmed.ncbi.nlm.nih.gov/20433913/
  7. https://www.sciencedirect.com/science/article/abs/pii/S0304416520300325
  8. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4243973/
  9. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6215296/
What is IV Therapy- IV Therapy Benefits for Detoxification and Nutrient Support

IV Therapy for Vaccine Recovery 

Many people are interested in supporting their body’s detoxification systems after receiving a vaccine. The truth is that vaccines can be toxic to the body; this is intentional. After all, vaccines aren’t just a viral antigen; they contain many other ingredients designed to provoke the immune system and deliver the active ingredient. 

When making decisions about vaccines, toxin exposure is something to consider, and many people decide that the vaccine’s benefits outweigh the risks. Yet, others who are more vulnerable to these toxins or have been injured by vaccines previously may make a different choice. 

The additives in vaccines are also one reason why people may experience post-vaccine symptoms, such as low energy or brain fog. 

IV therapy is an excellent strategy for vaccine recovery to support the body’s clearance of toxins. It can be used in addition to detoxification supplements as well as diet and lifestyle change. 

This article will cover the ins and outs of nutritional IV therapy. You will learn more about: 

What is IV Therapy? 

IV therapy is a medical treatment where nutrients enter the bloodstream through intravenous delivery. It requires an IV drip set up and a needle inserted into a vein from a doctor, nurse or phlebotomist. 

A PIV, or peripheral intravenous line in the arm, is how IV nutrition therapy is most often delivered. IV therapy can also be administered via PICC line (peripherally inserted catheter) or CVAD (central venus access devices0, allowing people to receive frequent treatments. 

IV therapy is offered through IV clinics by Functional Medicine or integrative health care providers. Your doctor can tailor the mixture or cocktail of nutrients to your individual needs or needs or goals, including detoxification support. 

IV nutrition isn’t new; it has a long history of use in hospitals to treat nutrient deficiencies in malabsorption syndromes, alcoholism or provide nutrition when a patient can’t eat food.  

IV Therapy Nutrients 

IV nutrition therapy for detoxification, and other purposes, doesn’t provide total nutrition support but is designed to be used in addition to the nutrients one obtains through the diet. 

An IV can provide the following nutrients:

An example of a popular IV nutrient formula is the Myers’ cocktail, named for the doctor who developed it in the early 1980s.

Includes:

It’s essentially a B complex with electrolytes and vitamin C. The IV solution appears yellow because of the riboflavin, vitamin B2. 

IV Therapy Health Benefits

Nutrients delivered via IV supports a range of symptoms and diseases, including: 

IV therapy also supports wellness and overall well-being. 

In one placebo-controlled trial of the Meyer’s cocktail use in fibromyalgia, study participants saw an improvement in tender points, pain, depression and quality of life following the treatments. Because of this study’s small sample size and the placebo effect, the placebo group also experienced an improvement in tender points over four weeks. 

As another example of IV therapy, IV vitamin C is being used as part of a Covid treatment protocol in some hospitals because of the benefit to upper respiratory infections and the immune system

Advantages To IV Therapy 

IV therapy offers many advantages compared to oral nutrients from food, medical foods or supplements.

These advantages include: 

 

 

 

 

IV Therapy For Detoxification 

The goal with IV therapy in vaccine recovery is to use this fast and efficient delivery system to provide abundant nutrients to support detoxification. These nutrients assist the body, and specifically the liver, in neutralizing and eliminating toxins from the body.

Since the liver can get overwhelmed from toxin exposure, IV therapy just makes sense. In addition, many of us have increased requirements for certain nutrients, because of genetic polymorphisms, for example. You may be able to recover faster post-vaccine than using diet and supplements alone. 

Nicotinamide adenine dinucleotide (NAD+) and Phosphatidylcholine are two IV infusions used therapeutically for detoxification support. 

NAD+ is the active cofactor form of vitamin B3 (niacin) used by every cell in the body for energy metabolism. NAD levels decline with age and increasing levels in the body via oral supplementation, IV therapy, strength training and flavonoids that inhibit NAD breakdown are strategies used in anti-aging medicine and chronic disease management from the Functional Medicine perspective. 

Because NAD+ works to decrease inflammation and enhance immune function, it is a helpful tool for the prevention or treatment of both viral illnesses and vaccine injury and may be particularly supportive in the elderly. More research is being conducted in this area, but clinical results are already being seen. 

Phosphatidylcholine is another molecule that is administered intravenously and orally to support detoxification. Phosphatidylcholine is the most abundant phospholipid in the cell membranes and mitochondrial membranes throughout the body.

In this role, it helps to protect cells from damage caused by toxins and displace toxins from the membranes themselves. 

Phosphatidylcholine is also important for liver health, a main site of detoxification in the body and the choline component supports methylation, which is also required for effective liver detoxification of a variety of chemicals. 

People recovering from vaccines may experience changes in brain health and memory. A recent animal study found that phosphatidylcholine administration increases levels of the neurotransmitter acetylcholine in the brain, thus improving memory and reversing dementia.  

Safety And Downsides To IV Therapy

IV therapy is generally safe; however, since it is mainly unregulated be sure to work with a trusted provider for your care. When using IV therapy specifically for detoxification, your doctor can tailor the IV formula to your body’s needs and specific toxins you are working to clear from the body. 

The main downsides to IV therapy include cost and access. IV therapy treatments may cost $200-1000 per session and may not be available in all areas. If cost or access are a barrier for you, depending on what’s included in the IV, effective detoxification protocols using diet, lifestyle and supplements are recommended and can be quite successful. 

If you are recovering from a vaccine, talk with your Functional Medicine provider to determine if IV therapy would be a good addition to your treatment plan.

While benefits may be seen from IV nutrients alone, a holistic and integrative approach also requires dietary diligence, lifestyle support and well-placed supplements

Many people find receiving IV nutrients to be quite pleasant and relaxing. It usually involves resting in a comfortable chair in a spa-like room, so you get the full benefits to body and mind. 

References

  1. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2894814/ 
  2. https://pubmed.ncbi.nlm.nih.gov/12410623/ 
  3. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7762433/ 
  4. https://pubmed.ncbi.nlm.nih.gov/10956380/ 
  5. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7558103/
  6. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3562414/ 
  7. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3729018/ 
  8. https://pubmed.ncbi.nlm.nih.gov/7782901/ 

 

How to Detox Your Liver – Best Tips for Detoxification in Your Organs

Diet And Lifestyle Tools for Vaccine Detoxification

We live in a sea of toxins. Toxins make their way into our bodies through the water we drink, the food we eat, the air we breathe and the products we use. It’s a reality of living in the modern world.

Unfortunately, the accumulation of toxins in the body is linked to most chronic diseases such as autoimmunity, diabetes, cancer, and vascular diseases. The good news is that when we become educated about the sources of toxins, we can avoid them, reduce them or support the body’s ability to remove them. 

Sometimes we are exposed to a toxin (or several) through routine medical interventions, such as getting a vaccine. The toxic additives in vaccines may account for vaccine injury and symptoms that some people experience post-vaccine. In this case, we can be prepared to help the body handle the extra burden placed upon the detoxification systems. 

This article will dive into the diet and lifestyle solutions to help heal and detoxify from vaccines. Many of these tools are free, low cost and widely available. Many of them are things that can be done regularly to support everyday detoxification.

Keep reading to learn more about: 

Detoxification Basics

When something foreign gets into your body, the body has systems in place to remove it. The body also needs to remove waste materials generated by its metabolism. This removal is detoxification. Your body is detoxifying 24/7, every day of your life. 

Detoxification is something that you generally don’t have to think about. But, given how much we are exposed to compared to just a few generations ago, it’s smart to give detoxification a little thought. And if you are planning to get a vaccine or are recovering from one, extra detoxification support may help your body recover with more ease.  

Let’s start with the basics. Many toxins are fat-soluble. Therefore, they can get into cells. The liver is likely what you think of first when you think about detoxification, and it’s the liver that transforms fat-soluble toxins into water-soluble ones so they can be transported out of the body. 

This is a nutrient – and energy-dependent process and happens in two phases – Phase 1 and Phase 2.

After liver transformation, or if the toxin is already in a form that can be eliminated, it will leave the body through the colon, lungs, kidneys/bladder or the skin.

Supporting each of these five organs allows the body to detoxify more effectively. We support the body in doing what it inherently knows how to do.

Let’s walk through each detoxification organ and how we can support it using diet and lifestyle tools.

How To Support Liver Detox 

The liver is the main site of biotransformation, along with the many other metabolic processes. Since the liver can easily get overloaded, we want to make sure it has the resources needed to do its job. Here’s how to give your liver a little extra love:

 

 

 

How To Support Colon Detox

Many toxins leave the liver via the bile and enter the digestive system, to make their exit. Good digestive health is vital for detoxification. Here are some ways to support the colon:

 

 

How To Support Kidney Detox

The kidneys filter some toxins from the blood that collect in the bladder and leave the body via the urine. Here are some ways to support this detoxification pathway:

 

How To Support Skin Detox 

The skin is yet another organ of elimination. Like the digestive tract, the skin creates a barrier between the outside world and the internal body.

It regulates what gets in and what goes out. Here are some ways to promote effective skin detoxification:

.

How To Support Lung Detox

The lungs are the final organ of detoxification that we’ll discuss. Just as we exhale carbon dioxide, some toxins exit the body in the same way. Here are some ways to support this process:

Intentional deep breathing is supportive of releasing more of the air out of the lungs, therefore clearing more toxins. Deep breathing also increases oxygen to the liver and other organs. Try 10 mindful deep breaths several times per day. You can also focus on practices that encourage deeper or focused breathing, such as exercise, yoga, meditation or breathing exercises. 

As you can see, the way we live and the simple habits we practice daily or weekly, may have a significant impact on the body’s ability to detoxify. You can employ the strategies discussed here to support vaccine recovery or anytime the body is exposed to additional toxins. Often simple solutions yield maximum support.

References:

  1. https://pubmed.ncbi.nlm.nih.gov/1749210/
  2. https://pubmed.ncbi.nlm.nih.gov/25672622/
  3. https://pubmed.ncbi.nlm.nih.gov/26657326/
  4. https://pubmed.ncbi.nlm.nih.gov/34329091/
  5. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3312275/
  6. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5360950/
  7. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3524711/
Supplements for Detoxification After Vaccination

Supplements To Support Detoxification and Vaccine Recovery

We are all exposed to toxins daily through the air we breathe, what we eat and drink and the products that fill our homes, not to mention the toxin exposures from medical interventions, such as vaccines. Because of the modern environment, we all need to be thinking about detoxification. 

After receiving a vaccine, some people may experience a new onset of symptoms related to difficulties with detoxifying the ingredients in the vaccine.

Specific antioxidants and mitochondrial support supplements can be helpful for vaccine recovery.

Keep reading to learn more about some of these supplements and why you might want to have them on hand during the post-vaccine period.

We will discuss: 

The Vaccine – Detox Connection

Pharmaceuticals, over-the-counter medications and vaccines all contain foreign ingredients. The body works to detoxify these substances and eliminate them from the body.

The liver is essential for transforming toxins before they leave the body through the lungs, GI tract, sweat or urine.

Designed to alert the immune system that something foreign has entered the body, vaccines evoke an immune response. Adjuvants are ingredients added to vaccines to enhance this immune response. Aluminum is an adjuvant you’ll see in some vaccines.

Other ingredients you might find in vaccines include preservatives, stabilizers, antibiotics along with the antigen (from a virus or bacteria) that the vaccine delivers. 

Some of the symptoms we experience after a vaccine, such as a fever or body aches, might be due to the body’s immune response. The immune system sees the antigen and is working to identify it, attack it and develop antibodies for future exposures. It is the immune response that creates local inflammation and discomfort. 

Other symptoms we experience after a vaccine, and in the case of vaccine injury, might be due to some of the vaccine additives and the body’s response to these toxins.

The likelihood of health complications post-vaccine may have to do with the health of the person getting the vaccine, their level of immune function, underlying disease, toxic burden and genetics. Because of these factors, and likely others, some people can be more sensitive to vaccines than others.

But we can probably all benefit from supporting the body’s detoxification systems after getting a vaccine. Think about it like flushing the body, clearing what is no longer needed through detoxification pathways. 

Supplements For Post-Vaccine Detoxification

Supplements can be an incredibly supportive tool for optimizing detoxification while protecting the body from the damage caused by toxins found in vaccines. Let’s look at some specific supplements and their role in this process. 

Phosphatidylcholine

Phosphatidylcholine is a phospholipid, composed of two fatty acid tails attached to a phosphorus-based head. Phosphatidylcholine is the most abundant type of phospholipid, accounting for 50 percent of the phospholipids that make up cell membranes. 

In the cell membranes, phospholipids arrange themselves in a bilayer. This structure creates a barrier to what can enter and leave a cell, allows for both strength and flexibility and is vital for cellular communication. 

Phospholipids also are an integral structural component of mitochondrial membranes. Mitochondria are the energy centers of the cells where glucose and fats transform into energy as ATP. 

As a supplement, phosphatidylcholine supports detoxification, energy and cellular health. Here are some ways it does that:

Every Life Well Phosphatidylcholine Pure Liquid is a concentrated liquid containing polyenyl phosphatidylcholine (PPC), an effective supplemental form of phosphatidylcholine.

NAD

NAD, or nicotinamide adenosine dinucleotide, is derived from niacin, or vitamin B3. It is an essential coenzyme in every cell. Mitochondria contain over 70 percent of NAD, where it is required for energy production. In addition, NAD is required for over 500 reactions in the body, playing a role in most body processes. 

NAD exists in two forms: as NAD+ and NADH. NAD+ is considered the active form because it accepts electrons and produces energy.

NAD levels decrease with age, toxin exposure, chronic disease and other factors, effectively creating a NAD deficiency that affects cells and processes throughout the body. 

Supplementing with NAD is a promising therapy for neurodegenerative diseases. Restoring levels promote an increased life span and health span. 

When it comes to detoxification, the liver requires a significant amount of energy to transform toxins, hence the need for NAD. Supporting mitochondrial health with supplemental NAD, supports detoxification in the cells, the liver and other detoxification organs. 

Most supplemental NAD is in the form of a precursor called NR or nicotinamide riboside, which requires conversion to the active form to be used by cells. 

Real NAD+ offers NAD in its active, NAD+ form and is only available through healthcare practitioners. You’ll find it as part of the Every Life Well Mitochondrial Bundle, which also includes phosphatidylcholine and CoQ10. 

CoQ10

CoQ10, short for coenzyme Q10, is another crucial mitochondrial molecule that we can use for vaccine detoxification. You’ve likely heard of CoQ10 in terms of heart health, brain health and antiaging medicine. 

As mitochondria make energy, they also make free radicals that damage the mitochondria, just like toxins do. CoQ10 is a powerful antioxidant that lives in the mitochondria, helping to prevent this damage, so energy production remains efficient. 

This ability for CoQ10 to reduce oxidative stress is why it is so helpful for chronic diseases, including cardiovascular disease, fatty liver and neurodegenerative disease. 

Toxins from the environment and vaccines are a source of oxidative stress that CoQ10 can quench. In addition, CoQ10 plays a role in reducing inflammation, recycling the antioxidants vitamin C and vitamin E and supporting DNA. All these roles make it helpful for vaccine recovery. 

As discussed with NAD, CoQ10 has two forms: ubiquinol and ubiquinone. The ubiquinol form is the active form. The delivery method of the supplement, such as using a liposome (phospholipid membrane) increases absorption and activity of CoQ10 as well.

Supplemental CoQ10 options include: 

Discover what version works best for you!

Glutathione 

We can’t talk about vaccine detox without mentioning glutathione. This peptide (protein) is the body’s master antioxidant. It also has anti-inflammatory and immune-promoting benefits. 

Not only does glutathione help protect cells from damage caused by toxins, but it’s also involved in the liver detoxification of many chemicals. Specifically, Phase 2 liver detoxification requires glutathione for a reaction called glutathione conjugation. 

Some toxins that require glutathione for detoxification include heavy metals, benzene, mycotoxins  and bisphenol A. Because glutathione helps neutralize such a wide range of toxins, some refer to it as the master detoxifier

The more toxins you are exposed to, the greater your need for glutathione. Although glutathione can be recycled and therefore reused with the help of vitamin C. 

Increasing glutathione levels post-vaccine may be incredibly supportive. Every Life Well Liposomal Glutathione uses the phospholipid delivery to increase absorption and direct glutathione to the cells that need it most. 

Supplements are a helpful tool to aid in detoxification and support mitochondrial health every day, and especially after receiving a vaccine. To learn more about other lifestyle tools to support the body’s detoxification systems, please read The Importance of Detoxification and How to Detox. 

If you are recovering from a vaccine or have one scheduled, now is a great time to stock up on supplements that will help detoxify, reduce inflammation and support the body’s natural immune response.

Please always consult your trusted Functional Medicine provider for personalized guidance regarding vaccines, supplements and detoxification protocols.

 

References

  1. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2642958/ 
  2. https://pubmed.ncbi.nlm.nih.gov/9253764/ 
  3. https://academic.oup.com/ajcn/article/83/1/5/4649586 
  4. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3562414/ 
  5. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3729018/ 
  6. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3122232/ 
  7. https://pubmed.ncbi.nlm.nih.gov/26785480/ 
  8. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6342515/ 
  9. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8261484/ 
  10. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7660335/
  11. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7555759/
  12. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2430228/ 
  13. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6002464/
  14. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7278868/ 
  15. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3942754/ 
  16. https://pubmed.ncbi.nlm.nih.gov/12809732/ 
mRNA Covid Vaccines and Clinical Trials – Flaws and Impacts  

The first vaccines for SARS COV-2 were authorized for use under Emergency Use Authorization (EUA) by the FDA in December, 2020.

According to the FDA, they may temporarily authorize the use of unapproved products if the Secretary of Health and Human Services (HHS) determines that a qualifying emergency exists that can cause a serious or life-threatening disease and that the authorized product is believed to treat or prevent the disease.  

The HHS must also establish that the potential benefits outweigh the known and potential risks; and that there are no approved, adequate, and available treatment alternatives. Products authorized by an EUA may be marketed and used for the authorized use while the emergency persists unless FDA revokes the EUA.  

Since Covid-19 emerged a highly contagious, novel respiratory virus, with no established treatment, and became a pandemic “emergency” situation, the procedure to develop and introduce a new vaccine was expedited.  

Typically, traditional vaccines follow established guidelines and take 10-15 years to complete and establish safety and efficacy. 

Moderna and Pfizer, two of the three companies who used mRNA technology to make their vaccines, developed, tested, received EUA, and began administering all within one year. 

How did these manufactures produce the COVID-19 vaccines so quickly? First, messenger mRNA technology is not new. In fact, genetic therapies using both mRNA as well as DNA have been under development since the 1990s, but were discovered thirty years before, in the early 1960s. However, specific guidelines for mRNA vaccine development have not been established.  

The road to our current Covid-19 mRNA inoculations, however, was long. mRNA and DNA challenges, and limitations resulted in decades of scientific study, billions invested, and many failures.   

DNA vaccines were the first genetic vaccines to be considered for infectious disease indications as early as the 1990s. In 1990, University of Pennsylvania scientist Katalin Karikó proposed using mRNA as an alternative to DNA-based gene therapy. She reasoned that since mRNA is a temporary fix, it would alleviate some of the long-term safety concerns with DNA therapy, which effects are permanent.  

DNA vaccines were defined as “purified plasmid preparations containing one or more DNA sequences capable of inducing and/or promoting an immune response against a pathogen.”  

Since DNA technology was being considered and studied for potential vaccine development, the World Health Organization (WHO) produced guidelines for DNA vaccine development (appendix). 

The FDA also released a document , Guidance for Industry Considerations for Plasmid DNA Vaccines for Infectious Disease Indications in which they encourage animal testing for DNA vaccines and that manufacturers should assess whether modulation of human immune system will result in adverse consequences, such as chronic inflammation, autoimmunity or immunopathology.“   

DNA technology was considered superior because it would cause a permanent change, whereas mRNA was a temporary solution.  But mRNA was turning out to be a difficult technology.  

Several pharmaceutical companies were having issues getting the mRNA into cells without triggering side effects. Scientists could isolate only small amounts of the material, which was unstable and destroyed easily. Immune reactions to mRNA injections in animals suggested this option wasn’t as safe as scientist Karikó had hoped. 

It wasn’t until scientists discovered that by adding nano-lipid particles to the mRNA, they could successfully deliver them into cells. This opened the door to a variety of applications and prompted companies to invest in developing products 

Founded in 2012, Moderna was especially excited about the prospects of mRNA technology. Stephen Hoge, the president of Moderna, stated in an interview that “You could ultimately use mRNA to express any protein and perhaps treat almost any disease…Its almost limitless what it can do.” 

Moderna secured billions to fund their investments into this new technology from the U.S. government and the Bill & Melinda Gates Foundation. Originally the funding was for mRNA vaccine programs for diseases caused by viruses like Zika and HIV.  

As previously mentioned, vaccines historically go through a lengthy process before finally approved by the FDA. In a 2014 PubMed article, “mRNA vaccine delivery using lipid nanoparticles, the authors state that the major advantage of using mRNA vaccines over DNA vaccines is regulatory in nature, which “eases the requirements for preclinical and toxicological studies”.

It is interesting to note, that one of the authors of this article is Robert Langer, a co-founder and member of the board of directors of Moderna therapeutics. 

On Dec. 2020, the WHO released a document, Evaluation of the quality, safety and efficacy of RNA-based prophylactic vaccines for infectious diseases: regulatory considerations that stated “Although there are recent publications that have discussed some of the safety, production, and regulatory issues associated with this new technology , as of December 2020, there is no formal regulatory guidance specifically for mRNA-based vaccines”. 

 The WHO gives this explanation for not having set guidelines: “Because detailed information on the methods for production and control for safe, efficacious mRNA-based vaccines is not yet standardized, and for candidate vaccines certain details remain proprietary and thus not publicly available, it is not feasible to set specific international guidelines at this time”. 

Since billions were invested in mRNA vaccines and they were developed without specific regulations or guidelines at “warp speed”, it is important to look at the safety, efficacy and methods used that resulted in EUA as well as a concerted effort by the current administration to try to impose vaccine mandates. 

The Canadian Covid Care Alliance (CCCA) reviewed the Pfizer mRNA vaccine trial in particular and produced a compelling video (and PDF) identifying flaws and missing data, which they say resulted in a vaccine that does “More Harm than Good”. 

To watch the full video, click here. To read Pfizer’s clinical trial, which is public information, click here. 

As noted, Pfizer is one of two US manufactures that developed Covid-19 inoculations using mRNA technology. They released results of their Phase 1 clinical trial in November of 2020. The results were then published in the New England Journal of Medicine, which was used to achieve the consequential FDA approval under the FDA’s Emergency Use Authorization (EUA).  

This was a historic event and achievement, but was it based on infallible information?  

When medical students graduate form medical school they recite the Hippocratic Oath, in which one of the statements is “first, do no harm”. This is a premise from which any company developing a medical or health intervention should abide by. 

Governments too, have the responsibility to protect the health of their citizens. When a medical intervention is approved by a regulatory agency like the FDA, it must be proven safe. To prove safety, best evidence, determined through rigorous scientific research and established guidelines, should be the required standard. Randomized controlled trials are currently considered the gold standard trial when proving something is safe.  

The Covid-19 vaccine clinical trials were used as the evidence to prove safety and efficacy. Since the results of these trials led to FDA’s EUA, which subsequently led to millions being taking the Covid-19 vaccines, it is critical to understand the trial design, the data, and the consequences. 

PFIZER’S CLINICAL TRIAL 

The CCCA did a thorough job identifying missing data and insufficient methods in Pfizer’s trial – pointing out that the trial results do not explicitly prove evidence of safety.  

Following are some of the concerns that the CCCA addresses in their video, and the supportive data and tables taken directly from Pfizer’s study and report. 

The first issue relates to Pfizer’s efficacy claims and how their results were calculated 

Pfizer’s phase 1 clinical trial lasted only 2 months. The trial included a total of 43,548 participants, of whom 43,448 received injections: 21,720 received the BNT162 inoculation and 21,728 were given a placebo. The original trial report was published in New England Journal of Medicine on December 10, 2020. 

Pfizer claims in their original trial report, dated December 3, 2020, that the inoculations were safe and showed 95%, efficacy 7 days after the 2nd dose. This 95% refers to Relative Risk Reduction (RRR), not Absolute Risk Reduction (ARR), which was only 0.84%. This 95% number does not tell you the vaccine protects you 95% of the time. The ARR is what you need to tell you what your overall risk that is reduced by vaccination. The difference is how the number is calculated.  

 

Misleading demographicsTrial Participants 

Pfizer states that their primary objective of the trial is “To describe the safety and tolerability profiles of prophylactic BNT162 vaccines in healthy adults after 1 or 2 doses”.  

When looking at the trial participants, they were generally healthy people. Only 4% were over the age of 75 and only 21% of them had one or more comorbidities. It is important to note that of the people who actually died with covid, 95% had at least one comorbidity, (the average was 4), and over 85% were over the age of 75.  

The trial did not include people who would benefit from the treatment the most, the elderly and people with co-morbidities.  

When the Covid-19 vaccines were approved under the EUA, however, the first people to be receive them were the elderly and the sickest. 

The trial also excluded people with allergies, pregnant women, breastfeeding woman, people with bleeding disorders, immunocompromised people, and people who had previously tested positive for covid. In fact, two steps listed in Pfizer’s screening of study participants, were to perform urine pregnancy test (if appropriate) and to confirm the use of contraceptives (if appropriate). 

The inoculation was never tested on these groups, yet they were not excluded from mandates, nor were they given informed consent about the possible risks.  

ThirdPfizer’s Timeline.  

According to the history of vaccines, vaccine development is a long complex process that  

As mentioned earlier, vaccine development can take 10-15 years. FDA guidelines for traditional vaccines encourage animal studies, and then 3 phases of human and safety testing. Pfizer’s development and testing for their mRNA vaccine was completed in 1 year.  

Pfizer began their study in October 2020, as a randomized control trial, with 2 groups, one who were given the vaccine, and the other group, the control group took a placebo. It was an observer-blind trial, meaning that the participants did not know which group they were in, but the trial inspectors did.  

The blind trial was supposed to go on until 2023. However, instead after only 2 months they unblinded the participants and everyone in the trial was offered the vaccine.  Most of the placebo group decided to take it and moved over to the inoculated group.  

At this point there was no longer a control group, and therefore no evidence of true effectiveness, or safety could be provided. Animal studies were skipped, and combined phase 2 and 3 into 6 months. 

Phase II 6-month report data 

After 6 months of data collected in the un-blinded trial, Pfizer’s released their 6-month report on September 15, 2021. The results were published in the New England Journal of Medicine NEJM on November 4, 2021. Pfizer indicated an efficacy of 91.3 % – meaning a reduction in positive cases compared to the placebo group. However, it is important to note that the report also showed an increase in illnesses and deaths in the vaccinated group.  

Fourth – Adverse Events – in the supplemental appendix of trial.  

Below is a screenshot from Pfizer’s Supplementary Appendix showing Adverse Events. Table S3 -Participants Reporting at Least 1 Adverse Event from Dose 1 to 1 Month After Dose 2 During the

This table shows the inoculations actually increase illness. Over 5000 people who had received the vaccine had Adverse Events that were related to the inoculation.  

It also shows severe adverse events are 75% more likely in the vaccinated group. This is evidence of harm that the vaccine increases illnesses rather than decrease it. This information fails to prove that their vaccine is safe.  

DEATHS 

This table shows that there were more deaths in the inoculated group than in the placebo group – 15 vs 14. The kinds of deaths are concerning. There were twice as many cardiovascular deaths in inoculated arms than in the placebo group.  

In the 6-month report, an additional 3 more participants in the inoculated group and 2 in the original placebo group, who then received the vaccine after unblinding, died. So that makes the total 20 deaths in the inoculated group.  

Pfizer states in their report that “None of these deaths were considered to be related to BNT162b2 by the investigators” however, unless they provide more information on the cause of death, there is no way to know the accuracy of this statement, and therefore the safety.  

Limited and Inadequate control groups   

Pfizer’s trial consisted of only 2 groups – the unexposed and uninoculated, and the unexposed and inoculated. People who were previously exposed to Covid-19 were not included in the study.  

Since Pfizer omitted people who had recovered from Covid-19 and had natural immunity. So, there is no evidence to prove that it is safe for these people to take the vaccines, or even how effective the inoculation would be for these groups.  

Data comparing natural immunity to immunity provided from the vaccine would have been another control group that should have been studied. The fact that this information was not included may suggest that Pfizer was not confident in what the results would be.  

 

LOW quality safety science because they did not track pre-clinical safety biomarkers  

Pfizer tested antibodies and tracked for adverse events post inoculation. However, they never looked at pre-clinical biomarkers (labs) to determine any pre-symptom adverse events. They could have looked at early warning indicators, with a few lab markers prior and post inoculation, but they didn’t. The only blood test they did was one to test antibodies prior to inoculation.  

In order to make sure that the vaccine does not cause harm, the study should have focused on all-cause mortality and illness. Instead, the objective of the study was to determine if people who took the vaccine test positive less than people who don’t. In other words, the study does not show evidence that there is less illness and death in people who have taken the vaccine. In fact, as noted earlier, there are more illnesses and deaths among the vaccinated group than in the unvaccinated control group. They also should have done more long-term safety studies to provide more data on how the vaccines impacted long term health as well. 

Spread reduction and transmission not included 

Pfizer did not include the objective of spread reduction or transmission in their trial. Since this wasn’t studied, they cannot claim that the vaccine has the capability of reducing spread or transmission. It is possible that the vaccine actually increases transmission. 

Prior to entering the trial, the investigators were given the option to test participants based on symptoms, which means many asymptomatic people may have been entered into the study. Subsequently, subjectively was introduced into the study. This is unscientific and unethical. 

Missing data 

There were 8 confirmed Covid-19 cases after 2 months in the inoculated group and 162 in the placebo or uninoculated group. This is a small number of cases, especially considering that after the 2 months, study the investigators lost touch with 80 participants in the inoculated group and 86 in the placebo group.  

They also had 1,594 suspected cases in the inoculated group and 1,816 in the uninoculated group – but they never tested these people for COVID-19. Had they tested them, and they were all positive, the results could have been very different – and not in their favor. The relative risk reduction would have been a lot lower (19%) and they needed a 55% RRR to be eligible for the FDA’s Emergency Use Authorization. 

A whistleblower at Ventavia, the research company in charge of Pfizer’s clinical trial confirmed this, telling the British Medical Journal (BMJ) that Ventavia didn’t have enough people to collect swab samples from trial participants who had reported symptoms that were consistent with COVID-19. Because the trial’s endpoint was to identify laboratory-confirmed symptomatic COVID-19, these revelations suggest the data could have been skewed by samples not being collected from participants who had had COVID-like symptoms. 

Children  

Pfizer’s clinical trial for children was very small, not large enough to gather sufficient data. Only 1005 were inoculated vs 978 placebo group. Since COVID-19 does not pose a significant risk to children it is important to be sure that the inoculation poses less risk. In fact, children without serious medical condition have almost a 0% chance of dying from Covid-19.  

As in the adult study, “children with no or stable preexisting conditions were eligible to participate, except those with an immunocompromising or immunodeficiency disorder, those with a history of MIS-C, or those receiving immunosuppressive therapy (including cytotoxic agents and systemic glucocorticoids)”. In addition, in the Phase 1 study, children who had previous Covid-19 diagnosis were excluded. Therefore, the safety and efficacy of the vaccine has not been established in these groups.  

When asked whether more information is needed to justify mandates in children aged 5-11, William Moss, Executive Director, International Vaccine Access Center at John Hopkins University responded that the trials for children 5 to 11 years of age were small, had a very short follow up, and that the FDA requires longer follow-up studies before considering full final approval. He also noted that the trial was not large enough to access the risk of myocarditis and pericarditis that had been observed in young men after receiving mRNA vaccines.  

Even though the trial was small, there was at least 1 serious adverse event. A 12-year-old, Maddie de Garay was hospitalized within 24 hours. She was on a feeding tube, wheelchair bound. Pfizer described the adverse event as “Functional Abdominal Pain.” To hear Maddie’s story watch Senator Ron Johnson’s expert panel on federal vaccine mandates. 

In the 5–11-year-olds, Pfizer acknowledged that the inoculation could cause myocarditis. Myocarditis weakens the heart and causes blood clots. There is also a 20% mortality rate after 6 years. This poses an unacceptable risk for children.  

Medical interventions like vaccinations must be proven safe before administering to the general public. However, the Covid-19 vaccines are being tested on children to prove their safety. 

Neither Pfizer nor the FDA investigated the claims made about Ventavia (the company who conducted the trial) after a whistle blower from that company pointed out the flaws in the trial. See article in the British Medical Journal. 

Passive surveillance (VAERS)  

The Vaccine Adverse Event Reporting System (VAERS) is a passive reporting system, meaning it relies on individuals or doctors to report adverse events. Anyone can submit a report to VAERS, including patients, parents, and healthcare providers. Doctors are required by law and expected to complete lengthy and involved forms – which may hinder reporting. 

As of May 27, 2022 a quick search of VAERS data using the medalergs.org showed an astounding 1,259,063 adverse events of which 235,041 were serious, and there were 28,532 deaths reported. 

 Potential for adverse events in ovaries as evident in Pfizer’s organ distribution table. 

This tables shows concentration of Pfizer vaccine by organ.  

Study now being conducted COVID-19 Vaccine and Ovarian Reserve – Full Text View – ClinicalTrials.gov

Conflicts of interest 

CCCA concluded their presentation by stating their position that the inoculations should be withdrawn. Their argument is compelling.  

Unfortunately, only time will tell of the full health ramifications of these vaccinations. The risks particularly appear to outweigh benefits to children and adolescents.  

COVID-19 variants, and new coronaviruses will continue to impact the world, and may be with us indefinitely. They also bring new challenges and opportunities to pharmaceutical companies to produce new mRNA vaccines. Before this new mRNA technology is used again, any and all development plus clinical trials should include more control groups, be randomized for a longer period, and include in-depth follow-ups on study participants for the long-term.  

It took decades for the scientific and pharmaceutical industries to get this new technology ready to implement in a pandemic situation. The WHO and the FDA must now take the time to create more rigorous guidelines for the development and trials of any future mRNA vaccines.  

Scientists and medical professionals have the great responsibility of ensuring the health of our public. Any scientific and technological inventions and advancements like mRNA technology that have significant potential to save lives are to be commended, however, like any new health intervention, the benefits should outweigh the risks and those risks must always be provided with informed consent. 

_____________________________________________________________________________     

If you experience a side effect after receiving a vaccine, be sure to inform your medical professional and encourage them to report on VAERS, the Vaccine Adverse Event Reporting System here. 

Links to Pfizer trial Pfizer trial

Vaccine listed ingredients 

The Pfizer-BioNTech COVID-19 Vaccine includes the following ingredients:
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), potassium chloride, monobasic potassium phosphate, sodium chloride, dibasic sodium phosphate dihydrate, and sucrose
 

The Moderna COVID-19 Vaccine contains the following ingredients:
Messenger ribonucleic acid (mRNA), lipids (SM-102, polyethylene glycol [PEG] 2000 dimyristoyl glycerol [DMG], cholesterol, and 1,2-distearoyl-sn-glycero-3-phosphocholine [DSPC]), tromethamine, tromethamine hydrochloride, acetic acid, sodium acetate, and sucrose.
 

The Janssen (Johnson & Johnson) COVID-19 Vaccine includes the following ingredients:
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.
 

 

REFERENCES: 

  1. COVID-19 Vaccines | FDA 
  2. https://www.canadiancovidcarealliance.org/wp-content/uploads/2021/12/The-COVID-19-Inoculations-More-Harm-Than-Good-REV-Dec-16-2021.pdf 
  3. The randomized clinical trial: an unbeatable standard in clinical research? 
  4. Can mRNA disrupt the drug industry? 
  5. Polyethylene glycol (PEG)  is a cause of anaphylaxis to the Pfizer/BioNTech mRNA COVID‐19 vaccine 
  6. PEGylated DNA/transferrin-PEI complexes: reduced interaction with blood components, extended circulation in blood and potential for systemic gene delivery – PubMed (nih.gov) 
  7. mRNA Vaccine Era—Mechanisms, Drug Platform and Clinical Prospection 
  8. https://cen.acs.org/business/start-ups/mRNA-disrupt-drug-industry/96/i35 
  9. Why are we vaccinating children against COVID-19? 
  10. 12 Covid-19: Researcher blows the whistle on data integrity issues in Pfizer’s vaccine trial 
  11.  Outcome Reporting Bias in COVID-19 mRNA Vaccine Clinical Trials. 
  12. Developing mRNA-vaccine technologies 
  13. Ensuring the Safety of Vaccines in the United States 
  14. Delivery of mRNA Therapeutics for the Treatment of Hepatic Diseases 
  15. Establishing Preferred Product Characterization for the Evaluation of RNA Vaccine Antigens 
  16. Guidelines for assuring the quality and nonclinical safety evaluation of DNA vaccines 
  17. Guidelines for assuring the quality, safety, and efficacy of DNA vaccines Proposed revision of Annex 1 of WHO Technical Report Series, No. 941 
  18. Guidance for Industry Considerations for Plasmid DNA Vaccines for Infectious Disease Indications 
  19. mRNA Vaccine Delivery Using Lipid Nanoparticles 
  20. Evaluation of the quality, safety and efficacy of RNA-based prophylactic vaccines for infectious diseases: regulatory considerations 
  21. Myocarditis after BNT162b2 Vaccination in Israeli Adolescents 
  22. Myocarditis after BNT162b2 mRNA Vaccine against Covid-19 in Israel 
  23. Pre-Licensure Vaccine Safety 
  24. Covid-19: Researcher blows the whistle on data integrity issues in Pfizer’s vaccine trial 
  25. Lavishly funded Moderna hits safety problems in bold bid to revolutionize medicine 
  26. Nearly 35,000 Reports of COVID Vaccine Injuries Among 5- to 17-Year-Olds, CDC Data Show 
  27. Pfizer-BioNTech COVID-19 Vaccine ingredients 
  28. SARS-CoV-2 vaccine-associated-tinnitus: A review – PubMed (nih.gov) (add in content) Adverse events section 
  29. Covid-19: Researcher blows the whistle on data integrity issues in Pfizer’s vaccine trial 
  30. Company That Managed Pfizer Vaccine Trial Sites ‘Falsified Data’: Whistleblower 
  31. mRNA vaccine delivery using lipid nanoparticles 
  32. Diverse Applications of Nanomedicine 
  33. Dendrimers and Polymer Drugs Conjugate Market Global Size, 2019 Sales, Recent Trends, Demand, Industry Revenue Analysis by Starpharma Holdings Ltd., AstraZeneca Plc., Eli Lilly & Co., Nektar Therapeutics etc. | Medgadget 
  34. The Development of mRNA Vaccines for Infectious Diseases: Recent Updates (includes information on dendrimers) 
  35. Dendrimer-RNA nanoparticles generate protective immunity against lethal Ebola, H1N1 influenza, and Toxoplasma gondii challenges with a single dos