January 17, 2021
I would like to preface this blog with the assertion that I am not against the COVID-19 vaccine and all it symbolizes. A safe and effective vaccine against COVID-19 would be a remarkable achievement.
There is currently no evidence that any of the coronavirus vaccines worsen coronavirus infection rather than confer immunity to it, but this phenomena, called Antibody Determined Enhancement (ADE), WAS supposed to be something scientists closely monitor. In the meanwhile, medicine brings no attention to this concern and is completely ignoring that ADE is the reason we have never had a successful vaccine against coronaviruses after the 2002 SARS-CoV-1 epidemic.
We knew that the earlier severe coronavirus (SARS-CoV) carried the potential for reemergence since the Severe Acute Respiratory Syndrome (SARS-1) outbreak in 2002. Hence, researchers have been trying to develop a coronavirus vaccine since that time. Yet, these efforts have historically been thwarted by ADE.
SARS-CoV-2, the causative agent of coronavirus disease 2019 (COVID-19), is closely related to SARS-CoV (with ~80% sequence identity), which caused the SARS outbreak in 2002. Its next closest human coronavirus relative is Middle East respiratory syndrome-related coronavirus (MERS-CoV), which caused Middle East respiratory syndrome in 2012. SARS-CoV-2 is also genetically related to other endemic human coronaviruses that cause milder infections.
A major goal of the COVID-19 vaccine development is to generate antibodies that prevent the entry of SARS-CoV-2 into cells.
Antibody-dependent enhancement, ADE.
Ever heard of it? I thought not. ADE resembles Cytokine Storm in its worst presentation and Cytokine Storm is what kills people with our current SARS-CoV-2 infection.
Cytokine storm
Cytokine Storm is not new to humans and the Severe Acute Respiratory Syndrome CoronaVirus 2 (SARS-CoV-2) pandemic has reminded us of the critical role of an effective host immune response and the devastating effect of immune dysregulation. This year marks 10 years since the first description of a cytokine storm.
The term Cytokine Storm denotes a hyperactive immune response characterized by the release of mediators that our immune system utilizes to destroy and clear infectious agents. Cytokine storm implies that the levels of released cytokines have become injurious to our cells.
In a nutshell, whenever a healthy body is fighting an infection, the natural immune system response that occurs involves releasing cytokines that essentially signal the immune system to start doing its job. Cytokines are meant to be helpful to us in moderation, but when a certain pathway is engaged too much, the immune system starts causing damage to the patient through cytokine mediated inflammation in the body. It is at this juncture that if cytokines, which normally play an important role in our healthy immune responses, are released in large amounts all at once, cytokine storm can ensue. Cytokine storm seen in COVID is responsible for Acute Respiratory Distress Syndrome (ARDS) and life threatening multiple organ failure which can lead to death from systemic inflammation and organ shut down.
Antibody-dependent enhancement, ADE
In some instances, the presence of specific antibodies to a virus are actually beneficial to the virus. Known as Antibody-Dependent Enhancement (ADE) of virus infection, the ADE of virus infection is a phenomenon in which virus-specific antibodies enhance the entry of virus, and in some cases the replication of virus, i.e. upregulate viral infection and potential infectivity. Besides the common receptor/coreceptor‐dependent mechanism of cellular attachment, the fact that viruses can rely on antiviral antibodies for their efficient entry into target cells has been well known now for over 20 years, makes Antibody-Dependent Enhancement (ADE) of virus infection by vaccines a very important potential to avoid and carefully watch for, PRIOR to global vaccination. To make matters worse, ADE associated with SARS-CoV infection has been historically shown to be primarily mediated by the Anti-spike antibodies, the very ones we produce with the vaccine in our body.
Antibody Dependent Enhancement (ADE) of a disease is always a concern for the development of vaccines because the mechanisms that underlie antibody protection against any virus has a theoretical potential to amplify the infection or trigger harmful immunopathology, resembling cytokine storm.
ADE was first seen in natural viral infections with the Dengue virus and some of its relatives. ADE has been observed in SARS, MERS and other human respiratory virus infections including RSV and measles.
Essentially, ADE is associated with decreased levels of the anti-inflammatory cytokines in our body and increased levels of the pro-inflammatory chemokines. It is seen in individuals with secondary infection, or if infected after vaccination for the virus.
The concern is that when people are:
How do we know without extensive investigation whether those antibodies created during the first-time infection (or with vaccine) do not end up enhancing the disease rather than protecting against subsequent infections?
Called Antibody-Dependent Enhancement; ADE, has been demonstrated in animals during the coronavirus vaccine research since 2002. Therefore this research never progressed to human trials, not at least until the recent SARS-CoV-2 vaccine, where currently the millions of humans receiving the vaccine are the primary test animal. Remember, the reason for LENGTHY vaccine safety investigation is just that. We are not limited to immediate collections of data for reactions to the vaccine. A mild fever, body aches and fatigue are really all that are currently reported 2 months into the Pfizer and Moderna studies. What about long-term adverse effects? No data.
Always ask the question....how will I know if a future medical issue I may develop, is not related to a vaccine whose safety was untested and whose regulation was lost with EUA. This is the biggest issue on the chalk board right now...followed by way too many question marks! Putting aside that fact that the mRNA vaccine is a new vaccine never to be used to inoculate a human (for reasons that are in a future blog), we must be smart about CONCERNING and unrevealed reasons that the coronavirus has not proven eligible for a safe and effective vaccine.
Remember there is significant scientific knowledge of the potential risk for any COVID-19 vaccine exacerbating COVID-19 severity via antibody-dependent enhancement (ADE) in the scientific community, which is disregarded when the FDA approved the EUA of the COVID-19 vaccines.
Going forwards, it has been considered CRUCIAL by the scientific community to evaluate animal and clinical datasets for signs of ADE, and to balance ADE-related safety risks against intervention efficacy if clinical ADE is observed. Ongoing animal and human clinical studies were to provide important insights into the mechanisms of ADE in COVID-19. Such evidence is sorely needed to ensure product safety in the large-scale medical interventions required to reduce the global burden of COVID-19.
YOU ASK WHERE ARE THE STUDIES and WHY DOESN'T MEDICINE TALK ABOUT COVID-19 SAFETY on this level???
GOOD QUESTION. Remember EUA?
What is EUA?
In certain emergencies, the FDA can issue an Emergency Use Authorization (EUA) to provide access to medical products that may potentially be used when there are no adequate, approved, and available options.
The EUA process is different than an FDA approval or clearance. Under an EUA, in an emergency, the FDA makes a product available to the public based on the best available evidence, without waiting for all the evidence that would be needed for FDA approval or clearance.
After two decades of failed vaccine trials in animal, why EUA a coronavirus vaccine for humans without a well-established safety profile??
Answer: the Vaccination Dilemma
The Vaccination Dilemma is defined as competition between a clinical trial for vaccine efficacy and safety as well as long-term value and it's emergency use. Remember, once a vaccine is granted emergency approval, there is pressure on developers to offer the immunization to trial participants who received the placebo. But if too many people cross over to the vaccine group, WE LOSE OUR CONTROL PLACEBO group. This means the companies lose the data to study and to establish long-term outcomes of efficacy and safety.
Why is this important? Other than the obvious, "WE LOSE OUR CONTROL PLACEBO group. This means the companies lose the data to study and to establish long-term outcomes of efficacy and safety", let's also answer this question with a return to the Pfizer and Moderna studies that led to EUA. Of the 70,000 people that entered the 2 company studies and were divided into vaccine and non-vaccine ( placebo) groups, the 95+% efficacy of the vaccines was extracted from 0.5% of this testing population, 4-5 weeks into their respective Phase 3 (human) studies. The statistical ethical issue I raise in this measurement comes from the fact that only 0.5% of the 70,000 patients between the two groups were used to create the touted 95% efficacy. PLUS, this statistic came only 8 days after the 2nd vaccine was provided in both groups. Yes, of the 70,000 people between the two studies, less than 350 people between the two study groups was used to generate the 95% efficacy statistic which led to EUA approval, 8 days after the 2nd vaccine inoculation.
My hopes:
With the knowledge that antibody-dependent enhancement, ADE, occurs with coronaviruses, there is a real risk for ADE with the SARS-CoV-2 vaccines. But, the hope is that we will reduce the risks of ADE of SARS-CoV-2 with the COVID-19 vaccines if we deliver high doses of potent neutralizing antibodies, rather than lower concentrations of non-neutralizing antibodies that would be more likely to cause ADE. So the hope is that the mRNA vaccines we are using will avoid the possibility of generating non-neutralizing antibodies that are not strong enough and can cause ADE.
“If you’re just giving the immune system the only choice of making an antibody”, like we do with the mRNA, then you drastically limit the possibility of inducing ADE,” states James Crowe, an immunologist at Vanderbilt University Medical Center. “This is very hard to study in humans”, he goes onto affirm.
My strongest recommendation for all my readers is to please take into consideration the lack of real scientific support either the Moderna or Pfizer drug companies have right now to substantiate their safety.
COVID research is seriously looking into and demonstrating efficacy of anti-inflammatory drugs to prevent COVID deaths. Does this come as such a surprise to you, the reader, after what you just read about Cytokine storm and ADE in this blog?
Natural Immune Support and Inflammation Prevention
Although recommended to many patients for their SARS-CoV-2 prevention and treatment program, I have not raised my all time favorite choice for thwarting systemic inflammation to the table in a blog. So, please consider adding ENFLA-MEND to your repertoire for cellular health and inflammation prevention.
Enfla-Mend Px balances NF-kB (nuclear factor- kappa B), mediating inflammatory cytokine release.
This formula supports the total body to include brain health and works as a natural anti-oxidant, neutralizing (reduces) inflammation:
Please take 2 daily.
January 07, 2021
I am routinely asked for recommendations regarding Natural COVID Protection.
Vitamin D is an important part of your 2020-2021 COVID and FLU Prevention program. PLEASE remember this fact and refer to the Corona Virus and Influenza Prevention program found here.
Throughout the ongoing COVID-19 outbreak and pandemic, prevention is imperative. In 2020, there has been growing evidence mounting in Europe, demonstrating a significant negative correlation (i.e. inverse relation = lower the level of D associated with increased COVID Infection cases) observed between mean vitamin D levels and COVID-19 cases per one million population in European countries.
Several studies have also demonstrated the role of vitamin D in reducing the risk of acute viral respiratory tract infections and pneumonia due to direct inhibition of viral replication as well as it's anti-inflammatory and immunomodulatory power. Vitamin D supplementation has been shown as safe and effective against acute respiratory tract infections and in a critical meta-analysis it was suggested that “those people who are at higher risk of vitamin D deficiency during this global pandemic should consider taking vitamin D supplements to maintain the circulating 25(OH)D in the optimal levels." VERY INTERESTING is that the European OPTIMAL LEVEL FOR VITAMIN D LEVELS is 75-125nmol/L of Vitamin D!!! This is a different and higher optimum level in comparison to our routine laboratories in the US (reference range 20-100 - with NO OPTIMUM levels). Hence, routine labs in this country use a reference range that allows doctors to MISS D deficiency in their patients. Worse is when many patients have their Vitamin D levels rise into therapeutic range, their physician will tell them to stop the Vitamin D.
Vitamin D is part of an ancient complex molecular effort to protect our immune system in every imaginable way. But Vitamin D's ability to do its work is created by the molecular dance on receptors of the human cell when A, D, and K work together. These lipid-based molecules are all powerful antioxidant nutrients which are intricately bound through shared receptors. They balance and enhance each other, and as a group, profoundly influence genes, immunity, inflammation, and the healthy balance of life in our body.
Vitamin D may be one of the most important nutrients in our nutritional armamentarium—and currently, one of the most misunderstood. Vitamin D can help us fight infections and reduce the risk of multiple sclerosis, diabetes, heart disease, cancer (colon, breast, skin and prostate, etc.), osteoporosis, cavities, lupus, rheumatoid arthritis, mood disorders (depression) and much more. There are 1000’s of peer review studies on vitamin D, stretching all the way back to 1922.
Vitamin A deficiency is more common than we realize because vitamin A-rich foods are rarely eaten and vitamin A toxicity has been overblown, to our profound immunological detriment.
Vitamin A is necessary for optimal mucosal immunity—and is a key nutrient in balancing the pro-inflammatory cytokines. (CYTOKINE STORM caused by COVID often leads to incipient death).
Most important, vitamins D and A are an ancient and inseparable team that evolution has honed through time. They must be supplemented together in order to not create a “functional” deficiency of either one. Excess D will create a “relative” deficiency of A, even when dietary levels are adequate. And vice versa.
Receptors for vitamin A and vitamin D are found in every cell and when they dock at the same receptor, they initiate a cascade of responses throughout the entire body.
Vitamin K2 is not to be forgotten as it serves as a molecular ‘link’ between hormonal receptors and intracellular signaling pathways. As is a true hormone, like vitamin D and A, they circulate throughout the body eliciting specific effects on the activity of cells situated remotely from their point of origin.
Vitamin K2 as you remember from former blogs, enhances vitamin D’s impact on bone, and protects against vascular disease, atherosclerosis.
I believe that I have outlined a very strong, proactive, yet simple viral prevention program and it is on my website homepage.
Please stay tuned, as I continue to educate thereader about WHY I make my specific recommendations for you and your friends and family to maintain health and wellness during these challenges times!
Always there for you!
Dr. Ariane Cometa
your holistic doc
This program is recommended for those who want to support the immune system AND protect themselves from viruses of all types - to include COVID and Influenza (FLU), in 2020-2021. Please consider these simple suggestions
January 26, 2020
In this day in age, with all the toxic exposures we have from our environment, it is comforting to know that we can select from nature, an effective array of products to safely ingest as well as apply to our skin. It takes only 26 seconds for toxic products and fillers used on the skin to enter the blood stream. In this collection, I present to you the most toxic-free natural products to address your first aid needs for the skin and scalp as well as acute care products for conditions such as heartburn, urinary tract symptoms and vaginal health support. These natural solutions have been selected through years of research and investigation as well as through my own alchemist training. Please enjoy yourself as you peruse through the assortment of natural products that you can use to address your needs on my Natural First Aid, Acute Care and Vaginal Health page:
https://www.cometawellness.com/collections/first-aid-acute-care-and-vaginal-health
January 05, 2020
Let's face it, many of us can no longer "rest on the laurels" of our youth. In addition, the sun is a major life force for me and many of us. Not to mention, most of us 50+ folks were not raised with the concept that the sun can damage our skin. Although the sun has damaged our skin, I am not alone when I say there is something very wrong with throwing toxic chemicals on our skin to prevent skin cancer. Worse, I am convinced that high SPF (sun protection factor) can cause skin cancer due to potential cancer promoting effects of the toxic ingredients in the SPF product. These ingredients are not tested for our skin safety but for efficacy against the sun's rays. Ever wonder why no other country has the incidence of skin cancer we do in the USA? Mohs surgery is virtually unheard of outside of the USA. BIG INDUSTRY...this "skin cancer". Why test something that would kill an entire pharmaceutical arm of the stock market? But that is another topic I will delve into at another time.
It has been an arduous task over the years for me to determine what Natural Skin Care products are effective in preserving as well as restoring youthful skin and are also not going to be toxic to our health. Most 100% non-toxic skin care is either drying, ineffective, smells terrible, too expensive or all of the above! As it only takes 26 seconds for something applied to the skin to be in the blood stream, it only makes sense to insure the safety of what we place on our skin.
I will tell you that I have immediately noticed a difference in my sun damaged Jersey beach girl facial skin texture with the Ann Webb Products. To learn more about ALL the Natural Skin Care I am proud to offer, please visit me on my Natural Skin Care page. Please feel free to use the STAYWELL (all caps) discount code when you check out! This offer is for a limited time but I am offering it on ALL products purchased on the YOUR HOLISTIC DOC pharmacy.
May we have a blessed and healthy 2020 together,
Ariane Cometa, holistic doc