If you are confused about the COVID VACCINE decision, you are not alone. I promise to review Ivermectin very soon, but I am compelled to review the COVID vaccine Dilemma at this time. Some of you may have viewed the video I sent in the March 27, 2021 YHD newsletter, (different from my blog). In the video, Dr. Hotze asserts that the current shots available for COVID-19 do not provide immunity against COVID-19 — which explains why the FDA and CDC warn it is still possible for people to get and spread SARS-CoV-2 even if they have gotten the shot. Indeed, these unapproved “vaccines” — which were authorized for use without any long-term data nor published animal studies — do not meet the CDC’s own definition of a vaccine.  Vaccinated people could potentially still get COVID-19 and spread it to others.  https://www.cdc.gov/coronavirus/2019-ncov/science/science-briefs/fully-vaccinated-people.html

In most contexts, it is perfectly acceptable to use “approval” and “authorization” interchangeably. But not at the Food and Drug Administration (FDA), and not when it comes to COVID-19 vaccines.

WHY haven’t the COVID-19 vaccines received FDA APPROVAL?

No COVID-19 vaccines have been FDA APPROVED. Approval means the FDA has officially decided that a product is safe and effective for its designated use. The process for approval involves rigorous reviews of all available data on the product. It takes several months and usually years. I reviewed this in the last posted blog, but to remind you the top line of this table is what the average vaccine approval time line looks like:

HOW are FDA APPROVAL and FDA Emergency Use Authorization (EUA) different?

The FDA regulates vaccines. APPROVED Vaccines undergo a rigorous review of laboratory, clinical and manufacturing data to ensure the safety, effectiveness, and quality of these products. Vaccines approved for marketing may also be required to undergo additional studies to further evaluate the vaccine and often to address specific questions about the vaccine's safety, effectiveness, or possible LONG TERM side effects.

To speed things up in an emergency like a pandemic, the FDA can grant an Emergency Use Authorization (EUA).

An EUA, as its name implies, authorizes a product for use during unusually urgent circumstances if the benefits of its use outweigh any known or potential risks. But even when speed is of the essence, the FDA still takes the time to be sure patients are not subjected to untested therapies that do more harm than good and THEREFORE DO NOT APPROVE UNTESTED THERAPIES.

Under an EUA, FDA may allow the use of unapproved medical products, or unapproved uses of approved medical products in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions when certain statutory criteria have been met, including that there are no adequate, approved, and available alternatives. https://www.fda.gov/vaccines-blood-biologics/vaccines/emergency-use-authorization-vaccines-explained

When the FDA uses an alternative evaluation process such as the EUA, its purpose is to vet things more quickly than the usual FDA approval regimen.

WHO DO YOU THINK IS VETTING the COVID-19 vaccines that are EUA?

You GOT IT. All the people who receive it.

An EUA can last only if a public health emergency is in effect. But scientists anticipate that the coronavirus will continue to circulate in humans even after the COVID-19 pandemic ends. In that case, vaccine makers that want to keep their products on the market will need to have regular FDA approval — and to get it, they will need to keep their Phase 3 clinical trials going.

But the scientific community (i.e. the real scientists) are concerned that EUA could compromise the ongoing clinical trials that seek to show conclusively how well the vaccines work. Why do you think it takes years to prove a vaccine is theoretically safe?

Once a vaccine is granted emergency approval, there is pressure on developers to offer the immunization to trial participants who received the placebo (the control group). But if too many people leave the control group and cross over to the vaccine group, the companies might not have enough data to establish long-term outcomes, such as safety, how long vaccine protection lasts and whether the shot prevents infection/disease. https://www.nature.com/articles/d41586-020-03219-y

The FDA said it expects vaccine makers who receive emergency use authorizations to “continue to collect placebo-controlled data in any ongoing trials for as long as feasible” so they can apply for regular approval.

HOW?

• How does the FDA do any long-term rigorous study and evaluation of the COVID-19 vaccines SAFETY over time?
• How will anyone know if the vaccines cause any long-term complications if all we look at short-term side effects from the vaccinations given AND WE LOSE OUR PLACEBO group DUE TO EUA in the very PHASE III trials they depend on to report this information?
• Where is the control group to compare long term effects of the vaccine over years on our children, our adult selves and our new-born population now being born to vaccinated women, if we have had no time to evaluate safety through well designed studies that compare vaccinated to UNvaccinated study populations?
• (SEE FOOTNOTE FOR MORE DETAILS)

To remind you, the mRNA gene therapy has never been tested in humans, because of its failure in previous animal studies. I spoke to this in detail in former blogs. The media tells you that this technology has been around for decades. This is true. It has been tested and declared too UNSAFE to trial in humans for 2 decades.

 DID you know that by law, pharmaceutical companies are not liable for vaccine-related injuries or deaths?  Moderna, Pfizer, and J&J (through this FDA LAW) are marketing their drugs as vaccines and are preemptively  protecting themselves against future litigation.

What these experimental gene therapy drugs called COVID-19 vaccines are likely best at doing is to minimize infection symptoms if you do become infected. PLEASE REMEMBER that COVID-19 vaccinated people could potentially still get COVID-19, be asymptomatic and spread it to others. 

ALL THREE COVID vaccines that are in EUA Status, are experimental Gene Therapy.

The Pfizer-BioNTech and Moderna vaccines are lipid nanoparticle-formulated, nucleoside-modified mRNA vaccines encoding the prefusion spike glycoprotein of SARS-CoV-2, the virus that causes COVID-19.

The J&J vaccine is a recombinant replication-incompetent adenovirus type 26 (Ad26) vector encoding the stabilized prefusion spike glycoprotein of SARS-CoV-2. https://www.cdc.gov/vaccines/covid-19/info-by-product/clinical-considerations.html

None of the currently authorized COVID-19 vaccines are live-attenuated or inactivated (killed) virus vaccines. This will be my COVID-19 vaccine choice IF I choose to get vaccinated (my biggest concern is air travel in the future if vaccination is mandated). The inactivated (killed) virus vaccines have been used for decades all over the world for infection prevention and the Influenza vaccine is just one example. For a complete list of COVID vaccinations in development or in use: https://www.biopharmadive.com/news/coronavirus-vaccine-pipeline-types/579122/

 PLEASE REMEMBER Antibody Determined Enhancement as a long-term impact on the vitality and health of those who are currently receiving Gene Therapy injections https://yourholisticdoc.com/blogs/yhd-blog/covid-19-vaccine-safety. 

For those of you who have lost family, friends and loved ones, it is difficult to hear the fact that few patients with this disease require hospitalization and even fewer die. 

I will continue to recommend people use clean eating, exercise, adequate sleep habits and stress reducing behavior that brings them joy and happiness as a first line approach towards avoiding infection or complications from COVID-19. With the current awareness of coronavirus mutations and the strong possibility that we will need to learn to live with this smart virus and its 'variants', I encourage all to do what they can to take good care of themselves with the measures highlighted above. In addition, I have put three supplements together that will support your immune system and total cell health. 

If you would like to learn more about this program, you can click on the below supplements or the picture of the 3 supplements bundled together. 

T- Cell Balance - capsule daily for total immune system support

Osteo-Px - 1 capsule daily for D3 5000iu, A 2500iu and K2 500mcg/capsule to nourish your cell strength and immune support

LDA Trace Minerals with Zinc 30mg in a well balanced immune and cell support formula

COVID PROTECTION, CELL AND IMMUNE SUPPORT

As always I am here to provide my scientific research and natural health support to all those who are interested.

To our Global Health,

Dr. Ariane Cometa

your holistic doc

FOOTNOTE:

Vaccine efficacy is evaluated through RCT (Randomized Controlled Trial) measurement of those who contract Influenza and those that do not, by comparing the frequency of influenza positive - tested illness in the PRE-DETERMINED vaccinated and the PRE-DETERMINED unvaccinated (placebo) groups. In an RCT, vaccine allocation is usually double-blinded, which means neither the study volunteers nor the researchers know if a given person has received vaccine or placebo.

Just as there are no RCT placebo-controlled trials any longer for the FLU Shot since 2010, when the CDC endorsed its vaccine Advisory Committee for Immunization Practices (ACIP) group's recommendation, for universal Flu vaccine as an annual influenza vaccination in all U.S. residents aged 6 months and older … We are effectively doing this with the COVID vaccine, since EUA enacted the same vaccine Advisory Committee for Immunization Practices (ACIP) Universal Recommendation in December 2020 for the COVID -19 vaccine. When the CDC’s Advisory Committee for Immunization Practices (ACIP) recommendation are placed into effect, it becomes UNETHICAL to perform placebo-controlled, Randomized Controlled Trials (RCTs), because assigning people to a placebo group could place them at risk for serious complications from the disease we are trying to prevent. https://pubmed.ncbi.nlm.nih.gov/20689501/

In the case of EUA COVID vaccines, the ACIP greatly disables the ongoing RCTs in place to evaluate the long term testing for vaccine efficacy AND SAFETY of all EUA vaccines.