When the coronavirus COVID-19 variant emerged in the United Kingdom during the month of December 2020, the possibility that similar COVID mutations may exist elsewhere caused a good amount of global alarm as we questioned whether the newly launched phased allocation of the COVID-19 vaccines would even be effective. The immediate US ‘experts’ response to this concern was that the COVID-19 vaccines “being rolled out will likely still work on COVID-19 variants”. 

There is simply no possible way for anyone to know this yet. For those of you who know me, what I have shared from the onset of this pandemic with COVID-19, is that mutation is essential for viral longevity and reproduction and is a rule, not an exception. Hence, I have proposed that a COVID-19 vaccine may be less effective than expected, desired, and needed to protect us from SARS-CoV-2 infection. Mutation and variants are so common in the evolutionary history of viruses and viral infection, that scientists use viral mutation as the virus moves through a population, to track the spread of a virus from one place to another. In fact this known fact in the science of viruses is utilized to create the Influenza Vaccine each year.

Mutation creates viral variants and allows/enables the virus to outsmart the host from resisting infection.  But if a virus mutates significantly enough, one worry is that current vaccines might no longer offer as much protection.

"My expectation is, this will not be a problem," said Moncef Slaoui, the chief science adviser for the U.S. government's COVID-19 vaccine push.

In my opinion, Ariane Cometa, MD, the mRNA vaccine is too new, both as we pioneer them in humans for the first time in an attempt to prevent SARS-CoV-2 infection and in their very recent history of use for five months, since July 27, 2020, when we commenced the phase 3 clinical trials for both the Moderna and Pfizer vaccine. The vaccines have simply not been tested long enough in humans, to make the above statement or others purporting the efficacy of the current mRNA COVID-19 vaccine, as the virus mutates. Anything currently supporting efficacy of the vaccine to withstand the natural viral mutation process, is based upon 'evidence' demonstrated in a test-tube (in vitro).

The COVID-19 variants of concern are worrisome, because COVID-19 mRNA vaccines are created against the very SPIKE PROTEIN demonstrated to have the COVID-19 mutation (enabling the virus to potentially be more virulent (stronger) and potentially escape the current vaccination protocol.

Some more medical expert jargon:

• Anthony Fauci states that U.S. “will do tests to be sure”.
• Stanford epidemiologist, Dr. Yvonne Maldonado, says there have been many COVID-19 variants. The concern with the UK variant is that the mutations are on the spike protein - the basis for immunity. "Everyone is watching that protein like a hawk," said Dr. Maldonado.
• UCSF infectious disease doctor, Mike Reid, who runs San Francisco's contact tracing program states, "It bears watching to track variants, because some of them can develop more and more mutations”.
• “Viruses mutate all the time,” said William Schaffner, an infectious-disease specialist at Vanderbilt University in Nashville, Tennessee. The question, he said, is “whether the pathogen has mutated enough that it is “sufficiently deviant” from previous iterations”.

Viruses constantly change through mutations that arise naturally as they replicate and circulate in their hosts. As a result of this ongoing process, many thousands of mutations and distinct lineages have already arisen in the SARS-CoV-2 genome since the virus emerged in late 2019. Scientists are heavily focused on mutations that involve genes which encodes the SARS-CoV-2 spike protein; as in that altered in the U.K. variant. The Spike protein is what we have targeted with the mRNA vaccines, as it is this spike protein that allows viral entry into cells. Our immunity to SARS-CoV-2 infection and vaccine efficacy hinges on the ability for the current vaccines to thwart viral entry into our cells.

Let’s just face it…we know this...

Why do we change the Influenza vaccine annually? It mutates.

QUESTION: 

Where has the spotlight moved onto regarding COVID-19 potential for mutation?

ANSWER:

Onto the COVID-19 vaccine

Is there a conflict of interest which exists between COVID-19 vaccination campaign AND informing the public that the COVID-19 mutations and variants being produced could interfere with vaccine efficacy?

If we know that mutation and variants are so common in the evolutionary history of viruses and we use this knowledge to track viruses from one place to another, why are we creating a "holy grail campaign" around the current COVID-19 vaccine push?

These are my questions, not my criticism of the mRNA COVID vaccines being distributed. 

 WHAT SCIENCE IS SAYING:

Pfizer and Moderna are tracking the variants and “if they detect that a piece of the virus is no longer susceptible to their vaccines, they can tweak them in a matter of months…

"What you can do is you can change the RNA of the vaccine to match the new mutation, and then make antibodies to the mutation as well, so they can do that. We do that with the flu vaccine every year."

QUESTION:

• What research is being done to carefully monitor COVID-19 vaccine and efficacy after it's EUA by the FDA?  This is a MAJOR ISSUE! WHY?

• Once a vaccine is granted emergency approval (EUA is another blog in the wings), 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, such as :

1) long term safety of the vaccine

2) how long vaccine protection lasts 

3) conclusively establishing whether the vaccine prevents people getting infected with SARS-CoV-2, or whether it simply protects infected people from getting the disease

Finally, if we lose long-term follow up in these vaccination trials that were supposed to continue for 2 years,

how will we ever know if someone who received the COVID-19 vaccine, can still become infected and spread the virus, but not be sick? How will we know? We can't test them for COVID-19 any longer after vaccination AND they will already have antibodies that neutralize SARS-CoV-2 from the vaccine.

The Vaccination Dilemma

This competition between a clinical trial for vaccine efficacy and safety as well as long-term value and it's emergency use is new for us in vaccine development because of the following:

The speed of these authorizations reflects the urgency of the pandemic, and is a testament to the scientific advances that made rapid vaccine development possible, said immunologist James Hildreth, president of Meharry Medical College in Nashville, Tennessee, at the panel meeting on Thursday. “To go from having a sequence of a virus in January to having two vaccines available in December is a remarkable achievement.” and is being fondly called the Vaccination Dilemma. 

Many have asked me to share with them what I recommend with the vaccination options being offered at this time.

My role as both a physician and a scientist is to remain well informed and current in the field of Medicine. It gives me great pleasure to present my research and knowledge. You all know I am highly opinionated and yet I feel strongly, it is important for me to reserve my opinions and recommendations when possible, and instead provide information and insight to those interested. I hope in this small way, I am able to facilitate the ability for people to make their own educated decisions.

Viruses are smarter than we humans and as evolution would have it, they are much older too! To hold up our immune fortress against viruses, I recommend a constant surveillance program that upholds our fortitude and strength against infection and disease. 

As patients, family and friends can all attest to and quote me repetitively stating,

"we need to be more tenacious than the virus" if we are going to outsmart it!" 

Elderberry, Vitamin D, Zinc, Vitamin C are all backbones to our immune support and strength. 

In addition, one of my favorite immuno-regulating herbal preparations to protect us from viral infection is T-Cell Balance Px. This wonderful natural formula combines a unique assortment of natural compounds created to stabilize the immune system and support healthy liver function. T-Cell Balance Px:

• promotes equilibrium within the immune system
• helps to reverse and calm an over-active immune response so it works more efficiently and effectively
• increases white blood cell production and balances T and B lymphocyte biosynthesis of the immune system
•  has antioxidant properties that can reduce inflammation in the body as well as "cytokine storm" while aiding in the prevention of oxidative damage to the liver 
• STRONG immune-modulatory activity by balance T-cells and neutrophils with potent immuno-balancing effects  

As always, I welcome and really appreciate your Comments on the blog. Please stay-tuned, as I have more blogs to follow soon:

TOPICS:

• COVID-19 Vaccine Safety Concerns
• COVID -19 Vaccine  and the Flu Vaccine - how they are similar and how they differ
• COVID-19 Vaccine Emergency Use Authorization- what does that mean? Is it Safe?
• COVID-19 and Vitamin D
• COVID -19 and Medical Therapeutics, such as Ivermectin and Budesonide

To our Global Health and Well-Being in 2021!

Ariane Cometa

your holistic doc