In a recent paper titled COVID-19 Vaccine Frontrunners and Their Nanotechnology Design, the authors make the introductory statements:
​
Moderna reached clinical trials 63 days after their sequence selection. It is striking that an unestablished nanotechnology formulation reached clinical testing almost a full month before established approaches (ie, inactivated and live-attenuated vaccines) entered clinical trials.

And, ...

It is also of note that in previous severe coronavirus outbreaks of SARS-CoV and MERS-CoV clinical trials were not reached until 25 and 22 months after the outbreaks began.

And, ...

The improved speed into clinical trials is hopeful, but despite the rapid progress, there are still reasons for concern.
​
The fact is, vaccine development does not happen overnight. They must be preventative but also risk-free. Most substances are given to unwell patients, but vaccines are dispensed to healthy individuals and so necessitate an extremely high protective promise.

The current SARS CoV 2 vaccines are emergency use drugs and have bypassed usual developmental methodology.  It is important to note, because it has previously been shown with other respiratory type viruses (SARS-CoV, MERS-CoV, RSV and measles) that antibodies produced can intensify disease ferocity via antibody dependant enhancement (this means the infection can get worse or the intensity of the immune response can be overwhelming).

The Pfizer and AstraZeneca vaccines are ‘nanotechnologies’ and these have not been proven before in clinical environments. In fact, this technology (called an mRNA vaccine) has been researched and tested for 30 years but never been approved.

Every virus is contrasting so there isn’t one perfect solution for all infections. Even within this single SARS-CoV 2 virus some hugely infected people are asymptomatic while others become critical. The enormous inconsistency may infer that a vaccine will not deliver consistent or prolonged immunity in all?

​The Questions ...

One of the major questions is what type of immune response in needed to guard against the virus?

At this point in time, we don’t know definitively. This should be somewhat of a concern given that we now have two (in Australia) vaccines available designed to produce a response without knowing if it the specific response we need.

In the entire history of vaccines, there has only ever been one that has eradicated a disease: the smallpox vaccine.  Some have come close, but eradication is evasive: polio, measles and mumps ...
Respiratory viruses, as the SARS-CoV 2 is, are particularly hard to vaccinate for, despite heavy efforts to manufacture a vaccine. This is partly because the airways and lungs are not an enclosed environment and can’t be protected as can cervical cancer, for example. With respiratory viruses you can be continuously exposed to the infection, in theory.

Most vaccines are delivered by intramuscular injection, and as such, they produce an antibody response that is better developed in the blood (called IgM or IgG responses). The type of protection we need on the mucosal surfaces of the lungs is an IgA response, which is minimal with intramuscular vaccines. At this point in time, there are other vaccines in trials that are looking at improving the IgA response, but this is not the mechanism of the vaccines that are on offer in Australia.

SARS-CoV 2 is different for a respiratory virus because it hitches to a receptor called the angiotensin converting enzyme 2 (ACE2).  This receptor is found in almost all organs but particularly on the surfaces of the lungs and the digestive system, along with the brain. Hence, this particular virus damages at sites distal to its entry point. This is why it can have such destructive and broad effects. Predominantly, it hangs around in respiratory, circulatory, nervous and urogenital systems and why it’s responsible for many varied symptoms. Much of the pathology here, outside of the airway, is defended by IgG antibody responses, and this is the target of the vaccines we now have. This is vital to note, because the vaccine is not designed to promote an IgA response, and therefore, it’s not designed to prevent infection or its transmission in the airways.

This is one of the issues that hasn’t been addressed by governments or chief health officers. If the vaccine isn’t designed to prevent positive tests, do we shut down a city or state again when someone tests positive, as they will?

So, what is different about the Pfizer and AstraZeneca vaccines compared to traditional vaccines?

Both rely on nanoparticle technology.  These nanoparticles are of the same proportions as the virus. As such, it confers an ability to enter cells as the virus would. Nanoparticles encapsulate the nuclear material (mRNA for Pfizer and DNA for AstraZeneca) and adjuvants for use of the immune system once inside the target cells.

Once inside the nucleus of the cell, the lab formulated genetic material from the virus is incorporated with our genetic material to produce an inert viral protein that our cells recognise as foreign and subsequently mounts an immune response.

Different nanoparticles are available. In the case of Pfizer, they use lipid (fats) nanoparticles (LNPs) and for AstraZeneca, they use another virus (which comes from chimps. It can enter human cells but seems to be inert once inside).

Older types of vaccines would have used actual live or dead virus.

What about the issue of adjuvants?

Adjuvants are immunostimulatory molecules that are designed to annoy the inflammatory and immune systems to hopefully produce a heightened response to vaccine stimulation. The issue here is that many adjuvants have earlier not passed muster due to toxicity pitfalls. In the past, and at times today, the adjuvants in vaccines include molecules like mercury and aluminium. These have no business being in the human body.

Where the Australia’s available vaccines should potentially improve their efficacy is that when encapsulated in nanoparticles, both viral nucleic material and adjuvants should reach their target destination cells. This serves multiple purposes that other types of vaccines don’t.

Firstly, it means that adjuvants aren’t as likely wander off and affect other cells. If you are targeting lung cells, you don’t want the adjuvants backstroking towards the brain, for example.

Secondly, it may mean that the amount of adjuvant is less because you don’t have to account for the loose amount that wanders off, reducing its effectiveness.

Thirdly, the adjuvant is less likely to degrade along its journey, also reducing its effectiveness.

Fourthly, if the antigen (here, nucleic material) and the adjuvant arrive at the target cells at different times, it can set up an autoimmune response where we react against our cells (self-antigens) if these other cells, rather than the target cells,  have taken up the adjuvant.

This type of nanoparticle delivery process is already utilised with common supplements or formulas you may have taken.  For example, liposomal vitamin C or Mutaflor (an Iron formula), in which the iron molecule is attached to a sugar molecule for ease of absorption.

Another possible positive for this nanoparticle process is that the smaller molecules can also move through the spaces between cells, where other larger, non-nanoparticle vaccines cannot. Material in these spaces is picked up by the lymphatic system rather than the circulatory system. The lymphatic system is vital to our immune response whereby certain cells in the lymphatic system called antigen presenting cells take the antigen (inert viral material) to the lymph nodes to meet other immune cells which go on to stimulate much longer lasting immune responses (sometimes years, although we’re not sure this is the case yet with SARS-CoV 2?).

Although this may be seen as a positive, what is not talked about is that if viral material can be delivered to the lymphatic system, then so can the adjuvants. If we react to the adjuvants then this is a problem, because as many of you will know, once something is in the lymphatic system (like cancer), it can end up creating a problem anywhere.

So, while nanoparticle technology would seem to be a safer, more efficient way of delivering a vaccine, there are issues as noted in the previous paragraph.

So, what are they adjuvants in the Pfizer and AstraZeneca vaccines?

Only 29 of the 202 companies that applied to produce a vaccine made it through the initial standards to start trials. Of these companies, very few have released their initial data on safety and ability to produce an immune response.

To get the viral material into the cellular mechanism, amongst others, Pfizer has used lipid nanoparticles cholesterol, phosphatidylcholine and polyethylene glycol-lipid.  They did not list all the LNPs they used.  There is no indication from Pfizer that they did or did not use adjuvants.  However, they do mention that the viral material can act as an adjuvant and there is increasing use of certain LNPs themselves as adjuvants.  This would seem to be better than, say, mercury.

Early trials did not list any severe reactions, but common adverse events included headache, fever and pain. Note here that Pfizer was judging its response on IgG mediated assays, which, as already mentioned, is not aimed at preventing infection or transmission of coronavirus.

The AstraZeneca vaccine doesn’t mention whether it used an adjuvant. It only tested for an IgG response and its adverse events were listed as pain, fatigue and headache.

Of the 29 listed trial participants, only 4 companies directly mention the use of adjuvants. The rest? Do they or don’t they?

Part of the problem with both vaccines is that limited information is available. Many researchers and scientists outside of the company bubble are guessing at the possible mechanisms of function.

Adjuvants should be fully and specifically listed. According to an article in Frontiers in Immunology titled Adjuvants for Coronavirus it is written:

Aluminium salt-based adjuvants (alum) were the first adjuvants used in licensed human vaccines. They are still the most widely used because of their wide-spectrum ability to strengthen immune responses and their excellent track record of safety.  In limited coronavirus vaccine studies, it has been suggested that neutralizing antibody against the spike protein might be mechanistically correlated with immune protection. When alum was formulated with S protein or receptor- binding domain (RBD), it significantly enhanced humoral immune responses. This was demonstrated by higher titres of serum IgG1, increased high affinity viral neutralising antibodies, and the generation of long-lasting memory B cells in mice.

The Pfizer vaccine uses the S protein / RBD mechanism for its action, but it doesn’t it doesn’t say whether it does or doesn’t use aluminium as a adjuvant?

Mentioned above in the Pfizer vaccine ingredient list is the lipid nanoparticle polyethylene glycol. Whilst it is not a heavy metal adjuvant like mercury or aluminium, please read the following article elsewhere in this newsletter:

Immediate Hypersensitivity to Polyethylene Glycols and Polysorbates: More Common Than We Have Recognized.

This article highlight just a few of the questions that should be asked about when making this important decision.  Unfortunately, it’s not the kind of information you are likely to get via many of the media outlets we utilise.  It’s important to be informed.

​Be well.

Polyethylene glycols (PEG) have many and varied uses in medical and commercial environments.  

They are commonly used as carrier molecules in liquid or solid type medications.  It is used to conjugate (bind) with medications to improve their efficiency, their effectiveness and ability to generate an immune response.

It is a petroleum based product, although more natural forms have been developed.  It has been banned from organic cosmetic products in the EU.

In the US, it is used as the primary component in oral bowel preparation formulas for colonoscopy.

In recent times, focus has been on its role in anaphylaxis to bowel prep liquids.  There seems to be insufficient understanding of its reactive capability in medications.  There have been reports of multiple skin related exposures to topical creams containing PEG.

Gastrointestinal exposure is suggested to cause reactions in those with already impaired mucosal barriers.  In general, impaired epithelial lining of the gut and blood vessels (here called endothelium) is thought to be one of the factors associated with the co-morbidities of CoV-19.

At this point in time, it is important to know that the mechanism of action is not well understood.

It may be relevant to note that PEG is being used as a lipid nanoparticle (LNP) to help increase the efficacy of the current Pfizer vaccination.  Part of its role may be to act as a adjuvant to provoke the tissue into a heightened inflammatory or immune response?

​Be well.

By the way, if you’d like to read more (and I suggest you do!) have a look at the following:

The Dirty Dozen: PEG Compounds and their contaminants
Safety Evaluation of Polyethylene Glycol (PEG) Compounds for Cosmetic Use
​Probable neuropsychiatric toxicity of polyethylene glycol: roles of media, internet and the caregivers

​The first thing I want to say, is that I sincerely hope that you are doing fine?  We are at a crossroads in history and the knock-on effects from SARS CoV 2 will likely travel as both waves and ripples across life as we know it from now on.  
 
There are many ways to examine SARS CoV 2 but the issue concerning me at the moment is the social isolation that has been forced upon us.
 
Now, the circumstances around SARS CoV 2 are a serious issue, but just as in treatment sessions with you, I often pause to feel the path of least resistance within a problem, and this morning, I decided to embody the spirit of Steve McQueen.  I was thinking about the greatest self-imposed or imposed isolation movies of all time and added the ‘Great Escape’ to that list (is that irony?)
 
Take a moment to escape the gravitas of the Corona virus and imbibe the Steve McQueen cool.  Double click on the clip and cue the theme music ...

So, you’ll still be here when I get out, right?
 
The social isolation that has been forced upon us is a serious issue.  Despite having a more than reasonable understanding of the immune system and virology and having had to accept the mandate around social distancing, it is still perturbing for me, as a human being, to remain isolated for months and to have people jump back when they suddenly realise I’m in the vicinity or to be faced with the open palm upon approach; and to have to deal with the defensively raised voice and the constant wide-eyed analysis over what you’re next move might be in the shopping isle.  Little things they might be, but they have a snowballing effect on your psyche.
 
When you spend time exploring the plethora of research papers comparing social isolation with various health issues and outcomes, you realise the magnitude of this situation.  To be fair, there is research arguing both sides of the coin:  social isolation does and does not affect health outcomes.  However, the majority of evidence ups in favour of poorer health for those that are isolated.  Most of us will not need to read through research statistics to know this.
 
It doesn’t matter whether the outcomes are emotional, mental physical or otherwise.  When you analyse all-cause morbidity (this means it doesn’t matter what you die from), those that are socially isolated die sooner within a given time frame than those who have regular social contact.  You can smoke, drink, have high blood pressure, diabetes or heart disease – it doesn’t matter what you die from, you are much more likely to die earlier than if you have these issues but maintain your connections.
 
The following points I wish to stress here are highlighted in an article - Social Isolation: A Predictor of Mortality Comparable to Traditional Clinical Risk Factors (2013).
 

• Social isolation factors predicted mortality at hazard ratio levels similar to or higher than those of several standard clinical risk factors.  The paper goes on to suggest that social isolation affects mortality just as much as smoking and more than other clinical benchmarks, including ethnicity, age, education levels, and income.

 

• In models comparing social isolation variables, unmarried status and infrequent religious activity are predictive of mortality in both men and women.

 

• A lack of group memberships predicted mortality amongst men and infrequent social contact predicted mortality amongst women.

 

• A point to note: amongst socially isolated people, only smoking and high blood pressure were (constantly) predictive of mortality amongst other variables measured.  Obesity and cholesterol levels were not.

 
The point we have to understand here in relation to SARS CoV 2, is that social isolation affects your health.  Does this matter?  You bet.
 
The paper Social regulation of gene expression in human leukocytes (2007) clearly highlights some of the biological mechanisms produced by social isolation.  For example, gene expression alters when you are socially isolated.  This means the make-up of your genes change such they (and therefore, your cells and organs) produce different by-products or that they don’t produce their normal by-products at all.  To be specific:
 

• Isolated individuals had greater expression of genes producing pro-inflammatory cytokine signalling and prostaglandin synthesis.  In short, you house more inflammation.  If prolonged, it’s a sure pathway towards autoimmune issues and chronic disease.

 

• Isolated people had under-expression of genes related to antiviral resistance, antibody production and lymphocyte function.  This last sentence is worth reading again.

 
My point here is that there is a cost-benefit analysis to be done comparing protective biological mechanisms with social isolation.  I haven’t even touched on the mental and emotional issues, but they need to be included here, as well.  
 
This is just information, but information is power.  What you do with it is up to you.  My goal here is to have people think, and when it comes down to it, make informed decisions for the greater good around the Corona Virus.
 
I have noticed in my clinic, that people want to talk about the Corona Virus.  People NEED to talk about it.  VENT about it, even.  Whilst people are towing the isolation line, there is a sense of fear, frustration and a lack of trust.  People have questions.  And rightly so!
 
So, stay connected.  Observe reasonable and common-sense restrictions but stay connected with what it means to be human.  Get out and get some sun and exercise.  You can still exercise with another.  Grab a coffee on the way back.  Be in touch. Don’t give in to the fear.  Encourage others to do the same.  
 
I’ll still be here when you get back!