The effects of the COVID-19 virus will be with us forever and will have long-lasting effects, if you consider how it has affected our health, our society, our freedoms, the economy, and our capability as a nation to compete in world-markets. I’d be surprised to hear any one person state that they have yet to have been affected by the virus as it has, in one way or another, essentially impacted every age group, every race, irrelevant as to geographical location, and social status.

There is a tremendous amount of information “out there” regarding the virus, and it is becoming difficult to separate truth from fiction – thus I decided to post some questions that I had about COVID-19 on a LinkedIn group that I found called, “Global Public Health – COVID-19, Influenza and Pandemic Preparedness Group” – thinking they might be able to offer some clarity. I was gravely disappointed when I next logged in and found that my question had been removed and my membership from the group revoked. Frankly I found this insulting. I have since posted these questions on ResearchGate.Net, and while my question has been up-voted by some researchers, unfortunately nobody has answered them. So I decided to post my question here as well – please feel free to add to this information – hopefully someone can answer my questions.

What is a Vaccine?

As according to Horizon, the Research and Innovation online magazine, vaccines work by teaching the body to recognise and respond to the proteins produced by disease-causing organisms, such as a virus or bacteria. There are two main types: Traditional and mRNA.

Traditionally, vaccines were made up of small amounts of the whole disease-causing organism, or inactivated (dead or altered) versions, or just the proteins that the organism produces. One of these methods would be introduced into the body (needle or nasal spray) to provoke the immune system into responding. It would be sensible that by not introducing any live virus into the body, then the body can more easily mount a defense against the ‘attack’ without having to contend with the virus itself.

New mRNA vaccines work by tricking the body into producing the protein (spike protein) by itself. This is done by using messenger RNA (mRNA) to deliver the required ‘instructions’ to the molecule that essentially puts DNA instructions into action – the cell then uses the template to build the protein which is ‘displayed’ on the surface of the cell. These proteins cannot assemble to form the virus – the immune system can detect them and start to produce a defensive response. Because mRNA is rapidly degraded in the body and the cells don’t readily take up foreign mRNA, the mRNA molecule was modified to make it more stable and was packaged in fats (called lipids) that help increase cell delivery efficiency. These advances increase the amount of spike protein produced by your cells, thereby stimulating a more effective immunal response. Once injected into the cell, it can stay for up to two days, which is why people need two injections to develop the best immune response. Therefore, mRNA vaccines do not include any version of the virus (dead, alive, or synthetic). Also notice that this approach only enables the body visibility to just one part of the total virus – different parts of the virus trigger the immune system to produce different antibodies to neutralise the virus. Do not pay attention to advisories referencing DNA integration as it cannot enter the nucleus which contains DNA.

How do they interact with the human Immune System

Our immune system is made up of two parts:

  • the innate representing the defences we are born with
  • the acquired which is developed as we are exposed to the environment

Classical vaccine molecules usually only work with the acquired immune system – however the Innate immune system can be activated using an ingredient called an adjuvant. New mRNA vaccines can also trigger the innate immune system without having to include the adjuvant. It is suspected that it will be required for a part of the acquired immune system called the B cells to become activated. The B cells produce antibodies that mark the virus out for destruction by the immune system. I have read that beyond animal infection models, little seems known about how this works.

Brief Summary

While there is a lot of promise in the use of mRNA vaccines, note that there remains a lot of work to be done in the understanding of the body’s response, how long this protection lasts, and any downsides. Because mRNA vaccines are only now beginning to be tested in humans, there are a lot of fairly basic unknowns which can only be answered through human trials, which have not had the duration in which we have become accustomed with (other already existing vaccines). Take notice however, that mRNA is not new – human trials of cancer vaccines using the same mRNA technology have been taking place since at least 2011.

While this helps raise confidence, time and analysis is needed to answer such questions as: if these vaccines will be able to mount a sufficiently protective immunal response, what quantities of mRNA are required, whether the correct proteins were chosen, how effective these vaccines will be in guiding the immune system in detecting varients, how long immunity will last, and any possible side-effects (such as increased inflammatory responses or aggravating disease). mRNA solutions are still maturing. In the case of COVID-19, there simply hasn’t been enough time for lengthy clinical trials – and it will require years of clinical study in human trials to improve accuracy and determine all possible side-effects. Here are a couple of articles; Article, Article.

For those feeling what I would consider to be ‘overly confident’ and suggesting that there are not real issues, then I ask if the confidence levels are so high, then why have vaccine manufacturers been offered an immunity by governments, that they not be held responsible for any deaths or side-effects caused by their products? Article. Article.

Release / Trials

Vaccine trials take place in stages, starting with trials on animals, and then three trials on people. Pfizer’s Phase 3 trial involved more than 40,000 people and began in July 2020. Moderna’s Phase 3 trial involved more than 30,000 people and also began July 2020. It has been stated that safety issues that would affect significant numbers of vaccines mostly appear within two months. However, with a vaccine having been given to millions of people, very rare side effects that cannot be anticipated from clinical trials could develop, so researchers and regulators will be keeping a close eye on how the vaccine rollout goes. This will be especially important for Covid-19 vaccines based on innovative technology.

Benefits of mRNA vaccines

Safety: Unlike live-attenuated or viral-vectored vaccines, mRNA is non-infectious.

Reduced chemical count: Other strategies such as protein-based or inactivated vaccines require additional chemicals. mRNA does not require inactivation and thus does not pose any concerns regarding possible contamination with toxic agents.

Time to manufacture: Traditional vaccine manufacturing methods require many steps in the manufacturing process (manufacturing cell cultures, etc.) – whereas mRNA requires less steps.

Usage: There are many benefits in approaching the adjustment of an person’s immune system using mRNA technology – like awaking the body to certain cancers that it would not have noticed before, Ebola, Zika virus, influenza, etc.. And theoretically, mRNA technology could produce proteins missing in certain diseases, like cystic fibrosis.

Possible concerns

Speed of Creation

You should be aware that these vaccines have not undergone the years of proofing as we are used to. Approximately 11 months after the discovery of COVID-19 regulators in the United States and the United Kingdom confirmed that an mRNA vaccine for COVID-19 was ready. Previously, no new vaccine had been developed in less than 4 years! In fact, I noted that the vaccines have only been released the US Food and Drug Administration (FDA) for Emergency Use Authorizations (EUA) only – and that under an EUA, the 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“.

And, people will have differing points of view of “Safe” – for instance, I was dismayed when I read that when a company requests permission to release a ‘solution’ to an EUA, the FDA only requires “…a phase 3 safety database of well over 3,000 vaccine recipients, representing a high proportion of participants enrolled in the phase 3 study, who have been followed for serious adverse events and adverse events of special interest for at least one month after completion of the full vaccination regimen.”. To me, when comparing risk ratio’s, a test bed of 3,000 people compared against possibly administrating it to the 332,000,000 people currently living in the US seems like a light-weight benchmark (statistical comparision). In other words, your burdening the risk on the result of a study effectively performed on 0.001% of the total population. Personally I’d much rather that number to be significantly higher, as this would expose more issues. But please, before commenting, notice that I am not attacking their procedure, integrity, analysis, or etc. – I am merely pointing out that this is all happening VERY quickly, and it does not raise my personal level of confidence.

Antibody Depenent Enhancement (ADE)

What is ADE? Antibodies are supposed to prevent cell entry – but on rare occasions they can actually increase the ability of a virus to enter cells. This is called antibody-dependent enhancement (ADE). Article. Article. This consideration must be taken into consideration when developing COVID vaccines. Unfortunately in testing, most animal models and in vitro models seldom predict ADE, thus we need more studies to define the clinical correlation with protective immunity. We need to carefully analyze the safety of mRNA vaccine in humans because ADE of diseases cannot be predicted after administrating antibodies and vaccination.

Researches of mRNA vaccines against bacteria and parasites are limited. No vaccine relating to bacteria and parasites has been approved so far. As for bacteria, they are one hundred times larger than viruses. Hence, there are differences in the structural complexity and immunology between them. Although mRNA vaccines in tumors and viruses have multiple advantages, they are still in the initial stage. Currently, safety is the most significant issue. ADE should be considered in developing mRNA vaccines.

Speaking to ADE, Brian Lichty, PhD, an associate professor in pathology and molecular medicine at McMaster University in Toronto, spoke with Medpage Today, who published,

“To date, there’s really no evidence of ADE with the COVID-19 vaccines. It’s all theoretical,” he said. “I think all the evidence so far is that ADE is not turning out to be a problem with any existing vaccines or viral variants.” One reason could be that SARS-CoV-2 just may not affect macrophages in a way that can produce ADE, although scientists are still working out the details. ADE has been reported after natural infection with other viruses, such as HIV, Ebola, and coxsackievirus, as well as other coronaviruses like SARS and MERS. Throughout the pandemic, scientists have been looking for ADE associated with SARS-CoV-2, but so far they haven’t found any cases of it, noted Lichty. “This coronavirus may already be sufficiently adapted to humans, so that if it does get into macrophages via a non-neutralizing antibody interaction, it may not allow the macrophage to produce enough cytokine to cause an obvious pathology,” he said.

From what I am reading, more time is required, however at the moment it seems to not be of much concern.

Viroprons

Viroporins are small multifunctional viral proteins (~ 60–120 amino acids) that modify cell membranes, thereby facilitating virus release from infected cells. Viroporins are capable of assembling into oligomeric ion channels or pores in the host cell’s membrane, rendering it more permeable and thus facilitating the exit of virions from the cell. Many viroporins also have additional effects on cellular metabolism and homeostasis mediated by protein-protein interactions with host cell proteins. Viroporins are not necessarily essential for viral replication, but do enhance growth rates. Their absence does weaken or attenuate the virus and diminishes its pathogenic effects. Viroporins are sensitive to changes in the cellular environment. The charge on the lipid head group of membranes can modulate the ion-selectivity of the viroporin. Recent efforts have been directed toward understanding how mutant CoV E viruses carrying ion channel-inactivating mutations revert to their original pathogenic state. While some of these mutations appear to merely restore the loss of ion channel activity, it is not entirely inconceivable that revertant viruses could acquire gain of function mutations rendering it more virulent. Viroporins are common to RNA viruses, such as COVID-19. Article.

Fact or Fiction?

Statements purported to have been spoken by Nobel Prize winner Luc Montagnier

Fiction

Fact

While reading some Fact Check articles I understood and agreed that the above quotations were not true. That said, the nobel prize winner did speak to his opposition to mandatory vaccinations in France and drew criticism from fellow academics for broadcasting what they cconsidered to be “dangerous messages”.  And in an interview posted online Montagnier claimed that the vaccines have produced new coronavirus variants and that “the curve of vaccination is followed by the curve of deaths“, thanks to “antibody dependent enhancement,” (ADE) which he says can create more severe disease.

COVID-19 Shedding

Fiction

You can get COVID-19 from someone who has been vaccinated, through a process called Shedding.

Fact

It is not possible for this to occur, as none of the vaccines have the COVID-19 virus in it (active or deactivated). Luigi Warren, tweeted regarding that the mRNA solutions could cause those vaccinated to shed the spike protien that is created. Twitter deleted the tweet, to which he responded that he is “the inventor of the technology on which Moderna was founded”, implying that he might just know what he’s talking about. While this seems to remain in question, as it has been contested by other scientists, Luigi supported that the shedding would be miniscule and would not affect others. So essentially, this is a mute point.

My Questions

Vaccine vs Treatment

Question: Essentially I am to understand that a vaccine is medically and legally defined as serving two purposes: to stimulate both an immunity in the person receiving it and to disrupt transmission. Questions as to whether these mRNA solutions are actually Vaccines has arisen.
Answer: In what I read, depending on whose definition used it might be classified as a device. While this will stimulate an immuno-response in the body it will not induce an immuno-transmissive response (it does not disrupt transmission of the virus).
Question: This leads me to wonder if people are looking for a way to bypass the exemption these vaccine manufacturers have been offered (by the government) to ensure they are not responsible for any deaths?

Possible side-effects:
Question: I read that studies have shown that the expression of the pathogenic envelope being generated by the cells (the expression of that piece of the virus now being created by the body) are known as leading to / linked to conditions such as; multiple sclerosis, Lou Gehrig’s disease, Alzheimer’s, and accelerated cancers. Is this factual in any way – speculation – or simply information that has been falsified?
Answer: It seems that I am having troubles finding these studies. Perhaps they were ‘buried’? Perhaps they do share some similarities? I’ll keep looking – out of interest – as nobody seems willing or able to answer this question yet.

The auto-immune response:
Question: This is a question I’ve never seen asked, but it makes me wonder as to if this explains some of the extreme adverse effects posted, is what happens if the body cannot destroy the cells that, per the delivery method, have now been re-programmed to make the pathogenic portion of the virus in the body? Does the person carry this as a problem with them forever? Is there a way to re-program the cells again – return them back to normal? How is this problem detected?
Answer: As I’ve read – it seems that the body does not continue to manufacture this after a period of approximately 2 days. I’m looking into why now.

While I’ve had to answer many of my own questions, I am hoping someone can shed some light on those above that have not yet been answered.

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