No mRNA vaccine has ever been mass-produced to fight a disease — coronavirus would be the first
Which means this is a very, very, very experimental vaccine. Unproven. Unprecedented (without precedent) Novel (never seen or done before, ever) The use of the military screams authoritarian, martial law, and experimental. Recall the simplest version of marital law? Needing no declaration?
"involving the suspension of ordinary law" We've had lots of that this last little while.
Freedom of movement: restricted. Freedom ofspeech: restricted. Placed in Lockdown. Forced business closure (small business, of course) Suspension of ordinary laws? Check!
If the Pfizer and Moderna vaccines successfully put an end to the COVID-19 pandemic, as they seem poised to do, (the vaccines were not tested or designed for that purpose) we will owe our salvation to the development of mRNA vaccines — an unprecedented, novel vaccine technology that may revolutionize how vaccines are made.
Indeed, an mRNA vaccine has never been mass-produced and licensed to treat an infectious disease. The mRNA vaccines to treat the novel coronavirus would be the first.Hence the Covid Vaccine Guinea Pig label
Yet what is particularly striking is that both are mRNA vaccines, mRNA being short for "synthetic messenger RNA." Understanding why these are so novel requires some background on the history of vaccination.
The third and completely new technology, and the crux of this story, is the mRNA (messenger rna) vaccine. For these, scientists create synthetic versions of mRNA, a single-stranded RNA molecule that complements one of the DNA strands in a gene. They then inject a bespoke (custom made- genetically modified) version of the mRNA into the body, so that cells can produce proteins like those found in a given virus and train the immune system to fight a particular disease before it enters your bloodstream. Think of it as being a bit like training a soldier to fight against actors playing an enemy so they can be better prepared to fight the actual enemy.
In the case of the SARS-CoV-2 mRNA vaccines, these (allegedly) train the body's cells to recognize a protein associated with SARS-CoV-2, the virus that causes COVID-19, known as Spike. Spike is the protein that creates the little points that stick out around the sphere of the virus like the spines of a sea urchin. By helping the body's cells to produce Spike, the vaccines in the process train the immune system to recognize it and protect the human body from novel coronavirus infections.
That's the theory and we'll get to more on that post haste! (with great speed or immediacy)
The holy grail of vaccine technology?Oh, yes it is a double whammy- With the potential for double trouble as you will read.. Stay tuned folks. We just gotta get through the basics first, okay?
Dr. Katalin Karikó, a Hungarian biochemist who specializes in RNA-mediated mechanisms and work as a senior vice president at BioNTech RNA Pharmaceuticals, explained to Salon about what makes these new vaccines so different.
"Vaccines containing killed viruses or viral proteins will only induce antibodies," Karikó explained, referring to how conventional vaccines work. "Meanwhile, mRNA vaccines, in addition to antibodies, also induce cellular immune response," she added, "because the encoded viral proteins are synthesized inside the cell of the vaccinated person." This is an immunological double-whammy: the mRNA injected makes one's body literally synthesize the same proteins that the virus will synthesize, as though it's a dress rehearsal for real infection.
Karikó added that cellular immune response is important because although antibodies will eliminate and recognize viruses in the blood, there is a second type of white blood cell called T cells that recognize infected cells, and destroys them. In other words, antibodies patrol the bloodstream; T cells look for houses that have already been infiltrated. "That's what the BioNTech mRNA vaccine demonstrated," Karikó said. "It induced coronavirus-specific antibodies and T cells."
As for mRNA vaccines like the ones developed by Moderna and Pfizer/BioNTech — which are technically known as "nucleoside-modified mRNA vaccines" — Pardi explained that they are "have two more critical advantages: the flexibility of antigen design stemming from their fully synthetic nature and the ease of production." He emphasized that "once you have the coding sequence(s) of your antigen(s) you want to target you can quickly make these vaccines." He noted that Moderna made their vaccine in just 42 days after they had figured out SARS-CoV-2's genetic sequence.
These mRNA vaccines are also quicker and easier to modify if necessary, Pardi noted. "You can use the same manufacturing procedure to produce different mRNAs . . . this makes production much faster, simpler, and potentially cheaper."
Faster, simpler, cheaper = much more profitable. Obviously. Though Salon's puffy piece didn't think to mention that, in your face, fact
The long road to mRNA vaccines
"There was very slow progress in the development of mRNA-based therapeutic approaches because there were two major hurdles that needed to be overcome," Pardi told Salon. The first hurdle was "the instability of mRNA and the lack of a safe and efficient carrier molecule that can protect mRNA from rapid degradation." Because mRNA is fragile, you can't just put it in water and inject it; it needs to sit inside something.Have these hurdles been cleared? There is no real way of knowing. (though there has been some indication of problems) Hence mass guinea pigs needed.
The second problem was more macroscopic: inflammation. Or, as Pardi described it: "the lack of methods that could decrease inflammation induced by the administration of mRNA."
The inflammation problem was solved in 2005 by Karikó and a colleague from the University of Pennsylvania, Dr. Drew Weissman. The two of them discovered that, by "replacing some of the building blocks of mRNA," they could almost eliminate inflammation
"This key discovery allowed them to produce safe, therapeutic quality mRNA, so-called nucleoside-modified mRNA," Pardi said.
As for the carrier molecule problem, Pardi added that subsequent technological advancements helped develop better delivery materials for mRNA, particularly a material called lipid nanoparticles, or LNPs. "Both the Moderna and Pfizer/BioNTech SARS-CoV-2 vaccines use the nucleoside-modified mRNA-LNP platform," Pardi said. This method has been found to be safe and effective in the Phase III clinical trials from both companies. (safe and effective? Okay?)
Karikó made considerable career sacrifices in the name of developing mRNA vaccines. Her belief that they could work got her demoted at the University of Pennsylvania in 1995, according to STAT News, which pointed to the fact that there was no money coming in to sponsor her work on mRNA. Yet Karikó has since been amply vindicated; the 2005 papers by her and Weissman were noticed by scientists who later helped found Moderna and BioNTech, Pfizer's future partner
Dr. Derrick Rossi, who helped found Moderna, bluntly told STAT News that Karikó and Weissman deserve the Nobel Prize in chemistry. "If anyone asks me whom to vote for some day down the line, I would put them front and center," Rossi said. "That fundamental discovery is going to go into medicines that help the world."You can, of course, read the entire Salon article for yourself. It's a bit too fawning for my personal taste- The jury is out on the safety and efficiency of these vaccines. By efficiency I'm referring to reduce illness and block transmission- We already know the trials were not designed to test for this. So, what were the trials designed for? Specifically? Marketing? Mass experimentation? (This wouldn't be a first)
The Protein Spike and the Vaccination Theory?
Be sure to read the information contained in the linked study:
Results of the study
COVID‐19 vaccines designed to elicit neutralising antibodies may sensitise vaccine recipients to more severe disease than if they were not vaccinated. Vaccines for SARS, MERS and RSV have never been approved, and the data generated in the development and testing of these vaccines suggest a serious mechanistic concern: that vaccines designed empirically using the traditional approach (consisting of the unmodified or minimally modified coronavirus viral spike to elicit neutralising antibodies), be they composed of protein, viral vector, DNA or RNA and irrespective of delivery method, may worsen COVID‐19 disease via antibody‐dependent enhancement (ADE). This risk is sufficiently obscured in clinical trial protocols and consent forms for ongoing COVID‐19 vaccine trials that adequate patient comprehension of this risk is unlikely to occur, obviating truly informed consent by subjects in these trials.
Antibody-dependent enhancement (ADE) of disease is a general concern for the development of vaccines and antibody therapies because the mechanisms that underlie antibody protection against any virus have a theoretical potential to amplify the infection or trigger harmful immunopathology.
Conclusions drawn from the study and clinical implications
The specific and significant COVID‐19 risk of ADE should have been and should be prominently and independently disclosed to research subjects currently in vaccine trials, as well as those being recruited for the trials and future patients after vaccine approval, in order to meet the medical ethics standard of patient comprehension for informed consent.
1: THE RISK OF ADE IN COVID‐19 VACCINES IS NON‐THEORETICAL AND COMPELLING
Vaccine‐elicited enhancement of disease was previously observed in human subjects with vaccines for respiratory syncytial virus (RSV), dengue virus and measles.1 Vaccine‐elicited enhancement of disease was also observed with the SARS and MERS viruses and with feline coronavirus, which are closely related to SARS‐CoV‐2, the causative pathogen of COVID‐19 disease.
When it is stated that the risk is non theoretical and compelling... it means the evidence of risk is accurate and convincing-
The immune mechanisms of this enhancement have invariably involved antibodies, from direct antibody‐dependent enhancement, to immune complex formation by antibodies, albeit accompanied by various coordinated cellular responses, such as Th2 T‐cell skewing.2-7 Notably, both neutralising and non‐neutralising antibodies have been implicated. A recent study revealed IgG‐mediated acute lung injury in vivo in macaques infected with SARS that correlated with a vaccine‐elicited, neutralising antibody response.8 Inflammation and tissue damage in the lung in this animal model recapitulated the inflammation and tissue damage in the lungs of SARS‐infected patients who succumbed to the disease. The time course was also similar, with the worst damage occurring in delayed fashion in synchrony with ramping up of the immune response. Remarkably, neutralising antibodies controlled the virus in the animal, but then would precipitate a severe, tissue‐damaging, inflammatory response in the lung. This is a similar profile to immune complex‐mediated disease seen with RSV vaccines in the past, wherein vaccinees succumbed to fatal enhanced RSV disease because of the formation of antibody‐virus immune complexes that precipitated harmful, inflammatory immune responses. It is also similar to the clinical course of COVID‐19 patients, in whom severe COVID‐19 disease is associated with the development of anti‐SARS‐CoV‐2 serum antibodies,9 with titres correlating directly with the severity of disease.10 Conversely, subjects who recover quickly may have low or no anti‐SARS‐CoV‐2 serum antibodies.11
The elicitation of antibodies, specifically neutralising antibodies, is the goal of nearly every current SARS‐CoV‐2 vaccine candidate. The prior evidence that vaccine‐elicited, antibody‐dependent enhancement (ADE) of disease is likely to occur to some degree with COVID‐19 vaccines is vertically consistent from controlled SARS studies in primates to clinical observations in SARS and COVID‐19. Thus, a finite, non‐theoretical risk is evident in the medical literature that vaccine candidates composed of the SARS‐CoV‐2 viral spike and eliciting anti‐SARS‐CoV‐2 antibodies, be they neutralising or not, place vaccinees at higher risk for more severe COVID‐19 disease when they encounter circulating virusesAre you understanding the points being made? I do hope so. Simply put, if you take the vaccine (vaccinees) YOU are at higher risk for more severe Covid-19 when ever you may encounter the circulating virus then if you would NOT have been vaccinated.
Also bear in mind this previously mentioned fact- for those of you who regularly take the influenza vaccine-
"Receiving influenza vaccination may increase the risk of other respiratory viruses, a phenomenon known as virus interference.Simply put
Vaccine derived virus interference was significantly associated with coronavirus and human metapneumovirus;
Vaccine derived interference was significantly and specifically associated with increasing risks from other respiratory virus- particularly the coronavirus. Covid-19 is a coronavirus.
Imagine the two vaccines, in partnership, in your body. I shudder to think of the repercussions
Maybe it's a triple whammy!