After yesterday saw the approval sailing through the FDA Advisory council to give young children the vaccine and the later announcement of a fourth booster to adults I thought it time to revisit the story of little Johnny whom I wrote about in a prior post.
In that blog post was a video of Moderna's chief operating officer Tal Zak's doing a Ted Talk on mRNA vaccines. He was telling the story of Johnny who had a debilitating life threatening disease, Methylmalonic Acidemia, MMA, children born with the disorder faced certain death at some point in their lives. He used the story of little Johnny and his death to overcome the moral and ethical concerns involved with the mRNA technology, what if, he says, we could replace that missing protein using gene therapy, he called information therapy, rewriting the genetic code. As I said in the article no one could question moral or ethical concerns if someone was facing certain death, certainly doing something would be better than doing nothing. What on the other hand would be the implications for using such an unproven technology for those who aren't facing certain death?
Most people have been lied to about this technology, many people are under the impression this technology has been around for decades and has proven it's worth. It has been around for awhile but it has never proven it's worth.
Israelis celebrated on Friday when Prime Minister Benjamin Netanyahu announced that the country had signed a deal with Pfizer Inc. to buy its novel coronavirus vaccine. But the fact remains that if Pfizer succeeds – or Moderna, with whom Israel also has a contract – these will be the first-ever messenger RNA (mRNA) vaccines brought to market for human patients.
I'd think most people would be surprised to learn that use of this technology has failed in every endeavor they've tried it on, we can't even be rested assured it wouldn't have had any long term devastating effects on the little Johnny's of the world as Tal Zak dropped the human trial version of the little Johnny's as they were gathering up study participants right when covid hit. The little Johnny studies were to be based off a twelve week study done with 16 mice. In that study some of the mice were given repeated shots to keep producing the missing protein.
As systemic hMUT mRNA therapy will require chronic, repeat IV infusions every few weeks, the clinical adoption of such a therapy remains to be determined in this disorder. However, this dosing regimen is similar to several enzyme replacement therapies prescribed for multiple lysosomal storage disorders (e.g. Fabry, Gaucher, and Mucopolysaccharidoses). Additionally, clinical implementation of a potential mRNA therapy will largely be influenced by safety and efficacy results from upcoming clinical trials in patients and ultimately, the cost-effectiveness of the therapy.
And just like that the little dying Johnnies of the world were dropped in favor of having the whole global community as test subjects based off the study of replacing a protein in twelve mice using mRNA technology.
Additionally, clinical implementation of a potential mRNA therapy will largely be influenced by safety and efficacy results from upcoming clinical trials in patients and ultimately, the cost-effectiveness of the therapy.
One could reasonable argue that last part should read "effectiveness of profits", but none the less the scientific community already had doubts of the efficacy of this technology:
She said her concerns have less to do with the use of mRNA and more to do with the long-term efficacy of the vaccine, as well as other challenges that could cause something to go wrong and lead people to believe they are vaccinated when they are not.
“It would be the worst [scenario] if people behave like they are immune but can still become infected,” Linial said.
So they either knew or she had one heck of a crystal ball that allowed her to see all the way from Israel. The article was written in November 2020. Let's take a look at what the article states could be some of the challenges she speaks of.
But he acknowledged that there are unique and unknown risks to messenger RNA vaccines, including local and systemic inflammatory responses that could lead to autoimmune conditions.
An article published by the National Center for Biotechnology Information, a division of the National Institutes of Health, said other risks include the bio-distribution and persistence of the induced immunogen expression; possible development of auto-reactive antibodies; and toxic effects of any non-native nucleotides and delivery system components.
Autoimmune conditions would be when your own immune decides to recognize the protein as a foreign invader and produces anti drug antibodies (ADA). That leads to what's know as immunogenicity.
Immunogenicity has the potential to be a significant obstacle in the development of successful biological drugs. Many of the protein therapeutics elicit immune response when administered to patients (Schellekens, 2002). Similarly as human proteins are foreign to animals, it is common for animals to develop ADAs, which can lead to increased clearance of the biopharmaceuticals, thus yielding exposure reduction and overestimation of safety. In some cases, the formation of neutralizing and nonneutralizing antibodies reduces drug efficacy and potency. In general, immune responses to biological products tend to induce less severe adverse effects, resulting mostly in affecting efficacy of the product, but it has been shown that immune responses to certain biotechnology products can have serious clinical consequences in humans.
What can some of those serious consequences in humans be:
Immunogenicity refers to the ability of therapeutic protein products to stimulate an immune response, specifically, the development of antidrug antibodies (ADAs). These antibodies act by neutralizing or binding to therapeutic protein products, and their presence is often concerning for impending biologic failure. Moreover, ADAs can trigger potentially dangerous immune-complex AEs, such as serum sickness, bronchospasm, thromboembolic events, and Arthus and infusion reactions.
What could be toxic effects of any non-native nucleotides and delivery system components?
Vaccine is one of the most effective strategies for preventing and controlling infectious diseases and some noninfectious diseases, especially cancers. Adjuvants and carriers have been appropriately added to the vaccine formulation to improve the immunogenicity of the antigen and induce long-lasting immunity. However, there is an urgent need to develop new all-purpose adjuvants because some adjuvants approved for human use have limited functionality. Graphene oxide (GO), widely employed for the delivery of biomolecules, excels in loading and delivering antigen and shows the potentiality of activating the immune system. However, GO aggregates in biological liquid and induces cell death, and it also exhibits poor biosolubility and biocompatibility. To address these limitations, various surface modification protocols have been employed to integrate aqueous compatible substances with GO to effectively improve its biocompatibility. More importantly, these modifications render functionalized-GO with superior properties as both carriers and adjuvants. Herein, the recent progress of physicochemical properties and surface modification strategies of GO for its application as both carriers and adjuvants is reviewed.
"To address these limitations, various surface modification protocols have been employed to integrate aqueous compatible substances with GO to effectively improve its biocompatibility" These "surface modifications" my best bet is these are the redacted ingredients of the vaccines. I am not at one hundred percent yet but I have a pretty good guess at what they are, so that right now is just another unknown among the many concerns listed. The statement further high lights, and please do check the date of the statement, June 6, 2020.
STATEMENT OF SIGNIFICANCE: Due to its unique physicochemical properties, graphene oxide is widely employed in medicine for purposes of photothermal treatment of cancer, drug delivery, antibacterial therapy, and medical imaging. Our work describes the surface modification of graphene oxide and for the first time summarizes that functionalized graphene oxide serves as a vaccine carrier and shows significant adjuvant activity in activating cellular and humoral immunity. In the future, it is expected to be introduced into vaccine research to improve the efficacy of vaccines.
Wasn't much of a future was it? I think they call that cherry coating the unknown. No worries folks we use this stuff all the time just not in any vaccines yet. We're sure you don't mind being the test subjects on whether we are getting it right or wrong.
If all that isn't a bad enough reason for not allowing the injection of children with protein therapeutics there's this, notice the date of which immunogenicity assessment of protein therapeutics started receiving significant attention from the industry and regulatory agencies.
The immunogenicity assessment of protein therapeutics has received significant attention, both from the industry and regulatory authorities. Preclinical immunogenicity testing has been limited to monitoring antibody formation in rodents and NHPs. There are currently no animal models available to predict reliably the potential for a protein therapeutic to induce an immunogenic response in humans.
Immunogenicity has the potential to be a significant obstacle in the development of successful biological drugs. Many of the protein therapeutics elicit immune response when administered to patients (Schellekens, 2002). Similarly as human proteins are foreign to animals, it is common for animals to develop ADAs, which can lead to increased clearance of the biopharmaceuticals, thus yielding exposure reduction and overestimation of safety. In some cases, the formation of neutralizing and nonneutralizing antibodies reduces drug efficacy and potency. In general, immune responses to biological products tend to induce less severe adverse effects, resulting mostly in affecting efficacy of the product, but it has been shown that immune responses to certain biotechnology products can have serious clinical consequences in humans (Casadevall et al., 2002). Because of these adverse clinical consequences, regulatory agencies will expect detailed clinical evaluation of the potential for immunogenicity prior to marketing. Depending on the product, a substantial postmarketing commitment to monitor immunogenicity in the relevant clinical setting may be demanded as well (Chamberlain and Mire-Sluis, 2003). Indeed monitoring for antibodies during clinical trials and postmarketing surveillance remains an important issue for all therapeutic proteins
"In some cases, the formation of neutralizing and nonneutralizing antibodies reduces drug efficacy and potency."
There's that conflict of interest popping up again, the inability of neutralizing and non neutralizing antibodies to get along when injected in humans, thus reducing drug efficacy and potency. It's not just restricted to the efficacy and potency of the drug being used as demonstrated above, it can cause serious injuries and deaths. In that regard we can only wish the last part was being taken seriously.
Because of these adverse clinical consequences, regulatory agencies will expect detailed clinical evaluation of the potential for immunogenicity prior to marketing. Depending on the product, a substantial postmarketing commitment to monitor immunogenicity in the relevant clinical setting may be demanded as well (Chamberlain and Mire-Sluis, 2003). Indeed monitoring for antibodies during clinical trials and postmarketing surveillance remains an important issue for all therapeutic proteins.
There's no regulatory agencies demanding let alone expecting any detailed clinical evaluation of adverse clinical consequences. If you listen to the video of Zak Tal's Ted Talk he's every explicit on how mRNA technology works:
Now we can go see what's screwed up in a patience and we can use that information to make a vaccine. We take that information, say a patient with lung cancer, we take a biopsy, we figure out the sequence, we figure out their immune system, that all becomes information that goes up into the cloud that combines an algorithm then automatically makes a vaccine that we administer to try wake their immune system. Now the challenge, of course, is that everybody's cancer is different. Mutations happen by random chance so in order to do this you have to make it personalized. So this is me, (silhouette pops up on a screen), but if every patient is different (silhouette's in different colors pops up behind him) what we're going to have to do is make a personalized vaccine for every patient.
"We figure out their immune system but if every patient is different what we're going to have to do is make a personalized vaccine for every patient." In my opinion this isn't even post vaccine criminal medical negligence this is pre-vaccine criminal medical negligence. He knew before he even hosted this vaccine upon the world the vital critical importance of how mRNA technology worked. Now they want to sit there and describe it to your kids as being in comparison to putting a UBS drive into one's computer. What they will neglect to remind them, and all the rest of us, is that just one UBS drive doesn't fits all computers, an importance distinction to make, unless of course you want to wreck your USB drive or computer trying to jam it in there which is exactly what will happen to many bodies jabbing them with a vaccine that the technology wasn't meant for a one vaccine fits all, our immune systems are to diverse.
Just as easily as Tal used little Johnny's story to pull at your heartstrings listening to him talk about his own fake personal, emotional devastating experience when he walked into work as an intern and found that little Johnnie died he'll have no problem walking out as he did on the little Johnnies of the world just as easily as he's watching your prepare for those very same prospects. In reality he did exactly that, he planned his departure, packed his billions and left....ironically just about the expected timeframe he himself figured they'd announce it's time for a booster. As I wrote at the conclusion of my last blog....
"So in conclusion I want to announce that Tal Zak will be leaving Moderna in September this year, just about the same time they will likely announce to the world similarly what they found in studies with mice using their mRNA vaccine to replace the missing proteins of the little Jonathans of the world. That being a life of repeated injections of the vaccine to maintain the protein required to keep the little Jonathans alive the same will be required of covid"
Don't let them get their hands on your kids.