Time to Launch Government-funded Investigations Into the COVID-19 Vaccines

While the COVID-19 vaccines, particularly the mRNA base product developed by both Pfizer-BioNTech and Moderna, became vital tools and countermeasures as part of a global emergency response to the SARS-CoV-2 (COVID-19) pandemic, a lot of problems have been suppressed by a confluence of government, industry and health establishments.

Yes, the Phase 3 mRNA studies showed a remarkable benefit as measured in efficacy, and documents accessed via the Freedom of Information Act (FOIA) suggest a significant surge in vaccine-related side effects. We must remember the COVID-19 vaccines were non-sterilizing and possess questionable durability and breadth. The vaccines were helpful tools during COVID variant surges and overall, the safety record has been decent for most people. The vast majority of these side effects are mild and go away within a few hours to a few days.

However, life is rarely so simple and convenient, and COVID-19 is no exception. A significant number of rare, but real adverse events (AEs) have led to vaccine injury. In fact, TrialSite has tracked enough studies pointing to some connection of the mRNA vaccines to inflammatory actions possibly associated with lipid nanoparticles, used to help deliver the mRNA (payload).

The other culprit for vaccine-related AEs comes as a consequence of the production of the spike (S) protein as well as related subunits and peptide fragments manufacturing across human tissue or organ(s). Much research to date focused on lab tests at the cell or model organism level.

A growing body of evidence points to AEs associated with the COVID-19 vaccines linked to the spike protein, likely associated with molecular mimicry with human proteins or via ACE2 ligand according to some researchers. It's perfectly OK and in fact, part of the scientific tradition to be open, critical and upfront with concerns.

The official medical establishment narrative is as follows: the mRNA vaccines are safe and effective, and that’s the end of the story. Like any vaccine or medication they can have side effects, but these are mostly mild and temporary. But the reality is that no medicine or vaccine is perfect, and in fact, there are no solutions but only tradeoffs, based on multiple considerations such as overall public health.

Serious side effects, however, associated with the mRNA jabs can and do occur. They have been associated with myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining around the heart) and recently validated in a Korean national cohort study, sudden death in a few extremely rare cases. The most at-risk cohort for these cardiovascular-related risks is young men, typically from the teens up to 30.

Other side effects associated with the mRNA vaccines, although rare, can and do occur and include the presentation of acute myocardial infarction, Bell’s palsy, cerebral venous sinus thrombosis, Guillain–Barré syndrome, myocarditis/pericarditis (mostly in younger ages), pulmonary embolism, stroke, thrombosis with thrombocytopenia syndrome, lymphadenopathy, appendicitis, herpes zoster reactivation, neurological complications and autoimmunity (e.g., autoimmune hepatitis and autoimmune peripheral neuropathies.

Anti-Vaccine activists point to the exponential increase in reported cases of AEs in the Vaccine Adverse Event Reporting System (VAERS), however, the logging of these reports doesn’t automatically prove that the AEs are vaccine-related. Historically, VAERS counts, which are managed by the U.S. Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration, are undercounted. This means that the actual number of serious adverse events associated with the mass COVID-19 vaccine response in America (270 million primary series in just a couple years) could be far higher than represented in VAERS. But we cannot be sure. As of March 1, 2023, 19,476 deaths are logged in VAERS. Again, this doesn't mean that these deaths are linked to the COVID-19 vaccines (again the vast majority were vaccinated with mRNA-based products).

However, some anti-vaccine activists point out that over 50% are reported within a week or so of the jab, meaning a likely temporal connection. Regardless, over 19,000 deaths represent a lot of deaths possibly linked to vaccines logged in the very system that’s supposed to track incidences. Moreover, VAERS is historically undercounted. But again, as fact-checkers point out in VAERS, correlation does not imply causation — just because an adverse event is reported as having occurred does not mean that a vaccine was the cause.

But based on our ongoing tracking of research around the globe we believe sufficient safety signals are sufficiently present for government investment in specific research to identify the true risks associated with these novel products.

I say novel here because the mRNA vaccines were accelerated due to the declared emergency and completed in 10 months. Importantly, while mRNA research has been going on for a couple of decades, actual commercialization efforts are far newer. For example, Moderna’s own investor disclosures as recent as the end of 2019 acknowledge that these products have never been commercialized and significant risk is consequently attached to the entire research, development and manufacturing initiative. See the link.

TrialSite secured evidence from leaked European Medicines Agency (EMA) emails that at least some prominent employees there were bothered by the pressure to rush the products. Sonia Elijah has reported on this in detail.

We also reported on the avoidance of all required pre-IND enabled studies; biodistribution data accessed via a Japanese FOIA which was given to use by Canadian researchers early in the pandemic.

Additionally, variation in lot quality reported in TrialSite by Sasha Latypova points to potential quality issues in the production of the mRNA vaccines. Sonia Elijah tracked multiple packages of documents released as a result of FOIA. Potential issues are identified.

We are aware of problems directly in the Pfizer clinical trials based on the Brook Jackson lawsuit. While that lawsuit has been tossed by the judge, this author reviewed internal documentation directly involved with that litigation which points to severe quality problems at the Texas-based trial site network (Ventavia).

Any normal study would have been put on hold based on what we reviewed. Multiple media point to grossly inadequate FDA oversight of the mRNA vaccine trials.

While pregnant women were told to get the vaccine by the summer of 2021, they were done so before any regulatory edict. This was seemingly orchestrated between CDC observational data and physician societies focusing on women’s health. Both were concerned with a risk-benefit equation favoring vaccination, but adequate safety data was never produced.

While female rats are a start, it's absolutely outrageous that this class of data was used as evidence to justify the injection of a novel product into a highly vulnerable class of humans. To this day, the FDA package inserts for both Pfizer and Moderna are troubling to say the least. For example, the FDA package inserts for Pfizer’s mRNA Comirnaty as of this writing explicitly declare a lack of data to know whether it's safe or not. See the link. The FDA declares:

“Available data on COMIRNATY administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy.”

For studies involving vaccination of pregnant women follow the link to the following TrialSite piece “ACIP Vote Unanimously to Add mRNA-based COVID-19 Vaccine Shots for Children Program.”

We have delineated a timeline of exactly what group recommended vaccination for pregnant women and when. We don’t argue for a conspiracy, but we do argue that herd mentality was at play. Now only investigational products (boosters) are recommended by the FDA. Although, there is an argument that the Pfizer and Moderna mRNA platforms are validated.

Access to other documentation via FOIA such as the CDC’s V-Safe database (thanks to attorney Aaron Siri) pointed to up to 7% of the population receiving the COVID-19 vaccines experiencing an adverse event requiring medical attention. We have acknowledged that the data source can’t prove anything but we don’t summarily discount the data either. While anti-vaccination activists point to the 7% figure as a proxy for vaccine-injured numbers, TrialSite doesn’t agree with this assessment. Our estimation of COVID-19 vaccine injured is far less than anti-vaccine activists. While the latter argues for tens of millions, our estimates at TrialSite suggest anywhere from half a million to 2 million people have been impacted by adverse events which in some way impact quality of life.

Those actually permanently debilitated by the COVID-19 vaccines we believe are a number under 50,000. But this would still be an unacceptable number, demanding not only a government-funded investigation but also a change in vaccine injury compensation policy. Currently, only a handful of people have even been compensated under the government’s Countermeasures Injury Compensation Program (CICP). The average award is under $2,000 dollars and the whole affair is a national disgrace in this author’s opinion. How can there be a mandated policy for a novel medical product (countermeasure in emergency terms) and no viable mechanism to care for people hurt by such a product? What kind of society accepts this? Governments in places like Taiwan and Singapore do a far better job than the United States on this front.

While the majority of investigators in academic medicine line up and report overwhelming safety and efficacy data there are exceptions. We at TrialSite track National Institutes of Health (NIH) awards and record research payments over the past couple of years are allocated to major academic medical centers.

In one study looking at the problem more critically Peter Doshi, and colleagues, all serious physician-scientists, demonstrate based on an extensive review of clinical trials that the mRNA vaccines are “associated with an excess risk of serious adverse events of special interest of 10.1 and 15.1 per 10,000 vaccinated over placebo baselines of 17.6 and 42.2 (95 % CI −0.4 to 20.6 and −3.6 to 33.8), respectively.

Combined, the mRNA vaccines were associated with an excess risk of serious adverse events of special interest of 12.5 per 10,000 vaccinated (95 % CI 2.1 to 22.9); risk ratio 1.43 (95 % CI 1.07 to 1.92). The Pfizer trial exhibited a 36 % higher risk of serious adverse events in the vaccine group; risk difference 18.0 per 10,000 vaccinated (95 % CI 1.2 to 34.9); risk ratio 1.36 (95 % CI 1.02 to 1.83). The Moderna trial exhibited a 6 % higher risk of serious adverse events in the vaccine group: risk difference 7.1 per 10,000 (95 % CI –23.2 to 37.4); risk ratio 1.06 (95 % CI 0.84 to 1.33). Combined, there was a 16 % higher risk of serious adverse events in mRNA vaccine recipients: risk difference 13.2 (95 % CI −3.2 to 29.6); risk ratio 1.16 (95 % CI 0.97 to 1.39).”

Does the mRNA spike protein stay in the body or is it expeditiously flushed out of the human body?

According to conventional medical establishment, the mRNA vaccines do not cause the spike protein to say in the body indefinitely. This is generally the case as the mRNA vaccine provides instructions to cells in the body to produce a harmless piece of the spike protein found on the surface of the SARS-CoV-2 virus. This spike protein is then displayed on the surface of the cells temporarily.

The wisdom tells us that the immune system recognizes the spike protein as foreign and mounts an immune response to it. This response includes the production of antibodies and the activation of immune cells. Once the immune response is triggered and the spike protein is recognized, it is broken down and eliminated from the body.

As the logic goes mRNA is a transient molecule that is rapidly degraded within cells. After the spike protein is produced and the immune response is activated, the mRNA from the vaccine is also broken down and eliminated.

Although mRNA is considered a gene therapy, it's not of the type, according to the medical establishment, that alters a person’s DNA or integrates into the genome. The mRNA is supposed to remain in the cytoplasm of the cell, as there it is used as a template to generate the spike protein. Key to the medical establishment’s declaration that the vaccine is not a traditional gene therapy: it doesn’t breach the nucleus of the cell where DNA is based. But make no mistake, TrialSite has verified it's classified as gene therapy by the manufacturers themselves in investor disclosures, directly from the proverbial “horse's mouth.”

While the standard medical establishment understanding means that the spike protein only remains in the body for a temporary period of time, and the mRNA associated with the jabs is rapidly degraded and eliminated, there are plenty of exceptions that are frankly suppressed by the media.

TrialSite supports vaccine injured group React19 to organize the largest data repository of post-COVID-19 vaccine serious adverse event case series, observational and randomized studies. Follow the link for the repository. This is something the federal government should have financed. See the link to access over 3,400 studies.

We have studied enough to know better. There was enormous pressure to not spook consumer markets during the COVID-19 pandemic across local, state and national governments in the U.S, and across other nations around the world. That pressure started in the Trump admin—the POTUS at the time admitted in the Woodward interview that he downplayed the seriousness of SARS-CoV-2, likely for political purposes. Among other problems, this created a cult of COVID-19 denial.

On the other hand, Biden declared a COVID-19 mandate when the science was absolutely clear that the mRNA COVID-19 vaccines were not of the sterilizing variety—meaning they could not reliably stop viral transmission, even though at least in surges of 3 to 12 months they could reduce the probability of morbidity and mortality.

The mandate was clearly unethical, representing some form of power play, and a clear example of executive overreach that the courts recognized in part. We at TrialSite suggest that both Republicans and Democrats politicized the pandemic for their own aims and that the American people are the pawns in a bigger socio-political and economic game. This is one reason for ever more intensive divisive politics—they want us divided and at each other’s throats.

So as long as we have enough readers/subscribers that demand actual objective, unbiased (or as unbiased as possible) news and analysis, we at TrialSite will continue to bring as much transparency and clarity to biomedical and health-related research as possible—our original and only mission, started when we founded and launched the site in late 2018, focused on the translation of complex biomedical research for busy professionals and other consumers interested in research. That mission continues on.

And based on all of the data and analyses we have accumulated over the past two-and-a-half years, not to mention extensive discourse with intelligent experts around the world, we do believe formal investigations must be launched to better understand the true risks associated with the COVID-19 vaccines.

https://www.trialsitenews.com/a/time-to-launch-government-funded-investigations-into-the-covid-19-vaccines-5d9147a0

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Also see my other blogs. Main ones below:

http://edwatch.blogspot.com (EDUCATION WATCH)

http://antigreen.blogspot.com (GREENIE WATCH)

http://pcwatch.blogspot.com (POLITICAL CORRECTNESS WATCH)

http://australian-politics.blogspot.com (AUSTRALIAN POLITICS)

http://snorphty.blogspot.com (TONGUE-TIED)

https://immigwatch.blogspot.com (IMMIGRATION WATCH)

https://awesternheart.blogspot.com (THE PSYCHOLOGIST)

http://jonjayray.com/blogall.html More blogs

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