COVID-19 MRNA VACCINES

Lessons learned from the Registrational (human clinical) Trials and global vaccination campaign: A peer reviewed study.

COVID-19 MRNA VACCINES: Lessons Learned from the Registrational Trials and Global Vaccination Campaign- a peer-reviewed study

We are now four years into the pandemic. What have we learned from the mandatory vaccination campaign? Here, we examine an NIH peer-reviewed study on gene therapy products, which are misnomer-ed as vaccines. 

“As there were no specific regulations at the time of the rapid approval process, regulatory agencies quickly “adapted” the products, generalized the definition of “vaccine” to accommodate them, and then authorized them for EUA (emergency use authorization) for the first time ever against a viral disease. However, the rationale for regulating these products as vaccines and excluding them from regulatory oversight as GTPs (Gene Therapy Products) lacks both scientific and ethical justification”.

Published reports from the original randomized phase 3 trials concluded that the COVID-19 mRNA vaccines could greatly reduce COVID-19 symptoms. However, problems with the methods, execution, and reporting of these pivotal trials existed.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10810638/

Re-analysis of the Pfizer trial data reveals statistically significant increases in severe adverse events (SAEs) in the vaccine group following the EUA, which include cancers, autoimmune, reproductive, cardiac events (myocarditis), and death. This data was unavailable or minimized during the vaccination campaign.

The mRNA products never underwent adequate safety and toxicological testing in accordance with previously established scientific protocols.

Prior to the rapid authorization process, no vaccine had been permitted for market release without undergoing a testing period of at least four years. Previous time frames for Phase 3 trials had been ten years. Health departments have stated that 10-15 years is the normal time to determine vaccine safety, and Pfizer completed its trials in seven months.

“Preclinical studies of the mRNA product’s biodistribution and potential toxicities from repeated doses (to mimic multiple vaccinations), were circumvented to enable accelerated clinical testing”.

It is not surprising that many doctors, scientists, and public health officials immediately voiced concerns about the mRNA products. At the time, they were considered outliers, conspiracy theorists, misinformation pushers, and worse. Many were censored or lost jobs as a result of speaking out.

Follow the money:

“The public funding provided for developing these products through Operation Warp Speed surpassed investments in any prior public initiative. Once the pandemic began, $29.2 billion (92% of which came from US public funds) was dedicated to the purchase of COVID-19 mRNA products; another $2.2 billion (7%) was channeled into supporting clinical trials, and $108 million (less than 1%) was allocated for manufacturing and basic research. This profuse spending of taxpayer dollars continued throughout the pandemic”.

U.S. federal agencies were biased towards a successful result.

Political pressures to rapidly deliver a solution to the pandemic were enormous. They compromised the thoroughness and integrity of adequate scientific evaluation while downplaying the concerns and potential risks of mRNA technology.

Revisiting the trials:

U.S. public health officials promised the vaccines were “safe and effective.”

The trial study designs were never intended to determine if the vaccines could help prevent severe disease or death.

Trials were unblinded by week 20, and placebo volunteers were given the vaccine.

Vaccine efficacy was found to be only 19%, far below the 50% RR threshold required for regulatory authorization.

Unblinding the study greatly eliminated any risk-benefit evaluations.

There was underreporting of severe harms, including Serious Adverse Events.

mRNA vaccines show a high relative risk rate for Serious Adverse Events.

The likelihood of severe COVID-19, hospitalization, and dying from the infection has always been very low.

The infection fatality (IFR) rate for children and adolescents was 0.0003% (nearly zero).

In those aged 60-69, the IFR was 0.5% 

In age groups 70+ years, the IFR varies from 1-5% depending on comorbidities and treatment access. 

In Sweden, where 1.8 million children were allowed to freely attend school in 2020, zero COVID-19 deaths were recorded by summer 2021.

What did the trials reveal about overall all-cause mortality?

“After carefully analyzing the all-cause mortality in the Pfizer and Moderna trials, Benn and colleagues found 61 deaths total (31 in vaccine, 30 in placebo) and a mortality RR of 1.03 (0.63-1.71), comparing the vaccinated to placebo. These findings can be interpreted as “no significant difference” or no gold-standard evidence showing these mRNA vaccines reduce mortality. The lack of significant differences in deaths between the study arms is noteworthy”.

Even the six-month Pfizer trial failed to show any reduction in all-cause mortality. A reanalysis of the post-marketing data provided to the FDA suggests the opposite effect.

The public was never allowed access to the registrational trials’ raw data, thus precluding independent verification of adverse events by the scientific community. These were revealed later, after widespread distribution of the inoculations. Such secrecy enabled the industry to more easily present an inflated and distorted estimate of the genetic injections’ benefits and a gross underestimation of potential harms.

Federal officials said the COVID-19 mRNA vaccines were “safe and effective.” They often added that the products were “95% effective against the infection”. Later studies revealed that any protective benefit was short-lived, with immunity waning after only a few months.

“The final analysis of the NIH study, comparing benefits to harms, reveal that more lives are lost than saved by the full course of Pfizer mRNA vaccinations.”

While the physical and mental harms perpetrated on an unsuspecting public have been enormous, the societal harms, from the quarantines, loss of jobs, and loss of schooling for children, will never be fully evaluated. The pandemic vaccine rollout represents a tremendous loss to public health and has compromised our trust in government to protect us. What have we learned from this lesson?

Pauli Halstead