A leading expert has warned the public that government officials and pharmaceutical companies bypassed “laws and regulations” that are in place to protect Americans when Covid mRNA shots were rolled out for public use.
The warning comes from a new analysis on the creation of the mRNA shots by Debbie Lerman, a graduate of Harvard and retired science writer.
Lerman uncovered evidence showing that the vaccines, that were purported to help victims fight the COVID-19 virus, were imposed on Americans by bypassing all of the “laws or regulations that we count on to protect us from potentially harmful, or deadly, medical products…”
In a report on her analysis, Lerman charges:
“The COVID-19 mRNA vaccines were acquired and authorized through mechanisms designed to rush medical countermeasures to the military during emergencies involving weapons of mass destruction (WMD).”
“These mechanisms did not require the application of, or adherence to, any laws or regulations related to vaccine development or manufacturing,” she adds.
“The Food and Drug Administration’s (FDA) Emergency Use Authorization for the vaccines was based on clinical trials and manufacturing processes conducted with no binding legal standards, no legally prescribed safety oversight or regulation, and no legal redress from the manufacturer for potential harms. (This last point is being challenged in multiple court cases, so far to no avail.)”
In the aftermath of Covid, there has been confirmed an epidemic of people dying “suddenly” or “unexpectedly.”
There are epidemics of heart-related deaths, caused by myocarditis or pericarditis, and “turbo cancers.”
The government’s own data from the Centers for Disease Control and Prevention’s (CDC) VAERS database shows spikes in heart problems among the young and soaring injuries and deaths among the vaccinated.
“What all of this means is that none of the laws or regulations that we count on to protect us from potentially harmful, or deadly, medical products was applied to the COVID-19 mRNA vaccines,” Lerman warns.
“The assertion of ‘safe and effective’ was based entirely on the aspirations, opinions, beliefs, and presumptions of government employees.”
Lerman wrote that the government signed a contract with Pfizer to produce 100 million doses of a “vaccine to prevent COVID-19.”
The deal was worth $1.95 billion.
Additional doses also were contemplated.
The analysis explains that this contract was not normal, but it occurred during the pandemic, which was not in normal times.
“The government declared that we were ‘at war’ with a catastrophically dangerous virus that would kill millions and millions of people of all ages unless we could develop ‘medical countermeasures’ (a military term) and get everyone to take them as quickly as possible,” Lerman notes.
She explained on the government’s side of the deal, it was the Department of Defense that made the deal, and its organizations that “are charged exclusively with military objectives.”
“This is crucial because the laws and procedures governing military procurement have a very different set of assumptions and cost-benefit considerations than those used in civil society,” she wrote.
“In fact, agencies governing civilian and public health, such as the National Institutes of Health, the National Institute of Allergy and Infectious Diseases, and the Department of Health and Human Sevices (HHS), do not have the authority to grant certain types of special acquisition contracts, which is why the COVID-19 vaccine contracts had to be overseen by the DOD.”
To push the injection through for public use, the government used an “Other Transaction Agreement” (OTA) process that involves procedures that operate “outside the Federal Acquisition Regulations.”
That means standard requirements for competition, accounting, cost management, records, and more simply don’t apply.
Also rules regarding research on people, and privacy laws.
The analysis confirms that the specific OTA for Pfizer was set up to have the government pay Pfizer “to show that it can manufacture 100 million doses of a never-before produced or tested product, while also acquiring those 100 million doses, and potentially hundreds of millions more.”
Regarding the regulatory oversight of the development and manufacturing processes, the analysis revealed contract notes:
“Pfizer will meet the necessary FDA requirements for conducting ongoing and planned clinical trials, and with its collaboration partner, BioNTech, will seek FDA approval or authorization for the vaccine, assuming the clinical data supports such application for approval or authorization.”
According to the rules, “an emergency use authorization can be granted by the Food and Drug Administration once HHS and/or the DOD have declared that there is an attack, threat of an attack, or national security threat created by a CBRN agent (a weapon of mass destruction).”
However, that emergency authorization wasn’t intended to cover new vaccines, a Harvard Law article notes.
Lerman’s analysis points out:
“Here’s the kicker about EUA: because it was intended to be issued only in war and WMD-related emergencies, there are no legal requirements for how it is issued, beyond the determination of the FDA that such authorization is appropriate.
“There are no legal standards for how clinical trials are conducted.
“There are no laws regulating the manufacturing processes.
“There are only ‘reasonable beliefs’ based on whatever evidence is available to the FDA at the time that it makes its determination.”
Nevertheless, federal law protects those providers from lawsuits over injuries their experimental vaccines cause.
“This is provided by the PREP (Public Readiness and Emergency Preparedness) Act, which was designed to go hand in hand with EUA,” the analysis highlights.
“Again, it is possible to envision a bioterrorism scenario, such as an anthrax attack, in which the government needs to get lots of countermeasures very quickly.
“Many people will inevitably die in the attack, but if there’s a chance that the countermeasure will work, it needs to get made and distributed as quickly as possible.
“If it has some bad side effects, or even if it kills some people, one could argue that the manufacturer should not be held liable.”
The analysis concludes that this process was not intended to apply to untested shots for public use.
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