New Court Created for COVID Vaccine Injuries

Buried in the March 17, 2020, Federal Register — the daily journal of the U.S. government — in a document titled, “Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19,”1 is language...

New Court Created for COVID Vaccine Injuries

Buried in the March 17, 2020, Federal Register — the daily journal of the U.S. government — in a document titled, “Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19,”1 is language that establishes a new COVID-19 vaccine court — similar to the federal vaccine court that already exists for injuries and deaths caused by federally recommended vaccines for children and pregnant women.

The U.S. vaccine industry operates under a liability shield unlike any other in existence. In most cases, if a product injures or kills a person, its manufacturer can be held accountable in a civil court of law. With FDA-licensed and CDC-recommended vaccines, however, this is not the case.

In the U.S., there is a federally operated vaccine injury compensation program (VICP) that Congress created under the National Childhood Vaccine Injury Act of 1986. The U.S. Court of Federal Claims in Washington, D.C., handles contested vaccine injury and death cases in what has become known as "vaccine court."

The newly established COVID-19 vaccine court appears largely the same, except instead of focusing on injuries or deaths related to the recommended vaccines for children and pregnant women, it will be centered on those stemming from a new COVID-19 vaccine.

Just for Those Injured or Killed by a COVID ‘Countermeasure’

Journalist Jon Rappoport highlighted the section in the document, which reveals the establishment of the new COVID vaccine court, which includes compensation for covered “countermeasures” for COVID-19, such as a vaccine:2,3

“Countermeasures Injury Compensation Program … Section 319F-4 of the PHS Act, 42 U.S.C. 247d-6e, authorizes the Countermeasures Injury Compensation Program (CICP) to provide benefits to eligible individuals who sustain a serious physical injury or die as a direct result of the administration or use of a Covered [COVID] Countermeasure [e.g., a vaccine].

Compensation under the CICP for an injury directly caused by a Covered Countermeasure is based on the requirements set forth in this Declaration, the administrative rules for the Program, and the statute. To show direct causation between a Covered Countermeasure and a serious physical injury, the statute requires ‘compelling, reliable, valid, medical and scientific evidence.’”

At face value, it sounds reasonable to establish a way for those who are injured by what will inevitably be a fast-tracked experimental vaccine to be compensated. However, not only will the vaccine makers be shielded from what should be their liability, but compensation will likely be difficult to obtain, as it is in the existing vaccine court. Rappoport wrote:4

“A quick piece of important history. In the mid-1980s, vaccine manufacturers were facing a blizzard of law suits from parents of vaccine-injured children. The very nervous manufacturers told the government they were going to get out of the vaccine business. The financial hit was going to be too deep.

The government said WAIT. Meetings were held. A plan was devised. A law was passed exempting the manufacturers from financial liability. Instead, for any of the recommended childhood vaccines, parents had to go to a government court to file a claim for compensation, after their children had been injured or killed by a vaccine.

And the government made this court a VERY tough place to win compensation. That’s the precise model for this new COVID vaccine court. And it’s based on the same unstated confession that existed in the 1980s: there are MANY vaccine injuries.”

Is the Government Expecting Significant Vaccine Injuries?

Is the establishment of a preemptive COVID vaccine court a sign that the federal government foresees many lawsuits related to this fast-tracked vaccine in the near future? Rappoport thinks so. “Bottom line,” he says, “the government expects many COVID vaccine injuries. That’s what they aren’t saying. They’re just preparing. With a new vaccine court. To handle injury and death of children and adults. That should not give you a warm secure feeling. Quite the opposite.”5

You may also be interested in “Operation Warp Speed,”6 which is a partnership among U.S. health organizations, including the Centers for Disease Control and Prevention, the Food and Drug Administration, the National Institutes of Health, the Department of Defense (DoD) and others. Its goal is to produce and deliver 300 million doses of “safe and effective vaccines” with the initial doses being rolled out by January 2021.

Operation Warp Speed is part of a broader strategy aimed at accelerating the development, manufacture and distribution of COVID-19 vaccines, therapeutics and diagnostics, which collectively are known as countermeasures (the same countermeasures referred to in the Federal Register document).7

So far, as part of Operation Warp Speed, the U.S. Department of Health and Human Services has supplied $456 million in funds for Johnson & Johnson’s candidate vaccine and made available up to $483 million for Moderna’s COVID-19 vaccine and up to $1.2 billion available for AstraZeneca’s COVID-19 vaccine.8

Severe Adverse Events Already Seen With Moderna’s Vaccine

Moderna partnered with the National Institute of Allergy and Infectious Diseases (NIAID) headed by Dr. Anthony Fauci to create its vaccine. In February 2020, its stock price increased 78.1% when it announced that its messenger RNA vaccine was ready for clinical trials.9 “The company's CEO has become a new billionaire overnight,” wrote Barbara Loe Fisher, co-founder and president of the National Vaccine Information Center (NVIC).

It began human trials of its experimental mRNA vaccine in March 2020, and its stock soared again in May, hitting $29 billion, even though the company currently doesn’t sell any products,10 when it released early results from its Phase 1 study of 45 healthy volunteers between the ages of 18 and 55 — the first released from a study involving human volunteers.

Moderna’s press release11 stated that 25 participants who received two doses of its low or medium dose vaccine had levels of binding antibodies — the type that are used by the immune system to fight the virus but do not prevent viral infections — at levels approximating or exceeding those found in the blood of patients who recovered from COVID-19.12

Data for the more significant neutralizing antibodies, which stop viruses from entering cells, was reported for only eight people, with Moderna stating that levels in each of these initial participants met or exceeded antibody levels seen in recovered COVID-19 patients.

Four study subjects experienced a “Grade 3” adverse event, which is described by the U.S. Department of Health and Human Services as “severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; limiting self-care” such as “bathing, dressing and undressing, feeding self, using the toilet, taking medications.”13

During Phase 2 trials, 600 people will receive the vaccine, while the expanded Phase 3 trial began July 27, 202014 — an unprecedented move in terms of typical vaccine development timelines. Signs of trouble continue to mount, including reports that Moderna has no legal rights to a key patent for its vaccine delivery system, and that company executives have been dumping their stocks.

AstraZeneca Halted Vaccine Trials Due to Side Effects

As part of Operation Warp Speed, AstraZeneca agreed to make available at least 300 million doses of their experimental COVID-19 vaccine for the U.S., according to HHS, “with the first doses delivered as early as October 2020.”15 A large-scale Phase 3 clinical trial began on August 31, 2020, but was temporarily halted September 8 after “a suspected serious and unexpected adverse reaction” in a British participant.16

The participant reportedly suffered from transverse myelitis, which is inflammation of the spinal cord, and related neurological symptoms.17 Transverse myelitis has previously been linked to vaccination.18 By September 15, 2020, AstraZeneca had resumed clinical trials of its COVID-19 vaccine in the U.K.,19 but trials remained on hold in the U.S. as of October 1, where the FDA is investigating the patient’s “unexplained illness.”20

Results from AstraZeneca’s Phase 1 and 2 studies also revealed side effects, including fatigue, headache, malaise, chills and fever, in a significant number of participants:21

“Fatigue and headache were the most commonly reported systemic reactions. Fatigue was reported in the ChAdOx1 nCoV-19 [COVID-19 vaccine] group by 340 (70%) participants without paracetamol and 40 (71%) with paracetamol and in the MenACWY [meningococcal conjugate vaccine, which acted as a control] group by 227 (48%) participants without paracetamol and 26 (46%) with paracetamol, whereas headaches were reported in the ChAdOx1 nCoV-19 group by 331 (68%) participants without paracetamol and 34 (61%) with paracetamol and in the MenACWY group by 195 (41%) participants without paracetamol and 21 (37%) participants with paracetamol.

Other systemic adverse reactions were common in the ChAdOx1 nCoV-19 group: muscle ache (294 [60%] participants without paracetamol and 27 [48%] with paracetamol), malaise (296 [61%] and 27 [48%]), chills (272 [56%] and 15 [27%]); and feeling feverish (250 [51%] and 20 [36%]).

In the of ChAdOx1 nCoV-19 group, 87 (18%) participants without paracetamol and nine (16%) participants with paracetamol reported a temperature of at least 38°C, and eight (2%) patients without paracetamol had a temperature of at least 39°C.”

The fact that the COVID-19 vaccine was tested against another vaccine instead of a true placebo is also in and of itself problematic, as trying to measure safety of a vaccine against the safety profile of another vaccine that can also cause side effects can yield skewed results.

Vaccine Makers Have Nothing to Lose

The expansion of federal vaccine court to include makers of experimental COVID-19 vaccines allows the irresponsible sale and marketing of vaccines that have been poorly tested and formulated because the manufacturers have no liability and "nothing to lose." Ruud Dobber, a senior AstraZeneca member, even told Reuters that fast-tracking a COVID-19 vaccine to market necessitates that makers be shielded from liability:22

"This is a unique situation where we as a company simply cannot take the risk if in … four years the vaccine is showing side effects. In the contracts we have in place, we are asking for indemnification. For most countries it is acceptable to take that risk on their shoulders because it is in their national interest.”

As noted, it’s via the Public Readiness and Emergency Preparedness (PREP) Act, passed in the U.S. in 2005, that the U.S. has established the new COVID vaccine court, to secure freedom from liability for manufacturers of COVID-19 vaccines. Children injured by vaccines are supposed to be able to receive swift and just compensation from the existing federally operated vaccine injury compensation program (VICP) created in 1986 under the National Childhood Vaccine Injury Act.

However, this program was gutted by Congressional amendments and by the HHS and Department of Justice under rule making authority within years of the 1986 law's enactment and has only gotten worse over the years, again protecting vaccine manufacturers' interests more than anything else.

If and when a COVID-19 vaccine is rolled out, even with all the potential pitfalls remaining — for instance, the vaccines are relying on novel mRNA technology that has never been used in vaccines before23 — be aware that the vaccine makers have nothing to lose by marketing their experimental shots, even if they cause serious injury and death. As Rappoport’s tongue-in-cheek statement suggests:24

“‘We know — and don’t ask us how — that millions of you are going to get headaches. To prevent that, we’re going to hit all of you on the head with a very heavy sledgehammer. If, ahem, a few of you happen to sustain an injury or die, we have a court where your relatives can try to get money out of us. By the way, in this court, we’ll do everything we can to deny you money. Good luck.’

Yes, the government knows exactly what’s coming when they approve a COVID vaccine. And now, so do you.”




 Comments (1)