Cohort study to evaluate effect of vitamin D, magnesium, and vitamin B12 in combination on severe outcome progression in older patients with coronavirus (COVID-19)
Use of a combination of vitamin D, magnesium, and vitamin B12 (DMB) in patients with coronavirus disease (COVID-19) was studied.
Fewer patients ≥50 y of age with COVID-19 on DMB suffered clinical deterioration.
Further studies are warranted to ascertain the full benefit of DMB in patients with COVID-19.
Abstract
Objectives
The aim of this study was to determine clinical outcomes of older patients with coronavirus (COVID-19) who received a combination of vitamin D, magnesium, and vitamin B12 (DMB) compared with those who did not. We hypothesized that fewer patients administered this combination would require oxygen therapy, intensive care support, or a combination of both than those who did not.
Methods
This was a cohort observational study of all consecutive hospitalized patients ≥50 y of age with COVID-19 in a tertiary academic hospital. Before April 6, 2020, no patients received the (DMB) combination. After this date, patients were administered 1000 IU/d oral vitamin D3, 150 mg/d oral magnesium, and 500 mcg/d oral vitamin B12 upon admission if they did not require oxygen therapy. Primary outcome was deterioration leading to any form of oxygen therapy, intensive care support, or both.
Results
Between January 15 and April 15, 2020, we identified 43 consecutive patients ≥50 y of age with COVID-19. Seventeen patients received DMB before onset of primary outcome and 26 patients did not. Baseline demographic characteristics between the two groups were significantly different by age. In univariate analysis, age and hypertension had a significant influence on outcome. After adjusting for age or hypertension separately in a multivariate analysis, the intervention group retained protective significance. Fewer treated patients than controls required initiation of oxygen therapy during hospitalization (17.6 vs 61.5%, P = 0.006). DMB exposure was associated with odds ratios of 0.13 (95% confidence interval [CI], 0.03–0.59) and 0.20 (95% CI, 0.04–0.93) for oxygen therapy, intensive care support, or both on univariate and multivariate analyses, respectively.
Conclusions
A vitamin D / magnesium / vitamin B12 combination in older COVID-19 patients was associated with a significant reduction in the proportion of patients with clinical deterioration requiring oxygen support, intensive care support, or both. This study supports further larger randomized controlled trials to ascertain the full benefit of this combination in ameliorating the severity of COVID-19.
Not only is remdesivir ineffective, it’s toxic and a group of attorneys representing the families of patients who claim their loved ones were injured or killed after being administered Remdesivir for covid are suing hospitals.
Remdesivir Gets FDA Approval, but WHO Says Drug Ineffective for COVID
By Jeremy Loffredo
As far back as April, U.S. National Institute of Allergy and Infectious Diseases (NIAID) Director Dr. Anthony Fauci was touting Gilead’s antiviral remdesivir as “the standard of care for patients with COVID-19.”
Remdesivir is the only antiviral authorized in the U.S. to treat COVID and is also authorized for use in roughly 50 countries. Yet the drug has absolutely no effect on a COVID patient’s chances of survival,according to recent data from the World Health Organization (WHO).
Starting in March 2020, WHO’s Solidarity Trial followed 11,266 adults in 30 countries to study the effects on COVID of four antivirals: remdesivir, hydroxychloroquine, lopinavir, and interferon. On Oct. 15, WHO reported that remdesivir not only failed to produce any measurable benefit in terms of mortality reduction, but that it also didn’t reduce the need for ventilators, or the length of hospital stays.
After WHO issued its report, remdesivir’s manufacturer, Gilead, was quick to point out that the Solidarity Trial hasn’t been peer reviewed or published in a scholarly journal. In a statement, the company said: “It is unclear if any conclusive findings can be drawn from the study results.”
Gilead also called attention to an earlier trial by the NIAID, which showed remdesivir to reduce the duration of one’s hospital stay from 15 days to 10 days (median). Yet while this study was ongoing, NIAID researchers changed the study’s primary outcome from mortality to recovery length.
Still, citing the “promising results” of this NIAID study, the U.S. Food and Drug Administration (FDA) in May issued an emergency use authorization to Gilead for remdesivir.This allowed remdesivir to be distributed throughout the country without formal FDA approval.
Gilead is now marketing remdesivir under the brand name Veklury, which was recently projected to generate $3 billion in sales for the drugmaker in the upcoming year. Numerous governments already pre-ordered the drug in July, and the U.S. Department of Health and Human Services (HHS) purchased500,000 treatment courses.
U.S. taxpayers covered some of the research and development costs for Veklury, to the tune of $70.5 million.
On Oct. 1, the FDA revised the Emergency Use Authorization (EUA) for Veklury, withdrawing government responsibility for the drug’s allocation, leaving Gilead responsible for its distribution and U.S. hospitals responsible for its purchase.
But the cost of the drug hasn’t changed in the transition from government allocation to commercial sales. Medicare does not reimburse directly for remdesivir, and one five-day treatment course costs more than $3,000 for U.S. patients with private insurance and more than $2,000 for government purchasers like the Department of Veterans Affairs.
This high price stands in stark contrast to that of another antiviral, hydroxychloroquine, which costs 30 cents a pill. Hydroxychloroquine, FDA-approved since 1955, is far safer than most popular over-the-counter drugs like Tylenol and aspirin. Physicians can prescribe it for any off-label use and the Centers for Disease Control and Prevention deems the drug safe for pregnant women, breastfeeding women, children, elderly patients, immunocompromised patients and healthy persons of all ages.
Since the beginning of the COVID pandemic, dozens of new studies have demonstrated the effectiveness of hydroxychloroquine and its first cousin, chloroquine, against COVID. These studies occurred in China, France, Saudi Arabia, Italy, India, New York and Michigan. However, such proof of hydroxychloroquine’s benefit to patients with COVID has posed an existential threat to Gilead sales throughout the COVID outbreak.
Under federal law, new treatments do not qualify for emergency use authorization if an FDA-approved treatment exists for the same disease. If hydroxychloroquine had been shown to be effective in COVID patients, Gilead, along with other companies making therapeutics and vaccines for COVID, could not have been granted EUA. The companies would have had to complete standard safety testing and await FDA approval — meaning less profits, longer runways to market, and an end to the lucrative COVID vaccine gold rush.
As Dr. James Todaro wrote in OmniJournal, “Perhaps no other company has more to gain in the immediate future from hydroxychloroquine’s failure than Gilead.”
In June, French epidemiologist Didier Raoult testified to the French Parliament that after being vocal about the possibility that hydroxychloroquine could reduce mortality for COVID patients, he began to receive death threats from a scientist working for Gilead. Raoult and his team in Marseille have used hydroxychloroquine on more than 4,000 patients, reporting a mortality rate of about 0.8%.
The U.S. government’s preferential treatment of Gilead has been transparent. For the past half a year, U.S. national authorities have championed remdesivir while discrediting the use of hydroxychloroquine as a cheaper alternative.
“Right now, today, the cumulative scientific data that has been put together and done over a number of different studies have shown no efficacy,” Fauci said of hydroxychloroquine in July. “[Remdesivir] does work,” said White House Coronavirus Task Force Coordinator Deborah Birx. “The President has been very clear and given me very clear direction to get that out to every single state.”
In April Fauci said: “The data shows that remdesivir has a clear-cut, significant, positive effect.”
When Fauci was asked about a Chinese study published in the Lancet which concluded remdesivir failed to help COVID-19 patients, Fauci criticized it, calling it “underpowered” and “not an adequate study,” despite the fact that the Chinese study was published and peer reviewed, and his NIH study was ongoing, neither published or peer reviewed.
Bill Gates, who has emerged as an unofficial national authority onthe pandemic, has weighed in on several occasions, both dismissing hydroxychloroquine and promoting remdesivir. In August, Gates told Wired Magazine that if he were infected with COVID, he would want to be prescribed remdesivir.
Gates didn’t mention during this interview that his foundation owns more than $1.3 million in Gilead stock and more than $3.2 million in Gilead bonds, according to the drugmaker’s most recent U.S. Securities and Exchange Commission filing.
According to the latest update to the NIH COVID webpage, the Treatment Guidelines Panel still recommends doctors give remdesivir to certain hospitalized patients. Since the beginning of the pandemic, as many as 81%of the people on this panel who declared financial conflicts of interest were taking money from Gilead. So far, the NIH panel hasn’t yet updated its recommendation based on the new data from the WHO.
Watch Robert F. Kennedy, Jr., chairman of Children’s Health Defense, discuss this topic on RT America:
Jeremy Loffredo is a reporter for Children’s Health Defense.
Sign up for free news and updates from Robert F. Kennedy, Jr. and the Children’s Health Defense. CHD is implementing many strategies, including legal, in an effort to defend the health of our children and obtain justice for those already injured. Your support is essential to CHD’s successful mission.
The following article also points out an ugly conflict of interest web between Gilead, the manufacturer of Remdesivir and UNITAID which Soros, Gates, and the Clinton Health Access Initiative, are large investors – with Drs. Fauci and Birx associated with the Clinton Health Access initiative. And of course, Dr. Fauci has worked with Gilead for a long, long time. Government employees should not be allowed to have financial ties to manufacturing companies and then turn around and make public health policy. https://principia-scientific.org/a-tale-of-2-drugs-deep-state-chose-money-power-over-lives/
Excerpt:
Approximately $70 million in U.S. taxpayer funding began Gilead’s partnership with the U.S. Army, Centers for Disease Control and Prevention (CDC) and National Institutes of Health (NIH) to develop remdesivir. Initially for treating Ebola, it failed to show benefit and was shelved. If remdesivir is used to treat COVID-19, Gilead shareholders, not the taxpayers, will profit.
Gilead’s own press release revealed the side effect of acute respiratory failure in 6% of patients in the remdesivir five-day treatment group, and 10.7% of patients in the 10-day treatment group, clearly ominous findings with a drug designed to treat respiratory failure caused by COVID-19.
Dr. Steven Nissen, a Cleveland Clinic cardiologist who has conducted dozens of clinical trials, explained to The New York Times:
“The disclosure of trial results in a political setting, before peer review or publication, is very unusual. Scientists will need to see figures on harms associated with the drug in order to assess its benefits. … This is too important to be handled in such a sloppy fashion.”
Going back to 1997, Donald Rumsfeld chaired the Board of Directors at Gilead and after 2001 he held share packages valued at $5-25 Million. Gilead originally developed Tamiflu.George P Shultz, US Secretary of State also was on the board. He sold stocks at a value of more than $7 million. CA governor’s Pete Wilson’s wife also sat on the board.
“‘I don’t know of any biotech company that’s’ so politically well-connected [as Gilead],‘ Andrew McDonald, of the analyst firm Think Equity Partners, told Fortune.” (Source: “Virus Mania, How the Medical Industry Continually Invents Epidemics Making Billion Dollar Profits At Our Expense”)
Background: Biomarkers to predict Coronavirus disease-19 (COVID-19) outcome early at infection are urgently needed to improve prognosis and treatment. Zinc balances immune responses and also has a proven direct antiviral action against some viruses. Importantly, zinc deficiency (ZD) is a common condition in elderly and individuals with chronic diseases, two groups with more severe COVID-19 outcomes. We hypothesize that serum zinc content (SZC) influences COVID-19 disease progression and thus might represent a useful biomarker.
Methods: We run a retrospective observational study with 249 COVID-19 patients admitted in Hospital del Mar. We have studied COVID-19 severity and progression attending to SZC at admission. In parallel we have studied SARS-CoV2 replication in the Vero E6 cell line modifying zinc concentrations.
Findings: Our study demonstrates a correlation between serum zinc levels and COVID-19 outcome. Serum zinc levels lower than 50 mcgg/dl at admission correlated with worse clinical presentation, longer time to reach stability and higher mortality. Our in vitro results indicate that low zinc levels favor viral expansion in SARS-CoV2 infected cells.
Interpretation: SZC is a novel biomarker to predict COVID-19 outcome. We encourage performing randomized clinical trials to study zinc supplementation as potential prophylaxis and treatment with people at risk of zinc deficiency.
_____________________
**Comment**
While this is awaiting peer review, it’s not a novel concept nor is it surprising; however, our public ‘authorities’ would rather rivet on mask wearing(which doesn’t work and gives a false sense of security), their expensive antiviral Remdesivir (which has been shown to be of little to no benefit), and their expensive, experimental vaccine(which has caused all sorts of side-effects already in human volunteers).
The best and safest approach is always prevention.
Please learn all you can on how to make your body a tough target for disease. Start by eating a whole-food diet, reducing your stress, getting adequate sleep, and exercising. Then, work with your medical practitioner to determine your imbalances/weaknesses and appropriately supplement using reputable products.
Caution: zinc is a fat-soluble vitamin and will build up in the body. Testing is needed to determine your level and how much to take.
These simple nutritional issues are what our ‘authorities’ should be educating the public on. The fact that they aren’t doing so reveals their true motive.
Despite the growing number of Lyme disease cases in the United States, many individuals still receive conflicting information and wonder: What is Lyme disease, how do you get it, what is the best treatment, and can it be cured?
Lyme disease is an infection caused by the bacteria Borrelia burgdorferi (Bb), a spiral-shaped organism. The bacterium can be transmitted to a person through the bite of an infected Ixodes scapularis tick (a.k.a., the deer tick or black-legged tick).
Borrelia burgdorferi bacteria is a type of spirochete that can penetrate virtually any organ or system in the body, including the brain and central nervous system, joints, muscles, and heart. This is why Lyme disease is often considered the “Great Imitator,” as it can cause symptoms that mimic many different disorders. Patients with Lyme disease may initially be misdiagnosed with multiple sclerosis (MS), fibromyalgia, chronic fatigue syndrome, lupus, rheumatoid arthritis, psychiatric disorders, among others.
A growing percentage of deer ticks are infected with Borrelia burgdorferi, along with other pathogens that can cause various diseases or co-infections. A study in Long Island, NY found that more than half (60%) of the deer ticks were infected with the Lyme disease bacteria, while dual infections were found in 19% of the ticks. ¹
Not all tick bites will lead to Lyme disease. But the longer an infected tick is attached the greater the chances are that it will transmit the disease or another tick-borne infection to an individual. Many reports indicate that a tick must be attached for at least 24 hours for it to transmit the bacteria. But this is debatable.
“There is no definitive window of time following a tick bite which we can quote to assure the public they are safe from acquiring the Borrelia spirochete.” ³ In referring to Lyme disease, the authors write, “transmission can occur in less than 16 hours, and the minimum attachment time for transmission of infection has never been established.” ³
Bacteria hides in tissue
The spirochete can be transmitted when the tick feeds on the blood of its host (person or animal). As it ingests blood, it also releases Borrelia burgdorferi bacteria into the bloodstream. The spirochete disseminates fairly rapidly throughout the body until they burrow into soft tissues and organs.
Borrelia burgdorferi spirochete can lie deep in the tissue and remain undetected by tests, yet still cause debilitating symptoms.
Who is most at risk?
Lyme disease is estimated to impact at least 300,000 people annually in the United States. Older individuals and children are the most at-risk. According to the Centers for Disease Control and Prevention (CDC) adults, ages 45 to 54 years and children, 5 to 14 years old reportedly have the highest infection rates.
Anyone can get Lyme disease, however. No one is immune. Even if a person has had Lyme disease, they can get the disease again following a new infection or tick bite.
People who spend time outdoors (hiking, gardening, camping, working) are particularly vulnerable since they are exposed to ticks. Interestingly, one study found that ticks prefer feeding on individuals with Type A blood.[4] But more research is needed in this area.
The majority of cases occur in the Northeast, and Upper Midwest, according to the CDC. But Lyme disease cases have been reported in all 50 states and the disease appears to be spreading to other regions of the country, as global warming enables ticks to migrate to new territories.
When was Lyme disease discovered?
Lyme disease appears to have been around since the Ice Age. Researchers came to this conclusion after discovering and examining the tissue of a 5,300-year-old male who had been frozen in a glacier pool in the Italian Alps. The frozen mummy (dubbed the Iceman or Otzi) appears to have had the oldest known case of Lyme disease, according to genetic analysis.
But scientists first identified Lyme disease in 1977 in a group of children and adolescents living in Lyme, Connecticut. The children suffered from recurrent attacks of asymmetric swelling and pain in several large joints, particularly in the knee. They were initially diagnosed with juvenile rheumatoid arthritis.
Several years later in 1982, Dr. Willy Burgdorfer discovered the presence of spirochetes (later named Borrelia burgdorferi) in ticks from the endemic region and determined this to be the causative agent behind Lyme disease.
References:
Sanchez-Vicente S, Tagliafierro T, Coleman JL, Benach JL, Tokarz R. Polymicrobial Nature of Tick-Borne Diseases. MBio. 2019 Sep 10;10(5). https://mbio.asm.org/content/10/5/e02055-19
Eisen L. Pathogen transmission in relation to duration of attachment by Ixodes scapularis ticks. Ticks Tick Borne Dis. 2018. https://pubmed.ncbi.nlm.nih.gov/29398603/
Shih CM, Telford SR, 3rd, Pollack RJ, Spielman A. Rapid dissemination by the agent of Lyme disease in hosts that permit fulminating infection. Infect Immun, 61(6), 2396-2399 (1993). https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4278789/
Zakovska A, Janecek J, Nejezchlebova H, Kucerova HL. Pilot study of Ixodes ricinus ticks preference for human ABO blood groups using a simple in vitro method. Ann Agric Environ Med. 2018;25(2):326-328. https://pubmed.ncbi.nlm.nih.gov/29936803/
A new COVID vaccine court, which includes compensation for covered “countermeasures” for COVID-19, such as a vaccine, has been established by the federal government
Not only will pharmaceutical companies developing and marketing COVID-19 vaccines be shielded from what should be their liability in the civil court system, but federal compensation will likely be difficult to obtain, as it is in the existing vaccine court created under the National Childhood Vaccine Injury Act of 1986
The establishment of a preemptive COVID vaccine court could be a sign that the government foresees many lawsuits related to this fast-tracked vaccine in the near future
The expansion of a 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”
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,”1is 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
up to $483 million for Moderna’s COVID-19 vaccine
up to $1.2 billion available for AstraZeneca’s COVID-19 vaccine8
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 placebois 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.”
