Pfizer Documents Reveal Govt Authorities and Pfizer knew COVID Vaccine caused Vaccine-Associated Enhanced Disease
/From [HERE] Confidential Pfizer documents that the U.S. Food and Drug Administration has been forced to publish by Court Order, confirm that both Pfizer and the FDA knew Vaccine-Associated Enhanced Disease was a possible consequence of the mRNA Covid-19 injections.
They also reveal that they received evidence of it occurring, including several deaths, but swept it under the carpet and claimed “no new safety issues have been raised”.
The consequences of this cover-up are now being realised in official Government data that strongly suggests the fully vaccinated population have been suffering Antibody-Dependent Enhancement since the beginning of 2022.
With figures showing the fully jabbed are up to 2 times more likely to be hospitalised with Covid-19, and 2 to 3 times more likely to die of Covid-19.
Before we dive into the Pfizer documents, let’s take a look at the real-world consequences of Medicine Regulators and Pfizer ignoring the fact the Covid-19 injections have the ability to cause Vaccine-Associated Enhanced Disease.
Intensive research conducted by health experts throughout the years has brought to light increasing concerns about “Antibody-Dependent Enhancement” (ADE), a phenomenon where vaccines make the disease far worse by priming the immune system for a potentially deadly overreaction.
ADE can arise in several different ways but the best-known is dubbed the ‘Trojan Horse Pathway’. This occurs when non-neutralizing antibodies generated by past infection or vaccination fail to shut down the pathogen upon re-exposure.
Instead, they act as a gateway by allowing the virus to gain entry and replicate in cells that are usually off limits (typically immune cells, like macrophages). That, in turn, can lead to wider dissemination of illness, and over-reactive immune responses that cause more severe illness.
Here’s a short video of the Chief Medical Advisor to the U.S. President, Dr Anthony Fauci, explaining the undesirable consequence. In it he confirms it could be a possible danger of the Covid-19 injections and that this would not be the first time it has happened.
Unfortunately, it looks like ADE may now be occurring because of the Covid-19 injections; and it looks as if the UK Health Security Agency have been doing their best to hide it.
The Consequences
At the turn of the year the UK Health Security Agency (UKHSA) decided to stop publishing the case, hospitalisation and death rates for the double vaccinated, instead choosing to only publish the rates for the triple vaccinated in their weekly Covid-19 Vaccine Surveillance report.
The rates are calculated by dividing the total population size of each vaccination status group by 100,000; and then dividing the total number of cases, hospitalisations or deaths among each vaccinated group by the calculated figure.
e.g. – 3 million Double Vaccinated / 100k = 30
500,000 cases among double vaccinated / 30 = 16,666.66 cases per 100,000 population.
However, the UKHSA produces a separate report containing the overall population size by age group and vaccination status, meaning we can take these figures and actually calculate the hospitalisation and death rates per 100,000 among the double vaccinated ourselves.
Here’s the table taken from the Week 12 Influenza and Covid-19 Surveillance Report –
Now that we know the population size all we have to do is divide each population by 100,000; and then divide the number of hospitalisations and deaths by the answer to that equation, to calculate the hospitalisation and death rates.
Here’s a chart showing the number of Covid-19 hospitalisations among both the unvaccinated and double vaccinated in the Week 5, Week 9 and Week 13 UKHSA Covid-19 Vaccine Surveillance reports
[MORE]
CDC report Acknowledges 74.2 Million people have not had a single dose of a COVID Injection and 157 Million have refused a 2nd or 3rd dose
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From [DI] The American people have seen right through President Biden’s propaganda and lies on the effectiveness of the Covid-19 injections because according to CDC data, 70% of the entire population of the USA have not had either a first, second or third dose of the Covid-19 vaccine.
President Joe Biden has lied to the American people and is still lying to the American people. In July 2021, Biden falsely stated that “You’re not going to get COVID if you have these vaccinations,” and “If you’re vaccinated, you’re not going to be hospitalized, you’re not going to be in the ICU unit, and you’re not going to die.”
Then in December 2021, Biden falsely claimed “This is a pandemic of the unvaccinated. The unvaccinated. Not the vaccinated, the unvaccinated. That’s the problem. Everybody talks about freedom and not to have a shot or have a test. Well guess what? How about patriotism? How about making sure that you’re vaccinated, so you do not spread the disease to anyone else.”
There is plenty of evidence out there that proves the above statements made by President Biden are outright lies (see here), but the most hilarious evidence of all must be the recent outbreak that occurred due to journalists and Government leaders attending the ‘Gridiron Dinner at the beginning of April 2022. An annual event in Washington DC.
All guests at the event were required to show proof of vaccination. A week later at least 72 of the 630 fully vaccinated/boosted guests tested positive for Covid-19.
But it would appear the majority of the American people can already see through President Biden’s lies without us needing to put the record straight. Because according to data published by the US Centers for Disease Control, 74.2 million Americans are still completely unvaccinated, and a further 157 million Americans have refused a second or third dose of the Covid-19 injection.
Meaning 50% of the entire country has potentially become wise to the propaganda and lies spouted by the American Government, Dr Anthony Fauci, and the mainstream media over the past two years.
Vax is Safe, Not Harming People? As stated, Fact Checkers are Coin Operated Liars Whoring for CrimethInc: A Study of 23 Million People Shows Risk of Myocarditis After COVID Vaccines
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From [CHD] A new study involving 23 million people proves a COVID-19 vaccine side effect — once labeled “misinformation” — is real.
So claimed comedian, writer and political commentator Jimmy Dore on the Monday episode of “The Jimmy Dore Show.”
Dore examined an April 21 article in the U.K.’s Express, “Vaccine Study of 23 Million Shows Risk of ‘Heart Problems’ from Moderna or Pfizer Jab.”
The article reported on an investigation published online in JAMA Cardiology on April 20: “SARS-CoV-2 Vaccination and Myocarditis in a Nordic Cohort Study of 23 Million Residents.”
The JAMA study vindicates commentators who discussed connections between heart problems and the COVID-19 vaccines months or even years ago — and who were dismissed or vilified, said Dore.
Podcaster Joe Rogan, for instance, was harshly criticized and accused of spreading “misinformation” when he first discussed the vaccine-myocarditis connection.
But according to the study, “both first and second doses of mRNA vaccines were associated with increased risk of myocarditis and pericarditis. For individuals receiving 2 doses of the same vaccine, risk of myocarditis was highest among young males (aged 16-24 years) after the second dose.”
Specifically, among young men receiving two doses of the same vaccine, between four and seven excess myocarditis and pericarditis events occurred in 28 days per 100,000 vaccinees after the second dose of the Pfizer vaccine, and between nine and 28 excess myocarditis and pericarditis events occurred per 100,000 vaccinees after the second dose of the Moderna vaccine.
The study concluded, “The risk of myocarditis in this large cohort study was highest in young men after the second SARS-CoV-2 vaccine dose” and recommended, “this risk should be balanced against the benefits of protecting against severe COVID-19 disease.”
Myocarditis is inflammation of the heart muscle that can lead to cardiac arrhythmia and death. Pericarditis is inflammation of the tissue surrounding the heart that can cause sharp chest pain and other symptoms. The Defender has featured stories of people developing myocarditis and pericarditis after COVID-19 vaccinations.
Dore pointed out that Denmark in October 2021 suspended administration of the Moderna vaccine to people younger than 18, while Sweden did the same for people under 30.
Dore also recalled the days when Kamala Harris and Joe Biden expressed hesitancy about vaccination when then-president Donald Trump endorsed it.
When people form an opinion about the vaccines based on the political climate, not on data, it shows they are either wedded to their fear or disingenuous, he said.
Utility Companies [elite whites] Have Disconnected the Electricity of More than 3.5 Million Homes Since the Plandemic, while shareholder returns and executive compensation have skyrocketed
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From [HERE] Electric utilities have disconnected U.S. households more than 3.5 million times since the beginning of the COVID-19 pandemic, while shareholder returns and executive compensation have skyrocketed, according to Powerless in the Pandemic 2.0, a new report from the Center for Biological Diversity and BailoutWatch.
The massive wave of power shutoffs preceded Russia’s war on Ukraine, which has led to high volatility in fossil gas prices that may put more families at risk of disconnection.
Changes in gas prices generally pass through to utility customers rather than utilities, according to the U.S. Energy Information Administration.
“It’s appalling that millions of families in the United States have lost electricity while utility oligarchs reap huge windfall payouts,” said Jean Su, director of the Center for Biological Diversity’s energy justice program. “Russia’s war on Ukraine has only heightened household energy fragility and put more folks at risk. This moment is a clarion call to the federal government to reform the broken utility power sector, which relentlessly puts profits over people and the planet.”
“Utility companies are deliberately prolonging their dependence on fossil fuels and passing volatile fuel prices on to consumers,” said Chris Kuveke, data analyst at BailoutWatch and principal of Tiger Moth LLC. “Our research shows that millions of Americans are disconnected when they can’t pay their monthly electric bills, while these utilities pass windfall profits to shareholders and executives through dividends and bonuses.”
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The report’s key findings:
Households had their power shut off more than 3.6 million times between January 2020 and December 2021, with an increase of 79% between 2020 and 2021.
A 12-member Hall of Shame — including utility holding companies NextEra Energy (parent of Florida Power & Light), Duke Energy, Southern Company (parent of Georgia Power), Exelon (parent of Pepco), and DTE — perpetrated 87% of all documented disconnections. These companies shut off customers more than 3 million times in 2020 and 2021 while increasing shareholder payouts by $1.9 billion, or 13%. Those shareholder payout increases could have forgiven the unpaid bills five times over.
Eight Hall of Shame companies laid off employees while increasing executive compensation by an average of 24%.
Five states accounted for 69% of all disconnections: Florida, Georgia, Indiana, Pennsylvania and Illinois.
Only 33 states and Washington, D.C., require utilities to disclose disconnections. There is no federal oversight to address this lack of transparency. Though this report presents the most exhaustive data set available, it covers a fraction of the people affected.
The House Energy and Commerce Committee recently demanded that top utility companies answer for their high customer shutoff rates during COVID-19.
In September 2021, the Center for Biological Diversity and BailoutWatch published “Powerless In the Pandemic: After Bailouts, Electric Utilities Chose Profits Over People,” which found that electric utilities had shut off the electricity of poor U.S. households nearly 1 million times during the first year of the COVID-19 pandemic, increasing the likelihood people would become sick and die.
A recent analysis by InfluenceMap showed that top private utilities have actively fought to obstruct climate policy that would rein in carbon pollution. Utility companies Southern Company and First Energy top the list for both high disconnection rates and actions taken against climate policy progress.
India Top Ct Rules the Right to Bodily Integrity Includes the Right to Refuse COVID Shots. Finds No Basis for Discriminatory Treatment of Unvaxed b/c They Don’t Pose Any Greater Risk to Spread COVID
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From [HERE] The Supreme Court of India Monday held that the right to bodily integrity of a person includes the right to refuse vaccination under Article 21 of the Indian Constitution.
The present writ petition was filed by Dr. Jacob Puliyel, a former member of the National Technical Advisory Group of Immunization. The petition challenged the constitutional validity of the vaccine mandates imposed by states like Delhi, Madhya Pradesh, Maharashtra and Tamil Nadu. The petitioner also raised issues of non-disclosure of vaccine trial data, improper collection and reporting of Adverse Events Following Immunisation (AEFIs) and vaccination of children.
The petitioner’s [low budget] case was limited however as it appeared to rest on scientific and newspaper articles as opposed to actual in court expert testimony directly from the doctors and researches themselves.
The Government also contended the ambit of judicial review on the present matter, and the court clarified that it can decide an issue if:
It violates articles of the Constitution;
It dehors the provisions of the Act and the regulations;
The delegatee has acted beyond its power of delegation; or
If the executive policy is contrary to the statutory or a larger policy.
The government has the authority to impose limits on individual rights in the name of public health, but those restrictions must fulfill the court’s three-part legality, genuine necessity and proportionality test established in the Puttaswamy decision.
The court found that mandatory vaccination imposed by various state governments and other authorities in the consideration of the COVID-19 pandemic is “not proportionate” because no sufficient evidence has been presented on the record to establish that the risk of COVID-19 virus transmission from unvaccinated people is higher than from vaccinated people. The court found it undisputed that
“an unvaccinated person does not pose a greater risk than a vaccinated person in terms of transmission of the infection.”
It also stated,
“neither the Union of India nor the State Governments have produced any material before this Court to justify the discriminatory treatment of unvaccinated individuals in public places by imposition of vaccine mandates.”
The court further ordered the Government to publish reports on AEFIs from the general public and physicians on a publicly accessible basis without jeopardising the privacy of those who report adverse events. Lastly, on the issue of vaccination of children, the court held that it won’t second guess the opinion provided by the experts and vaccination shall continue as per global standards and practices.
CDC finds majority of Americans have natural immunity against COVID
/From [HERE] A new CDC study shows that the record number of infections during the Omicron wave gave many Americans infection-induced immunity. Between December 2021 and February 2022, the estimated percentage of the U.S. population with infection-induced antibodies increased from 34% to 58% across all age groups. The largest increases were in children and adolescents (see figure below).
Here are the details from the CDC report:
During December 2021–February 2022, overall U.S. seroprevalence increased from 33.5% (95% CI = 33.1–34.0) to 57.7% (95% CI = 57.1–58.3).
Over the same period, seroprevalence increased from 44.2% (95% CI = 42.8–45.8) to 75.2% (95% CI = 73.6–76.8) among children aged 0–11 years and from 45.6% (95% CI = 44.4–46.9) to 74.2% (95% CI = 72.8–75.5) among persons aged 12–17 years. [Note the very high levels reached for children.]
Seroprevalence increased from 36.5% (95% CI = 35.7–37.4) to 63.7% (95% CI = 62.5–64.8) among adults aged 18–49 years, 28.8% (95% CI = 27.9–29.8) to 49.8% (95% CI = 48.5–51.3) among those aged 50–64 years, and from 19.1% (95% CI = 18.4–19.8) to 33.2% (95% CI = 32.2–34.3) among those aged ≥65 years.
Look at the figure below to more clearly see how the natural immunity increased for different age groups. [MORE]
James Clyburn and Maxine Waters are Among the Congressional Puppeticians Pressuring the FDA to Inject Infants and Children with Experimental, Deadly COVID Treatments
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From [HERE] There is probably no other single issue in American politics today that unites both Democrats and Republicans more than the topic of vaccines, and especially the topic of COVID-19 experimental “vaccines” and issuing as many emergency use authorizations (EUAs) as possible to inject as many people as possible with these deadly shots.
You cannot hold a political office at the federal level today if you are anti-vaccine. Being pro-vaccine and supporting Big Pharma is a requirement for both Democrats and Republicans who want to be elected, and it is the one issue that both previous U.S. President Donald Trump and current U.S. President Joe Biden agree on today.
A group of pro-child abuse and pro-attempted murder of babies and young children members of Congress are now pressuring the FDA to approve COVID-19 vaccines for babies and young children under the age of 5.
They are the members of the Select Subcommittee on the Coronavirus Crisis, originally setup in April of 2020 under then President Donald Trump, and they are upset that the FDA has not issued an EUA for babies and children under the age of 5 so that parents can attempt to murder and abuse their children with one of these deadly shots.
Even though most people in the U.S. have been eligible for COVID-19 vaccines and boosters for quite some time, children under 5 still don’t have vaccine options. Now, lawmakers are asking the FDA to lay out its plans in this age group—and address a perceived delay for Moderna’s product.
Yesterday, Congress’s Select Subcommittee on the Coronavirus Crisis sent a letter (PDF) to FDA Commissioner Robert Califf, M.D., requesting a briefing on the status of COVID-19 vaccines for the under 5 age group.
The letter comes after U.S. chief medical adviser Anthony Fauci, M.D., indicated on CNN that the FDA is considering holding off on reviewing Moderna’s vaccine candidate in order to authorize it at the same time as Pfizer’s to “not confuse people” with a staggered rollout, the lawmakers wrote. That could lead to a potential delay of several weeks for Moderna’s shot, they said.
Moderna reportedly plans to submit its vaccine for the under-5 age group by the end of April. Pfizer, for its part, is prepping a filing for June, the lawmakers wrote.
Congress is hopeful that the FDA briefing requested would provide scientific rationale for the potential Moderna delay. (Full article.)
These members of Congress are complicit with the criminal act of attempted murder against the nation’s babies and children, and I encourage everyone who reads this to contact them and let them know that they will be held accountable for their actions, if not in this life, then when they die and meet their Creator.
England’s National Health Service Data Shows that Only 5,115 People Died Solely Due to COVID. The Remaining 109k Deaths Occurred to Persons who Had Fatal Pre-existing Conditions such as Heart Disease
/From [HERE] The UK Government claims over 160,000 people have died of Covid-19 in England since March 2020, and they have used these claimed deaths to frighten people into compliance with ridiculous rules for the past two years.
But reports published by England’s National Health Service (NHS) reveal that as of 20th April 2022, just 5,115 people have died of Covid-19 in England since the alleged pandemic began.
And the same reports also reveal that Covid-19 deaths have increased by 176% compared to the number of alleged deaths that occurred prior to the first Covid-19 injection being administered in England. Is this what we would expect to see if the jabs are 95% effective at preventing death?
The NHS has been publishing a weekly report on the number of Covid-19 deaths to have occurred in England’s hospitals since the beginning of the alleged Covid-19 pandemic.
Heres the table taken from the ‘COVID-19 total deaths – weekly summaries’ report published 21st April 2022 –
The report shows us that the NHS claim 114,721 people have died in hospitals in England after testing positive for Covid-19 since March 2020. But what’s suprising here is the extremely low number of people who had no pre-existing conditions and have died of Covid-19 alone.
Of the 114,721 deaths just 5,115 have been solely attributed to Covid-19, and 109,606 deaths have occurred among people suffering with pre-existing conditions such as chronic kidney disease, chronic pulmonary disease, and heart disease among several others.
This equates to just 4.45% of all alleged Covid-19 deaths since March 2020 being solely due to Covid-19. Yet the UK Government claims over 150,000 people have died of Covid-19 in England within 28 days of a positive test since March 2020.
However, there is something else that is unusual about these figures that can only be realised once we look at the numbers in a historical report.
The first Covid-19 injection was administered in England on the 9th December 2020, and as we will all know through endless propaganda, it was claimed to be 95% effective at preventing infection, hospitalisation and death.
The claim that it was 95% effective at preventing infection is both deeply troubling and hilarious when you look at the Covid-19 case rates in England at the moment. Official data from the UK Health Security Agency shows the Covid-19 case-rates per 100,000 are highest among the triple vaccinated in all age groups.
The data actually shows Covid-19 vaccine effectiveness against infection has fallen to minus-391% among triple jabbed 60-69-year-olds, and between minus-298% and minus-324% among those aged 30 to 59.
All other age groups have also suffered a significant drop in vaccine effectiveness with figures showingall triple vaccinated adults now between 3 and 5 times more likely to be infected with Covid-19 than unvaccinated adults. [MORE]
Economics Professor at Michigan State University Estimates that COVID Injections Have Killed at Least 300,000 Americans
/How Many People Died from the Covid-19 Inoculation? An Estimate Based on a Survey of the United States Population (Working Paper)
By Mark Skidmore
Mark Skidmore is Professor of Economics at Michigan State University where he holds the Morris Chair in State and Local Government Finance and Policy. His research focuses on topics in public finance, regional economics, and the economics of natural disasters. Mark created the Lighthouse Economics website and blog to share economic research and information relevant for navigating tumultuous times.
Executive Summary
From [HERE] This paper examines potential fatalities and injuries from the Covid-19 inoculation using an online “Covid-19 Health Experiences Survey” administered to a representative sample of the US population. The sample is composed of 3,000 respondents balanced on age, gender, and income to the extent possible. The survey was administered in December 2021, collecting information regarding respondents’ experiences with the Covid-19 illness and the Covid-19 inoculations as well as Covid-19 health experiences within respondents’ social circles. The survey also collected respondent economic and demographic information. Using these data, I find the following:
Covid-19 inoculation-related fatalities:
Assuming that all the respondents who know somebody who they believe died from the inoculation actually died from the inoculation, estimated fatalities are about 308,000.
Subtracting out those who may have died regardless of inoculation yields an estimated 294,000 inoculation-induced fatalities. This is an initial first pass estimate—more evaluation is needed.
Factors associated with being inoculated:
The likelihood of being inoculated is significantly less for those who identify themselves as African American, Hispanic, and Asian, and Republican or Independent. Democrats, Caucasians, and more the highly educated are more likely to be inoculated.
Those who indicated that they obtain information about Covid-19 from alternative news sources were less likely to be inoculated. Those who obtain information from mainstream news and official government source are more likely to be inoculated.
Knowing someone who experienced a significant health problem from the Covid-19 illness increased the likelihood of being inoculated.
Knowing someone who had been injured by the Covid-19 inoculation substantially reduced the likelihood of being inoculated.
The official position of the US government is that the Covid-19 inoculations have resulted in nine fatalities (CDC, 2022). The experiences shared by hundreds of respondents in this survey suggests that many people died or were injured following inoculation. Which data are more believable—nine fatalities or as many as 300,000 fatalities? Surveys have limitations in assessing the impacts of health interventions. However, this type of evaluation offers an important point of triangulation. The experiences of people captured in surveys generally should be consistent with official government data. In the case of Covid-19 inoculations, there is a tremendous divergence which should be cause for further inquiry. My hope is that this research will motivate a full and transparent examination by independent health and medical scholars to ascertain the degree of harm being caused by the Covid-19 inoculations.
The full paper can be accessed at: How Many People Died from the Covid-19 Inoculations? An Estimate Based on a Survey of the United States Population
American Airlines Pilot who Went Into Cardiac Arrest Minutes after Landing Plane says COVID Injection Caused His Heart to Stop
/From [HERE] An American Airlines pilot suffered cardiac arrest minutes after landing his plane. Thankfully he survived, and he fully believes the Covid-19 injection he was forced to get by his employers is to blame.
Steve Kirsch sat down for an interview with Josh Yoder of US Freedom Flyers about American Airlines Captain Bob Snow. Snow had a cardiac arrest minutes after landing the plane. He nearly died.
According to Snow, it’s pretty clear that his cardiac arrest was due to the experimental COVID vaccine that American Airlines forced him to take to keep his job.
Key points in the video interview below include:
How Snow knows it was the vaccine and not just “bad luck”
American Airlines never called Snow in the hospital even though it was their fault he took the vaccine and almost died. You’d think he’d get a call from the CEO. Instead, the only thing they did was fly his family to the hospital to meet with him.
We need to be testing every vaccinated pilot with EKG, D-dimer, troponin, and cardiac MRIs to assess their health. This is for their health and for the safety of the flying public. The airlines and/or FAA should be requiring this. Myocarditis can be subclinical so pilots may not know they are injured.
The airlines are NOT doing the screenings required to assess pilot health and passenger safety. Presumably, this is because doing those screenings would: 1) reveal to the public how unsafe the vaccines are and increase vaccine hesitancy, and 2) disqualify too many pilots. Yoder estimates that 30% of the pilots may need to be disqualified due to heart conditions caused by the vaccine. Therefore, the most likely outcome is that the airlines will pretend this incident never happened and the CDC will claim without evidence that there is no link to the vaccine like they usually do. The press will give them a pass on this and not ask any hard questions.
When a plane goes down and people are killed, it’s OK for the airlines because the insurance companies will pay and everyone will pretend it was just a freak accident that couldn’t have been avoided.
Wisconsin Family Launches Billboard Campaign that Claims Hospital COVID Treatment Protocols Killed Their Daughter Grace
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From [HERE] On October 13, 2021, Grace Schara passed away at Ascension’s St. Elizabeth’s Hospital in Wisconsin. Her parents say the doctors and hospital killed Grace by their insistence to follow ineffective COVID treatment protocols.
On Oct. 13, 2021, at 7:27 pm, beautiful Grace Schara—an inquisitive young woman with Down-Syndrome—died a tragic and preventable death at a Wisconsin hospital. Rather than using treatments proven to combat COVID-19, Ascension’s St. Elizabeth’s Hospital followed the U.S. government’s ineffective COVID-19 treatment protocols, for which they reap significant financial rewards. On the final day of Grace’s life, as her doctor assured her parents she was doing well, Dr. Gavin Shokar also “unilaterally labeled Grace a DNR and ordered a lethal combination of IV sedatives and narcotics”—a fatal combination of the drugs Precedex, Lorazepam, and Morphine—which were administered over an incredibly short period of time. Notably, all three drugs are manufactured by mRNA “vaccine” maker and pharmaceutical giant Pfizer.
The Schara family is still speaking out about their daughter’s tragic death. The family of Grace Shara is now running over a dozen billboards in the FOX Valley area.
From the press release:
Grace was admitted to St. Elizabeth’s for Covid-19 respiratory issues, but was recovering before a doctor began giving sedatives to her.
Dr. Gavin Shokar, MD, apparently found it so likely she would die from his administration of Precedex – a powerful sedative used in surgery – that he wrote his own do-not-resuscitate (DNR) order on her a mere eight minutes after giving her the maximum dose. When Grace was still alive Shokar then combined Precedex with Lorazepam (another powerful sedative) and a Morphine push within minutes of one another on Grace’s last day to finish her off. A 14-year ICU nurse, Hollee McInnis, delivered the lethal dosage.
“Each of these medicines, on their own, have an increased risk of serious or life-threatening breathing problems and cardiac arrest,” said a doctor familiar with Grace’s case. “There’s an additive effect when used in combination. To use them like they did in a person with a diagnosis of acute respiratory distress is beyond believable as to intention,” she said.
A DNR order is legally required to be discussed with family and consented to in writing, neither of which occurred in Grace’s case. Grace was not given a DNR bracelet, which is required by law. In fact, family members were never told Grace had a DNR designation until her last breaths, when doctors and nurses did nothing to help her, despite the family telling them Grace didn’t have a DNR. Apathetic medical staff allowed Grace to die as her sister at her bedside helplessly begged them to revive her, while her parents – who were not allowed in her room – watched her die via FaceTime.
Remdesivir = Run Death is Near: FDA Rubber-Stamps Remdesivir for Infants w/o Evidence of Safety. Experimental Drug Used To Treat COVID in Hospitals Causes Liver/Heart/Kidney Failure and Kills Adults
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From [CHD] The U.S. Food and Drug Administration (FDA) on Monday approved the use of the antiviral therapy, remdesivir, to treat COVID-19 in infants four weeks and older.
Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said in a press release:
“As COVID-19 can cause severe illness in children, some of whom do not currently have a vaccination option, there continues to be a need for safe and effective COVID-19 treatment options for this population.
“Today’s approval of the first COVID-19 therapeutic for this population demonstrates the agency’s commitment to that need.”
According to the press release, the FDA’s decision to approve the therapy, marketed under the name Veklury, is supported by a clinical study conducted on infants 4 weeks and older weighing a minimum of 6.6 pounds.
The study is underway and will not be completed until February 2023. There are no published results.
However, Gilead Sciences, maker of remdesivir and sponsor of the study, provided the following details in a company press release:
A total of 53 hospitalized pediatric patients were enrolled in the clinical study.
72% suffered adverse events.
21% suffered serious adverse events determined to be unrelated to the drug.
Three children died from either underlying conditions or COVID-19.
Nevertheless, Gilead Science assured that “no new safety signals were apparent for patients treated with Veklury.”
The study was of single-arm, open-label design.
A single-arm study has no control group, making it impossible to compare its effectiveness against standard of care.
Open-label means participants and investigators were aware they were receiving the drug, making it impossible to separate placebo from drug effect.
Studies show little or no benefit
Beyond the absence of any publicly available data on the efficacy and safety of this drug in humans of this age, available studies on older subjects indicate remdesivir offers no more than a meager benefit to those who survive its use.
In fact, this is why the World Health Organization (WHO) in November 2020 recommended against the use of remdesivir to treat COVID-19. The WHO only recently (April 22, 2022) updated its recommendation to support the drug’s use in patients who are at high risk for hospitalization.
Nevertheless, the FDA explains its long-standing support of remdesivir use in adults here, citing six studies that had the greatest impact on the agency’s position.
Here is a summary of the findings of each study from the FDA’s webpage:
ACTT-1 Trial: Time to clinical recovery was shortened from 15 days to 10 through the use of remdesivir. There was no difference in mortality. The drug was no better than placebo when administered to patients who required high-flow oxygen, non-invasive respiratory support, mechanical ventilation or extracorporeal membrane oxygenation at baseline. A benefit was seen only in patients who required low levels of supplemental oxygen.
Discovery Trial: There was no clinical benefit of remdesivir in hospitalized patients who were symptomatic for >7 days and who required supplemental oxygen. There was no difference in mortality between remdesivir and standard of care. Investigators judged three of 429 participants who received remdesivir died from the drug.
WHO Solidarity Trial: Remdesivir did not decrease in-hospital mortality or the need for mechanical ventilation compared to standard of care. Four hundred and forty patients in this study were also enrolled in the Discovery trial above.
Journal of the American Medical Association (moderate disease): After 10 days of treatment with remdesivir, clinical status was not significantly different from standard of care.
New England Journal of Medicine (severe disease): No difference between five and 10 days of remdesivir treatment. No placebo group, thus “the magnitude of benefit cannot be determined.”
PINETREE study: Three consecutive days of IV remdesivir resulted in an 87% relative reduction in the risk of hospitalization or death when compared to placebo.
As demonstrated, the first five studies used to justify the FDA’s approval of remdesivir showed little, if any, benefit to hospitalized patients with moderate or severe disease.
This is in contrast to the sufficiently proven benefit of off-label use of the previously licensed medications hydroxychloroquine and ivermectin.
Only the PINETREE study investigated the benefit of remdesivir for outpatient use. In that study, the drug provided a substantial benefit in preventing hospitalization when given in three separate doses over three days.
However, only eight individuals under the age of 18 were enrolled in the study, and none were younger than 12.
The primary endpoint, a composite of COVID-19-related hospitalization or death from any cause, did not occur in the under-18 group.
In other words, the study — funded by Gilead Sciences — showed the drug offered no benefit in this cohort.
Nevertheless, in reporting on the FDA’s approval of remdesivir for infants and young children, CNN found someone to support the FDA’s decision.
CNN wrote:
“The FDA’s approval of remdesivir for young children is ‘great,’ said Dr. Daniel Griffin, an instructor in clinical medicine and associate research scientist in the Department of Biochemistry and Molecular Biophysics at Columbia University.”
Safety ‘not established’ in pediatric patients
Not only is there scant evidence that remdesivir is an effective treatment for COVID-19, the drug’s safety is debatable.
With regard to its use in infants, even the FDA must acknowledge nobody knows how safe it is.
After all, the manufacturer’s label states:
“The safety and effectiveness of VEKLURY (remdesivir) have not been established in pediatric patients younger than 12 years of age or weighing less than 40 kg.”
With regard to pharmacokinetics (where the drug distributes in the body) the label states:
“The pharmacokinetics of VEKLURY in pediatric patients have not been evaluated.”
An indictment of the drug regulatory process
Let’s reflect on what the director of the FDA’s Center for Drug Evaluation and Research saidregarding the approval of remdesivir for treating COVID-19 in infants 4 weeks and older :
“As COVID-19 can cause severe illness in children, some of whom do not currently have a vaccination option, there continues to be a need for safe and effective COVID-19 treatment options for this population. Today’s approval of the first COVID-19 therapeutic for this population demonstrates the agency’s commitment to that need.”
To summarize:
Some children do not have a vaccination option.
They need a safe and effective treatment.
The FDA meets that need by approving a drug with no safety and efficacy record in children.
Safety and efficacy apparently can be conveniently established by fiat, not evidence.
In the end, the FDA’s approval of remdesivir is not an assurance of the drug’s safety and efficacy but an indication the agency is no longer interested in protecting the public from potentially harmful and ineffective therapies — or, in other words, in doing its job.
There will undoubtedly be doctors like Griffin who welcome this approval.
However, I don’t believe every pediatrician will accept the FDA’s guidance so readily.
It’s not easy to place an intravenous line to administer remdesivir in the tiny vein of an irritable baby coming from home with a positive rapid test. And then do it again the next day. And the day after that.
At some point, clinicians’ sensibilities will be challenged enough to compel them to actually examine how the FDA arrived at its conclusions.
Guidelines are meaningless if doctors choose not to abide by them.
