More Vaccine-Injured Pilots Speak Out as Groups Pressure Airlines, Regulators to End Mandates
By Michael Nevradakis, Ph.D.: Sharp chest pains. Myocarditis and pericarditis. Heart attacks. Strokes and subsequent blindness.These are just some of the many COVID-19 vaccine-related adverse events reported by commercial airline pilots and by a growing number of advocacy groups representing aviation industry workers.
According to these individuals and groups, the number of pilots speaking out about their vaccine injuries is dwarfed by the number of pilots who are still flying despite experiencing concerning symptoms — but not speaking out because of what they describe as a culture of intimidation within the aviation industry.
These individuals fear they will lose their jobs and livelihoods in retaliation if they reveal their symptoms or go public with their stories, sources told The Defender.
Still, a growing number of pilots are coming forward.
Last month, The Defender published the accounts of several pilots — and of the widow of a pilot who died from a vaccine-related adverse event.
Since then, more pilots have shared their stories, including one who is currently flying for a commercial airline.
A growing number of advocacy organizations, representing workers across the aviation industry and in several countries, are joining these pilots in speaking out.
The Defender previously reported on actions by the U.S. Freedom Flyers (USFF) and other legal advocates in the U.S.
Since then, representatives from the Global Aviation Advocacy Coalition (GAA) and the Canada-based Free To Fly also spoke with The Defender about their initiatives.
Meanwhile, pilots in Canada and the Netherlands recently reported significant legal victories in separate vaccine-related cases.
In interviews with The Defender, pilots injured by COVID-19 vaccines said despite a “culture of fear and intimidation” they are compelled to speak out against vaccine mandates that rob pilots of their careers — and in some cases their lives.https://t.co/YYMCVg9ywV
— Robert F. Kennedy Jr (@RobertKennedyJr) May 6, 2022
More pilots come forward, speak to The Defender
Steven Hornsby, a 52-year-old pilot with a legacy passenger airline company, was once an active weightlifter and cyclist, biking 10-26 miles every other day.
He is also a veteran of the U.S. Marine Corps and Operation Enduring Freedom. Per FAA requirements, he passed 24 medical exams in the past 12 years, including 12 electrocardiograms (ECGs).
Hornsby told The Defender, “I’ve never had any cardiovascular issues in my life, nor have I ever had any major health issues … I eat healthy and live what I believe to be a balanced lifestyle.”
Hornsby, however, is not flying today because, he said, he was “coerced … to get the COVID-19 vaccine,” and his employer “made it very clear that all employees would be required to get it and that medical/religious exemptions would be very difficult to get.”
Hornsby’s difficulties began after receiving the second dose of the Pfizer COVID-19 vaccine.
“After my second shot, I initially had zero issues, with little more than light fatigue on day two, Hornsby said. “The 12th day, however, was the culmination of the vaccine and the continuous stress I was adding to my heart from rigorous exercise.”
As he was driving with family, Hornsby said he felt sharp chest pains, “pain radiating through my left arm, and my heart rate spiked as if beating in my neck.”
Hornsby said it took several different diagnoses from doctors and medical practitioners to make a connection between his health issues and the vaccine.
A nurse at an urgent care facility first told him his symptoms did not correlate to a heart attack and were most likely unrelated to the vaccine. Later, at a hospital emergency room, he was again told his symptoms were not likely to be related to the vaccine.
“At that point,” Hornsby said, “I was indignant. Why would a healthcare provider dismiss that perspective? This was my eye-opening reality that a major cover-up was in play.”
Hornsby was ultimately diagnosed with elevated blood pressure but was told he had not suffered a heart attack. Doctors advised him to follow up with a cardiologist, and told him they would not report his case to the Vaccine Adverse Event Reporting System (VAERS).
Hornsby said his cardiologist, after performing blood work, told him his heart was healthy, and though the doctor didn’t dismiss the possibility that his heart issues were connected to the vaccine, he told him the symptoms were “most likely from stress or a musculoskeletal problem.”
“I had to stop trying to force my perceived diagnosis — bias against the vaccine — and listen to the professionals,” Hornsby said, adding “I needed to be patient,” even after a union doctor also dismissed Hornsby’s concerns that his symptoms were related to the vaccine.
Hornsby continued experiencing “intermittent pains,” despite taking home remedies such as tea and supplements to calm his heart rate, which he said were helpful.
It was only in December 2021, when his medical certification was due for renewal, that his aeromedical examiner (AME) advised him to wear a Holter monitor (a type of portable ECG) for one week to monitor his heart.
“That is when I discovered that I had arrhythmia issues, heart palpitations and [an] irregular heart rate, which was occurring almost exclusively at night,” said Hornsby. “I reported back to my AME, who then told me I was grounded and that I should go find a good cardiologist and get healthy.”
The following month, another cardiologist diagnosed Hornsby with vaccine-induced myocarditis.
“My heart was inflamed,” said Hornsby. “After an echocardiogram, it showed my heart mildly dilated with fluid behind my heart.”
Hornsby said he’s “doing much better,” but he’s still not flying. He’s disappointed with the dismissive manner in which several doctors addressed his concerns.
“Had doctors been willing to view my case — and I suspect others — with an open mind, this could have been diagnosed much, much earlier,” he said. “Looking back, had my heart not been healthy, I would have surely died from cardiac arrest like you’re seeing in young athletes.”
Hornsby said he believes other pilots with similar symptoms are still flying.
“I suspect there are many pilots flying around with minor and perhaps major issues,” Hornsby said. “The vaccine is/was experimental and for good cause. No one knows the long-term effects.”
He added:
“How many years have been shaved from my life? Will I develop scar tissue in my heart? Will I get cancer as a result? Has this trash degraded my immune system? Only God knows.”
Pilot injured by Moderna shot: ‘I have a family to feed’
In fact, The Defender interviewed another pilot — currently flying for a commercial airline in the U.S. — who is experiencing such health difficulties.
The pilot, who spoke to The Defender on condition of anonymity, said:
“I was experiencing chest pain, usually at night, almost like somebody had their hand around my heart and was squeezing.
“Generally, [the pain] would subside during the day, but … would appear occasionally out of nowhere and I would need to lie down.
“It would manifest as pain, but also like something was lodged deep in my esophagus, like I had a piece of food or air that was pressing upon my chest area.”
According to the pilot, his symptoms “began about a week after the second Moderna vaccination.
He said the airline he works for threatened to terminate anyone who didn’t get the vaccine. “I have a family to feed, so I was left with little choice.”
He said he is “on reserve” and not flying often. While his symptoms have recently subsided, he felt that “looking into further treatment would result in an answer that would be unfavorable to my medical [certification].”
He added:
“In the back of my mind though, the thought of what it could mean for my future health is there.
“The current situation I am faced with is that supporting a family is what is most important to me. Fear of loss of my pilot medical [certification] after being mandated to get this vaccine is the path I am currently on.”
Terminated after 19 years for refusing COVID shot, former Australian pilot advocates for others
Australia, like Canada, has a government-level vaccine mandate for airline crew and airport workers. In Australia, this mandate went into effect on Nov. 15, 2021.
Glen Waters is a former captain with Virgin Australia who is now a spokesman for a group of employees from the same airline.
Waters, who had held the rank of captain for 19 years before being terminated by Virgin Australia for refusing the vaccine, spoke to The Defender on behalf of several pilots who are suffering from vaccine injuries.
According to Waters, “none of the pilots suffering from injuries are prepared to talk” because “the company is actively trying to terminate anyone reporting vaccine injury.”
Waters said employees whose health issues are characterized as “unrelated” to the vaccine are being treated by Virgin Australia “as you would expect a company to care for its employees.”
Waters stated “there are several reasons injured pilots will not come forward,” including:
- “There is a stigma attached to anti-vaccine sentiment in any form.
- There is a reluctance on the part of the medical community to get involved with possible vaccine injuries.
- Vaccine makers will actively fight against injury claims.
- Insurance companies have distanced themselves from claims involving the vaccine.
- Pilots don’t want to lose their medical certifications, jobs or careers.
Waters said of approximately 900 pilots flying with Virgin Australia, he is aware of nine who are no longer flying because of medical complications that could be linked to the vaccine.
“No doubt there are many more who are continuing to fly with troubling symptoms,” he said.
These symptoms, according to Waters, most commonly include myocarditis and pericarditis. Some symptoms, however, are even more serious.
Waters told The Defender:
“We have one captain [who had] a stroke and went blind, and another had a heart attack and fell down the boarding stairs after landing.
“There have been complaints of constant headaches and numerous reports of chest pains and shortness of breath.
“A number of cabin crew have reported pins and needles in their limbs, almost like electric shocks that persist for hours at a time.
“I have heard [about cases of] tinnitus, vertigo and brain fog, including temporary blindness, in several crew. Disrupted menstrual cycles are reported frequently, perhaps affecting dozens [of employees].”
However, according to Waters, perhaps due to the work environment, not all pilots are comfortable in stating openly that there may be a connection between their health difficulties and the vaccines.
“I’m only aware of three who say the symptoms started within an hour of the vaccine, one within seven days,” he said.
“The stroke and heart attack victims are not attributing their medical event to the vaccine as far as I am aware. Neither [did] the captain who died of a sudden onset of cancer early this year.”
Some employees may not understand their symptoms might be related to the vaccine, Waters said. “Many of the early warning signs — persistent headaches, chest pains, breathlessness — are not recognized by aircrew as possible adverse reactions,” Waters said.
“The heart attacks and strokes are occurring in otherwise fit and healthy individuals. They are sudden and are a real risk to flight safety.”
Waters explained that Australia’s Civil Aviation Safety Authority, similar to other such bodies globally, has “a 1% rule” for pilots: If they have a medical condition “that presents a greater than 1% chance of resulting in an incapacitation event within the next 12 months, then they are considered medically unfit to fly.”
In light of this, according to Waters, “numerous aviation doctors, including Lt. Col.Theresa Long and Lt. Col. Peter Chambers, have recommended tests that will help determine the real risk to pilots.”
These include the D-dimer test for blood-clotting conditions, a complete blood count, post-vaccination ECG analysis, a cardiac MRI and others.
As pilots speak out, there are some legal victories
Despite what numerous pilots call a hostile environment in the aviation industry toward claims of vaccine injury, a recent series of legal decisions were in pilots’ favor and more legal actions are in progress.
A judge at the Amsterdam Court of Appeals in the Netherlands on June 2 ruled in favor of the Dutch Airline Pilots Association, in a case that challenged vaccine mandates introduced by Dutch airline KLM for new pilots.
According to the ruling:
“It is considered that requesting and demanding a vaccination against corona constitutes an unjustified infringement of the fundamental rights of the candidate pilots.
“In particular, it infringes the privacy (Article 8 ECHR) [the European Convention on Human Rights] of the candidate pilots.
“After all, the decision whether or not to have yourself vaccinated is something that belongs pre-eminently to this private sphere.
“Requiring the candidate pilot to be vaccinated and to give a positive answer to that question about vaccination status, therefore, violates this. KLM thus leaves no choice to candidate pilots who want to join KLM.”
Per the June 2 ruling, KLM is prohibited from requesting or collecting such information from candidate pilots, or rejecting candidates on the basis of their vaccination status, under penalty of €100,000 (approximately $105,000) per violation.
Following the ruling, the Dutch Pilots Association issued a statement, remarking:
“The [association] endorses the government’s position that vaccination is important, but that compulsory vaccination by the employer is not permitted.
“We were of the opinion that KLM did not comply with this and, moreover, violated our agreements about this, without there being any operational necessity.”
In Canada, the federal government on June 14 announced most travel-related vaccine mandates would be lifted as of June 20.
Responding to this announcement, in a statement sent to The Defender, Free to Fly credited those who opposed the mandates, stating:
“This dark season helps reinforce an important maxim; true change only comes about through tenacity, courage, and the relentless pursuit of truth by principled men and women.
“Across our nation, many Canadians refused to give up on freedom and fought for our fragile democracy. We feel no ‘gratitude’ towards an emboldened state for ceasing to violate God-given freedoms.
“We must never forget our recent travails, and cannot be lulled into complacency, certainly with Trudeau’s government openly threatening reinstatement of mandates with any ‘new variant’.”
“We will continue to pursue them, insisting on uncompromising standards in our industry and the assurance we never again go down this road of medical segregation.”
In another recent development, Canadian pilot Ross Wightman became just one of a small number of people who have received compensation from Canada’s Vaccine Injury Support Program.
Wightman was diagnosed with Guillain-Barré Syndrome, a rare condition that affects the nervous system and may cause muscle weakness, paralysis or even death.
He developed the condition within days of receiving his first and only dose of the COVID-19 vaccine. For the past year, Wightman has been unable to work, as he has substantially limited mobility in his arms and legs.
Global Aviation Advocacy Coalition pens open letter to aviation industry
In an open letter to the aviation industry, the GAA raised serious allegations regarding industry vaccine mandates, which the GAA said resulted in a growing number of vaccine-injured pilots who are unable to fly and who may never do so again — and an increasing number of pilots who continue to fly while experiencing potentially serious symptoms.
The letter was signed by organizations including the USFF, Free To Fly Canada, the Aussie Freedom Flyers, the UK Freedom Flyers, the International Medical Alliance, the Global Covid Summit, the Canadian Covid Care Alliance, the UK Medical Freedom Alliance, the Association of American Physicians and Surgeons, and several other groups in the U.S., France, the Netherlands, Switzerland and the U.K., as well as more than 17,000 physicians and medical scientists from around the world and “thousands of pilots at over 30 global airlines.
The GAA said it is in communication with pilots at the following U.S.-based airlines: Alaska, American, Delta, Frontier, JetBlue, Southwest, Spirit and United, and 12 major air carriers in Australia, Canada, France, Germany and the Netherlands.
According to the GAA’s open letter, the organization and the scientists and doctors it works with “are hearing daily from vaccine-injured airline pilots” about conditions including “cardiovascular issues, blood clots [and] neurological and auditory issues.”
The injured pilots are experiencing a broad spectrum of symptoms, “ranging up to death,” the GAA wrote, adding the symptoms “at least correlate to receiving COVID-19 vaccinations.”
The GAA wrote that in many instances, these conditions are serious enough that “pilots have lost medical certification and may not recover the same,” while others “are continuing to pilot aircraft while carrying symptoms that should be declared and investigated, creating a human factors hazard of unprecedented breadth,” and “a landscape which should greatly concern airlines and the traveling public.”
Pilots continue to fly despite experiencing such symptoms, said the GAA, because those “who report their injury face possible loss of licensing, income, and career while receiving little to no support from their unions, and a prosecutorial invective from employing airlines.”
The GAA said many pilots were reluctant to receive the COVID-19 vaccine and opposed mandates:
“Pilots are trained to be careful analysts of their environment, recognizing risks and actively mitigating. For many, their training and differential risk analysis led to concerns and negative conclusions regarding the compatibility of COVID-19 vaccination with health and flight safety.
“Not only did many pilots disagree with arbitrary requirements embodied in vaccination mandates, but they also saw risks in the unanswered questions and unjustified speed and pressure behind the vaccine rollouts. They lobbied their airlines and politicians, recommending caution and opposing mandates.”
However, stated the GAA, for many pilots, it was a choice between vaccination and job loss:
“Once airlines mandated vaccination, many pilots steadfastly refused based on risk and were subsequently put on unpaid leave or outright terminated.
“Principled professionals were forced out of aviation and the industry lost hundreds of thousands of hours of experience. Now, the global airline industry is heading into a dire staffing crisis.
“Thousands of other pilots were coerced into vaccination to provide for their families. This has taken a toll on their mental health.”
For the GAA, blame lies with the mandates — and more broadly, with the airlines, regulators and unions:
“ … there appears to be no evidence of aviation regulators, airlines or unions having performed any of their own due diligence into COVID-19 vaccines and the impact on pilot health or performance.
“This is at complete odds with existing aviation medical standards. Questions exist around competence and possible negligence.
“Failure to address this potential medical watershed will make the airlines and unions complicit in a culture shift that has rocked the aviation mantra of ‘safety first, always.’”
The GAA called on civil aviation authorities such as the Federal Aviation Administration, Transport Canada, UK Civil Aviation Authority, the European Union Aviation Safety Agency and Australia’s Civil Aviation Safety Authority to begin fulfilling their regulatory obligations.
“The crisis in pilot health must be publicly addressed by airlines and representing unions to restore flight safety to what we once knew,” their letter stated.
GAA called for:
- “Where it exists, mandated COVID-19 vaccination for aviation workers must be discontinued.
- A permissive environment for self-reporting needs to be reemphasized by regulators and airlines.
- Thorough and objective aviation medical screenings of pilots and cabin crew need to be a high priority. These must be backed by the regulator and should focus on high prevalence harms which are now showing up in the general public and in our flight crews.
- Airlines and regulators hold data about sickness and medical certificate suspension, including symptoms and causal reasons. This data should be analysed by independent third parties to establish or rule out COVID-19 vaccination as a possible cause.”
Free to Fly steps up pressure Canadian authorities, airlines
Canada-based Free to Fly represents close to 3,000 aviation professionals, according to its director, Greg Hill, who spoke to The Defender.
These professionals include pilots, flight attendants, air traffic controllers, maintenance workers and customer service representatives.
According to Hill, industry workers have reported a wide range of health issues, including “generalized chest pains, myocarditis, enlarged heart, blood clots, hearing loss, partial paralysis, lymph issues [and] broad autoimmune dysfunction.”
Some of the injured pilots are “high-end athletes” who experienced a “major decrease in their performance capacity.”
“We’ve had some inexplicable deaths at unreasonably young ages,” Hill said, and “an increase in in-flight diversions with one of our airlines in particular.”
While Hill left open the possibility that at least some of these incidents weren’t vaccine-related, he said that Canadian authorities show “an unwillingness to do a proper investigation.”
“Transport Canada, the airline industry, the airlines and the unions have been uniformly silent on the matter,” Hill said.
Indeed, Hill said the aviation industry, regulators and unions in Canada have not been responsive to outreach from Free to Fly.
Referring to a document, prepared in conjunction with the Canadian COVID Care Alliance, that said flight crew pilots were most at risk of vaccine-related adverse effects due to their work environment, Hill said:
“We gave this to the two largest pilot unions in the country, the Air Canada Pilots Association and ALPA, the Airline Pilots Association … they have refused to respond to it.
“We also sent it to management at two of our largest airlines … they also have refused to even respond to it. And this was raising very explicitly the risks that these medical professionals felt needed, at the very least, to be investigated.
“And as yet, we’ve had nothing but silence formally as far as a response from these groups, as far as adverse events, vaccine injuries.”
The document provides: information on a union’s obligation to its members; a differential risk analysis of COVID-19 versus the vaccines; an analysis of natural versus vaccine-induced immunity; an analysis of adverse reactions to the vaccines and particular risks faced by flight crews; a list of alternate treatment options for COVID-19; and a discussion of informed consent and coercion.
According to Hill, the policy is “no jab, no job” for pilots and aviation professionals in Canada, unless they are granted religious or medical exemptions.
But, said Hill, even in the rare instance when an exemption is granted, those employees nevertheless have found themselves out of work, due to airline practices that Hill described as extortionate.
Hill told The Defender:
“If you’re not willing to take the jab and you can’t be accommodated with a religious or medical exemption, then you are either on unpaid leave or outright terminated. Some of our pilots have already been terminated.
“The vast, vast majority of these accommodations were outright denied … some of the stories of people that were denied medical accommodations are truly shocking, the same on the religious aspect.
“The handful that were approved … are simply another round of extortion. Some of them were denied, then they were approved retroactively … essentially they were approved, but then it didn’t change anything … you continue your unpaid leave, but you’re allowed your benefits.”
Similar to claims made in an open letter hand-delivered to the U.S. Federal Aviation Administration (FAA) and major U.S. air carriers in December 2021, Free to Fly also alleged a violation of existing aviation regulations, this time in Canada.
According to Hill:
“There was, at one point, on the Transport Canada website, this was July 2021, a line that specifically said it remains a general position of Transport Canada … that participation in medical trials is not considered compatible with aviation medical certification.
“A number of us were asking questions … and saying, ‘Well, what’s up with this?’ And the answer was these [vaccines] are approved. And we said, ‘No, they’re not fully approved, they’re approved under interim order.’
Hill said if you read that interim order, it was quite laughable. It basically said, ‘We’ll roll these vaccines out and we’ll gather data. Right now we feel that they’re okay and we’ll continue to assess as we continue to jab people,’ which just seems insane.
“So we asked these explicit questions, got no suitable answers,” Hill said. “And the week following … they simply memory-holed it, they removed that line and it’s no longer on the website. That was their response.”
Hill also described a culture of intimidation in Canada among pilots and flight crews, resulting in a reluctance to come forward with vaccine injury claims:
“Unless the individuals involved are willing to speak to it, I can’t say … every pilot that’s currently still employed … is living in fear of speaking explicitly, certainly in any public forum … for fear of the retribution that has been rolled out against those of us who no longer have work because we refuse to go down this road and insisted upon medical freedom and in doing a proper analysis of what we’re up against here.”
This has not stopped Free To Fly from pursuing legal action in Canada. According to Hill, in Canada, “ … you can’t seek private representation against your company. You have to do it through your union. And when the unions decide to not engage, you’re left between a rock and a hard place.
Hill added:
“ … if you read through the case law precedent over the past year or two in Canada, the courts have very, very much chosen a side. And the concern is within an English common law system, if we continue to litigate, litigate and lose and lose and lose, you create precedent that makes it harder and harder to dig your way out.
“Unfortunately, in this country, the law is downstream of politics. It’s heavily influenced by it, certainly in my opinion. And politics, of course, is downstream of culture. So unless you impact culture and impact the broader narrative, it’s very difficult to see legal solutions.”
Free to Fly on June 6 sent a letter to Canada’s minister of transport, co-signed by the GAA, containing “important, detailed questions regarding COVID-19 vaccines and flight safety,” according to Hill.
As of this writing, the minister has not responded.
Hill said:
“It’s just mind-boggling … we’ve literally stood the [aviation industry’s] safety culture on its head, and that’s the greatest concern to us.
“It’s not an interest in a desire for conflict. I long for the world before this became an all-consuming role, where we’re pushing to try and get ourselves back to a sense of normalcy and proper risk assessment and risk mitigation, which is what pilots are really dedicated to.
“So that’s all we want: that ability to look at this properly and analyze it properly … aviation medical screenings focusing on some of the high prevalence harms that we’ve seen, that we’re hearing about … these screenings need to be backed by the [Canadian] regulator who, in our opinion, has not done their job properly over the past couple of years.
As far as suspensions, Hill said, pilot who are off and on have not been able to get their medical [certification] back. And these need to be analyzed by independent third parties.
Some pilots and aviation professionals, in addition to speaking out, are joining advocacy groups.
For instance, Hornsby and the pilot quoted in this story who opted to remain anonymous, have joined USFF, according to its co-founder, Josh Yoder, as are the pilots and air traffic controllers who previously shared their stories with The Defender.
USFF has recently begun filing a series of lawsuits against airlines and federal agencies in response to the vaccine mandates and their aftermath.
Ultimately, though, the public — not just pilots and aviation professionals — must also speak out, according to Hill.
“Whether it’s Canada, the United States, Australia, the United Kingdom, etc., we’d like to see the public as a whole rising up and speaking out publicly about these issues, asking why the regulators haven’t done proper risk assessments in regards to where we’re at with these jabs.
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Now Big Pharma, the FDA, and their Political Shills are going to MURDER THE CHILDREN
From the Tom Woods Letter: Now that the FDA has approved the Covid shots for infants and toddlers, it’s just a matter of waiting for the CDC to sign off on them.
Florida is the only state that has not ordered the shots for these children.
So CNN’s Bill Weir went to Twitter to say, “49 states preordered COVID vaccines for kids under 5 so they’ll be ready as soon as there is FDA approval. Take a guess which state did not.”
Christina Pushaw, press secretary for Ron DeSantis, replied: “The state everyone is moving to?”
In New York, a major cultural center known as 92NY has already announced, even before the CDC has said anything, that they will be enforcing a vaccine requirement on everyone above six months old.
They wrote in an email:
“We are also anticipating the release of the COVID-19 vaccine for children under the age of 5 and have made the decision to extend 92NY’s vaccine mandate to that age group once they are eligible. Currently, we plan to require proof of vaccination for children under 5 beginning in September. We will share more details once the vaccine is released.”
At this point there’s no sense in bothering to point out that the shots don’t stop the spread. The people making the decisions at 92NY surely know that. They are almost certainly now using the vaccine as a proxy, a way of keeping out the riff-raff. It’s a very particular kind of elite that will go to the extreme of doing this to an infant, and that elite is evidently their target clientele.
Given that the shots for young children already failed to get much traction, it is inconceivable that many normal people will want it for toddlers or infants.
Even the Democrats aren’t going to run on mandating this. Historic inflation and drag shows with small children ought to keep them on their toes for the midterms.
Vinay Prasad, a left-leaning commentator who has been pretty good on the lockdown regime, put it this way: “If someone says vaccines for kids under 5 lower the risk of severe disease or death, it’s important to remember that no data on earth proves that conclusion. The data we will soon get will be hopelessly confounded. And seroprevalance is already so high.”
In related news, Senator Rand Paul confronted Anthony Fauci again. A couple of key points:
Paul: “Can you tell me if anyone on the vaccine approval committees ever received money from the people who make vaccines?”
Fauci: “People who receive royalties are not required to divulge them.”
Stanford’s Jay Bhattacharya observes, “Undisclosed royalty payments are a conflict of interest, no matter what Tony Fauci says. Having him as de facto head of covid policy and also in charge of billions of dollars for government grants to scientists is also a conflict of interest. Why are government ethics watchdogs silent?”
Another exchange:
Paul: “Are you aware of any studies that show reduction in hospitalization or death for children who take a booster?”
Fauci: “Right now there is not enough data…to indicate that.”
That’s our world, ladies and gentlemen.
But thank goodness for the courageous few who have risked so much to tell us the truth.
No child under 5 should get these injections. No healthy child of any age. This is criminal, reckless, dangerous, and many healthy children will be harmed by these vaccines.
I was on the INSIDE & wrote Hahn, CDC, NIH with vax problems, they did not listen to me, nor to Trump, nor to Atlas…they did not care what we had to say, this is the deepstate bureaucracy we mean…but I argue they went too far and must be held to account in proper legal public inquiries. We financially penalize them and jail those we have to if it is shown they did wrong and were reckless and dangerous. We have to!
See my letter again, I wrote it as a research commentary but it was my warning to Redfield, Fauci, Hahn, the CDC, NIH…all of them on the inside. I wrote them. I spoke, I shared, I tried. Scientists and doctors from CDC and NIH and FDA and Moderna etc. met me quietly and secretly, at HHS, on the Washington Mall, to share, to tell me that Atlas is right, that I am right but they fear for their life and job, salary. I laid out the flaws in the vaccine OWS and what they had to address. I used the work ‘WARN’….
I used this phase yet they did not listen and look at the insanity of the vaccine today:
“This commentary serves as guidance but more as a warning to all COVID-19 vaccine developers”
Letter to Dr. Hahn, Commissioner of the FDA, 2020:
Clinical trials stopped early for efficacy or benefit at risk of overestimating treatment effects and distorting risk-benefit assessments: some guiding principles for the SARS-CoV-2 COVID-19 vaccine search
Paul Alexander1 MSc, PhD
1McMaster University, Evidence-Based-Medicine, Health Research Methods, Evidence and Impact (HEI), Faculty of Health Sciences, McMaster University, Hamilton, Ontario, Canada
Keywords: COVID-19, vaccine, clinical trial, early stopping, interim analysis
Corresponding author: Paul E. Alexander, Health Research Methods, Evidence and Impact (HEI), Faculty of Health Sciences, McMaster University, 1280 Main Street West, 2C Area, L8S4K1, Tel: 905-554-7283 or 905-525-9140 EXT 26771
e-mail correspondence to: alexap@mcmaster.ca
What is new?
There is unprecedented need to deliver effective therapeutic and preventative agents in the context of the global COVID-19 pandemic. This commentary emphasizes the methodological consequences of stopping clinical trials early, specifically COVID-19 vaccine trials, and particularly from seemingly beneficial results during multiple, early interim analysis of study data. This commentary reviews the evidence to declare a needed event number of at least 500 if the vaccine trial is to be stopped early for benefit. In addition, it is critical that a prespecified stopping rule explicitly outlines all facets of the stopping rule that includes not too many interim looks at the data by the DSMB. As much sample size accrual is critical and most critically, is the at least 500 events (infections) combined in both trial arms. There must be a stricter stopping rule/boundary of p<0.001 if stopping early for benefit is considered.
Commentary
In the context of the quest to produce a vaccine for SARS-CoV-2 coronavirus disease under the present pandemic emergency, it is essential to understand the methodological ramifications in randomized clinical trials (RCTs) that are stopped early for efficacy or benefit (immunogenicity), such trials also known as truncated trials (T-RCTs). Our concern surrounds whether the estimates of effect reflect the true effect of the vaccine. Importantly, we reflect on the safety which can be considered a far more critical consideration than efficacy/effectiveness. We must ensure the latter in this COVID-19 vaccine search with no room for error in this regard.
As a case in point in this rapid race to a COVID-19 vaccine, the United States Operation Warp Speed (OWS) is coordinating ongoing clinical trials development research in tandem with regulatory, manufacturing, and distribution processes to avoid delays in disseminating vaccines to the public to prevent the spread of SARS-CoV-2 coronavirus and potential COVID-19 disease (1). The public-private partnership is innovative and thus far quite favourable in driving towards an efficacious/effective vaccine (s), and involves the synchronous trialing of various vaccine platforms with a multiplicity of vaccines to deliver vaccines. While a near majority of vaccine development is based in the United States, the race for a COVID-19 vaccine is global effort, with China, Asia, Australia, and Europe also centers for rapid vaccine development(2). This commentary guidance applies to all global parties involved in vaccine development and as such, in the process of spearheading vaccine clinical trials.
Applicable to global COVID-19 pandemic vaccine rapid trial approach, are potential risks and justifiable questions on vaccine safety and efficacy, with the demand to ensure that only a safe vaccine will come to market. The public, clinical, and scientific community must be assured that no aspects of a safe and effective vaccine development have been breached before approval of a fast-tracked vaccine. The public must always ‘only’ receive therapeutic interventions (vaccine) that were based on the highest quality, most robust and trustworthy evidence that is underpinned by high certainty, precise estimates of effect. This commentary serves as guidance but more as a warning to all COVID-19 vaccine developers, of what must be in place to derive confidence by researchers and the public.
One such area that deserves acute attention surrounds the issue of stopping a trial early for benefit that has been discussed in the media, versus continuation of recruiting trial participants. No doubt it is best not to stop early when there are initial benefits shown because there is a very high risk of making the decision to stop early based on incomplete and inaccurate trial information. Enough data is likely to have not yet emerged for the estimate of effect to be definitive or as we argue, even accurate. Should we stop the trial if the early benefits are very substantial? Can the observed results possibly be too good to be true? What happens if a trial is not stopped before early indications of efficacy, and then goes on to reveal no effect or even serious harm? Then had the trial stopped early for benefit, this could have been catastrophic for future patients. Limited adverse event safety data is a real cause for concern if a trail is stopped early, and researchers must carefully consider and balance this need, and plan to ensure this safety data is clear enough and collected longer-term even when a decision is made to truncate.
Researchers must also consider the substantial ethical elephant in the room of enrolling participants who have a random chance of being assigned to the placebo group when you have earlier indications of a potentially large treatment effect (3). What should be done? Does appropriate adherence to study methodology then exclude control groups from the possibly beneficial treatment? Should we deny the control group a potentially beneficial vaccine? Is it more important to focus on the safety of prospective patients and the larger society so that they do not make treatment decisions based on inaccurate or incomplete or even dangerous information, while there is clinical equipoise? These are the issues that the data safety monitoring board (DSMBs), also known as the data monitoring committee (DMC), who will be assessing vaccine trial data, must confront.
Some RCTs are stopped early when investigators conclude that the
magnitude of effects of treatment are so large and not due to random
error or chance that they must stop the trial early for benefit and
administer the treatment, or vaccine. Our primary concern is that if
this is based on an interim analysis of the data, that this could indeed
be very misleading and drive inaccurate results. This is also very
different to when researchers stop a RCT for futility (4) or harm (5).
It is crucial to raise the cardinal issues that must be considered if a
SARS-CoV-2 coronavirus vaccine is stopped early for benefit to ensure
confidence by the public and the scientific community in the
effectiveness and safety of the vaccine candidate.
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The “Western democracies” Are Trying to Murder their Own Citizens
By Reiner Fuellmich and Perspektiv: After hearing the witness statements to the German Corona Investigative Committee by former vice president of Pfizer Dr Mike Yeadon who has been a scientist for 36 years, lawyers with Reiner Füllmich draw the same conclusion: The injections normally called Corona vaccines are designed to experiment on the human race and to find out what dosage of a yet unknown toxin is needed in order to kill people.
The mortality rate linked to the vaccines, according to Yeadon, is traceable in terms of lot numbers of the different batches, as some batches appear to be more lethal than others. When taking a look at the evidence available, the main goal with the injections all over the world is global depopulation, according to the lawyers involved. Dr Füllmich told Perspektiv that the lawyers preparing an international law suit were no longer in doubt: Poisoning and mass murder through so called Corona vaccines is intentionally being perpetrated on the peoples of the world.
Citizen Journalist Ulf Bittner from EU/EES Healthcare blog and Sverige Granskas stated in the interview that the situation with traceable lot numbers and injuries and death related to lot numbers is similar in the different health care regions of Sweden. Bittner is in contact with a vaccine coordinator who has provided documents to keep track of how many people have been injured and lost their lives related to the different batches of the so-called vaccines.
01:00 Different numbers on the barcodes on the bottom of the vaccine doses are placebo which has been given to politicians according to a Slovenian chief nurse. Is it the same in other countries?
1:54 Mike Yeadon and the LOT numbers of some shots of the brands Moderna, Johnson& Johnson and Pfizer/Biontech are related to much higher mortality than for the other manufacturers.
3:52 The producers of the so-called vaccines are experimenting with the correct dosages to kill people according to Dr Füllmich. This according to the Corona Investigative Committee, constitute compelling evidence for punitive damages and attempted mass murder. They are intentionally killing people.
08:30 Lawyers from India have filed complaints for premeditative murder.
09:55 Mike Yeadon as a witness for the coming legal action against the perpetrators.
10:44 Everyone who critizises the wrongdoings of the governments of the world is being called a ‘right wing extremist’. This has also happened to the internationally renowned scientist Mike Yeadon.
13:05 CDC withdrew the recommendation for the PCR-tests diagnosing SARS-CoV-2 from 31/12-2021. PCR- tests are the foundation of the pandemic. Why is Anthony Fauci now doing a 180-degree turn?
17:25 At least a million dollars per person will be claimed in punitive damages if the lawsuit is successful.
18:33 Previously only ten percent of all adverse effects were reported. In the situation the world is right now, the team estimated that in fact only one percent of all adverse effects were being reported.
19:25 CEO of Life insurance company from Indiana USA with 100 billions of dollars in assets said: ”Over the span of this past year there has been an excess mortality of 40 percent”. This is believed to be due to the injections.
21:05 What substance in the vials makes them so lethal? Is it Graphene Oxide/graphene hydroxide?
22:37 Any vaccin is a poison, it is the dosage which makes the difference. This is not a vaccine, as a vaccine provides immunity, while these products demand incessant injections. Either a vaccine works or it does not.
24:40 This is not gene therapy either, since a gene therapy means exchanging a broken gene with a fixed one. This is more like experimenting on people, and trying to kill us.
25.15 The doses are not tested by governments, while governments will be keeping the contracts hidden from the public for at least 55 years. How is this affecting the possibility of getting people punished? Dr Füllmich goes through all the lies paving the way for the tyrannical situation the world is now in.
28:25 The vaccines are neither safe nor effective. The producers are experimenting on lethal doses of poison. Everyone now taking part in intentional malicious infliction of harm will be punished.
30:05 How sure are legal experts about the conclusion that Mike Yeadon has drawn from this, that it is all about depopulation and intentionally killing people through injections? If close to 50 lawyers are of the same opinion, it is regarded as “irrefutable proof”.
32:08 Batches of injections in Sweden can be traced by an application.
32:45 Füllmich is in cooperation with people working within the secret service of Germany who do not wish to take the injections.
34:15 Dr Lee Merritt on combat pilots in the USA refusing to get the shots. According to Dr Füllmich, Dr Merrit explained: ”They understood that if they were forced to [get vaccinated] they were going to get killed.”
35:15 Information is being collected on batches in Sweden from every region, the Swedish health authorities (Folkhälsomyndigheten) and medical board (Läkemedelsverket). Every batch is traceable through an application. There is economic reward for the Swedish regions which manage to get more people injected. One of the expert lawyers involved in the upcoming court hearings is a specialist on Nuremberg Trials.
38:45 How will the trials be performed, and through what legal structure? A common design, the same structure as for the Nuremberg trials.
39:40 Free choice should reign for members of the European Union. Consumers of health care have consumer rights. Fraud means misleading the people and consumers of health care.
42:00 The so called vaccines are an adulterated product put on to the market. According to Mike Yeadon there is a law in the US that will make everyone liable for the harms created by the adulterated product. Toxins are being put into the vials other than the known lipids etc, which the people who took the vaccines never consented to.
43:40 The importance of decentralization of power and national independence rather than global organizations such as the European Union telling the people what to do. Disconnecting from the banking system, NGO:s and creating independent and strong agricultural supply chains, energy supply chains etc.
46:15 When are the trials going to take place? How will the indictments happen and how will the trials be held? One of the goals is to inform people and expose the wrongdoings by involving the alternative media so that the mainstream media won’t be able to ignore the trials. The crew is working on a new system of law in the USA, Africa and Germany.
50:48 Dr Füllmich believes the world is close to a tipping point and the whole narrative will fall apart very very soon, maybe in a couple of weeks or months.
54:13 Robert Malone, Robert F Kennedy and Mike Yeadon and others involved in exposing the agenda are in contact with each other, and a tour is planned with these whistleblowers in the USA in March
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