Adverse event risk disclosure should be provided at the level of detail disclosed in any drug package insert. However, the COVID shots have no such insert or detailed disclosure, and adverse event reports are even being suppressed and censored from the public.
Instead, as explained by the FDA,4 since the COVID shots are not yet licensed,5 rather than providing a package insert, the FDA directs health care providers to access a lengthy, online “fact sheet” that lists both clinical trial adverse events and ongoing updates of adverse events reported after EUA administration to the public.
A shorter, separate, online fact sheet with far less information in it is available for patients — but, provider or patient, you still have to know where to look up each of the three EUA vaccines separately on the FDA website to access those fact sheets.6
2. Adverse event risks must be communicated in a way that you can comprehend what the risks are — This means the disclosure must be written in eighth grade language. In clinical trials, researchers must actually verify participants’ comprehension of the risks.
3. The acceptance of an experimental product must be fully voluntary and uncoerced — enticement is forbidden. “I argue that all of this public messaging that we’ve all been bombarded with … constitutes coercion,” Malone says.
“The most egregious example of this that I’ve ever seen, is the federal government identifying 12 people … and labeling them as the dirty dozen, [saying] that they are responsible for causing death because they are disseminating what the government has determined to be misleading information about vaccines. This is mind boggling to me and to most of my colleagues.”
As you probably know, I am on that “disinformation dozen” list. The irony of this situation is that government officials are really the ones contributing to the deaths by not adhering to bioethical principles that are enshrined in law. It’s a classic case of 1984 Orwellian doublespeak.
As I mention in the interview, the “misinformation dozen” list is the creation of the Center for Countering Digital Hate (CCDH), a shady organization funded by dark money that sprung up less than two years ago.
“Yeah, you don’t even have to go to dark money. It’s out in the open. There’s this Trusted News Initiative led by the BBC. They announced … last fall that they have integrated Big Tech, Big Media and new media, Facebook, Google, Microsoft, et cetera, into an organization that was intended to control false narratives relating to elections, but they decided to turn it on what they perceived as false narratives for vaccines,” Malone says.
“As if that wasn’t enough, the Wellcome Trust and the Bill & Melinda Gates Foundation have announced initiatives where they’re making block grants to Facebook, which is then funding these new pop-up fact-checker organizations … [that] are employing methods to smear people and to ban information …
What happens is these fact-checker organizations will make their pseudo fact check, like what I experienced with Reuters — which was transparently false, their fact check — and then the media will recycle the fact check. So that moves up in the Google ranking and they’re citing themselves. That’s what’s going on. And it’s sponsored by the likes of Wellcome Trust and Bill & Melinda Gates Foundation and they’re quite proud of it.”
Why Target Children and Pregnant Women?
Considering the unknown risks involved, why are governments and vaccine makers pushing so hard for children and pregnant women to participate in this experiment? Both have an extremely low risk for complications from COVID-19, which makes adverse effects of the vaccine all the more unacceptable, if not all together intolerable.
There’s the appearance that there was manipulation of safety data analysis and reporting in the Phase 1, 2, 3 clinical trials … by focusing on patients who had completed the study per protocol, as opposed to those that entered the study as intended to treat. [If] you’ve only accepted one dose of vaccine under those clinical trial protocols and you have an adverse event … that information about the adverse event … is lost. It’s not included in the safety analysis. This is a classic way to manipulate safety data in clinical research, and it’s strictly forbidden. ~ Dr. Robert Malone
Making matters worse, there’s no process in place to capture all side effects. Somehow, this was left out, and there’s evidence to suggest this was done intentionally.
“I think it’s important for the listenership to recognize that what we have is still an emerging understanding of what the adverse events are,” Malone says. “I could tell you the story of how the cardiotoxicity adverse event was recognized, and it was not through official channels. There is [also] the appearance that the CDC is deliberately under-reporting adverse events to the public.
And there’s the appearance that there was manipulation of safety data analysis and reporting in the Phase 1, 2, 3 clinical trials for some of these products by focusing on patients who had completed the study per protocol, as opposed to those that entered the study as intended to treat.
That’s a subtle distinction, but what it means is that if you’ve only accepted one dose of vaccine under those clinical trial protocols and you have an adverse event, and you decide to drop it out, or they gently suggest that you shouldn’t take the second dose, that information about the adverse events that you received — which would have made you at even higher risk for the second dose — is lost. It’s not included in the safety analysis.
This is a classic way to manipulate safety data in clinical research, and it’s strictly forbidden. So, the FDA is onto that trick. Normally, if I was to do that, I would get slapped down immediately. Why they allow these large drug companies to do this (if, in fact they did) — and you can’t claim that Pfizer didn’t know what they were doing — is beyond me.
Now that we know about the adverse events associated with the cardiotoxicity in adolescents and the damage to the heart and the deaths associated with that, people can start to do calculations based on official CDC data, [but] those data are flawed.
They probably under-report the true adverse event rate by about a 100-fold if you’re relying on the various historic analysis information. But you can look at those data. And if you’re a data scientist, you can do the calculations that the CDC is not doing and not disclosing to us about risk benefit.
The ones that I’ve seen done by well-trained and highly experienced specialists, people that work for the insurance industry that do this for a living … come out literally upside down.”
If the clinical trials did not include patients dropped after Dose 1 in the safety analysis, this would indicate a “per protocol” safety analysis was performed, and therefore that the safety data analyses leading to the emergency use authorizations were not based on rigorous safety assessments.
Multiple patients claiming to have been included in COVID-19 clinical trials have also reported on social media that their reports were excluded from final safety analyses, although this cannot be verified.
Risks Significantly Outweigh Benefits
A study7 posted July 7, 2021, which looked at deaths occurring in children in the U.K. during the first 12 months of the pandemic, found 99.995% of children diagnosed with COVID-19 survived.
By July 19, 2021, in the United States, a total of 335 children under 18 had died with a COVID-19 diagnosis on their death certificate.8 An analysis by Marty Makary and colleagues at Johns Hopkins, together with FAIR Health, showed none of the children under 18 who died and were diagnosed with COVID-19 between April and August 2020 were free of preexisting medical conditions such as cancer.9
Now, while the average healthy child has a minuscule chance of dying from COVID-19, and their risk of developing heart inflammation from the COVID jab is also quite low, the risk associated with the injection is still significantly greater than any risk associated with the natural infection. As explained by Malone:
“That ratio comes out suggesting that there will be more lives lost to receipt of the ‘vaccine’ in a universal vaccine campaign than there would be if all those kids were infected by SARS-CoV-2. This upside-down ratio appears to extend or very close to equivalent at least up to the age of 30.
So, we’re in a position where the data that we have are admittedly flawed. Is that by intent or what? From my standpoint, the data are the data, so I can’t smoke out what somebody within health and human services intended to do, but I can look at the data, and others can.
And the data absolutely do not support a positive risk-benefit ratio for vaccination of infants through young adults, based on any normal criteria. So then why are they doing this crazy stuff? It seems to all be wrapped around the axle of the need to justify universal vaccination.
I argue that this is actually a mid-century policy that goes back to the ’50s and the ’60s polio vaccine campaign, when the government and world health authorities established a position that it was OK to lie, to withhold information about risk for vaccines, because to have the full spectrum of information about the risks of vaccines would cause people to not accept the vaccine.
So, ‘Shut up, we know it’s best for you and don’t question us’ is a firmly authoritarian position. It is intrinsically authoritarian and paternalistic. It’s exactly the kind of stuff that George Orwell wrote about in his book ‘1984.’ It was a warning … of how governments and authoritarian structures will behave and do behave.”
Denial of Vaccine Dangers Has Been Federal Policy Since 1984
Ironically, Malone points out that in the 1984 Federal Register,10 it’s stated that posting information into the federal register about vaccine risks that jeopardizes vaccine I uptake shall be suppressed.
“So, it’s a clear federal policy going back to 1984,” Malone says. “This is the way they’re going to handle things. And they’re going to handle it with the noble lie of saying, ‘No, there are no risks and what we’re doing is fully justified’ …
I don’t think we have to go to imagining some grand conspiracy at Davos between certain individuals. I think this is an emergent phenomena of the intersection of old-school thinking about information management and new-school capabilities and technologies.
I think the CDC, HHS, WHO, and Wellcome Trust or Bill & Melinda Gates foundation, etcetera, have just grossly misread the population, certainly in the United States. And so now we’re in a position where before, according to Del Bigtree, there was about 1% to 2% of people that self-identified as anti-vaxxers, and we’re now [above] 40%. Clearly, about 40 to 50% of the population are just dug in. They’re not going to accept these vaccines.
The White House now finds it necessary to have a special group to identify and target 12 American citizens for what they believe to be vaccine disinformation, and to make a big public press announcement about it. Don’t they have anything else to do? It seems like the world has got bigger problems than Dr. Mercola, but what do I know?
The whole thing is mind-bending. And a lot of people, including many Europeans, are really lit up over this. They remember. European intellectuals are very aware of the dynamics that happened in Germany in the 1930s … I think this could be a turning point in a lot of things.”
The Powers That Be Have Been Given Free Reign
While Malone is not interested in speculating about the intentions behind all this malfeasance, he’s intimately familiar with the power of Big Pharma to manipulate governments. As detailed in other articles, several of the COVID injection makers have a rich history of illegal activity and unethical behavior, and now they have been given free reign to do as they please.
They’re been completely absolved from liability if and when something goes wrong with these injections, and governments are enticing and bullying citizens to participate in Big Pharma’s experiment.
“If you give that kind of liberty and power to a global multinational and absolve them of any accountability, they will serve their stockholders,” Malone says. “They are not geared to serving the rest of us, whatever they may say in their press releases.
That’s just how big pharma behaves, and we’ve chosen this model. Messaging having to do with alternative treatments and the importance of wellness, those are not consistent with the ‘Take this pill, pay your price and shut up’ kind of business model.
Personally, I think that Mr. Gates and his foundation have done enormous irreparable harm to world health community through his actions and his own personal biases. He has really distorted global public health. At some point, there will be books written about this, and I’m sure an enormous number of Ph.D. theses will be granted. But meanwhile, we all have to live with it.”