René Magritte The false mirror 1928
Look, we get it. The people working at institutions such as the FDA and CDC were anonymous nobodies with science degrees for as long as they can remember, just following protocols written by others, and getting relatively well paid. And then Covid came, and everyone looked at them to save the nation. Especially the government and the pharmaceutical industry. And they exert a lot of pressure.
Pressure to ditch established protocols in particular. Because those stand between them and enormous amounts of profits and political power. So, yeah, we get that part. But these little clerks and their little managers are the last bastion to keep Americans safe from dangerous abuses from the nation’s chemical giants, so there can be huge amounts of American lives at stake. So ditching protocols and good practice is never really an option. You would think. Until now.
On August 5 (last update) this was still up on clinicaltrials.gov (U.S. National Library of Medicine) for the Pfizer trials:
May 2 2023. But the trial will be finished around August 25 2021 (just as Dr. Fauci has been “predicting“ for weeks now). Which leads to the somewhat bizarre paradoxical conclusion that as the FDA declares the vaccine “Safe”, at the same time it declares the opposite. Because there has been no time for the study of medium- to long term effects of the substance; they just skipped over those entirely.
Which in turn, given the questions raised by many medical professionals about such issues as antibody-dependent enhancement (ADE) and OAS (immune priming), is equally bizarre. At the very least, the forces in the government and the pharmaceutical industry, and now the regulatory agencies too, know there are very realistic risk factors related to the “vaccine”. And they just turn a blind eye.
We see people all the time discussing the credibility of these agencies, and that discussion is now over. That credibility will be reduced to zero around August 25. Is it really worth it? Guess that discussion is now obsolete as well.
And it’s not just the medium- to long term effects that are worrying. The same FDA has displayed no reaction whatsoever to the short term either. Here’s the US VAERS system on adverse reactions, August 13:
And its European sister, EudraVigilance, on August 14:
Both these systems are estimated to report 1 in 10 to 1 in 100 cases. They’re poorly set up on purpose, difficult to use etc. A Hawaii court care mentions 45,000 deaths. US statistician Mathew Crawford, whom I’ve cited a few times now, puts the number at 276,300. But even if we would limit ourselves to the “official”numbers, some 35,000 people in the EU and US have died from the vaccine (not all Pfizer, we know). And that’s just official numbers, that’s not the potenntially 10-100 times larger ones. I know, you might say: no way 350,000 died, someone would have told us! Okay, who told you about the 35,000, then?
Crawford also says: “At some point, when the potential for conflicts of interest are high and the point of failure is fundamental to the task of those doing the job, incompetence should no longer be differentiated from criminal intent.”
The FDA has strayed so far from its protocols and practices it’s hard to believe. A vaccine that killed more than 25-50 people in a trial would always be cut short. Now, at 35,000+ deaths, its crickets. And not just crickets, but an upcoming full approval. Someone should seriously look at taking the little clerks and their little managers to court for murder. Pfizer may have gotten full immunity, but perhaps they have not. And as of August 25, they will be just as guilty.
Let’s go to how the news today reported the approval.
No, we haven’t seen ADE (where your antibodies help the spike proteins enter your cells, to replicate and then kill them) take off on a large scale. But that was never expected, that would always take 6-24 months after inoculation. And even then, there’s nothing saying that what is now labeled Delta is not often already ADE. In the same vein, some are claiming that the rise in Covid in children is in reality RSV, not Covid. If the FDA and CDC are capable of what I’m describing in this article, who’s to say what they are not capable of?
But yeah, full approval would mean more pressure instruments, that’s the whole idea. Now everyone can take your Nuremberg and “Universal Declaration on Bioethics and Human Rights” rights away, because the little clerks and managers at the FDA said so. And when did all this happen? Just a year ago, none of those who now clamor to declare you a leper would have even dreamed of doing that. Then they saw the light.
Let me put this in simple terms: there is no chance in hell that they will ever get more than two-thirds of people “vaccinated”. None. And that means the entire vaccination scheme is moot from day one. One third of people will remain unvaccinated. And society, the economy, cannot afford to lose them. All it can do is threaten. And do you really think an approval without proper protocol will make another 10% “give in”? I don’t see it.
And besides, we already know the vaccines don’t work. All this talk about rare and one-in-a million events, humbug. It’s one every hour. No protection from infection, and very little from severe disease. You’re caught in a propaganda treadmill and it’s time to get out.
FDA ‘Finalizing Paperwork’ With Pfizer Aiming To Give Full Approval To Covid-19 Vaccine Next Week
The FDA will give full authorization to Pfizer’s Covid jab sometime next week, according to multiple reports, putting it on track to be the first in the US to get approval and likely paving the way for additional vaccine mandates. The US regulator is expected to give the greenlight for Pfizer’s immunization in the coming days, the New York Times and Politico reported on Friday, citing several “people familiar” with the agency’s planning. Though the FDA still has a “substantial amount of paperwork and negotiation with the company” to get through, it could give full approval as soon as Monday, the Times added. It was previously reported that the FDA hoped to grant authorization before Labor Day on September 6, and now appears set to meet that informal deadline.
With a number of hospital systems and universities around the US signaling plans to mandate vaccinations against Covid-19 upon full approval, the move is likely to trigger a spate of new requirements around the country. The US military, moreover, has also said it would compel immunizations for its 1.3 million active-duty troops by the middle of next month, but could do so sooner should the FDA give its blessing to Pfizer. While the Joe Biden administration previously suggested the president would issue a waiver to allow vaccine mandates for soldiers, it decided to hold off until regulators signed off.
Reports of the FDA’s plans come soon after the White House began promoting booster shots for all fully vaccinated adults, citing US health agencies, which noted the immunizations are losing effectiveness over time, particularly against more infectious Delta mutation. While the FDA hasn’t yet approved third doses for all healthy Americans, the agency did give the go-ahead for those with compromised immune systems, while Pfizer recently submitted its initial trial data for universal boosters. Health officials have voiced hopes that full approval for the Covid jabs could improve vaccination numbers in the US, which have been losing pace since hitting a peak in April. Recent polling by the Kaiser Family Foundation showed that more than 30% of respondents would be “more likely” to be vaccinated if the FDA authorized the shots, suggesting the move could indeed spur immunizations.
From the British Medical Journal. This simply stinks so badly, hell and high water got nothing. They don’t want a discussion, even if the protocol demands one. They don’t want Malone, McCullough or Yeadon, or you and me, to speak. And perhaps more importantly, they don’t want anyone to see the paperwork (re: “FDA ‘Finalizing Paperwork’ With Pfizer ..”) that the decision is based on. “The Science” has become awfully small.
FDA Set To Grant Full Approval To Pfizer Vaccine Without Public Discussion Of Data
Transparency advocates have criticised the US Food and Drug Administration’s (FDA) decision not to hold a formal advisory committee meeting to discuss Pfizer’s application for full approval of its covid-19 vaccine. Last year the FDA said it was “committed to use an advisory committee composed of independent experts to ensure deliberations about authorisation or licensure are transparent for the public.”1 But in a statement, the FDA told The BMJ that it did not believe a meeting was necessary ahead of the expected granting of full approval. “The FDA has held numerous meetings of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) related to covid-19 vaccines, including a 22 October 2020 meeting to discuss, in general, the development, authorisation, and licensure of covid-19 vaccines,” an FDA spokesperson said.
“The FDA also has held meetings of the VRBPAC on all three covid-19 vaccines authorised for emergency use and does not believe a meeting is needed related to this biologics license application.” The spokesperson added, “The Pfizer BioNTech covid-19 vaccine was discussed at the VRBPAC meeting on 10 December 2020.3 If the agency had any questions or concerns that required input from the advisory committee members we would have scheduled a meeting to discuss.” The vaccine has already been rolled out to millions of Americans through an emergency use authorisation. Companies typically apply for full approval after a longer period has elapsed so that more data are available for review.
But with the US government indicating this week that it plans to start making booster shots widely available next month, experts said the decision not to meet to discuss the data was politically driven. Kim Witczak, a drug safety advocate who serves as a consumer representative on the FDA’s Psychopharmacologic Drugs Advisory Committee,4 said the decision removed an important mechanism for scrutinising the data. “These public meetings are imperative in building trust and confidence especially when the vaccines came to market at lightning speed under emergency use authorisation,” she said. “The public deserves a transparent process, especially as the call for boosters and mandates are rapidly increasing. These meetings offer a platform where questions can be raised, problems tackled, and data scrutinised in advance of an approval.”
Witczak is one of the more than 30 signatories of a citizen petition5 calling on the FDA to refrain from fully approving any covid-19 vaccine this year to gather more data. She warned that without a meeting “we have no idea what the data looks like.” “It is already concerning that full approval is being based on 6 months’ worth of data despite the clinical trials designed for two years,” she said. “There is no control group after Pfizer offered the product to placebo participants before the trials were completed. “Full approval of covid-19 vaccines must be done in an open public forum for all to see. It could set a precedent of lowered standards for future vaccine approvals.”
Finally, from a Google Doc I can’t trace the origins of, other than Steve Kirsch is involved. It saves me some time from stating the obvious.
7 Reasons Why The Covid Vaccines And Vaccine Mandates Should Not Be Approved
1/ The vaccines kill more people than they save. Although the vaccines reduce the number of COVID deaths, that benefit comes at a steep price: death from other causes. Pfizer’s own Phase 3 study (6 month) showed that more people died who got the vaccine than who got the placebo. Today, there is no risk-benefit analysis showing that the vaccines have saved more lives than they’ve taken. The VAERS data shows that the vaccines are extremely unsafe and for those under 50 years old will kill more people than they save. The vaccines elevate dozens of serious adverse cardiovascular and neurological events, reactivate latent viruses, and can make cancers worse. Healthy young people have died shortly and unexpectedly after vaccination.
2/ Multiple studies show that the vaccines have killed 150,000 Americans so far. More than 10 different analyses show that approximately 150,000 Americans have been killed by the vaccines. These analyses have not been disproven despite a $1M reward for any scientist who does so.
3/ There are safer, more effective options available. Early treatments are faster, safer, cheaper, and more effective (over 99% for all variants). VIrtually no one hospitalized for COVID today was treated with a proven early treatment protocol. Unlike the vaccine, nobody dies from these treatments.
4/ The required safety testing still has not been done. The proper testing still hasn’t been done. We don’t know if the vaccine will make people more susceptible to COVID infections through antibody dependent enhancement (ADE) and/or linked-epitope suppression (“original antigenic sin”). No study to date has covered the span of a single human gestation cycle. We know the spike protein is associated with Lewy bodies which are associated with prion diseases like dementia.
5/ No open forum to resolve the concerns of qualified scientists who have safety concerns. The CDC and FDA refuse to engage in discussions with top scientists, such as Robert Malone, inventor of the mRNA vaccine, to discuss the fatality and VAERS analysis in a public forum. The CDC and FDA refuse to see the evidence that is contrary to the “safe and effective narrative.”
6/ No autopsies. There have been no autopsies of anyone dying after getting the COVID vaccine. This is troubling since one of the world’s top pathologists did such a study on 40 patients who died within 2 weeks after vaccination and found that at least 30% to 40% were killed by the vaccine. Despite the availability of robots that perform autopsies that include blood analysis, either none have been performed, or else they have been withheld from the public.
7/Clinical trial fraud. There was clear fraud in the Phase 3 Pfizer trial where at least one participant, 12-year old Maddie de Garay, was paralyzed less than 24 hours after receiving the vaccine. The FDA promised to investigate and did nothing. Today, Maddie cannot feel below her waist, cannot walk unassisted, cannot hold her head up, and must eat through a feeding tube. There were only 1,131 children in the treatment arm. One child in 1,131 being paralyzed is unacceptable to mitigate a potential risk that is close to zero.
Comments:
Unfortunately, it looks like full licensure of the Pfizer vaccine could be just around the corner. This breaks promises the FDA made, including accelerating the time to considering approval. So much data and associated concerns have accumulated in the past eight months, including recently learning that duration of immunity (DOI) is only ~4.5-6 months, which necessitates rapid boosting, which exacerbates safety issues (especially if damage is cumulative). And yet the FDA claims they have no questions beyond what they had in Dec. 2020. Narrowly focused immunity, ridiculously short DOI, largely ineffective against the delta variant, and the dangers associated with it have been underestimated by an unknown but substantial degree and there remain many questions about potential long-term harms. Unbelievable. Buckle your seatbelts. This is a runaway train that needs to be stopped immediately.
Dr. Byram W. Bridle,
Associate Professor of Viral Immunology,
University of Guelph, Ontario, Canada
It’s incredibly depressing to know that what was once the worlds most-respected medicines regulator is going full-on corrupt. They not only do not have anything enough duration after dosing to have a clue what’s going to happen, but the product has picked up enough baggage to warrant being pulled from the market, permanently. Anyone remember how the FDA handled thalidomide? Now look. I despise them.
Dr Mike Yeadon
PS: And the little clerks and mass murderers? Yes, I was very much thinking about the “decent” Germans in the 1940’s.
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