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The UK Covid Response: A Stool with Three Legs

BY CARL HENEGHAN AND TOM JEFFERSON | BROWNSTONE INSTITUTE | APRIL 28, 2022

Respiratory viruses are both unpredictable and commonplace. The name of the most well-known one, Influenza, originated in 15th century Italy, and comes from the old Italian expression influenza dei pianeti or influence of the planets. They could not explain its sudden and unaccountable behavior and ascribed its capricious nature to the influence of planets.

However, influenza is just one of the many agents involved in active respiratory infections; there are scores of known ones which give a spectrum of clinical presentations, from a mild cold to severe pneumonia. We have no idea how many agents there are. Since 1970, 1,500 pathogens have been discovered – 70% have come from animals. Some authors report that up to 40% of respiratory infections have no recognised causes.

Over 30 years, we have studied physical interventionsvaccines, and antivirals for registered compounds and ones which never made it to market. In 2014 we encouraged Roche and GSK to give up the business part of their regulatory submissions for their antivirals, opening up a whole new source of clinical study report evidence that is infinitely more reliable and complete than biomedical journal publications.

So when SARS-CoV-2 struck, we watched unfolding events with curiosity. We try to understand the effects of the agent and those of our leaders’ responses. To achieve this, you need reasonably good data.

We are used to wastage, error, and poor quality research underpinning patient care. The influenza field is further affected by flawed science, pandemic conspiracies and political contamination that leads to the inevitable box thinking with the advent of a newly identified agent.

In the UK, like in most other countries, the daily situation briefings delivered by top scientific advisers who we knew had little experience of respiratory virus epidemiology set the pace of the pandemic and the subsequent hysteria.

The briefings were devised to illustrate the seriousness of the COVID-19 situation by presenting running totals of new cases, hospital admissions and deaths. We call this the three-legged stool of the COVID narrative. The stool provided the rationale for an unprecedented level of restrictions on civil liberties and governmental diktats designed to control the unruly populace in the hope of managing – or even eradicating – the agent.

After exploring aggregate data, we looked in-depth into the science of the three legs: Speaking daily, we discussed and analyzed the certainty behind the summary figures and trends presented every night. Finally, we asked ourselves: what props the stool up?

We tried making sense of the various government websites, the relevant papers in biomedical journals, and the tests applied to identify “cases.” We soon understood that the PCR was inappropriately used as a mass screening tool. Its limits were not understood by those reporting its results or those presenting aggregate data.

Even with correct specimen management and a competent laboratory process, a simple PCR test cannot distinguish active cases from those recovering from SARS-CoV-2 infection who are no longer infectious and a danger to no one.

We used our systematic review skills to analyse the studies comparing the culture of SARS-CoV-2, the best indicator of current active infection and infectiousness, with the results of PCR.

Complete viable viruses are necessary for transmission, not the fragments identified by PCR. PCR picks up minute particles which take weeks to be cleared by our immune systems, not complete viruses, so governments were locking up the contagious with the non-contagious.

Misuse of PCR underpinned the whole narrative. Its very high sensitivity and robotic acceptance as a gold standard created the illusion of many more cases (i.e. active infections) than were really present and prompted long quarantines, disrupting society and lives.

Therefore, the first leg of the stool is unstable, made worse by the absolute refusal to link PCR results to the reporting of viral load estimates, which could (coupled with accurate history and thorough epidemiology) give a likelihood of infectivity.

The second leg, attribution of death, was affected by bureaucratic bungling and PCR misuse. We discovered that UK public health bodies had 14 different ways of attributing the role of SARS-CoV-2 to a death. Some totals included deceased who had tested negative. Post-mortem examinations were uncommon, as was independent verification of causes of death. So aggregate attribution of mortality figures was questionable – the second leg started teetering too.

We are currently analyzing the last leg of the stool: hospital capacity. Hospital episodes take time to reconstruct, but they are also underscored by PCR misuse, poor definitions, and confusing messaging. A coherent dataset is unlikely to exist, so we have to piece the puzzle together.

We reported our findings in a series of web reports for a charity and the mainstream media, the only avenues that evade some censorship.

Where did our data come from? From the only section of society which had an idea of what was going on, or at least were asking questions instead of accepting the “rule of six” or supermarket trolley police checks like obedient cattle, the public.

Freedom of Information (FOI) request sites in the UK are sources of amazingly bright questions and bureaucratic and sometimes misleading answers. Here are some examples. Public Health England does not know whether hospitals have a financial incentive to classify an admission episode as COVID-related, so how can they interpret the data?

Some deaths are classified as COVID-related, even though negative. The Department of Health has no idea how many and which of the PCR kits are in use, all with a different performance which has not been standardized. So they were adding apples with trees and hay bales and reporting the consequent nonsense daily.

The power of FOI host websites like WhatDoTheyKnow is immense and underutilized. The questions and responses are public for everyone to see, and most of the public’s questions are pin-sharp.

The FOI ACT provides access to information held by public authorities who are obliged to publish certain information about their activities; and members of the public are entitled to request information from public authorities.

However, the FOI respondents show poor science, bureaucracy, delegation to juniors to respond to “nuisance” questions and a lack of coherent vision – at times, the response is dismissive. Still, there are occasional nuggets of vital information.

Why not set up a similar FOI portal in every country? We think it is the only way to make these people accountable to voters. You can follow our attempts at getting to the bottom of hospital episodes in England, Wales and Northern Ireland by following our correspondence: 1 2 3 4.

The stool’s three legs remain vital to understanding the rationale for restrictions imposed throughout the pandemic.

Conflict of interest statements

TJ’s competing interests are accessible here. CJH holds grant funding from the NIHR, the NIHR School of Primary Care Research, the NIHR BRC Oxford and the World Health Organization for a series of Living rapid review on the modes of transmission of SARs-CoV-2 reference WHO registration No 2020/1077093. He has received financial remuneration from an asbestos case and given legal advice on mesh and hormone pregnancy tests cases. He has received expenses and fees for his media work including occasional payments from BBC Radio 4 Inside Health and The Spectator. He receives expenses for teaching EBM and is also paid for his GP work in NHS out of hours (contract Oxford Health NHS Foundation Trust). He has also received income from the publication of a series of toolkit books and for appraising treatment recommendations in non-NHS settings. He is Director of CEBM and is an NIHR Senior Investigator.

Authors

Carl Heneghan is Director of the Centre for Evidence-Based Medicine and a practising GP. A clinical epidemiologist, he studies patients receiving care from clinicians, especially those with common problems, with the aim of improving the evidence base used in clinical practice.

Tom Jefferson, Department for Continuing Education, University of Oxford, UK

May 1, 2022 Posted by | Science and Pseudo-Science, Timeless or most popular | , | Leave a comment

Parsing the “data” from Moderna’s selective leaks to the press about its failed clinical trial in kids under 6

The shot made no difference against Covid but it does cause myocarditis and came with a 15% to 17% adverse event rate. Meanwhile the CDC admits that 74.2% of kids already have natural immunity.

By Toby Rogers | April 30, 2022

On Friday, the NY Times and other stenographers for the cartel breathlessly announced that Moderna has asked the FDA to authorize its junk science mRNA shot in kids under 6. Oh, so that means Moderna submitted an application to the FDA? Well, not exactly. From the article:

“A top official at the company said it would finish submitting data to regulators by May 9.”

Wait, so Moderna is “asking” the FDA to authorize its product but Moderna will not even finish its application for another 10 days!? That’s weird. It’s like a kid asking his teacher for a A+ while his homework assignment is half-finished.

So already we’re seeing serious red flags and we’re not even out of the first paragraph.

Of course it gets worse.

To be clear, there is no data because Moderna has not even finished its application. But Moderna and the White House have been selectively leaking numbers to the press that dutifully prints them without question — and those numbers tell us that Moderna’s clinical trial was a disaster.

I need to provide some background and context and then I’ll get into the particular details about this failed clinical trial in kids.

Moderna applied for Emergency Use Authorization to administer its mRNA shot to adolescents 12 to 17 years old back on June 10, of 2021. But the application has been held up ever since. Why? Myocarditis. From the Wall Street Journal :

The Food and Drug Administration is delaying a decision on authorizing Moderna Inc.’s mRNA Covid-19 vaccine for adolescents to assess whether the shot may lead to heightened risk of a rare inflammatory heart condition, according to people familiar with the matter.

Moderna has at least two big problems in giving this shot to teenagers:

1) The dose they are giving to teenagers is the same dose as that given to adults — 100 mcg of mRNA — which is four times the amount in the Pfizer shot given to adults (25 mcg). So the Moderna shot is great at generating antibodies that target the spike protein of the original Wuhan lab leak strain. But some of that mRNA can migrate to the heart and generate myocarditis as well. Remember, Pharma’s capture of the FDA is so extreme, they should just be able to write “Iz Gud!” on a paper napkin and the FDA will approve it — as they did with Pfizer’s application to inject kids 5 to 11 — in spite of ZERO evidence supporting this use. So if the FDA has held up Moderna’s application in teens for nearly a year, the myocarditis signal must be truly terrifying.

2) Nordic countries are slightly less corrupt than the United States. Finland, Sweden, Denmark, and Norway have all suspended the use of the Moderna mRNA shot in teenagers because its leads to myocarditis. (Finland and Sweden even suspended its use in men under 30 years old.) Even the criminally corrupt European Medicines Agency acknowledged that both Pfizer and Moderna mRNA shots lead to myo- and pericarditis and added a warning to the product insert.

Okay what do we know about Moderna’s clinical trial in kids under 6?

Back on March 23, Moderna put out a press release claiming that:

vaccine efficacy in children 6 months to 2 years was 43.7% and vaccine efficacy was 37.5% in the 2 to under 6 years age group.

The NY Times of course printed that like it was a clay tablet handed directly from God to Moses just as they printed the “90% to 100% effective(TM)” lie in connection with the clinical trial in adults. By now everyone knows that the actual vaccine effectiveness is zero or even negative after 6 months.

Sane people pointed out that vaccine efficacy of 43% and 37% are BELOW the 50% threshold required for FDA authorization. It’s not clear why the geniuses at Moderna did not realize this — perhaps they just wanted to rub everyone’s noses in the sheer criminality of their enterprise?

But somewhere between March 23 and last Friday, Moderna staff got the message so they did what they always do, they just manipulated the data. From the NY Times :

Moderna said Thursday the vaccine appeared to be 51 percent effective against symptomatic infection among those younger than 2, and 37 percent effective among those 2 to 5.

Okay first off, lol that they still cannot get the number above 50% in kids 2 to 5 even when they are just straight up lying about the numbers. But how did they convert 43% to the magical 51% in kids 0 to 2? They simply deleted data that they did not like:

Those results were slightly better than the ones Moderna previously released for children under 2. The company said that was because the second time, the firm excluded infections that had not been confirmed with a P.C.R. test analyzed in a laboratory.

Let’s be clear — this is Moderna’s clinical trial. They control the whole process. If you’re a study participant who is having a heart attack in the middle of the night and call 911 and go to the hospital — they kick you out of the clinical trial for not seeing their doctors and following their protocol. So Moderna is the one who makes the decision as to whether to use “a P.C.R. test analyzed by a laboratory.” To now exclude (without any valid justification) infections that made their clinical trial look bad is gross scientific misconduct. The Moderna application, when/if it is submitted 10 days from now, should be rejected immediately because of this misconduct.

While the clinical trials in kids were failing, Pfizer and Moderna were running a half-hearted campaign to pressure the FDA to approve these shots in kids under 5 — in spite of zero data showing benefit and considerable evidence showing harms. The attempts were pathetic and included hashtags on social media like #immunizeunder5 that were likely only used by people taking money from these monsters. But of course the stenographers eagerly reported on this milquetoast effort and one of the talking points is, ‘well, okay, the shots do not meet the required 50% FDA threshold but some protection is better than none(TM) so please authorize my right to genocide my kids.’

Well, it turns out, these shots do NOT even offer “some protection”:

Moderna’s clinical trial data showed that the antibody response of the youngest children compared favorably with that of adults ages 18 to 25, meeting the trial’s primary criterion for success. Although the trial was not big enough to measure vaccine effectiveness…

What!? “The trial was not big enough to measure vaccine effectiveness.” Isn’t that the whole point of a clinical trial!? So Moderna (and the NY Times ) are saying that the clinical trial made ZERO difference on Covid-related health outcomes including infection, hospitalization, ICU visits, or deaths, because the SARS-CoV-2 virus is not a threat to healthy children in this age group — which we have been pointing out for months.

So how does Moderna try to finesse it? They look at antibodies in the blood, not health outcomes in the real world. They call it “immunobridging”. As I explained at length back in October, this is NOT a scientifically valid way to use immunobridging (claiming likely future health outcomes from antibodies alone when the trial showed no such thing). Immunobriding is only valid if one has clinically validated correlates of protection and conditions prevent one from conducting a proper RCT (neither of which apply in this case).

Even the hand-picked yes-men and women on the CDC’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) acknowledged at their last meeting that they do NOT have “correlates of protection” that would enable them to estimate health outcomes from antibody measures. Eric Rubin (Editor-in-Chief of the NEJM ) even stated, “We know what kind of antibody response can be generated, we just don’t know if it works.”

So Moderna is asking the FDA to authorize its mRNA shot in kids under 6 based on antibodies alone even though every member of the FDA’s VRBPAC acknowledges that antibodies tell you absolutely nothing about likely health outcomes.

(In fact, new evidence suggests that mRNA shots suppress the body’s innate ability to generate anti-N antibodies.)

What about side effects?

Side effects were at a similar level as those from previously approved pediatric vaccines, with fevers in 15 percent to 17 percent of the children, Moderna said.

Any shot with an adverse event rate over 1% should not be authorized. To authorize a shot with a 15 to 17% adverse event would be batsh*t insane.

Furthermore, we know that Moderna and Pfizer make cases of disability and death in their clinical trials disappear — so the actual adverse event rate is surely even higher than 15% to 17%.

Making this nightmare complete, the CDC acknowledged on April 26, 2022, that 74.2% of children ages 0 to 11 are already naturally immune to Covid-19 because of prior exposure. The 74.2% number came from February, so given the rate of increase at the time, by now nearly 100% of children ages 0 to 11 likely already have natural immunity which is superior to artificial vaccine immunity. There is no emergency in this population that would justify an emergency use authorization of this useless toxic product.

So to recap this painful saga:
• Moderna shots cause myocarditis and pericarditis which is why Moderna has not been able to get authorization to inject mRNA into teenagers.
• Moderna shots make no difference in connection with Covid-19 in this age group.
• Moderna shots come with at least a 15% to 17% adverse event rate.
• Nearly all children in this age group are already naturally immune so there is no emergency that would justify an emergency use authorization.

This is not hard to figure out. In a sane world this application would be dead on arrival, whenever Moderna gets around to actually turning in its application. Any reporter worth his/her salt should be ridiculing Moderna’s weird mix of hubris, incompetence, bad “data”, and malevolence. But our country, its “public health” agencies, and the mainstream media are run by Insane Nazi Clowns. I imagine many bougiecrats will drown in their own tears if they are not allowed to genocide their own kids with this shot (and then they’ll celebrate their sacrifice and take selfies with their kids in the ICU when the myocarditis kicks in, proclaiming #getvaccinated). Of course bougiecrats can already get this shot for their kid off label, so my hunch is that it’s really your kids who they want to genocide.

In future articles I’ll have additional thoughts about how we push back. In the meantime, this continues to be our best play and I encourage all of us to just get into the habit of contacting 25 people at the FDA every day to tell them to REJECT both the Moderna and Pfizer applications to inject mRNA into little kids.

May 1, 2022 Posted by | Corruption, Deception, Fake News, Mainstream Media, Warmongering, Science and Pseudo-Science | , , , | Leave a comment