Category: Safe and Effective

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Researcher blows the whistle on data integrity issues in Pfizer’s vaccine trial

In autumn 2020 Pfizer’s chairman and chief executive, Albert Bourla, released an open letter to the billions of people around the world who were investing their hopes in a safe and effective covid-19 vaccine to end the pandemic. “As I’ve said before, we are operating at the speed of science,” Bourla wrote, explaining to the public when they could expect a Pfizer vaccine to be authorised in the United States.1

But, for researchers who were testing Pfizer’s vaccine at several sites in Texas during that autumn, speed may have come at the cost of data integrity and patient safety. A regional director who was employed at the research organisation Ventavia Research Group has told The BMJ that the company falsified data, unblinded patients, employed inadequately trained vaccinators, and was slow to follow up on adverse events reported in Pfizer’s pivotal phase III trial. Staff who conducted quality control checks were overwhelmed by the volume of problems they were finding. After repeatedly notifying Ventavia of these problems, the regional director, Brook Jackson, emailed a complaint to the US Food and Drug Administration (FDA). Ventavia fired her later the same day. Jackson has provided The BMJ with dozens of internal company documents, photos, audio recordings, and emails.

BMJ is a provider of journals, clinical decision support, events and medical education. The company, legally the BMJ Publishing Group Ltd, is a wholly owned subsidiary of the British Medical Association..

Safe And Effective ®

Sask Health did a funny thing the other day.

This is how their Covid dashboard looked on October 21st. (Image is from a previous post.)

And this is how it looks today.

The “unvaccinated” now share a category with the newly vaccinated. Why would they do such a thing?

(I’ll let you finish yesterday’s math on your own.)

Related: This is what a real breakthrough infection report should look like.

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I have a question.

It’s about the upcoming approval (which is both inevitable and predetermined) of Covid-19 vaccines for children under 12.

My question is specifically addressed to our governing MLA’s, Cabinet, and health officials, along with the yapping jackals in opposition.

Should it come to pass – say in a five years time – that there’s a spike in leukemia, rare cancers, autoimmune disease or other long term side effects in these children that no one could have foreseen (because no one did long term trials) — what’s the game plan?

I mean, surely there’s a game plan?

Surely there has been discussion around the table at Cabinet, at Sask Health and elsewhere about how governments and health officials of the future will manage the fallout.

I mean, it’s not as though there aren’t precedents for the catastrophic failure of public health policy resulting from the advice and decisions of an expert medical class whose confidence was surpassed only by incompetence. One in particular comes to mind.

Parsons argues that the tragedy might have been contained, if not avoided, earlier than it was. That much is evident in testimony spilling each week from the federal inquiry into Canada’s blood supply, a multimillion-dollar exercise led by Justice Horace Krever of Ontario’s Court of Appeal. A veteran Ottawa journalist, Parsons builds a dry but unflinching case against a top-heavy blood bureaucracy – at its pinnacle, the Canadian Red Cross Society and the federal regulatory Bureau of Biologics – that operated a system riddled with flaws and false economies.

Safety was second to budget trimming, Parsons contends. Turf wars buried scientific data that alerted blood agencies to potential dangers. Hemophiliacs, who became the miners’ canaries of the blood system, were themselves self-destructively passive. At every turn, writes Parsons, “eyes were shut to mounting evidence, until it was too late.”

Because if you think that parents of injured children who were coerced by mandates won’t come looking for blood — think again.

It will be tainted blood scandal times 10,000.

Or — is the game plan the same as it always is? That being: “Sure, we’re spitballing. We have no fucking idea. Throw other peoples money at them, we assume. But, we have to get the media off our back. And I’ll be out of government by then, so that’s someone else’s problem”.

Because if that’s your game plan, I wouldn’t bet the house on it.

Not this time.

One last thing. Why is no one out there asking this question?

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Sweden suspends Moderna vaccine for those 30 and under.

“The reason for the pausing is “signals of an increased risk of side effects such as inflammation of the heart muscle or the pericardium” — the double-walled sac containing the heart and the roots of the main vessels, Sweden’s Public Health Agency said in a statement. “The risk of being affected is very small.” and “U.S. and European regulators caution, however, that both the Moderna and Pfizer vaccines appear linked to a rare reaction in teenagers and young adults — chest pain and heart inflammation.”

Meanwhile in Joe Bidens America

More have died from COVID-19 this year than from the virus in all of 2020, according to newly updated data from Johns Hopkins University.

Then there’s the vaccine miracle in New Brunswick. With 90% of the population jabbed, and 81% double jabbed cases are at an all time high and they just cancelled Thanksgiving.

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Anthony FureyThe Ontario government is now recommending the use of Pfizer over Moderna for 18-24yo males, due to their findings that Moderna has a 1 in 5,000 risk of myocarditis for that category.

Social media is a terrible platform to seek information, but it’s unequaled place for taking a pulse. The anecdotal reports from young men in treatment for post-vaccination myocarditis began rolling through Twitter months ago.

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@Andrew Bostom, MD, MS: “Landmark” NEJM study affirming C19 vax safety in pregnancy admits major analysis flaw

“No denominator was available to calculate a risk estimate for spontaneous abortions, because at the time of this report, follow-up through 20 weeks was not yet available for 905 of the 1224 participants vaccinated within 30 days before the first day of the last menstrual period or in the first trimester. Furthermore, any risk estimate would need to account for gestational week–specific risk of spontaneous abortion.”

Full text here: Preliminary Findings of mRNA Covid-19 Vaccine Safety in Pregnant Persons

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I’m old enough to remember when it was one-in-a-million: Incidence of myopericarditis overall was approximately 10 cases for every 10,000 inoculations.

Summary and Conclusions This is the largest series in the literature to clearly relate the temporal relationship between mRNA COVID vaccination, symptoms and CMR findings. In most patients, symptom onset began within the first few days after vaccination with corresponding abnormalities in biomarkers and on ECG. Cardiac MRI confirmed acute myocardial and pericardial changes with the presence of edema demonstrated with both tissue mapping and late gadolinium enhancement. Symptoms settled quickly with standard therapy and patients were discharged within a few days. No major adverse cardiac events and no significant arrythmias were noted during inpatient stay. Further follow up will be required to ascertain the longer-term outcomes of this patient group.

If you’ve been vaccinated and experience chest pain after — don’t ignore it. (Lord knows how many cases went unreported in those who recovered without seeking medical attention).

Don’t interpret any of my posts to suggest you shouldn’t get vaccinated. This isn’t a team sport in which you must pick a side (much as some of you want it to be). You are allowed to hold than one position at the same time. It’s not contradictory to choose vaccination and oppose mandates. It’s not contradictory to be vaccinated and yet skeptical of government claims about risk and effectiveness. It’s not contradictory to be vaccinated, while rejecting coercion and the scapegoating of those who choose not to.

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What’s the difference between Israel and Canada?

Time.

While most countries are still trying to finish inoculating their populations for the first time, Israel is already preparing for a second round of booster doses. The country is making efforts to secure sufficient supply in case a fourth round of Covid-19 shots is needed, according to a top health official.

“We don’t know when it will happen; I hope very much that it won’t be within six months, like this time, and that the third dose will last for longer,” Health Ministry Director General Nachman Ash said in an interview with Radio 103FM.

Israel began a drive to administer booster shots at the beginning of August, and has so far inoculated about 2.8 million people with a third dose.

Jeffrey Tucker;

How significant is it that the two top FDA officials responsible for vaccine research resigned last week and this week signed a letter in The Lancet that strongly warns against vaccine boosters? This is a remarkable sign that the project of government-managed virus mitigation is in the final stages before falling apart.

The booster has already been promoted by top lockdown advocates Neil Ferguson of Imperial College and Anthony Fauci of NIH, even in the face of rising public incredulity toward their “expert” advice. For these two FDA officials to go on record with grave doubts – and their perspective is certainly backed by the unimpressive booster experience in Israel – introduces a major break in the narrative that the experts in charge deserve our trust and deference.

What’s at stake here? It’s about more than the boosters. It’s about the whole experience of taking away the control of health management from individuals and medical professionals and handing it over to modelers and government officials with coercive power. […]

At no point in these 19 months have we seen a clear admission of failure on the part of government officials. Indeed, it’s mostly been the opposite, as the agencies double down, claiming effectiveness while citing no data or studies, while social media companies backed it all by taking down contrarian posts and brazenly deleting accounts of people who dare cite dissenting science.

The vaccine was the biggest gamble of all simply because the program was so expensive, so personal, and so wildly oversold. Even those of us who opposed every other mandate had hopes that the vaccines would finally end the public panic and provide governments a way to back out of all the other strategies that had failed.

That did not happen.

Most people believed that the vaccine would work like many others before them to block infection and spread. In this, people were merely believing what the head of the CDC said. “Our data from the C.D.C. today suggests that vaccinated people do not carry the virus, don’t get sick,” Rochelle Walinsky told Rachel Maddow. “And that it’s not just in the clinical trials, it’s also in real-world data.”

“You’re not going to get COVID if you have these vaccinations,”President Biden said, reflecting what was the common view in the summer of 2021.

That of course turned out not to be the case. The vaccines appear to have been helpful in mitigating against some severe outcomes but it did not achieve victory over the virus. Israel’s surge in infections in August was among the fully vaccinated. The same happened in the UK and Scotland, and that precise result began to hit the US in September. Indeed, we all have vaccinated friends who caught the virus and were sick for days. Meanwhile, team natural immunity has received a huge boost from a large study in Israel that demonstrated that recovered Covid cases gain far more protection than is conferred by the vaccine.

The fallback position then became the booster. Surely this is the answer! Israel was first to mandate them. Here again, the problems began to show, as yet another magic bullet of disease mitigation failed. Then the inevitable headline came: Israel preparing for possible fourth COVID vaccine dose. So think about this because there is a sense in which the vaccines rank among the biggest failures: in a matter of a few short months, we’ve gone from the claim that they fully protect to they are pretty okay provided you get regularly scheduled boosters forever.

Read the whole thing.

Updated with link to referenced Lancet letter.

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Prof Francois Balloux; (Thread)

This preprint is a bit of a bombshell.

The results point to natural infection affording longer-lasting and stronger protection against infection, symptomatic disease and hospitalization due to the SARSCoV2 Delta variant than vaccine-induced immunity.

Read it here: Comparing SARS-CoV-2 natural immunity to vaccine-induced immunity

Another paper in preprint just out from Osaka University: The SARS-CoV-2 Delta variant is poised to acquire complete resistance to wild-type spike vaccines

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@EricTopol

There needs to be truth-telling about the reduced protection of mRNA vaccines vs symptomatic Delta infections. It was 95% pre-Delta. Many are claiming it’s still ~80%.

It isn’t. 50-60% is best estimate from all sources (not US, since we don’t have the data) …

Look at Israel’s Delta case surge, a model country for vaccination, >15 per cent points more of total population vaccinated than the US. That, in itself, tells us about the reduction of protection of mRNA vaccines vs cases/spread.

Bumped for this update.

Maybe Geert Vanden Bossche knew what he was talking about, after all.

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Dr. Sebastian Rushworth;

A study recently published in the Lancet Healthy Longevity sought to estimate the extent to which drug trials underestimate side effects. It was funded by the UK Medical Research Council and the Wellcome Trust. The study chose as its particular focus people being treated for high blood pressure with a certain class of blood pressure lowering drugs known as RAAS blockers (which includes all drugs with names ending in -pril and all drugs with names ending in -sartan). The advantage with looking at this particular class of drugs is that there are a ton of trials. Every major pharmaceutical company has its own RAAS-blocker. It should therefore be possible to draw relatively broad conclusions about the results – whatever they show, they apply to the entire pharmaceutical industry, not just to a few specific companies. It’s also reasonable to think that the results apply to other classes of drugs too – there’s no reason to think trials of RAAS-blockers have been done differently than trials of other drug classes.

What the study sought to do more specifically was compare the rate of serious adverse events in clinical trials of RAAS-blockers with the rate observed in the real world. A serious adverse event is any event that is potentially life threatening or that results in death, hospitalization or lasting disability. If a trial has been designed in such a way that it is representative of reality, then the rate of serious adverse events in the trial should largely mirror that seen in the real world.

110 trials of RAAS-blockers were identified by the researchers. Of these, 11 were specifically designed to look at older people (i.e. didn’t recruit anyone under the age of 60). The data on serious adverse events from these 110 trials was extracted and compared to real world data on deaths and hospitalizations taken from a UK government funded database of 55,000 people living in Wales, who were being treated with RAAS-blockers. Deaths and hospitalizations are not exactly the same thing as serious adverse events (which as mentioned above also include “life threatening events”, and could for example include someone who is treated in an emergency department after a fall but not admitted to the hospital), but they’re close enough to allow a reasonable comparison.

So, what were the results?

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Let me begin by stressing that I’m not an anti-vaxxer — not by any stretch of the imagination. And every time I use this post title, I want you to remember that.

It’s not just that I’ve had childhood vaccines and a couple of tetanus shots, but vaccines remain the most important step forward for the health and longevity of purebred companion dogs (of which I am a breeder) of the last 100 years. Vaccines are a way of life here, and like many of you in the agriculture industry, I routinely administer them myself. They protect against the horrors of parvovirus and distemper. Diseases that once wiped out a lifetime of work in a week are no longer a threat, and for that I am grateful.

That said…

Holy Hell, failures like this have a way of making you sit up and pay attention.

Something strange started happening to calves in Europe in 2007: Horrific blood clotting issues & depletion of bone marrow Read how in 2010, under pressure, Pf!zer finally withdrew the BVD vacc!ne linked to Bleeding Calf Syndrome

From 2011: Vaccine linked to ‘bleeding calf syndrome’

Bleeding calf syndrome (bovine neonatal pancytopenia or BNP) affects new born calves resulting in low blood cell counts and depletion of the bone marrow. It first emerged in 2007 and a serious number of cases are reported each year. In affected calves, bone marrow cells which produce platelets are also destroyed. Consequently the calves’ blood does not clot and they appear to bleed through undamaged skin. There is evidence that BNP is linked to the use of a particular vaccine against “Bovine viral diarrhea virus” (BVDV). […]

Prof Till Rümenapf from Justus-Liebig-Universität Giessen commented that, “Alloantibodies (antibodies generated by one individual of a species against another of the same species) are produced by the mother if she has different MHC I than the bovine cells used to grow the vaccine. These do not harm the mother. However if her calf has the same MHC I as the vaccine production cells, the antibodies in her colostrum will destroy the calf’s cells, including those of the bone marrow. Destruction of megakaryocytes results in the calf being unable to produce platelets and consequently its blood cannot coagulate.”

I can guarantee no one at Pfizer saw that coming. Let’s hope they learned something from it.

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