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Pfizer Drip Feeds Data From its Pregnancy Trial

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From the Brownstone Institute

BY Maryanne DemasiMARYANNE DEMASI

In January 2021, in the absence of any human data in pregnancy, the CDC stated on its website that mRNA vaccines were “unlikely to pose a specific risk for people who are pregnant.”

Former CDC director Rochelle Walensky backed it up with a full-throated endorsement of covid-19 vaccination in pregnancy.

“There is no bad time to get vaccinated,” said Walensky.

“Get vaccinated while you’re thinking about having a baby, while you’re pregnant with your baby or after you’ve delivered your baby,” she added.

Behind the scenes however, Pfizer was scrambling to conduct a clinical trial of its vaccine in pregnant women.

By February 2022, Pfizer revealed it still did “not yet have a complete data set.” Its statement read:

“The environment changed during 2021 and by September 2021, COVID-19 vaccines were recommended by applicable recommending bodies (e.g., ACIP in the U.S.) for pregnant women in all participating/planned countries, and as a result the enrollment rate declined significantly.”

This month, Pfizer finally posted some trial results on clinicaltrials.gov.

The data do not appear in a peer-reviewed journal or a pre-print, nor has it been submitted to the FDA for evaluation.

I spoke with experts who have analyzed the data with a fine-toothed comb and made some alarming observations.

Trial design

Pfizer originally planned to recruit 4,000 healthy women aged 18 or older who were 24 to 34 weeks pregnant. Half would be randomized to the vaccine and the other half to a saline placebo.

The efficacy and safety of the vaccine would be determined by assessing covid-19 cases, antibody responses, and adverse events.

Peculiarly, Pfizer planned to vaccinate all the mothers in the placebo group, one month after giving birth to their babies.

Retsef Levi, a professor at the Massachusetts Institute of Technology Sloan School of Management said that vaccinating mothers in the placebo group during the assessment period would introduce a new variable into the experiment and “corrupt” the data.

“We now know that mRNA from the vaccine is detected in the breast milk, so those babies born from mothers who were all vaccinated after giving birth, are also potentially exposed to mRNA through breastfeeding,” explained Levi.

“This corrupts the comparison of the two groups of babies because you don’t have a true control group anymore,” he added.

Sample size too small

Less than 10 percent of the originally planned 4,000 study participants ended up in the trial.

“Only 348 women were recruited – 174 in each arm – meaning that the trial was never going to have the statistical power, particularly when analyzing potential harms,” said Levi.

Notably, study protocols indicate that Pfizer was given the green light as early as May 2021 by drug regulators to scale back the trial and reduce the sample size.

“To me, the wording in the protocol suggests that the FDA or another regulator basically gave Pfizer permission to do less,” remarked Levi.

“It’s not surprising though. The vaccine had already been recommended for pregnant women and many have taken it, so there is no upside to completing a trial that may detect signals of potential harms. It can only create problems for them, right?” he added.

Given that pregnant women were being vaccinated with a product that had not undergone rigorous safety testing in pregnancy, the FDA was asked if and why it allowed Pfizer to scale back the trial.

The FDA replied, “As a general matter, FDA does not comment on interactions it may or may not be having with sponsors about their clinical trials.”

Angela Spelsberg, an epidemiologist and medical director at the Comprehensive Cancer Center Aachen in Germany agreed that the integrity of the study had been compromised.

“There are just not enough babies in this trial to detect rare or very rare adverse events. We learned from studies in animals that lipid nanoparticles in the vaccine can deposit in many organs including the ovaries, so we must be extremely cautious about the potential negative impacts of the vaccine on reproductive health,” said Spelsberg.

“The scientific community urgently needs access to the pregnancy study data on the patient level for transparency and independent scrutiny of vaccine safety and efficacy because regulatory oversight is failing,” she added.

Exclusion criteria

The small sample size may have been the result of the strict selection process.

Pfizer recruited participants with an impeccable pregnancy history, and most were in their third trimester (27-34 weeks gestation), a stage when the baby’s major development has already occurred.

“It appears that they cherry picked the mothers to get the best results,” said Levi. “We have no idea what impact this vaccine has on the early stages of development of an embryo or foetus, because all the women had advanced pregnancies when they were recruited.”

Spelsberg agreed.

“The first trimester is particularly vulnerable to adverse reproductive health outcomes,” she said.

“Based on only weak observational evidence, regulators have reassured the public that the vaccines are safe throughout pregnancy. However, we don’t have reliable evidence on the vaccine’s impact on miscarriages, malformation, foetal deaths, and maternal health risks because they excluded pregnant women from pivotal trials,” added Spelsberg.

Missing data

Levi also noticed that “only partial data” were published.

“It doesn’t include any important metrics such as covid infections or antibody levels and its says we must wait until July 2024 for those results. It’s disturbing to say the least,” said Levi.

Also missing from the dataset was a full account of birth outcomes. Of the 348 women in the trial, Pfizer only reported on the birth of 335 live babies.

Of the 13 pregnancies unaccounted for, Pfizer reported one foetal death (stillbirth) in the vaccine group and the outcome of the other 12 pregnancies remains unknown.

“This is unacceptable,” said Levi. “Failing to report the outcome of 12 pregnancies could mask a potentially concerning signal of the vaccine in pregnancy. What happened to the babies, did they all die? Were their mothers vaccinated or unvaccinated?”

Trial dropouts

Finally, there were quite a few babies that were lost to follow-up in the trial.

“Twenty-nine babies in the placebo arm didn’t get to the end of the 6-month surveillance period, versus 15 babies in the vaccine arm.  That’s almost double. Again, this is concerning and requires a detailed and transparent explanation,” said Levi.

Overall, both Levi and Spelsberg say the delays and failure to disclose vital data are unacceptable.

“Pfizer took a year to publish the data. When they finally did, it is incomplete. And we are expected to wait until July 2024 for the next batch of results, while authorities continue to recommend the vaccine in pregnant women,” said Levi.

“We still don’t have solid scientific evidence whether this vaccine is safe for pregnant women and their babies,” said Spelsberg. “It’s a tragedy and a scandal that vaccine use has been recommended, even mandated to women before, during and after pregnancy.”

Questions were put to Pfizer, but the company did not respond by the deadline.

Moderna is also conducting a clinical trial of its mRNA vaccine in pregnancy, but no data are available.

Reprinted from the author’s Substack

Author

  • Maryanne Demasi

    Maryanne Demasi, 2023 Brownstone Fellow, is an investigative medical reporter with a PhD in rheumatology, who writes for online media and top tiered medical journals. For over a decade, she produced TV documentaries for the Australian Broadcasting Corporation (ABC) and has worked as a speechwriter and political advisor for the South Australian Science Minister.

After 15 years as a TV reporter with Global and CBC and as news director of RDTV in Red Deer, Duane set out on his own 2008 as a visual storyteller. During this period, he became fascinated with a burgeoning online world and how it could better serve local communities. This fascination led to Todayville, launched in 2016.

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Brownstone Institute

A Potpourri of the World’s Unexposed Scandals

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From the Brownstone Institute

By  Bill Rice  

How many genuine, shocking – and unexposed – scandals actually occurred in the last four years?  To partially answer this question, I composed another of my List Columns.

The Most Epic of Scandals Might Be…

The world’s most epic scandal might be the massive number of citizens who’ve died prematurely in the last four years. This scandal could also be expressed as the vast number of people whose deaths were falsely attributed to Covid.

My main areas of focus – “early spread” – informed my thinking when I reached this stunning conclusion:  Almost every former living person said to have died “from Covid” probably did not die from Covid.

The scandal is that (unreported) “democide” occurred, meaning that government policies and deadly healthcare “guidance” more plausibly explain the millions of excess deaths that have occurred since late March 2020.

My research into early spread suggests that the real Infection Fatality Rate (IFR) of Covid should have already been known by the lockdowns of mid-March 2020.

If, as I believe, many millions of world citizens had already contracted this virus and had not died, the Covid IFR would be the same, or perhaps even lower, than the IFR for the common flu – said to be 1 death per 1,000 infections (0.1 percent).

Expressed differently, almost 100 percent of people who contracted this virus did not die from it – a fact which could and should have been known early in the “pandemic.” The fact this information was concealed from the public qualifies as a massive scandal.

Evidence That Would ‘Prove’ This Scandal

Furthermore, one does not need early spread “conjecture” to reach the conclusion that only a minute number of people who were infected by this virus later died from Covid.

After April 2020, a researcher could pick any large group or organization and simply ascertain how many people in these groups later died “from Covid.”

For example, more than 10,000 employees work for the CDC. About 10 months ago, I sent an email to the CDC and asked their media affairs department how many of the CDC’s own employees have died from Covid in the past three-plus years.

This question – which would be easy to answer – was never answered. This example of non-transparency is, to me,  a massive “tell” and should be “scandalous.”

To be more precise, if the CDC could document that, say, 10 of their employees had died from Covid, this would equate to a disease with a mortality risk identical to the flu.

My strong suspicion is that fewer than 10 CDC employees have died from Covid in the last four years, which would mean the CDC knows from its own large sample group that Covid is/was not more deadly than influenza.

I’ve performed the same extrapolations with other groups made up of citizens whose Covid deaths would have made headlines.

For example, hundreds of thousands if not millions of high school, college, and pro athletes must have contracted Covid by today’s date. However, it is a challenge to find one definitive case of a college or pro athlete who died from Covid.

For young athletes – roughly ages 14 to 40 – the Covid IFR is either 0.0000 percent or very close to this microscopic fraction.

One question that should be obvious given the “athlete” example is why would any athlete want or need an experimental new mRNA “vaccine” when there’s a zero-percent chance this disease would ever kill this person?

The scandal is that sports authorities – uncritically accepting “guidance” from public health officials – either mandated or strongly encouraged (via coercion) that every athlete in the world receive Covid shots and then, later, booster shots.

Of course, the fact these shots would be far more likely to produce death or serious adverse events than a bout with Covid should be a massive scandal.

More Scandals

Needless to say, all the major pediatrician groups issued the same guidance for children.

In Pike County, Alabama, I can report that in four years no child/student between the ages of 5 and 18 has died from Covid.

I also recognize that the authorized  “fact” is that millions of Americans have now “died from Covid.” However, I believe this figure is a scandalous lie, one supported by PCR test results that would be questioned in a world where investigating certain scandals was not taboo.

Yet another scandal is that officials and the press de-emphasized the fact the vast majority of alleged victims were over the age of 79, had multiple comorbid conditions, were often nursing home residents, and, among the non-elderly, came from the poorest sections of society.

These revelations – which would not advance the desired narrative that everyone should be very afraid – are similar to many great scandals that have been exposed from time to time in history.

Namely, officials in positions of power and trust clearly conspired to cover up or conceal information that would have exposed their own malfeasance, professional incompetence, and/or graft.

This Might Be the No. 1 Scandal of Our Times

As I’ve written ad nauseam, perhaps the most stunning scandal of our times is that all-important “truth-seeking” organizations have become completely captured.

At the top of this list are members of the so-called Fourth Estate or “watchdog” press (at least in the corporate or “mainstream” media).

In previous articles, I’ve estimated that at least 40,000 Americans work as full-time journalists or editors for mainstream “news organizations.” Hundreds of MSM news-gathering organizations “serve” their readers and viewers.

In this very large group, I can’t think of one journalist, editor, publisher, or news organization who endeavored to expose any of the dubious claims of the public health establishment.

When 100 percent of professionals charged with exposing scandals are themselves working to conceal shocking revelations…this too should qualify as a massive scandal.

To the above “captured classes” one could add college professors and administrators, 99 percent of plaintiffs’ trial lawyers, 100 percent of CEOs of major corporations, almost all elected politicians, and, with the exception of perhaps Sweden, every one of the public health agencies in the world, plus all major medical groups and prestigious science journals.

Or This Might Be Our Greatest Scandal

Yet another scandal – perhaps the most sinister of them all – would be the coordinated conspiracy to silence, muffle, intimidate, bully, cancel, demonetize, and stigmatize the classes of brave and intelligent dissidents who have attempted to reveal a litany of shocking truths.

The Censorship Industrial Complex (CIC) is not a figment of a conspiracy theorist’s imagination.

The CIC is as real as Media Matters, News Guard, The Trusted News Initiative, the Stanford Virality Project, and the 15,000-plus “content moderators” who probably still work for Facebook.

Government officials in myriad agencies of “President” Joe Biden’s administration constantly pressured social media companies to censor content that didn’t fit the authorized narrative (although these bullying projects didn’t require much arm-twisting).

Here, the scandal is that the country’s “adults in the room” were identified as grave threats to the agenda of the Powers that Be and were targeted for extreme censorship and punishment.

When people and organizations principled enough to try to expose scandals are targeted by the State and the State’s crony partners, this guarantees future scandals are unlikely to be exposed…which means the same unexposed leaders are going to continue to inflict even greater harm on the world population.

This Scandal Is Hard to Quantify

Other scandals are more difficult to quantify. For example, it’s impossible to know how many citizens now “self-censor” because they know the topics they should not discuss outside of conversations with close friends.

This point perhaps illustrates the state of the world’s “New Normal” – a now-accepted term that is scandalous if one simply thinks about the predicates of this modifier.

It should be a scandal that the vast majority of world citizens now eagerly submit to or comply with the dictates and speech parameters imposed on them by the world’s leadership classes.

The “New Normal” connotes that one should accept increasing assaults on previously sacrosanct civil liberties.

What is considered “normal” – and should now be accepted without protest – was, somehow, changed.

As I routinely write, what the world has lived through the past four-plus years is, in fact, a New Abnormal.

This Orwellian change of definition would qualify as a shocking scandal except for the fact most people now self-censor to remain in the perceived safety of their social and workplace herds.

The bottom line – a sad one – might be that none of the above scandals would have been possible if more members of the public had been capable of critical thinking and exhibited a modicum of civic courage.

As it turns out, the exposure of scandals would require large numbers of citizens to look into the mirror (or their souls) and perform self-analysis, an exercise in introspection that would not be pain-free.

It’s also a scandal our leaders knew they could manipulate the masses so easily.

Considering all of these points, it seems to me that the captured leadership classes must have known that the vast majority of the population would trust the veracity of their claims and policy prescriptions.

That is, they knew there would be no great pushback from “the masses.”

If the above observation isn’t a scandal, it’s depressing to admit or acknowledge this is what happened.

To End on a Hopeful Note

What gives millions of citizens hope is that, belatedly, more citizens might be growing weary of living in a world where every scandal cannot be exposed.

Donald Trump winning a presidential election by margins “too big to steal” is a sign of national hope.

Mr. Trump nominating RFK, Jr. to supervise the CDC, NIH, and FDA is definitely a sign of hope, an appointment that must outrage and terrify the world’s previous leadership classes.

For far too long, America’s greatest scandal has been that no important scandals can be exposed. Today, however, it seems possible this state of affairs might not remain our New Normal forever.

Republished from the author’s Substack

Author

Bill Rice, Jr. is a freelance journalist in Troy, Alabama.

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Brownstone Institute

Freedumb, You Say?

Published on

From the Brownstone Institute

By Gabrielle Bauer 

“Authorities have attacked, detained, prosecuted, and in some cases killed critics, broken up peaceful protests, closed media outlets, and enacted vague laws criminalizing speech that they claim threatens public health”

Didn’t give much thought to freedom until four years ago, at age 63. Freedom was just there, like the water surrounding a goldfish. And then the Covid-19 pandemic blew in, the world locked down, and admonitions to “stay the ‘$^#&’ home” blazed through social media. No freedom was too important to discard in the name of public safety: jobs, family businesses, artistic endeavours, public meetings, social connections that kept despair at bay, all took a backseat to the grim business of saving grandma (who ended up getting Covid anyway). No discussion of moral or practical trade-offs, no pushback from the press, nothing. It felt wrong to me on a cellular level.

Apparently I was the only one in my middle-class liberal circle to harbour misgivings about this astonishing new world. If I tried, ever so timidly, to articulate my concerns on Facebook or Twitter, the online warriors shot back with a string of epithets. “Go lick a pole and catch the virus,” said one. “Crawl back into your cave, troglodyte,” said another. And my all-time favourite: “You’re nothing but a mouth-breathing Trumptard.”

From the get-go, I perceived Covid as more of a philosophical problem than a scientific one. As I wrote on more than one occasion, science can inform our decisions, but not dictate them. What ultimately powers our choices are the values we hold. I saw Covid as a morality play, with freedom and safety cast as the duelling protagonists, and it looked like safety was skipping to an easy victory.

It was a heady time for the health bureaucrats, whose increasingly arcane rules betrayed a naked impulse to control: the Canadian high-school students required to use masks on both their faces and their wind instruments during band practice, the schoolchildren forced (for hygiene reasons) to study on their knees for hours in an Alaska classroom, the “glory-hole” sex advised by the British Columbia Centre for Disease Control. The lack of public pushback against these absurdities heightened my awareness of the fragility of our freedoms.

One of the earliest memes to surface during the pandemic was “muh freedumb.” The locution became a shorthand for a stock character – a tattooed man wearing camo gear and a baseball cap, spewing viral particles while yelling about his rights. A selfish idiot. The memes kept coming: “Warning, cliff ahead: keep driving, freedom fighter.” “Personal freedom is the preoccupation of adult children.” Freedom, for centuries an aspiration of democratic societies, turned into a laughing stock.

Eventually, pro-freedom voices began trickling into the public arena. I wasn’t alone, after all. There were others who understood, in the words of Telegraph writer Janet Daley, that the institutional response to Covid-19 had steamrolled over “the dimension of human experience which gives meaning and value to private life.” Lionel Shriver decried how “across the Western world, freedoms that citizens took for granted seven months ago have been revoked at a stroke.” And Laura Dodsworth brought tears to my eyes when she wrote, in her 2021 book A State of Fear, that she feared authoritarianism more than death.

Once the vaccines rolled out, the war on freedom of conscience went nuclear. If you breathed a word against the products, or even the mandates, you were “literally killing people.” The hostility towards the “unvaxxed” culminated in a Toronto Star front page showcasing public vitriol, splashed with such sentiments as: “I honestly don’t care if they die from Covid. Not even a little bit.”

This, too, felt viscerally wrong. I knew several people who had refused the vaccine, and they all had well-articulated reasons for their stance. If they didn’t fully trust the “safe and effective” bromide recycled by all government and pharmaceutical industry spokespeople, I could hardly blame them. (And I say this as someone who writes for Big Pharma and got five Covid shots.)

One of the most deplorable casualties of Covid culture was freedom of expression, a core principle in the United Nations’ Universal Declaration of Human Rights. Experts speaking publicly about the harms of lockdown faced systematic ostracism from mainstream media, especially left-wing news outlets. By early 2021, Human Rights Watch estimated that at least 83 governments worldwide had used the Covid-19 pandemic to violate the lawful exercise of free speech and peaceful assembly.

“Authorities have attacked, detained, prosecuted, and in some cases killed critics, broken up peaceful protests, closed media outlets, and enacted vague laws criminalizing speech that they claim threatens public health,” the group wrote in a media release. “The victims include journalists, activists, healthcare workers, political opposition groups, and others who have criticized government responses to the coronavirus.”

But what about misinformation? Doesn’t it kill people? Newsflash: misinformation has always existed, even before TikTok. It’s up to each of us to sift the credible folks from the cranks. The best defence against misinformation is better information, and it’s the policy wonks’ job to provide it. Modern science itself depends on this tug-of-war of ideas, which filters out weaker hypotheses and moves stronger ones ahead for further testing.

Besides, misinformation comes not just from cranks, but from “official sources” – especially those tasked with persuading the public, rather than informing it. Remember when Rochelle Walensky, former director of the Centers for Disease Control and Prevention in the US, asserted that “vaccinated people do not carry the virus?” Or when Anthony Fauci maintained that getting vaccinated makes you a “dead end” in the chain of transmission? I rest my case.

The marketplace of ideas is like a souk, with a lot of hollering and arguing and the odd snatched purse – and that’s exactly how it should be. It’s an ingenious and irreplaceable process for getting to the truth. There are few ideas too sacrosanct to question or too ridiculous to consider. That’s why, unlike just about everyone in my left-leaning circle, I take no issue with Elon Musk’s shakedown of the old Twitter, now the Wild West of X.

Under Musk’s algorithms, my feed has become a true philosophical souk, with wildly disparate views smashing into each other, leaving me to sift through the rubble in search of a gold nugget or two. Love him or hate him, Musk offers a much-needed counterweight to the ideological lockstep in much of the mainstream media. And when it comes to free speech, Musk has put his money where his mouth is: when media personality Keith Olbermann recently hopped on X, where he boasts a million followers, to call for Musk’s arrest and detainment, Musk made no move to censor him. Works for me.

While the “old normal” has thankfully returned to our daily lives, save the odd mask in a shopping mall or subway car, the stench of censorship that blew in with the pandemic has yet to dissipate. An obsession with disinformation permeates the zeitgeist, spurring lawmakers in several Western countries to censor the flow of thoughts and ideas that gives a free society its pulse.

We cannot excise personal freedom from a democratic society, even in the interests of the “public good,” without poisoning the roots of democracy itself. Article 3 of UNESCO’s 2005 Universal Declaration of Bioethics and Human Rights states this plainly: “The interests and welfare of the individual should have priority over the sole interest of science or society.” In our post-pandemic reality, the statement seems almost quaint. Nonetheless, it expresses an enduring truth: that a democracy must never discard the idea of freedom – even in a pandemic.

Freedom desperately needs a comeback from its current incarnation as an expendable frill. In my own small way I’m trying to make this happen: never much of an activist before Covid, I’m now part of a small group preparing to launch a Free Speech Union in Canada, modelled after the highly successful one in the UK. The organisation will offer legal advice to individuals facing censorship, cancellation, or job loss because of their words. I look forward to supporting people caught in this anti-freedom web, including those whose words I heartily disagree with.

My newfound respect for free speech is also what propels me to keep talking about Covid. The response to the pandemic exceeded the bounds of public health, and we need to expose the forces that drove it. Here’s Daley again: “The world went crazy. There is no other way to account for what was an almost nihilistic dismantling not just of particular liberties and rights, but of the very idea of liberty.” We can’t let it happen again.

Republished from Perspective Media

Author

Gabrielle Bauer is a Toronto health and medical writer who has won six national awards for her magazine journalism. She has written three books: Tokyo, My Everest, co-winner of the Canada-Japan Book Prize, Waltzing The Tango, finalist in the Edna Staebler creative nonfiction award, and most recently, the pandemic book BLINDSIGHT IS 2020, published by the Brownstone Institute in 2023

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