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Brownstone Institute

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

Anthony Fauci Gets Demolished by White House in New Covid Update

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From the Brownstone Institute

By  Ian Miller 

Anthony Fauci must be furious.

He spent years proudly being the public face of the country’s response to the Covid-19 pandemic. He did, however, flip-flop on almost every major issue, seamlessly managing to shift his guidance based on current political whims and an enormous desire to coerce behavior.

Nowhere was this more obvious than his dictates on masks. If you recall, in February 2020, Fauci infamously stated on 60 Minutes that masks didn’t work. That they didn’t provide the protection people thought they did, there were gaps in the fit, and wearing masks could actually make things worse by encouraging wearers to touch their face.

Just a few months later, he did a 180, then backtracked by making up a post-hoc justification for his initial remarks. Laughably, Fauci said that he recommended against masks to protect supply for healthcare workers, as if hospitals would ever buy cloth masks on Amazon like the general public.

Later in interviews, he guaranteed that cities or states that listened to his advice would fare better than those that didn’t. Masks would limit Covid transmission so effectively, he believed, that it would be immediately obvious which states had mandates and which didn’t. It was obvious, but not in the way he expected.

And now, finally, after years of being proven wrong, the White House has officially and thoroughly rebuked Fauci in every conceivable way.

White House Covid Page Points Out Fauci’s Duplicitous Guidance

A new White House official page points out, in detail, exactly where Fauci and the public health expert class went wrong on Covid.

It starts by laying out the case for the lab-leak origin of the coronavirus, with explanations of how Fauci and his partners misled the public by obscuring information and evidence. How they used the “FOIA lady” to hide emails, used private communications to avoid scrutiny, and downplayed the conduct of EcoHealth Alliance because they helped fund it.

They roast the World Health Organization for caving to China and attempting to broaden its powers in the aftermath of “abject failure.”

“The WHO’s response to the COVID-19 pandemic was an abject failure because it caved to pressure from the Chinese Communist Party and placed China’s political interests ahead of its international duties. Further, the WHO’s newest effort to solve the problems exacerbated by the COVID-19 pandemic — via a “Pandemic Treaty” — may harm the United States,” the site reads.

Social distancing is criticized, correctly pointing out that Fauci testified that there was no scientific data or evidence to support their specific recommendations.

“The ‘6 feet apart’ social distancing recommendation — which shut down schools and small business across the country — was arbitrary and not based on science. During closed door testimony, Dr. Fauci testified that the guidance ‘sort of just appeared.’”

There’s another section demolishing the extended lockdowns that came into effect in blue states like California, Illinois, and New York. Even the initial lockdown, the “15 Days to Slow the Spread,” was a poorly reasoned policy that had no chance of working; extended closures were immensely harmful with no demonstrable benefit.

“Prolonged lockdowns caused immeasurable harm to not only the American economy, but also to the mental and physical health of Americans, with a particularly negative effect on younger citizens. Rather than prioritizing the protection of the most vulnerable populations, federal and state government policies forced millions of Americans to forgo crucial elements of a healthy and financially sound life,” it says.

Then there’s the good stuff: mask mandates. While there’s plenty more detail that could be added, it’s immensely rewarding to see, finally, the truth on an official White House website. Masks don’t work. There’s no evidence supporting mandates, and public health, especially Fauci, flip-flopped without supporting data.

“There was no conclusive evidence that masks effectively protected Americans from COVID-19. Public health officials flipped-flopped on the efficacy of masks without providing Americans scientific data — causing a massive uptick in public distrust.”

This is inarguably true. There were no new studies or data justifying the flip-flop, just wishful thinking and guessing based on results in Asia. It was an inexcusable, world-changing policy that had no basis in evidence, but was treated as equivalent to gospel truth by a willing media and left-wing politicians.

Over time, the CDC and Fauci relied on ridiculous “studies” that were quickly debunked, anecdotes, and ever-shifting goal posts. Wear one cloth mask turned to wear a surgical mask. That turned into “wear two masks,” then wear an N95, then wear two N95s.

All the while ignoring that jurisdictions that tried “high-quality” mask mandates also failed in spectacular fashion.

And that the only high-quality evidence review on masking confirmed no masks worked, even N95s, to prevent Covid transmission, as well as hearing that the CDC knew masks didn’t work anyway.

The website ends with a complete and thorough rebuke of the public health establishment and the Biden administration’s disastrous efforts to censor those who disagreed.

“Public health officials often mislead the American people through conflicting messaging, knee-jerk reactions, and a lack of transparency. Most egregiously, the federal government demonized alternative treatments and disfavored narratives, such as the lab-leak theory, in a shameful effort to coerce and control the American people’s health decisions.

When those efforts failed, the Biden Administration resorted to ‘outright censorship—coercing and colluding with the world’s largest social media companies to censor all COVID-19-related dissent.’”

About time these truths are acknowledged in a public, authoritative manner. Masks don’t work. Lockdowns don’t work. Fauci lied and helped cover up damning evidence.

If only this website had been available years ago.

Though, of course, knowing the media’s political beliefs, they’d have ignored it then, too.

Republished from the author’s Substack

Author

Ian Miller is the author of “Unmasked: The Global Failure of COVID Mask Mandates.” His work has been featured on national television broadcasts, national and international news publications and referenced in multiple best selling books covering the pandemic. He writes a Substack newsletter, also titled “Unmasked.”

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Brownstone Institute

RCMP seem more interested in House of Commons Pages than MP’s suspected of colluding with China

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From the Brownstone Institute

By Bruce Pardy 

Canadians shouldn’t have information about their wayward MPs, but the RCMP can’t have too much biometric information about regular people. It’s always a good time for a little fishing. Let’s run those prints, shall we?

Forget the members of Parliament who may have colluded with foreign governments. The real menace, the RCMP seem to think, are House of Commons pages. MPs suspected of foreign election interference should not be identified, the Mounties have insisted, but House of Commons staff must be fingerprinted. Serious threats to the country are hidden away, while innocent people are subjected to state surveillance. If you want to see how the managerial state (dys)functions, Canada is the place to be.

In June, the National Security and Intelligence Committee of Parliamentarians (NSICOP) tabled its redacted report that suggested at least 11 sitting MPs may have benefitted from foreign election interference. RCMP Commissioner Mike Duheme cautioned against releasing their identities. Canadians remained in the dark until Oct. 28 when Kevin Vuong, a former Liberal MP now sitting as an Independent, hosted a news conference to suggest who some of the parliamentarians may be. Like the RCMP, most of the country’s media didn’t seem interested.

But the RCMP are very interested in certain other things. For years, they have pushed for the federal civil service to be fingerprinted. Not just high security clearance for top-secret stuff, but across government departments. The Treasury Board adopted the standard in 2014 and the House of Commons currently requires fingerprinting for staff hired since 2017. The Senate implemented fingerprinting this year. The RCMP have claimed that the old policy of doing criminal background checks by name is obsolete and too expensive.

But stated rationales are rarely the real ones. Name-based background checks are not obsolete or expensive. Numerous police departments continue to use them. They do so, in part, because name checks do not compromise biometric privacy. Fingerprints are a form of biometric data, as unique as your DNA. Under the federal Identification of Criminals Act, you must be in custody and charged with a serious offence before law enforcement can take your prints. Canadians shouldn’t have information about their wayward MPs, but the RCMP can’t have too much biometric information about regular people. It’s always a good time for a little fishing. Let’s run those prints, shall we?

It’s designed to seem like a small deal. If House of Commons staff must give their fingerprints, that’s just a requirement of the job. Managerial bureaucracies prefer not to coerce directly but to create requirements that are “choices.” Fingerprints aren’t mandatory. You can choose to provide them or choose not to work on the Hill.

Sound familiar? That’s the way Covid vaccine mandates worked too. Vaccines were never mandatory. There were no fines or prison terms. But the alternative was to lose your job, social life, or ability to visit a dying parent. When the state controls everything, it doesn’t always need to dictate. Instead, it provides unpalatable choices and raises the stakes so that people choose correctly.

Government intrudes incrementally. Digital ID, for instance, will be offered as a convenient choice. You can, if you wish, carry your papers in the form of a QR code on your phone. Voluntary, of course. But later there will be extra hoops to jump through to apply for a driver’s licence or health card in the old form.

Eventually, analogue ID will cost more, because, after all, digital ID is more automated and cheaper to run. Some outlets will not recognize plastic identification. Eventually, the government will offer only digital ID. The old way will be discarded as antiquated and too expensive to maintain. The new regime will provide the capacity to keep tabs on people like never before. Privacy will be compromised without debate. The bureaucracy will change the landscape in the guise of practicality, convenience, and cost.

Each new round of procedures and requirements is only slightly more invasive than the last. But turn around and find you have travelled a long way from where you began. Eventually, people will need digital ID, fingerprints, DNA, vaccine records, and social credit scores to be employed. It’s not coercive, just required for the job.

Occasionally the curtain is pulled back. The federal government unleashed the Emergencies Act on the truckers and their supporters in February 2022. Jackboots in riot gear took down peaceful protesters for objecting to government policy. Authorities revealed their contempt for law-abiding but argumentative citizens. For an honest moment, the government was not incremental and insidious, but enraged and direct. When they come after you in the streets with batons, at least you can see what’s happening.

We still don’t know who colluded with China. But we can be confident that House of Commons staffers aren’t wanted for murder. The RCMP has fingerprints to prove it. Controlling the people and shielding the powerful are mandates of the modern managerial state.

Republished from the Epoch Times

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