From the Brownstone Institute
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.
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.
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.”
“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.
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?”
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
Witnessing the Media’s Covid Coverage from the Inside
From the Brownstone Institute
If right-leaning outlets wanted my words and left-leaning ones did not, my Occam’s razor landed on ideology as the explanatory factor. So-called progressive media had a story to uphold and rejected any plot twist that threatened the cohesion of its narrative.
In the movie An Education, the main character gets sidetracked from her studies by a smooth-talking art dealer who turns out to be a criminal—and married. Our protagonist learns more from that experience than from all the medieval literature books she cracked open before. I have similar feelings about my own education. While I’ve been earning my living as a writer for the past 29 years, it’s only during the Covid era that I learned what the writing business is really about.
I wear two hats in my professional life: medical writer, creating materials for doctors and the healthcare industry, and feature-article journalist for consumer magazines. It wasn’t until Covid that I began pitching essays and op-eds for publication.
I started with a piece called “A Tale of Two Pandemic Cities,” which grew out of my short trip to Amsterdam and Stockholm in the summer of 2020, when the European Union opened its doors to “well-behaved” countries like Canada. The Covid hysteria in my country had made me desperate to visit more balanced parts of the world, and my trip didn’t disappoint. The article found a home at a Canadian outlet called Healthy Debate, though the editor asked me to temper my enthusiasm for the Swedish strategy with an acknowledgement of its risks. Happy to find a legit publisher for my first Covid piece, I capitulated, sort of. (You can judge for yourself.)
Thus began a feverish outpouring of essays, each one motivated by the same bewildered questions: What the hell is happening to the world, and why? Has everyone else gone mad, or is it me? I had written a few controversial articles throughout my career, but never before had I held a “dissenting view” about an issue that affected the whole world—or felt such an urgent need to express it.
The Great Divide
I quickly learned that certain news outlets were less open to my pieces than others. Salon, fuggedaboutit. Spiked Online, bull’s eye on the first try. Washington Post, not a chance. Wall Street Journal, a couple of “close, but no cigar” efforts and then finally a yes. It boiled down to this: the further left a publication leaned, the less likely it would publish my pieces (or even respond to my inquiries). I’m sure a statistician could write an equation to capture the trend.
So why the radio silence from left-wing publications? I doubted I was tripping their “Covid disinformation” radars, as my pieces had less to do with scientific facts than with social philosophy: the balance between safety and freedom, the perils of top-down collectivism, the abuse of the precautionary principle, that sort of thing. If right-leaning outlets wanted my words and left-leaning ones did not, my Occam’s razor landed on ideology as the explanatory factor. So-called progressive media had a story to uphold and rejected any plot twist that threatened the cohesion of its narrative. (Not that right-wing media behaved much differently. Such is the age of advocacy journalism.)
Most nerve-wracking of all were the publishers who accepted my articles but, like that first Healthy Debate editor, insisted I make substantive changes. Should I concede or push back? I did a bit of both. The most important thing, I told myself, was to make people reflect on the topsy-turvy policies that had freeze-framed the world. If I had to soften a few sentences to get the word out, so be it. I have the utmost respect for writers who refuse to yield on such matters, but 29 years of paying the bills from my writing have tipped my internal compass toward pragmatism.
I did stand my ground with an article on the mask wars. My thesis was that the endless and pointless disputes on social media—masks work, no they don’t, yes they do, no they don’t—had less to do with science than with worldview: irrespective of the data, social collectivists would find a way to defend masks, while my freedom-first compatriots would never countenance a perma-masked world.
One editor agreed to publish the piece if I mentioned that some studies favor masking, but I argued that quoting studies would undercut my central argument: that the forces powering the mask wars have little to do with how well they block viruses. He wouldn’t budge, so we parted ways and I found a more congenial home for the piece at the Ottawa Citizen.
The process of pitching counternarrative essays, while arduous at times, led me to a smorgasbord of lesser-known, high-quality publications I never would have discovered otherwise. Topping the list was the glorious UnHerd, a UK news and opinion website with such daring thinkers as Mary Harrington and Kathleen Stock on its roster of contributors. The US-based Tablet magazine offered consistently fresh takes on Covid and never took the easy road in its analyses. In its pages I found one of the most powerful Covid essays I have ever read. The author, Ann Bauer (no relation), teased out the common threads between the “settled science” about the virus and the litany of quack theories about autism, which fed into her son’s death by suicide.
Then there was Quillette, whose contempt for the sacred cows of wokeism gave me a special thrill. True confession: I blew my chances with Quillette and it’s my own damned fault. Like many working writers, I sometimes pitch a piece to more than one outlet at the same time, a practice known as simultaneous submissions. This goes against protocol—we’re supposed to wait until an editor declines our pitch before approaching the next one—but the reality is that many editors never respond. With the deck thus stacked against us, we writers sometimes push the envelope, figuring the odds of getting multiple acceptances (and thus pissing off editors) are low enough to take the risk.
On this particular occasion, I submitted an article called “Lessons from my Half-Vaxxed Daughter” to three publications. Medpage Today responded right away, and I accepted their offer to publish it. (This was while Marty Makary, the dissident-lite physician who called out people’s distorted perception of Covid risk in mainstream media, led the editorial team.) A few hours later, Quillette’s Canadian editor sent me a slightly reworked version of my piece and told me when he planned to run it. I had no choice but to proffer a red-faced apology and admit I had already placed the article elsewhere. He never responded to my email or to a follow-up mea culpa a few weeks later—and has ignored everything I’ve submitted since then. I guess I’ll have to wait until he retires.
Earlier this year, Brownstone Institute published my book Blindsight Is 2020, which critiques the pandemic response through the lens of 46 dissident thinkers. By all standards a moderate book, it stays clear of any “conspiratorial” speculations about the origins of the pandemic or the political response to it. Instead, it focuses on the philosophical and ethical issues that kept me awake at night during the peak Covid years—the same themes I explore in my essays, but in greater depth. I wrote the book not just for “my team,” but for those who vehemently opposed my views—perhaps especially for them. I didn’t expect to change their minds as much as to help them understand why some of us objected so strenuously to the policies they cheered on.
After the book came out, a few podcasters invited me to their shows. I appeared on a Libertarian Institute podcast in which the host puffed on his hand-rolled cigarettes while we talked. I spoke to an amiable ex-con podcaster who made it his mission to share Ayn Rand’s ideas with the world. I bonded with Rupa Subramanya—a brilliant Canadian conservative journalist and podcaster featured in my book—over the Freedom Convoy we had both supported.
All told I’ve appeared on 22 podcasts to date, each of them hosted by a right-leaning or libertarian host. Crickets from the left. Not one to accept defeat, I’ve begun reaching out to left-leaning podcasters on my own. Perhaps one day I’ll hear back from them.
Covid media, like so much else in modern life, has become hopelessly fractured: the tall, left-facing trees dominate the landscape, telling the story of a deadly virus that we “did the best we could” to manage. Below the tree canopy lies the tangle of weeds that sway in the wind, whispering songs of freedom and warning against the totalitarian impulses that all too readily emerge during crises. While I’ll continue to throw my essays at those unyielding trees, the messy underbrush is where I’ve found my journalistic home.
Why So Many Countries Followed China’s Lockdown Example
From the Brownstone Institute
The answer to why countries followed China’s lockdowns is simple. They were told to do so by the World Health Organization (WHO). Why did the WHO tell them to do that? You might want to ask Dr. Bruce Aylward
A novel coronavirus that was 10 times deadlier than the flu had gripped the world in 2019. Without a compass to navigate the Covid-19 pandemic, all lessons learned from previous viral pandemics were thrown out the window. The World Health Organization was adamant, “This is not the flu.” Tony Fauci terrified the US House of Representatives with forecasts of disaster. Global populations were defenseless without a vaccine for the novel coronavirus that no one had ever seen before. The only viable defense at the time was to shut down the world.
China took the lead in lockdowns. Media exported from China showed people dropping dead in the streets. Caskets were piling up. Doors to buildings were sealed to lock in tenants. Throughout the panic, all reasonable alternative assessments of risks from the viral outbreak were ignored, censored, or rejected.
Nevertheless, I wondered whether a video of a person falling down in the street was really representative of the entire population. Were caskets piling up largely due to families fearing to claim them because of contamination with the virus? I noticed that the front doors to my local mall in Ontario, Canada had also been sealed, just like in China apartment buildings, but this was only to control access through a single entrance to the building, not to seal in customers.
My first clue that the emergency response to the outbreak of the coronavirus didn’t seem to make sense was when I heard Fauci tell television audiences that if our response seems to be overreacting, then we are probably doing the right thing. What? Since when is overreacting ever the right thing to do? Do generals win wars by overreacting?
I looked at the numbers that Fauci had presented to the US House of Representatives concerning case and infection fatalities of the coronavirus. They were backwards! His 10-times deadlier prediction was simply a made-up number! This was in March 2020. By May 2020 it was obvious that people were NOT dying at the inflated rate Fauci had predicted.
I published a paper on Fauci’s coronavirus mortality overestimations: Public Health Lessons Learned From Biases in Coronavirus Mortality Overestimation. But when I mentioned all this to my friends, they responded that the lower than predicted deaths just proved the lockdowns were working. Fauci was off the hook. Back to China.
WHO/China Joint Mission on Covid-19
The answer to why countries followed China’s lockdowns is simple. They were told to do so by the World Health Organization (WHO). Why did the WHO tell them to do that? You might want to ask Dr. Bruce Aylward, the Director of the WHO/China Joint Mission on Covid-19 investigating the coronavirus outbreak.
Aylward noticed a precipitous drop in novel coronavirus pneumonia (NCP) in China during February 2020. This was before China adopted WHO’s name of coronavirus disease 2019 (Covid-19). Upon seeing China’s surveillance data, Aylward announced the spectacular findings to the world and told the world to do what China has done and lock down. But he appeared to make a fundamental epidemiological error by wrongly assuming that the association of China’s lockdowns with lower deaths proved the lockdowns were working (just like my friends had told me).
Soon after in March 2020, China published its latest case definitions for NCP (Covid-19). In a nutshell, the definitions showed that no one could be declared to have died of the disease unless they had viral pneumonia (a severe acute respiratory illness), and only if no other virus normally associated with viral pneumonia was present, except SARS-CoV-2.
Coinfections with the coronavirus were not acceptable criteria, and what should have been a broad surveillance case definition with high sensitivity to monitor the spread of the virus within the population narrowed down considerably into an overly specific diagnostic case definition. That pretty much sealed the deal to declare Covid-19 deaths in only single digits for many months during the pandemic throughout China. This super-low outcome impressed Dr. Bruce Aylward enough in February 2020 to implore the world to lock down. Did we ever!
In the meantime, other countries used case and death definitions that went to the opposite extreme of China’s narrow diagnostic definitions, disseminating overinflated surveillance numbers without adjusting the numbers to remove bias. Even Fauci eventually admitted that reported cases and deaths counted WITH the coronavirus are much higher than cases and deaths counted FROM the coronavirus. Ironically, the WHO had previously published material on the correct use and interpretation of surveillance and diagnostic definitions in infectious disease outbreaks. Aylward didn’t appear to get the memo.
There is more to the story. Was this even really a novel coronavirus, or just a novel genetic sequence of the coronavirus showing greater detail than previously available? China supposedly received updated genetic sequencing technology in late 2019. They had abandoned surveillance of SARS in 2003 for lack of technology.
Now they were back in business again by the end of 2019. The team of virologists that reported the genetic sequence of the virus in Wuhan noted that it would be necessary to investigate the epidemiological evidence to guide infection control responses. Who has time for that? Shut it down!
If the novel coronavirus isn’t really so novel, this would explain why the lockdowns didn’t work. We had already known that lockdowns don’t work in other viral pandemics. Even China eventually gave up its Zero Covid Policy after it was obvious that lockdowns weren’t working. My friends owe me some explanations to justify their lockdown views. Maybe Fauci isn’t off the hook after all.
For more information on biases in Covid-19 case and death definitions, see my peer-reviewed article with cited references: Biases in COVID-19 Case and Death Definitions: Potential Causes and Consequences.
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