Brownstone Institute
Pfizer Drip Feeds Data From its Pregnancy Trial
From the Brownstone Institute
BY
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
Brownstone Institute
Jeff Bezos Is Right: Legacy Media Must Self-Reflect
From the Brownstone Institute
By
I can count on one hand the times I have seen leaders of media organizations engage in anything that could be described as hard-hitting forms of self-critique in the public square.
One of those times was when Meta CEO Mark Zuckerberg went on public record, in a letter to the Republican House Judiciary Committee (dated August 26th, 2024), that he “regretted” bowing to pressure from the Biden administration to censor “certain Covid-19 content.” Another was the almost unprecedented public apology in January 2022 (here’s a report in English) by a Danish newspaper that it had towed the “official” line during the pandemic far too uncritically.
We witnessed a third moment of critical introspection from a media owner the other day, when Jeff Bezos, who owns the Washington Post and is the largest shareholder of Amazon, suggested in an op-ed in his own newspaper that legacy media may have themselves at least partly to blame for the loss of public trust in the media.
In this context, he argued that his decision not to authorize the Washington Post to endorse a presidential candidate could be “a meaningful step” toward restoring public trust in the media, by addressing the widespread perception that media organizations are “biased” or not objective.
You don’t need to be a fan of Jeff Bezos, any more than of Mark Zuckerberg, to recognize that it is a good thing that prominent representatives of the financial and political elite of modern societies, whatever their personal flaws and contradictions, at least begin to express doubts about the conduct and values of media organizations. Some truths, no matter how obvious, will not resonate across society until prominent opinion leaders viewed as “safe” or “established,” say them out loud.
Bezos opens his Washington Post op-ed by pointing out that public trust in American media has collapsed in recent generations and is now at an all-time low (a substantial decline can be seen across many European countries as well if you compare the Reuters Digital News Report from 2015 with that of 2023 — for example, Germany sees a drop from 60% to 42% trust and the UK sees a drop from 51% to 33%).
In the annual public surveys about trust and reputation, journalists and the media have regularly fallen near the very bottom, often just above Congress. But in this year’s Gallup poll, we have managed to fall below Congress. Our profession is now the least trusted of all. Something we are doing is clearly not working…Most people believe the media is biased. Anyone who doesn’t see this is paying scant attention to reality, and those who fight reality lose.
Something we are doing is clearly not working. This is the sort of candid introspection we need to see a lot more of in journalists and media owners. If someone stops trusting you, it’s easy to point the finger at someone else or blame it on “disinformation” or citizen ignorance. It’s not so easy to make yourself vulnerable and take a long, hard look at yourself in the mirror to figure out how you’ve lost their trust.
The owner of the Washington Post does not offer an especially penetrating diagnosis of the problem. However, he does point out some relevant facts that may be worth pondering if we are to come to a deeper understanding of the fact that the Joe Rogan podcast, with an estimated audience of 11 million, now has nearly 20 times CNN’s prime-time audience:
The Washington Post and the New York Times win prizes, but increasingly we talk only to a certain elite. More and more, we talk to ourselves. (It wasn’t always this way — in the 1990s we achieved 80 percent household penetration in the DC metro area.)
More and more, we talk to ourselves. Much of the legacy media has become an ideological echo chamber, as I pointed out in an op-ed in the Irish Times a few years ago. Conversations go back and forth between journalists about things they care about, while a substantial number of ordinary citizens, whose minds are on other things, like paying their mortgage, getting a medical appointment, or worrying about the safety of their streets, switch off.
While there are some notable exceptions, the echo-chamber effect is real and may be part of the explanation for the flight of a growing number of citizens into the arms of alternative media.
The increasing disconnect between self-important legacy journalists and the man and woman on the street has been evidenced by the fact that so-called “populism” was sneered at by many journalists across Europe and North America while gathering serious momentum on the ground.
It was also evidenced by the fact that serious debates over issues like the harms of lockdowns and the problem of illegal immigration, were largely sidelined by many mainstream media across Europe while becoming a catalyst for successful political movements such as the Brothers of Italy, Le Pen’s Rassemblement National in France, Alternativ für Deutschland in Germany, and the Freedom Party in Austria.
Perhaps part of the problem is that those working in well-established media organizations tend to take the moral and intellectual high ground and severely underestimate the capacity of ordinary citizens to think through issues for themselves, or to intelligently sort through competing sources of information.
Indeed, even Jeff Bezos, in his attempt to be critical of legacy media, could not resist depicting alternative media exclusively in negative terms. “Many people,” he lamented, “are turning to off-the-cuff podcasts, inaccurate social media posts and other unverified news sources, which can quickly spread misinformation and deepen divisions.”
While there is undoubtedly an abundance of confusion and false and misleading information on social media, it is by no means absent from the legacy media, which has gotten major issues badly wrong. For example, many mainstream journalists and talk show hosts uncritically celebrated the idea that Covid vaccines would block viral transmission, in the absence of any solid scientific evidence for such a belief. Similarly, many journalists dismissed the Covid lab-leak theory out of hand, until it emerged that it was actually a scientifically respectable hypothesis.
We should thank Jeff Bezos for highlighting the crisis of trust in the media. But his complacency about the integrity of traditional news sources and his dismissive attitude toward “alternative sources” of news and information are themselves part of the reason why many people are losing respect for the legacy media.
Republished from the author’s Substack
Brownstone Institute
If Trump Wins
From the Brownstone Institute
By
How will he organize the “deportation” of illegal migrants? In the best case, it will be difficult. There will be scuffles and chases. Critics will charge the new Administration as cruel and worse. How much stomach will Republicans have for a messy process?
Trump enjoys the momentum. Four of the most recent major national polls show him up 2 to 3%, while Democratic-friendly outlets like the New York Times and CNN both show a TIE race in their final surveys. The 2016 and 2020 elections were razor close even though Clinton (5%) and Biden (8%) had solid polling leads at this point. We need to contemplate a Trump win not only in the electoral college but also in the popular vote.
Here are some thoughts:
- JD Vance ascendant, obviously. Big implications for the Republican trajectory.
- Will Trump replace Fed chairman Jay Powell? Or merely jawbone for a change in policy? In a new CNBC interview, former Fed governor Kevin Warsh argues that the Fed has juiced both the stock market and inflation. Would reducing inflation, which Trump has promised, automatically therefore lead to a stock market correction and economic slowdown? Not necessarily. If Trump unleashes productive economic activity and Congress ends the fiscal blowout, the Fed could normalize monetary policy without causing a major economic slump.
- Will Trump impose the broad and deep tariffs he proposed? Or will he mostly threaten them as a bargaining tool with China? I’m betting on some of the former but more of the latter. We notice, however, Trump allies are floating a trial balloon to replace income taxes with tariffs. As impractical and improbable as that may be, we’re glad to see the mention of radical tax reform reemerge after too long an absence from the national discussion.
- How will he organize the “deportation” of illegal migrants? In the best case, it will be difficult. There will be scuffles and chases. Critics will charge the new Administration as cruel and worse. How much stomach will Republicans have for a messy process? One idea would be to offer a “reverse amnesty” – if you leave peacefully and agree not to return illegally, we will forgive your previous illegal entry(s) and minor violations. This would incentivize self-identification and quiet departure. Plus it would help authorities track those leaving. Would migrant departures truly hit the economy, as critics charge? We doubt large effects. Substantial native populations are still underemployed or absent from the workforce.
- We should expect a major retrenchment of regulatory intrusions across the economy – from energy to crypto. Combined with recent Supreme Court action, such as the Chevron reversal, and assisted by the Elon Musk’s substance and narrative, it could be a regulatory renaissance. Extension of the 2017 tax cuts also becomes far more likely.
- Trump has never worried much about debt, deficits, or spending. But he’s tapped Elon Musk as government efficiency czar. It’s an orthogonal approach to spending reform instead of the traditional (and unsuccessful) Paul Ryan playbook. Can this good cop-bad cop duo at the very least return out-of-control outlays to a pre-Covid path? Can they at least cancel purely kleptocratic programs, such as the $370-billion Green Energy slush funds? Might they go even further – leveraging the unpopular spending explosion and resulting inflation to achieve more revolutionary effects on government spending and reach? Or will the powerful and perennial forces of government expansion win yet again, sustaining a one-way ratchet not even Elon can defeat?
- What if the economy turns south? One catalyst might be the gigantic unrealized bond losses on bank balance sheets; another might be commercial real estate collapse. Although reported GDP growth has been okay, the inflation hangover is helping Trump win on the economy. But many believe the post-pandemic economic expansion is merely a sugar-high and has already lasted longer than expected. A downturn early in Trump’s term could complicate many of his plans.
- How will NATO and its transatlantic network respond? Or more generally, what will the neocon and neoliberal hawks, concentrated in DC and the media, but little loved otherwise, do? Does this item from Anne Applebaum — arguing Trump resembles Hitler, Mussolini, and Stalin all rolled into one — portend continued all-out war on prudent foreign policy? Or will they adopt a more sophisticated approach? If the neocons move wholesale and formally (back) into the Democratic fold, how long will the coalition of wokes and militarists hold? On the economic front, Europe, already underperforming vis-a-vis the US, will fall even further behind without big changes. Reformers should gain at the expense of the transatlantic WEF-style bureaucrats.
- Can Trump avoid another internal sabotage of his Administration? Before then, if the election results are tight, will the Democrats seek to complicate or even block his inauguration? Can he win approval for his appointees in the Senate? Can he clean house across the vast public agencies? How long will it take to recruit, train, and reinvigorate talented military leadership, which we chased away in recent years? And how will Trump counter – and avoid overreacting to – taunts, riots, unrest, and lawfare, designed to bolster the case he’s an authoritarian?
- Will the Democrats reorient toward the center, a la Bill Clinton? Or will the blinding hatred of Trump fuel yet more radicalism? Orthodox political thinking suggests a moderation. Especially if Trump wins the popular vote, or comes close, pragmatic Democrats will counsel a reformation. James Carville, for example, already complains that his party careened recklessly away from male voters. And Trump’s apparent pickups among Black and Latino voters complicate the Democrats’ longstanding identity-focused strategy. Other incentives might push toward continued belligerence and extreme wokeness, however, and thus an intra-party war.
- Will the half of the country which inexplicably retains any confidence in the legacy media at least begin rethinking its information diet and filters? Or has the infowarp inflicted permanent damage?
- Will big business, which shifted hard toward Democrats over the last 15 years, recalibrate toward the GOP? Parts of Silicon Valley over the last year began a reorientation — e.g. Elon Musk, Marc Andreessen, David Sacks, and before them, Peter Thiel in 2016. But those are the entrepreneurs. In the receding past, businesses large and small generally lined up against government overreach. Then Big Business and Big Government merged. Now, a chief divide is between politically-enmeshed bureaucratic businesses and entrepreneurial ones. Does the GOP even want many of the big guys back? The GOP’s new alignment with “Little Tech” is an exciting development, especially after being shut out of Silicon Valley for the last two decades.
- Industry winners: traditional energy, nuclear energy, Little Tech. Industry losers: Green Energy, Big Tech, Big Pharma, Big Food. Individual winners: X (nee Twitter), Elon Musk, RFK, Jr.
- How will the Censorship Industrial Complex react? A Trump win will pose both a symbolic and operational blow to governmental, non-governmental, old media, and new media outlets determined to craft and control facts and narratives. It will complicate their mission, funding, and organizational web. Will they persist in their “mis/disinformation” framing and their badgering of old media and social media companies to moderate content aggressively? Or will they devise a new strategy? A.I. is pretty clearly the next frontier in the information wars. How will those who propagandize and rewire human minds attempt to program and prewire artificial ones?
- How will Trump integrate RFK, Jr. and his movement? Will RFK, Jr. achieve real influence, especially on health issues? Big Pharma and Big Public Health will wage a holy war to block reforms in general and accountability for Covid mistakes in particular.
- Trump has promised to end the war between Russia and Ukraine. On one hand, it should be easy. Despite what you hear from DC media and think tanks, Ukraine is losing badly. Hundreds of thousands are dead, and its military is depleted and faltering. Ukraine should want a deal quickly, before it loses yet more people and territory. Russia, meanwhile, always said it wants a deal, even before the war started, focusing on Ukrainian neutrality. Why Ukrainian neutrality should bother the US was always a mystery. And yet even critics of the West’s support for Ukraine, who want an agreement, think it will be difficult to achieve. The Western foreign policy establishment has invested too much credibility and emotion. It will charge “appeasement” and “betrayal” and make any deal difficult for Trump. Russia, meanwhile, has secured so much territory and now has Odessa and Kharkiv in its sights. Putin will not be eager to accept a deal he would have taken in 2021 or before. The far better path for all involved was a pre-war agreement, or the one negotiated but scuttled in April 2022.
- What if A.I. launches a new productivity boom, enabled by an agenda of energy abundance, including a nuclear power revival? The economic tailwinds could remake politics even more than we currently see.
- Can Trump, having run and won his last campaign, consolidate gains by reaching out and uniting the portions of the country willing to take an extended hand?
Republished from the author’s Substack
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