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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

Net Zero: The Mystery of the Falling Fertility

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From the Brownstone Institute

By Tomas FurstTomas Fürst  

If you want to argue that a mysterious factor X is responsible for the drop in fertility, you will have to explain (1) why the factor affected only the vaccinated, and (2) why it started affecting them at about the time of vaccination.

In January 2022, the number of children born in the Czech Republic suddenly decreased by about 10%. By the end of 2022, it had become clear that this was a signal: All the monthly numbers of newborns were mysteriously low.

In April 2023, I wrote a piece for a Czech investigative platform InFakta and suggested that this unexpected phenomenon might be connected to the aggressive vaccination campaign that had started approximately 9 months before the drop in natality. Denik N – a Czech equivalent of the New York Times – immediately came forward with a “devastating takedown” of my article, labeled me a liar and claimed that the pattern can be explained by demographics: There were fewer women in the population and they were getting older.

To compare fertility across countries (and time), the so-called Total Fertility Rate (TFR) is used. Roughly speaking, it is the average number of children that are born to a woman over her lifetime. TFR is independent of the number of women and of their age structure. Figure 1 below shows the evolution of TFR in several European countries between 2001 and 2023. I selected countries that experienced a similar drop in TFR in 2022 as the Czech Republic.

Figure 1. The evolution of Total Fertility Rate in selected European countries between 2000 and 2023. The data corresponding to a particular year are plotted at the end of the column representing that year.

So, by the end of 2023, the following two points were clear:

  1. The drop in natality in the Czech Republic in 2022 could not be explained by demographic factors. Total fertility rate – which is independent of the number of women and their age structure – dropped sharply in 2022 and has been decreasing ever since. The data for 2024 show that the Czech TFR has decreased further to 1.37.
  1. Many other European countries experienced the same dramatic and unexpected decrease in fertility that started at the beginning of 2022. I have selected some of them for Figure 1 but there are more: The Netherlands, Norway, Slovakia, Slovenia, and Sweden. On the other hand, there are some countries that do not show a sudden drop in TFR, but rather a steady decline over a longer period (e.g. Belgium, France, UK, Greece, or Italy). Notable exceptions are Bulgaria, Spain, and Portugal where fertility has increased (albeit from very low numbers). The Human Fertility Project database has all the numbers.

This data pattern is so amazing and unexpected that even the mainstream media in Europe cannot avoid the problem completely. From time to time, talking heads with many academic titles appear and push one of the politically correct narratives: It’s Putin! (Spoiler alert: The war started in February 2022; however, children not born in 2022 were not conceived in 2021). It’s the inflation caused by Putin! (Sorry, that was even later). It’s the demographics! (Nope, see above, TFR is independent of the demographics).

Thus, the “v” word keeps creeping back into people’s minds and the Web’s Wild West is ripe with speculation. We decided not to speculate but to wrestle some more data from the Czech government. For many months, we were trying to acquire the number of newborns in each month, broken down by age and vaccination status of the mother. The post-socialist health-care system of our country is a double-edged sword: On one hand, the state collects much more data about citizens than an American would believe. On the other hand, we have an equivalent of the FOIA, and we are not afraid to use it. After many months of fruitless correspondence with the authorities, we turned to Jitka Chalankova – a Czech Ron Johnson in skirts – who finally managed to obtain an invaluable data sheet.

To my knowledge, the datasheet (now publicly available with an English translation here) is the only officially released dataset containing a breakdown of newborns by the Covid-19 vaccination status of the mother. We requested much more detailed data, but this is all we got. The data contains the number of births per month between January 2021 and December 2023 given by women (aged 18-39) who were vaccinated, i.e., had received at least one Covid vaccine dose by the date of delivery, and by women who were unvaccinated, i.e., had not received any dose of any Covid vaccine by the date of delivery.

Furthermore, the numbers of births per month by women vaccinated by one or more doses during pregnancy were provided. This enabled us to estimate the number of women who were vaccinated before conception. Then, we used open data on the Czech population structure by age, and open data on Covid vaccination by day, sex, and age.

Combining these three datasets, we were able to estimate the rates of successful conceptions (i.e., conceptions that led to births nine months later) by preconception vaccination status of the mother. Those interested in the technical details of the procedure may read Methods in the newly released paper. It is worth mentioning that the paper had been rejected without review in six high-ranking scientific journals. In Figure 2, we reprint the main finding of our analysis.

Figure 2A. Histogram showing the percentage of women in the Czech Republic aged 18–39 years who were vaccinated with at least one dose of a Covid-19 vaccine by the end of the respective month. Figure 2B. Estimates of the number of successful conceptions (SCs) per 1,000 women aged 18–39 years according to their pre-conception Covid vaccination status. The blue-shaded areas in Figure 1B show the intervals between the lower and upper estimates of the true SC rates for women vaccinated (dark blue) and unvaccinated (light blue) before conception.

Figure 2 reveals several interesting patterns that I list here in order of importance:

  1. Vaccinated women conceived about a third fewer children than would be expected from their share of the population. Unvaccinated women conceived at about the same rate as all women before the pandemic. Thus, a strong association between Covid vaccination status and successful conceptions has been established.
  2. In the second half of 2021, there was a peak in the rate of conceptions of the unvaccinated (and a corresponding trough in the vaccinated). This points to rather intelligent behavior of Czech women, who – contrary to the official advice – probably avoided vaccination if they wanted to get pregnant. This concentrated the pregnancies in the unvaccinated group and produced the peak.
  3. In the first half of 2021, there was significant uncertainty in the estimates of the conception rates. The lower estimate of the conception rate in the vaccinated was produced by assuming that all women vaccinated (by at least one dose) during pregnancy were unvaccinated before conception. This was almost certainly true in the first half of 2021 because the vaccines were not available prior to 2021. The upper estimate was produced by assuming that all women vaccinated (by at least one dose) during pregnancy also received at least one dose before conception. This was probably closer to the truth in the second part of 2021. Thus, we think that the true conception rates for the vaccinated start close to the lower bound in early 2021 and end close to the upper bound in early 2022. Once again, we would like to be much more precise, but we have to work with what we have got.

Now that the association between Covid-19 vaccination and lower rates of conception has been established, the one important question looms: Is this association causal? In other words, did the Covid-19 vaccines really prevent women from getting pregnant?

The guardians of the official narrative brush off our findings and say that the difference is easily explained by confounding: The vaccinated tend to be older, more educated, city-dwelling, more climate change aware…you name it. That all may well be true, but in early 2022, the TFR of the whole population dropped sharply and has been decreasing ever since.

So, something must have happened in the spring of 2021. Had the population of women just spontaneously separated into two groups – rednecks who wanted kids and didn’t want the jab, and city slickers who didn’t want kids and wanted the jab – the fertility rate of the unvaccinated would indeed be much higher than that of the vaccinated. In that respect, such a selection bias could explain the observed pattern. However, had this been true, the total TFR of the whole population would have remained constant.

But this is not what happened. For some reason, the TFR of the whole population jumped down in January 2022 and has been decreasing ever since. And we have just shown that, for some reason, this decrease in fertility affected only the vaccinated. So, if you want to argue that a mysterious factor X is responsible for the drop in fertility, you will have to explain (1) why the factor affected only the vaccinated, and (2) why it started affecting them at about the time of vaccination. That is a tall order. Mr. Occam and I both think that X = the vaccine is the simplest explanation.

What really puzzles me is the continuation of the trend. If the vaccines really prevented conception, shouldn’t the effect have been transient? It’s been more than three years since the mass vaccination event, but fertility rates still keep falling. If this trend continues for another five years, we may as well stop arguing about pensions, defense spending, healthcare reform, and education – because we are done. 

We are in the middle of what may be the biggest fertility crisis in the history of mankind. The reason for the collapse in fertility is not known. The governments of many European countries have the data that would unlock the mystery. Yet, it seems that no one wants to know.


Author

Tomas Furst

Tomas Fürst teaches applied mathematics at Palacky University, Czech Republic. His background is in mathematical modelling and Data Science. He is a co-founder of the Association of Microbiologists, Immunologists, and Statisticians (SMIS) which has been providing the Czech public with data-based and honest information about the coronavirus epidemic. He is also a co-founder of a “samizdat” journal dZurnal which focuses on uncovering scientific misconduct in Czech Science.

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Brownstone Institute

FDA Exposed: Hundreds of Drugs Approved without Proof They Work

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From the Brownstone Institute

By Maryanne Demasi

The US Food and Drug Administration (FDA) has approved hundreds of drugs without proof that they work—and in some cases, despite evidence that they cause harm.

That’s the finding of a blistering two-year investigation by medical journalists Jeanne Lenzer and Shannon Brownleepublished by The Lever.

Reviewing more than 400 drug approvals between 2013 and 2022, the authors found the agency repeatedly ignored its own scientific standards.

One expert put it bluntly—the FDA’s threshold for evidence “can’t go any lower because it’s already in the dirt.”

A System Built on Weak Evidence

The findings were damning—73% of drugs approved by the FDA during the study period failed to meet all four basic criteria for demonstrating “substantial evidence” of effectiveness.

Those four criteria—presence of a control group, replication in two well-conducted trials, blinding of participants and investigators, and the use of clinical endpoints like symptom relief or extended survival—are supposed to be the bedrock of drug evaluation.

Yet only 28% of drugs met all four criteria—40 drugs met none.

These aren’t obscure technicalities—they are the most basic safeguards to protect patients from ineffective or dangerous treatments.

But under political and industry pressure, the FDA has increasingly abandoned them in favour of speed and so-called “regulatory flexibility.”

Since the early 1990s, the agency has relied heavily on expedited pathways that fast-track drugs to market.

In theory, this balances urgency with scientific rigour. In practice, it has flipped the process. Companies can now get drugs approved before proving that they work, with the promise of follow-up trials later.

But, as Lenzer and Brownlee revealed, “Nearly half of the required follow-up studies are never completed—and those that are often fail to show the drugs work, even while they remain on the market.”

“This represents a seismic shift in FDA regulation that has been quietly accomplished with virtually no awareness by doctors or the public,” they added.

More than half the approvals examined relied on preliminary data—not solid evidence that patients lived longer, felt better, or functioned more effectively.

And even when follow-up studies are conducted, many rely on the same flawed surrogate measures rather than hard clinical outcomes.

The result: a regulatory system where the FDA no longer acts as a gatekeeper—but as a passive observer.

Cancer Drugs: High Stakes, Low Standards

Nowhere is this failure more visible than in oncology.

Only 3 out of 123 cancer drugs approved between 2013 and 2022 met all four of the FDA’s basic scientific standards.

Most—81%—were approved based on surrogate endpoints like tumour shrinkage, without any evidence that they improved survival or quality of life.

Take Copiktra, for example—a drug approved in 2018 for blood cancers. The FDA gave it the green light based on improved “progression-free survival,” a measure of how long a tumour stays stable.

But a review of post-marketing data showed that patients taking Copiktra died 11 months earlier than those on a comparator drug.

It took six years after those studies showed the drug reduced patients’ survival for the FDA to warn the public that Copiktra should not be used as a first- or second-line treatment for certain types of leukaemia and lymphoma, citing “an increased risk of treatment-related mortality.”

Elmiron: Ineffective, Dangerous—And Still on the Market

Another striking case is Elmiron, approved in 1996 for interstitial cystitis—a painful bladder condition.

The FDA authorized it based on “close to zero data,” on the condition that the company conduct a follow-up study to determine whether it actually worked.

That study wasn’t completed for 18 years—and when it was, it showed Elmiron was no better than placebo.

In the meantime, hundreds of patients suffered vision loss or blindness. Others were hospitalized with colitis. Some died.

Yet Elmiron is still on the market today. Doctors continue to prescribe it.

“Hundreds of thousands of patients have been exposed to the drug, and the American Urological Association lists it as the only FDA-approved medication for interstitial cystitis,” Lenzer and Brownlee reported.

“Dangling Approvals” and Regulatory Paralysis

The FDA even has a term—”dangling approvals”—for drugs that remain on the market despite failed or missing follow-up trials.

One notorious case is Avastin, approved in 2008 for metastatic breast cancer.

It was fast-tracked, again, based on ‘progression-free survival.’ But after five clinical trials showed no improvement in overall survival—and raised serious safety concerns—the FDA moved to revoke its approval for metastatic breast cancer.

The backlash was intense.

Drug companies and patient advocacy groups launched a campaign to keep Avastin on the market. FDA staff received violent threats. Police were posted outside the agency’s building.

The fallout was so severe that for more than two decades afterwards, the FDA did not initiate another involuntary drug withdrawal in the face of industry opposition.

Billions Wasted, Thousands Harmed

Between 2018 and 2021, US taxpayers—through Medicare and Medicaid—paid $18 billion for drugs approved under the condition that follow-up studies would be conducted. Many never were.

The cost in lives is even higher.

A 2015 study found that 86% of cancer drugs approved between 2008 and 2012 based on surrogate outcomes showed no evidence that they helped patients live longer.

An estimated 128,000 Americans die each year from the effects of properly prescribed medications—excluding opioid overdoses. That’s more than all deaths from illegal drugs combined.

A 2024 analysis by Danish physician Peter Gøtzsche found that adverse effects from prescription medicines now rank among the top three causes of death globally.

Doctors Misled by the Drug Labels

Despite the scale of the problem, most patients—and most doctors—have no idea.

A 2016 survey published in JAMA asked practising physicians a simple question—what does FDA approval actually mean?

Only 6% got it right.

The rest assumed that it meant the drug had shown clear, clinically meaningful benefits—such as helping patients live longer or feel better—and that the data was statistically sound.

But the FDA requires none of that.

Drugs can be approved based on a single small study, a surrogate endpoint, or marginal statistical findings. Labels are often based on limited data, yet many doctors take them at face value.

Harvard researcher Aaron Kesselheim, who led the survey, said the results were “disappointing, but not entirely surprising,” noting that few doctors are taught about how the FDA’s regulatory process actually works.

Instead, physicians often rely on labels, marketing, or assumptions—believing that if the FDA has authorized a drug, it must be both safe and effective.

But as The Lever investigation shows, that is not a safe assumption.

And without that knowledge, even well-meaning physicians may prescribe drugs that do little good—and cause real harm.

Who Is the FDA Working for?

In interviews with more than 100 experts, patients, and former regulators, Lenzer and Brownlee found widespread concern that the FDA has lost its way.

Many pointed to the agency’s dependence on industry money. A BMJ investigation in 2022 found that user fees now fund two-thirds of the FDA’s drug review budget—raising serious questions about independence.

Yale physician and regulatory expert Reshma Ramachandran said the system is in urgent need of reform.

“We need an agency that’s independent from the industry it regulates and that uses high-quality science to assess the safety and efficacy of new drugs,” she told The Lever. “Without that, we might as well go back to the days of snake oil and patent medicines.”

For now, patients remain unwitting participants in a vast, unspoken experiment—taking drugs that may never have been properly tested, trusting a regulator that too often fails to protect them.

And as Lenzer and Brownlee conclude, that trust is increasingly misplaced.

Republished from the author’s Substack

 

Author

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.

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