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Pfizer Drip Feeds Data From its Pregnancy Trial

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From the Brownstone Institute

BY Maryanne DemasiMARYANNE DEMASI

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

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

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

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

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

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

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

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

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

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

Trial design

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

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

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

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

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

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

Sample size too small

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

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

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

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

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

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

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

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

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

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

Exclusion criteria

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

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

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

Spelsberg agreed.

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

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

Missing data

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

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

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

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

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

Trial dropouts

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

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

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

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

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

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

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

Reprinted from the author’s Substack

Author

  • Maryanne Demasi

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

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

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Brownstone Institute

Censorship and the Corruption of Advertising

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From the Brownstone Institute

The most powerful companies in the world have united against free speech, and they’ve deployed your tax dollars to fund their mission.

Last week, the House Judiciary Committee released a report on the little-known Global Alliance for Responsible Media (GARM) and its pernicious promotion of censorship. GARM is a branch of the World Federation of Advertisers (WFA), a global association representing over 150 of the world’s biggest brands, including Adidas, British Petroleum, Nike, Mastercard, McDonald’s, Walmart, and Visa.

The WFA represents 90% of global advertising spending, accounting for almost $1 trillion per year. But instead of helping its clients reach the broadest market share possible, the WFA has appointed itself a supranational force for censorship.

Rob Rakowitz and the Mission to Supplant the First Amendment

Rob Rakowitz, the leader of the WFA, holds a particular disdain for free speech. He has derided the First Amendment and the “extreme global interpretation of the US Constitution,” which he dismissed as “literal law from 230 years ago (made by white men exclusively).”

Rakowitz led GARM’s effort to boycott advertising on Twitter in response to Elon Musk’s acquisition of the company. GARM bragged that it was “taking on Elon Musk” and driving the company’s advertising income “80% below revenue forecasts.”

Rakowitz also championed the unsuccessful effort to have Spotify deplatform Joe Rogan after he expressed skepticism for young, healthy men taking the Covid vaccine. Rakowitz attempted to intimidate Spotify executives by demanding to hold a meeting with them and a team that he said represented “P&G [Proctor and Gamble], Unilever, Mars,” and five advertising conglomerates. When a Spotify employee said he would meet with Rakowitz but not his censorsial consortium, Rakowitz forwarded the message to his partner, writing “this man needs a smack” for denying his demands.

The WFA extended its efforts to direct manipulation of the news market. Through a partnership with the taxpayer-funded Global Disinformation Index, GARM launched “exclusion lists,” which created de facto boycotts from advertising on “risky” sites, which it described as those that showed the “greatest level of disinformation risk.” These lists included the New York Post, RealClearPolitics, the Daily Wire, TheBlaze, Reason Magazine, and The Federalist. Left-wing outlets, such as the Huffington Post and Buzzfeed News, were placed on the list of “Least risky sites,” which facilitated increased advertising revenue.

GARM, the WFA, and Rakowitz is the latest scandal demonstrating the destruction of our liberties at the hands of consolidated power. Like the Trusted News Initiative or the Biden White House’s censorship efforts, the aim is to remove all sources of dissent to pave the way for the further corporatization of the oligarchy that increasingly replaces our republic.

The WFA’s Attack on Democracy

Just as Rakowitz could not hide his contempt for the First Amendment, WFA CEO Stephan Loerke demanded that his conglomerate overtake the democratic process.

In preparation for the Cannes Lions Festival (a gathering of billionaires and multinational corporations in the South of France every June), Loerke released a statement demanding companies “stay the course on DEI and sustainability.” According to Loerke, these policies must include responses to “climate change” and the promotion of “net zero” policies,” which have already wreaked havoc on Europeans’ quality of life.

Loerke wrote: “If we step back, who will push for progress on these vital areas?” Though he suggests the answer must be nobody, traditionally self-governing countries would charter their own courses in those “vital areas.” And in that paradigm, the corporation would be subordinate to the state.

But instead, the WFA has inverted that system. Through its clients, the trillion-dollar behemoth extracts money from governments and then deploys those funds to demand that we accept their reshaping of our culture. The parasite becomes the arbiter of “progress,” eroding the society responsible for its very existence.

As the WFA sought to punish any groups that criticized the Covid response, its client Abbott Laboratories received billions of dollars in federal funding to promote Covid tests in the US Army. As Loerke demands “net zero” policies that will unravel the Western way of life, WFA patrons like DellGEIBM, and Microsoft receive billions in revenue  from the US Security State.

The organization is fundamentally detached from traditional advertising, which aims to connect businesses with consumers to sell products or services; instead, it is a force for geopolitical and cultural manipulation.

Perhaps no WFA client better represents this phenomenon than AB InBev, the parent company to Bud Light, which destroyed billions of dollars in market value last year after selecting Dylan Mulvaney as the icon for its advertising campaign.

On its surface, the selection of Mulvaney as a spokesman appeared to be the result of an executive class detached from their clientele. But Rakowitz and the WFA reveal a deeper truth; they don’t misunderstand the public, they loathe them.

The organization is a force designed to punish them for their unfavorable, unapproved belief systems. It is an attack on the freedoms written into our Constitution as “literal law from 230 years ago,” as Rakowitz scoffed. The mission is to eviscerate “the right to receive information and ideas,” as our Supreme Court recognized in Stanley v. Georgia, and to make our republic subservient to its corporate oligarchy.

The stakes here are very high. The economic revolution of the 15th century and following was about a dramatic shift in decision-making, away from elites and toward the common people. With that came a wider distribution of property and rising wealth over many centuries, culminating in the late 19th century. Along with that came a shift in the focus of marketing, away from elites and toward everyone else.

The consolidation of advertising and its control by states strikes at the very heart of what free economies are supposed to be about. And yet, states that desire maximum control over the public mind must go there. They must gain full hegemony and that includes advertising. It should be stopped before it is too late to restore freedom over corporatism.

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Brownstone Institute is a nonprofit organization conceived of in May 2021 in support of a society that minimizes the role of violence in public life.

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Brownstone Institute

Imagine Life without Fossil Fuels

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From the Brownstone Institute

By Thi Thuy Van Dinh

At 4 am on Tuesday 9th July in Seville (Spain), I woke up alerted by a text to my phone. “We had a bad night with Hurricane Beryl. Your house still stands and the critters are safe, two big trees down, no electricity, no Internet, and poor phone service.”

My children and I were visiting Andalusia, one of the oldest and most gorgeous European regions, blessed with the best food and the warmest people. This is one of my favorite places on earth, but for now, my family and I are calling South of Houston (Texas, US) home.

I panicked, being instantly seized by maternal instinct. Our entire house is run by electricity. On our return in a few days, there would be no warm food, no milk, no air conditioning, no TV, no running water, no toilet flushing. In town, neither kid activities nor story time at local libraries. These conditions are undoubtedly hard for young children who have only known comfort so far, although hundreds of millions of children are growing up in such circumstances daily.

Then I calmed down. The first thing to do should be thanking God for protecting human lives there, and for our wonderful friends and community.

I understood what happened immediately. Trees have fallen everywhere, taking down most of the grid and affecting more than a million people. It would take a few weeks to fix it. Houston would be first, of course, the crowded and business-minded urban areas will be rightly prioritized and rural areas follow after. After such largesse provided for the solar industry by successive American administrations, why has there been no money to put wires and cables underground in hurricane-prone regions?

We always have a month of canned meat and dry salami, drinking water, olive oil, lard, animal feed (we have some farm animals,) and 750 gallons of water in storage, candles, matches, and flashlights. For emergency situations like a war or a natural disaster. We have a pool conveniently built for Texan summer heat even though the filter won’t work. I can dig a hole in the garden if I want to give the kids some survival training, or I can use the pool water for toilet flushing. Our hens and ducks give us more than enough fresh eggs daily.

But I should have kept a few solar phone chargers and probably some solar panels for our well pump (solely activated by electricity). My husband should have had a better stock of gas to run our generator through the fridge and the two freezers. At least, I can still grill and the kids can help gather dry branches to make a fire and cook camping meals. After all, it is easier to survive without energy in a hot place than in a cold place.

My situation isn’t probably the worst, and I will be able to help some people around me with food and water. I will entertain the kids with games I used to play under the moonlight and the starry sky. However, with little or no gas (petrol) in town, and likely long lines at available stations, I will have to calculate our car trips well.

I told my 7-year-old what happened. He said he would fry eggs on the car and roast marshmallows on sticks. Young children are such marvelous beings. With only their imagination and innocence, they bring wonders to our world. Who knows, we might be lucky enough to catch some fireflies in a jar – I replied, nurturing his excitement. As his mother, I have the duty to minimize his suffering. Nevertheless, I would like to seize this opportunity to give him and his younger sister some duress training on life without fossil fuels – coal, gas, and oil to power modern devices – a bit like how I grew up.

Have the international, national, and non-governmental Net Zero crusaders ever lived a day without using any technology powered or facilitated by fossil fuels and their byproducts?

I would like to invite them to live here with us. I will show them that had I had solar panels on my roof, I would likely be cleaning up all of their dangerous debris around the house. Right now, a Tesla would be of less use than an ox cart in my Texan town.

But life at my homestead after Hurricane Beryl seems rather poetic. Well-prepared, a week or two without electricity might equal an ecological or soul-searching retreat with meditation time, good books on a hammock, bird-watching, simple yet exotic farm-to-table meals, and constellation identification.

For a real experience of a life without fossil fuels, climate leaders and activists should consider signing up for the sustainability internship program offered by Mr Jusper Machogu, a Kenyan farmer who was recently attacked by the BBC for his campaign on X requesting “Fossils Fuels for Africa.” Participants will learn how to grow foods without technologies powered by fossil fuels and live with a minimal impact on nature in rural Kisii.

Ploughing the land with bare hands before planting isn’t fun at all. Watering the crops regularly might well bring people closer to God with spontaneous prayers. Weeding or harvesting by squatting under the sun is tough. Even without factoring in any risk of pests, diseases. and unfavorable weather, what are the chances they would have to get out of poverty and food insecurity without cheap, reliable, abundant, and scalable energy?

Billions of subsistence families are still going through this. Worse, they continue to put their health at risk by cooking with agricultural wastes, wood sticks, and cow dung, while the Western world and their investment funds shamelessly demand poor countries and their populations to adopt intermittent, expensive, and unreliable green energies, instead of supporting fossil fuels (as well as hydropower and nuclear) production and infrastructure.

Secretary-General Antonio Guterres, who repeatedly called to “close the door on fossil fuel era” (on International Clean Energy Day – 26 January 2024), would you live entirely and produce your own foods without fossil fuels?

United Nations Environment Program’s (UNEP) Chief Inger Andersen, who, at the closing of the 28th Climate COP (Dubai, UAE), claimed that “we know the solutions, we know what needs to be done,” would you be able to build a town for your staff without using oil, gas, and their byproducts?

How may we, as voters and taxpayers, demand that decision-makers lead by example, truly adhering to their green agenda first, before they insist that others implement it?

Author

Dr. Thi Thuy Van Dinh (LLM, PhD) worked on international law in the United Nations Office on Drugs and Crime and the Office of the High Commissioner for Human Rights. Subsequently, she managed multilateral organization partnerships for Intellectual Ventures Global Good Fund and led environmental health technology development efforts for low-resource settings.

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