Pfizer documents reveal elevated neonatal deaths and miscarriage following Covid-19 vaccination. Australia’s TGA failed to check the clinical trial documents.

Pfizer documents reveal elevated neonatal deaths and miscarriage following Covid-19 vaccination. Australia’s TGA failed to check the clinical trial documents.

Pregnant and breastfeeding mothers all over the world are being encouraged by very clear messaging from health authorities to take the Covid-19 vaccination. In Australia, the federal government’s Health Department Fact Sheet is unequivocal:

“the risk of serious, negative outcomes from Covid-19 is higher for pregnant women and their unborn baby … Vaccination is the best way to reduce these risks”.

Given that extreme caution is normally applied to anything related to fertility, pregnancy and neonatal health, such confidence about an injection that uses novel biotechnology, is still only in Phase 3 of clinical trials and approved only under emergency use authorisation (EUA), is anomalous. Further investigation reveals that the evidentiary basis for the government’s encouragement to pregnant women was always lacking. Indeed, even the evidence cited by Australia’s Health Department to encourage vaccination for pregnant women, actually supports the case for caution.

In recent weeks, however, new evidence has emerged that indicates the false assurances issued by authorities about the safety of Covid-19 vaccination for pregnant women cannot be explained simply as a matter of administrative error. Dr Naomi Wolf’s latest substack article, “It's Really True: They Know they are Killing the Babies”, points to evidence from Pfizer’s clinical trials to demonstrate that the Covid-19 vaccination is killing babies and that Pfizer as well as the US FDA (Food and Drug Administration) knew about these harms but approved the product for pregnant women regardless. The FDA originally claimed it would take 75 years for them to respond to public demands for access to all documents relating to Pfizer’s clinical trials. A US court denied their plea for time and ordered the voluminous documents to be released in short order. Wolf is now leading a team of highly credentialled volunteers − in the work of combing through the clinical trial documents as they become available and reporting their findings.

The information has direct relevance to Australia because Australia’s Therapeutic Goods Administration (TGA) seems to have followed the FDA’s lead and taken the honesty of Pfizer’s conclusions on trust. Preliminary reports of increased rates of miscarriage and neo-natal death in babies born to mothers who have taken the Covid-19 vaccine are now emerging from Ontario (Canada), Scotland and Israel. Wolf is clear to emphasise that “these are only preliminary signals – but they are signals”. These indications that the adverse events seen in Pfizer’s clinical trials are now being replicated in the real world demand a response from regulators.

What did Australia’s TGA know and when?

In February 2021, Prof John Skerritt, head of the TGA, told the Australian public that the TGA had worked overtime in the summer to complete all the proper checks on Pfizer’s Covid-19 vaccine before recommending the product for provisional approval. His reassurance that “the safety evidence is pretty thorough” implied strongly that the TGA had, in fact, reviewed the trial data. By May 2021, the TGA was obliged to admit that this was not the case. Information provided in response to an FOI request clarified that the TGA had never seen or even requested patient data from Pfizer. Instead, the TGA had simply accepted that Pfizer’s reporting of study findings was accurate. The TGA has an information sharing agreement with the FDA, which is intended to “provide the means by which each Administration can obtain information that will enable it to make its own independent … regulatory decisions”. Presumably this means that the information Pfizer shared in confidence with the FDA would also have been available to the TGA had they requested it. Rather than forming independent decisions, the TGA appears to have simply followed where the FDA (and Pfizer) led.

The FOI request inquired specifically about the TGA’s statement on its website that:

"Studies in animals have not shown evidence of an increased occurrence of fetal damage". The TGA was asked to “[p]lease include the studies referenced in making the decision based on this assessment.” In June 2021, Doctors for COVID Ethics, reported that the only document produced by the TGA:

“was a heavily redacted single study (not studies, as claimed …) showing that the only investigation into the effects on the fetus was performed on 44 rats with no long term data on the offspring. It is impossible to assess this study fully because 98% of the document was removed in order to protect Pfizer’s intellectual property.”

The French rat study has since been published (here) and is critiqued by Wolf (here) as insufficient to prove safety. Rats have a gestation period of 21 days and the study lasted only 42 days. At 21 days, half of the rat pregnancies were terminated. The baby rats delivered by caesarean were then euthanized and anatomically studied. The other half of the rats delivered their babies naturally and the babies were monitored until they were weaned at 21 days old, at which point they were also euthanized and anatomically studied. Thus, the study cannot answer the question of whether or not the baby rats continued to develop normally and whether or not the vaccine affected their fertility in adulthood.

As Wolf comments:

“There are at least two glaring problems with this study.

First, it does not fulfill the requirements of a DART [Development and Reproductive Toxicity] study, which is ‘to detect any effects of a drug within a complete reproductive cycle as relevant to humans: from initial conception to reproductive capacity in the next generation.’ There is no way to know if any adverse effects on the development of those newborn rats occurred, let alone to know if their reproductive capacity (fertility) was altered. 

Second, there was a significant conflict of interest with the studies’ investigators. The ‘Declaration of Competing Interest’ disclaimer at the bottom of the publication reveals that nine out of ten of the authors of the study were employed by and held stock in either Pfizer or BioNTech.”

This, then, is the study – the only study – upon which the TGA relied for its recommendations that Covid-19 vaccination be encouraged for pregnant women in Australia.

The Australian Health Department website does not support its advice with evidence

At the time of writing (June 2022) the official Australian Government Department of Health Covid advice still plays up the risks of Covid for pregnant women and plays down the risks to both them and their babes from vaccination:

“COVID-19 is more dangerous for women who are pregnant. The best way to reduce your risk is to get vaccinated. Real-world evidence has shown that Pfizer and Moderna vaccines are safe if you are pregnant, breastfeeding, or planning pregnancy. You can receive the vaccine at any stage of pregnancy.”

The only source provided for this “real world evidence” is “a US study of more than 35,000 pregnant women” which, it is claimed, “showed no difference in side effects between those who were pregnant and those who were not.” On this evidence, the Health Department website reassures Australian women that “[v]accination does not increase the chances of pregnancy complications such as premature delivery, stillbirth, small for gestational age infants and birth defects.”

Unfortunately, the study they cite a) is not as authoritative as they imply and b) does not support the conclusions they claim to have drawn from it.

  • First, the “study” is not a clinical study, but an analysis of data collated from two databases, each of which is afflicted with acknowledged problems:
    • they rely on volunteer reporting, which means we are not dealing with a complete sample, and;
    • although under-reporting of adverse results is certain, the degree of underreporting is completely uncertain.
  • Second, the study was published in April 2021, meaning that many of the pregnancies listed in these databases had not yet completed and rates of follow-up were still very low (under 15% for one of the databases) – so, even such data as there was, was mostly incomplete.

The authors of this study conclude:

“Early data … do not indicate any obvious safety signals with respect to pregnancy or neonatal outcomes associated with Covid-19 vaccination in the third trimester of pregnancy. Continued monitoring is needed.” (emphasis added).”

Even this study then only offers preliminary reassuring data on vaccination during the third trimester. If this is the only study they relied on, then the Australian Government Health Department’s assurance to pregnant women that “[y]ou can receive the vaccine at any stage of pregnancy” seems an irresponsible extrapolation from (not particularly robust) evidence.  

Further “real world data” signals that Covid-19 vaccines are not safe for pregnant women and babies; Pfizer knew this

Wolf’s small army of credentialled volunteers combing through Pfizer’s clinical trial data have now discovered that, although pregnant women were excluded from the clinical trials, 270 of the women signed up for the trial fell pregnant. Against every protocol, Pfizer appears to have “lost” information on 234 of these women; the records say only “no known outcome”. The outcomes for the remaining 36, however, are not reassuring – 28 of these women lost their babies before or at birth. Pfizer and the FDA knew this before the vaccine was approved.

Even without the benefit of this information, Dr Michael Yeadon, former Vice President of Pfizer (now retired), argued that problems for pregnant women from the Covid-19 vaccine were foreseeable. In December 2020, Yeadon detailed a series of “mechanistic toxicology concerns” which he believed were reasonable to hold until evidence was produced to dismiss them. Yeadon’s concerns included “adverse impacts on conception and ability to sustain a pregnancy”. He even explained his reason for this concern:

“The spike protein from the virus encoded in the vaccines was related to a minor extent to syncytin that plays a crucial part in the carrying of a baby to term … We’d envisioned the risk that, in responding to the synthetic piece of virus spike protein, women’s immune systems would also make an immune response to their own placental protein.”

Perhaps attempting to disprove Yeadon’s grim hypothesis, a pre-print paper investigating the question instead confirmed that Yeadon’s concern could not be dismissed. According to Yeadon, this finding alone ought to have been sufficient to exclude all “women younger than menopause” from receiving the Covid-19 vaccine. (Further concerns for female fertility following vaccination are discussed here).

Scientists have known since 2012 that lipid nanoparticles (which convey the mRNA vaccine around the body) accumulate in ovaries. As Dr. James Thorp, an obstetrician with over 42 years of clinical experience, explains, this means that all the eggs of vaccinated women are “exposed to a potentially disastrous toxic lipid nanoparticle.” Further, these lipid nanoparticles:

“appear to cross all God-made barriers in the human body, the blood-brain barrier, the placental barrier during pregnancy, into the fetal bloodstream, and all the fetal tissues inside the womb, crossing the blood-brain barrier in the fetus, the baby in the womb.”

Through his practice, Thorp sees 6,000–7,000 high-risk pregnant patients a year and reports:

“What I’ve seen in the last two years is unprecedented: many, many, many complications in pregnant women, in moms and in fetuses, in children, offspring, fetal death, miscarriage, death of the fetus inside the mom [from Covid-19 vaccines].”

As early as March 2021, fertility clinics in Utah began to notice a significant jump in their rates of miscarriage from 28% to 40% −a 43% increase. Etana Hecht notes in her substack that, in July 2021, Dr Rick Nicholls from Waterloo, Ontario reported 86 stillbirths from a region where the baseline number is normally 5−6 per year. (There had been no noticeable rise in stillbirths in 2020, the year of Covid). In September 2021, Scotland launched the first of, now, two investigations into abnormal spikes in newborn baby deaths. A February 2022 report from Rambam Hospital in Israel demonstrates higher rates of neonatal death in babies born to vaccinated mothers (8%) compared with those born to unvaccinated mothers (6%):

“That’s a statistically significant odds ratio of 1.36 (CI 1.0-1.9), meaning your odds of having a stillbirth, abortion or miscarriage are 1.36 times higher if you are vaccinated.”

Examining the evidence cumulatively, Wolf – with apologies for the clumsy language borne of her great sense of urgency − describes the phenomenon as “a baby die-off”.

Breastfeeding

The dangers from the Covid-19 vaccine to babies do not end with pregnancy. Adverse events for babies breastfed by vaccinated mothers are also reported. In 2021, people who talked about “shedding” (whereby an unvaccinated person might report side-effects after contact with a vaccinated person) were debunked by “fact checkers”. But now, it turns out that Pfizer was aware of “environmental exposure” to the vaccine through human contact, meaning babies breastfed by vaccinated mothers are exposed to the vaccine and Pfizer/the FDA knew this. In 2021, everyone was reassured that the MRNA, spike protein and lipid nanoparticles in Covid-19 vaccines would not travel beyond the injection site in the deltoid muscle of the arm. Now, it transpires this too was false – “within 48 hours, [these travel] into the bloodstream, from there to lodge in the liver, spleen, adrenals, lymph nodes, and, if you are a woman, in the ovaries.” Clearly, there is potential for this to affect breast milk.

According to Wolf (here and here):

“[A] common side effect of [vaccination] is that your breastmilk stops. It starts up again three or four days later for most women but, if you have been a breastfeeding woman you know that, by then, the baby is on formula because otherwise the baby would starve. Breastfeeding women were not told ‘it’s going to stop your milk’.”

“[F]our of the lactating vaccinated women in the Pfizer documents reported ‘blue-green’ breast milk. I am not making this up.

… The Volunteers [investigating the Pfizer documents] found that a baby died after nursing from a vaccinated lactating mother, and was found to have had an inflamed liver. Many babies nursing from vaccinated mothers showed agitation, gastrointestinal distress, and failure to thrive (to grow), and were inconsolable.

I am hearing anecdotal reports of these symptoms in babies nursing from vaccinated mothers, now, from across the country.”

A pre-print study on lactation and vaccination conducted by the National Institutes for Health (NIH) concluded that “PEGylated proteins, were not found at significant levels in milk after vaccination.” Wolf points out that polyethylene glycol (PEG) is a petroleum by-product contained in the vaccine and, as the study acknowledges, this is making its way into the breastmilk of vaccinated mothers. How can they say what a safe level of PEG for new-borns might be?

“We’ve never experimented on human newborns by feeding them petroleum and seeing how they do, so there’s no way to conclude it’s not harmful and the evidence shows that these babies are distressed.”

PEG may be a factor, or may not be, but the burden of proof should lie with pharmaceutical companies to demonstrate safety, not to blithely dismiss indications of the opposite.

The strong evidence that Covid-19 vaccinations in pregnant women are causally related to the increases in infant mortality should prompt Australian health authorities to immediately suspend vaccinations for this vulnerable group, pending a thorough investigation of the evidence and review of the risks versus benefits of further Covid-19 vaccination. How long before the TGA begins to reconsider its encouragement for pregnant women to take the Covid-19 vaccination? How long before they revise the re-assuring messaging, which currently tells pregnant women that “side effects after COVID-19 vaccination during pregnancy” can mostly be treated with paracetamol? How long before we hear that the TGA has initiated a re-examination of the risk/benefit analysis that led them to provide such one-sided advice in the first place?

Australians who (rightfully) expect the TGA to operate as the watchdog of public health – rather than the lapdog of Big Pharma – have every right to expect that the TGA will take these preliminary signals of harm seriously and act accordingly.