COVID vaccination for pregnant & lactating women: The evidence

Calling on pregnant women to avoid a new and experimental vaccine designed to protect against a disease of extremely limited risk to them should have been self-evident. Instead, the opposite has occurred, and pregnant women along with all other women of childbearing age, including nursing mothers, are exhorted and even pressured to consent to be injected with a substance that is claimed to be “safe and effective” even though anecdotal accounts of associated dangers are legion.

How did such a situation arise, and why have so many medical doctors either acquiesced or remained silent?

This article will outline the assumptions inherent in the campaign to vaccinate young women for COVID, and show that they are false and dangerous.

• SARS-CoV-2 does not pose a significant risk to pregnant women, nor is it even proven to be more of a risk to pregnant women than non-pregnant women.
• Even if SARS-CoV-2 was proven to pose a significant risk to pregnant women, it by no means follows that vaccinating pregnant women is the sensible response.
• The efficacy of COVID vaccines in preventing COVID infection and/or serious cases of COVID has not been proven, and there is evidence that the vaccines are actually ineffective.
• Despite declarations and claims that the vaccines cannot possibly pass the placenta, there is no evidence to back this up, and strong reason to suspect that the vaccines may indeed be capable of passing the placenta and reaching the fetus.
• The vaccines have not been proven safe for pregnant women: Animal trials were insufficient and (accidental) human trials were inconclusive at best.
• Multiple anecdotal reports strongly suggest a causation between vaccination and adverse outcomes for unborn babies as well as nursing babies.

Are pregnant women really at high risk?

Early on in the pandemic, before much was known about the dangers of SARS-CoV-2, it became axiomatic that pregnant women and their unborn children were at significantly higher risk of complications and even death if they contracted COVID. More than two years later, this remains the prevailing view and one that is rarely if ever challenged. On closer examination, however, the evidence for this is weak. Studies cited involve only several hundred, or even mere dozens of participants and many fail to properly match with non-COVID-infected pregnant women, leading to significant discrepancies between the two groups in terms of comorbidities such as diabetes, obesity, and hypertension, long known to be risk factors for COVID.

Furthermore, finding the raw data from these studies is difficult and sometimes impossible, leaving the curious investigator with nothing more than relative risk to draw conclusions from, and no idea whether that refers to three women, thirty, or three hundred. One rather suspects the smaller number, given the often large confidence intervals, but that is of course speculation.

All the same, the INTERCOVID study that examined 706 pregnant women with a COVID diagnosis and paired each of them with two other women without such a diagnosis, does appear to show significantly increased morbidity and mortality rates for the COVID-infected women. On the other hand, a number of intriguing studies have emerged indicating that pregnant women may actually be in a favorable position as regards COVID when compared to matched non-pregnant women. The authors of this paper note a number of factors that can reasonably be believed to be “protective against severe COVID-19” during pregnancy, including hormonal and metabolic changes and also immunological adaptations – and they cite a number of studies indicating that pregnant women who contracted COVID had better outcomes than their peers. 

Another study published in the Journal of Perinatal Medicine (November 26, 2020) came to a similar conclusion after examining the maternal and neonatal outcomes of 10,996 cases in 15 countries: 

The results of our review demonstrate that the maternal characteristics, clinical symptoms, maternal and neonatal outcomes in almost 11,000 cases of COVID-19 and pregnancy described in 15 different countries are not worse or different from the general population.

We also suggest that the important gestational shift Th1-Th2 immune response, known as a potential contributor to the severity in cases of viral infections during pregnancy, is counter-regulated by the enhanced pregnancy-induced ACE2-Ang-(1-7) axis...

So, does SARS-CoV-2 really pose a significant danger to pregnant women? The answer to that question likely depends on whom you ask, but consider that a meta-analysis of 192 studies – one that concluded that COVID in pregnancy was associated with higher mortality rates and higher rates of neonatal ICU admission – found that the mortality rate for pregnant women infected with COVID was just 0.02 percent...

Vaccinated, but far from immune

But even supposing that falling ill with COVID during pregnancy is comparatively dangerous, does it automatically follow that vaccination is the optimum response? Perhaps, if the vaccines were effective... 

The CDC recommends COVID vaccination “at any point in pregnancy, as well as booster doses for those eligible.” They add that, “COVID-19 vaccination can protect you from getting very sick from COVID-19.”

And yet a study cited by the CDC supposedly showing vaccine effectiveness focuses on the results for newborns, comparing hospitalized infants with a COVID diagnosis to those without such a diagnosis. The study concluded that, “Effectiveness of maternal vaccination during pregnancy against COVID-19 hospitalization in infants aged <6 months was 61%.” Possibly the large confidence interval (31% to 78%), coupled with other significant limitations of the study led the researchers to only cautiously conclude that, “Completion of a 1-dose mRNA COVID-19 vaccination series during pregnancy might help prevent COVID-19 hospitalization among infants <6 months.”

This study was hardly representative of the general population given that the vast majority of newborns are not hospitalized for any reason. Furthermore, given that the purported reason to vaccinate expectant mothers is to protect primarily them and not their fetuses, one might have expected the CDC to focus on infection rates in the mothers.

For some reason, there is only a limited number of studies that investigate COVID infection in mothers following vaccination during pregnancy; an internet search of such studies came up with just two. (Other studies examine antibody titers following vaccination, with the assumption that they are predictive of lower infection rates, although this is far from proven.) 

The first of the two studies involves 2,002 pregnant women, of whom 140 received a COVID vaccine during pregnancy. Two of the 140 vaccinated women contracted COVID while pregnant (both before being vaccinated), versus 210 out of the 1862 pregnant unvaccinated women. There was, however, no significant difference between adverse outcomes in either group. In addition, this study did not match control and study groups, leading to several significant disparities between the groups, some of which the authors noted. 

The second study, a retrospective study of around 15,000 women, did match the two cohorts for most of the key risk factors for COVID, and found that infection rates were significantly higher in unvaccinated women. However, rates for hospitalization due to COVID-19 were almost identical – 0.2% in the vaccinated group versus 0.3% in the unvaccinated group. The study’s authors added that, “There were no notable differences between the vaccinated and unvaccinated groups regarding preeclampsia, intrauterine growth restriction, infant birth weight, abortions, stillbirth, maternal death, or pulmonary embolism.”

Studies that did claim to find a link between pregnancy and worse COVID outcomes note that women who fell seriously ill or died were almost uniformly those with one or more serious comorbidities, illnesses or conditions known to be predictive of falling seriously ill with COVID, such as diabetes, hypertension, and obesity – the last of which is often the main culprit. However, studies have also shown that obese people mount a far weaker immune response to vaccination, which is important to know when making a risk-benefit analysis of the shots. 

More worryingly, in an Israeli survey earlier this year examining the effects of COVID boosters, five to ten percent of people with diabetes or hypertension reported that their conditions worsened following the third shot. Furthermore, the shots have even been shown to cause dangerous changes in blood sugar levels in those not previously diagnosed as diabetic. In September of 2021, an American study reported several cases of hyperglycemic emergencies following vaccination; another study from China a month later demonstrated a “consistent increase” in blood sugar levels following vaccination that lasted several months. 

The mechanism via which the shots could cause prediabetes, worsen hypertension, or lead to a host of other alarming symptoms is far from clear. Despite widespread acknowledgement including by the CDC that COVID vaccines are linked to heart inflammation with serious outcomes including death, few in the mainstream seem to be overly interested in why that may be. Given that they view pregnant women as a high-risk category, it would seem even more pertinent to examine the possible risks of an essentially experimental treatment; instead, however, the vaccines are presented as a catch-all panacea, a “safe and effective” means to protect such women from the dire dangers of COVID, should they catch it. Many, of course, will not catch COVID even if they remain unvaccinated; exposure to the shots, however, is 100-percent certain for those who are injected.

Nanoparticles and spike proteins - whither do you go?

Initially, during the first months after the shots were rolled out, widespread claims were made that the mRNA doses in the Pfizer and Moderna products posed no danger whatsoever, as a) the mRNA itself degenerated very swiftly in the body and b) the mRNA did not distribute itself around the body but remained confined to the shoulder muscle where it was injected, possibly straying to the nearby lymph glands but surely no further. Therefore, it was claimed, there was no reason to worry that nanoparticles or stray spike proteins could end up in organs such as the ovaries, and certainly they could not cross the placenta and endanger a fetus.

Within a short amount of time, these claims were proven false. It is now known that the mRNA in the shots lingers in the body for weeks, not mere days, and Pfizer’s own studies have shown spike protein concentrations in various organs including the ovaries (in animal studies). While there is limited evidence that mRNA may not cross the placenta, (the fact that igM antibodies, formed in reaction to the antigen in the vaccine, do not seem to be found in babies born to vaccinated mothers in several studies), the possibility that mRNA can cross the placenta and affect the fetus has certainly not been excluded.

This is acknowledged in an article in JAMA (COVID-19 Vaccination in Pregnant and Lactating Women, February 8, 2021). "While no specific studies have evaluated the ability of the lipid nanoparticle vaccine to reach the fetus following vaccination, it is likely that the local muscle cells take up the lipid nanoparticles...” echoing the prevailing notion that the nanoparticles (NPs) did their job at or close to the injection site and then helpfully disintegrated. But was that a valid position to take, given the state of scientific knowledge regarding NPs at that point in time – and even years before?

Turning the clock back four years from that JAMA article, one finds a very informative review entitled, “Toxicity of Nanoparticles on the Reproductive System in Animal Models,” dated September, 2017. Over one hundred research papers are cited by the authors, who conclude that “studies confirm that NPs ... can readily pass through the placental barrier...” with a variety of disturbing results such as: 

... ovarian damage, decreased fertility and decreased pregnancy rate ... toxic effects on fetal development and a compromised fertility ... sperm production ... a significant increase in fetal deformities and mortality...

One study cited used intravenous injection of NPs into pregnant mice: 

This resulted in a 20-30% reduction in uterine weight, increased fetal resorption rate, and smaller fetuses ... all resulting from placental dysfunction.

Other studies using animal models demonstrated that “the brain and nervous system are directly affected by prenatal exposure to NPs,” as well as “the potential vulnerability of the fetal brain to the toxicity of a variety of different types of NPs.”

Several studies cited in the review also showed that NPs pass into the milk of lactating animals.

In short, the authors conclude, based on what seems to be overwhelming evidence, that, 

The small size of nanoparticles and their ready distribution to reproductive organs makes them prime candidates to breach the placental barrier.

Nanoparticle tests on 44 pregnant rats, none on humans

Three years later, with scientists racing to create a “safe and effective” COVID vaccine using NPs, one might have expected that their safety with regard to reproductive health would have been studied. After all, dozens if not hundreds of studies have already been completed on many other kinds of NPs, none of which were slated to be administered to the general population. This did not happen, nor, apparently, did the FDA require either Pfizer or Moderna to conduct such trials.

Instead, Pfizer conducted a very limited study on 44 pregnant rats, monitoring them for around six weeks (three weeks’ gestation and another three weeks’ lactation). Researchers noted the rats’ antibody response to vaccination as well as effects on fertility, neurofunctional and physical development, and “ovarian or uterine parameters” (without disclosing what those parameters were), along with various other observations. The rats were then euthanized and that was the end of that. 

It was good enough for Pfizer, because after all, they weren’t claiming that the vaccines were safe for pregnant women: 

Available data on [the vaccine] administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy (Pfizer, July, 2021).

And it was good enough for the FDA, as they, too, did not actually recommend that pregnant women receive COVID shots:

Available data on Pfizer-BioNTech COVID-19 Vaccine administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy,

and they then passed the buck to pregnant women themselves, along with their doctors: 

Pregnant or breastfeeding women should discuss potential benefits and risks of vaccination with their healthcare provider.

But the FDA also noted that, 

There is no contraindication to receipt of the vaccine for pregnant or breastfeeding women.

That sentiment was echoed by the director of the National Institutes of Health (NIH), Dr. Francis Collins, who said in June, 2021 that he was “pleased to report results from two new studies showing that the two COVID-19 mRNA vaccines ... appear to be completely safe for pregnant women.”

So are mRNA vaccines safe for pregnant women? Various reports and VAERS reporting

The two studies Collins was referring to were a JAMA study in which just 30 women were enrolled, and another study published in Obstetrics & Gynecology which examined the placentas of 84 women who had been vaccinated against COVID-19 during pregnancy. 

“The researchers detected no signs that the vaccines led to any unexpected damage to the placenta,” Collins writes (italics added. Exactly what he meant with this choice of words is purely a matter of conjecture.)

The researchers in this study were looking for certain markers they described as “characteristic of SARS-CoV-2 infection in pregnancy,” including “fetal vascular malperfusion” (placental lesions suggesting obstructions in the umbilical cord), and they didn’t find them. They then concluded that their findings “add to the growing literature supporting the safety of SARS-CoV-2 vaccination in pregnancy.”

This wasn’t the only study conducted on placentas during the COVID era. Another study published before the vaccine rollout, in the American Journal of Clinical Pathology (May, 2020), examined the placentas of 16 women who had severe COVID while pregnant, and found that “... third trimester placentas were significantly more likely to show at least one feature of maternal vascular malperfusion (MVM), particularly abnormal or injured maternal vessels, and intervillous thrombi.” The study cited by Collins failed to find these signs, but a quick search of the VAERS database reveals one case of “fetal vascular malperfusion” resulting in fetal death six days after the mother received the second dose of the Moderna vaccination (VAERS ID 2046121-1).

Further searches in VAERS reveal instances of blood clots behind the placenta, clots within the umbilical cord, placental abruption, fetal stroke associated with blood clotting, fetal growth retardation (indicating impaired placental function), all linked with COVID vaccines and all resulting in fetal demise.

None of this should have come as any surprise to Collins at the NIH, nor to the FDA or the CDC. Pfizer published its “Cumulative Analysis of Post-Authorization Adverse Event Reports” in April 2021 with regard to its application for FDA approval. Although no formal study had yet been made of COVID vaccination during pregnancy, a number of pregnant women had inadvertently been vaccinated and by that point in time, 270 cases were known of. For 238 of these, Pfizer reported that “no outcome was provided”; of the remaining 32, 28 had ended with the death of the fetus. 

These were categorized as 23 cases of spontaneous abortion, 2 cases of premature birth with neonatal death, 2 cases of spontaneous abortion with intrauterine death, and 1 spontaneous abortion with neonatal death. One baby had been born normally and survived, and 5 outcomes were pending.

The analysis also looked at 133 cases of lactating babies exposed to the vaccine during breastfeeding (via breast milk), with 3 events described as “serious” although they are not specified, being absorbed within a general category of 17 serious and non-serious cases that included: pyrexia, rash, irritability, vomiting, diarrhea, insomnia, vomiting, pain, and allergy to vaccine.

Pfizer’s conclusion? “There were no safety signals that emerged from the review of these cases of use in pregnancy and while breast feeding.”

Meanwhile, VAERS reports related to abnormalities seen during lactation were mounting. One such report describes: 

Patient received second dose of Pfizer vaccine on March 17 ... March 18 her 5-month-old breastfed infant developed a rash and within 24 hours was inconsolable ... blood analysis revealed elevated liver enzymes. Infant was hospitalized but continued to decline and passed away. Diagnosis of TTP.

TTP is a known adverse outcome from COVID vaccination that involves platelet clots in the blood. 

In another VAERS entry, a bereaved mother writes:

I had been breastfeeding my 6-week-old baby at the time that I received the first Pfizer vaccine. He became very sick with a high fever about 2 weeks after ... he presented with what they called an atypical Kawasaki disease. He passed away shortly thereafter from clots in his severely inflamed arteries.

Fertility under attack

In Scotland, an investigation is currently underway into two separate spikes in infant deaths, one last September, one in March of this year. The average newborn mortality rate in that part of the world was 1.49 per 1,000 births in 2019, but during the spikes, the rates rose to 5.1 and 4.6 per 1,000 respectively. 

Dr. Sarah Stock, an expert in maternal and fetal medicine at the University of Edinburgh, described the data as “troubling.” 

“I don’t think we know the reasons why yet,” she said. “What we do know it's not neonatal Covid – the rates of Covid-19 infection in babies are very low and deaths from Covid are thankfully very, very small so this isn't Covid affecting babies.” She (along with all other mainstream news commentaries) also stressed that the COVID vaccine was “not a factor,” without explaining how such a conclusion had been reached.

Since the COVID vaccines have been rolled out, there have been myriad reports of adverse effects in women related to their reproductive functions. Health authorities are now beginning to acknowledge the effects of the vaccines on menstrual cycles; more worrying, perhaps, are reports of resumed bleeding after menopause, or continual bleeding or spotting in pre-menopausal women. What is especially worrying is a dramatic increase in the number of reported cases of decidual cast shedding (DCS), which involves the entire uterine lining being shed at once. In the entire VAERS database there are four reported cases of decidual cast shedding (described as such), all related to the COVID vaccines. There is no doubt that VAERS does not even begin to capture the extent of the phenomenon; one study notes that 292 cases of DCS were reported in 2021 alone. To put this in perspective, note that in the past 109 years, less than 40 cases were reported.

What’s going on? Who is investigating any of this? Governments, health advisory bodies, and physicians continue to advise women of all ages to take the vaccines, insisting that the benefits outweighs the risks, and meanwhile, scores of women and children are paying the price.

Pfizer rides to the rescue

Well, it’s not all bleak... Pfizer, for one, has already stated its intention to conduct a “global phase 2/3 study to further evaluate the safety, tolerability, and immunogenicity” of its product. 

“We are proud to start this study in pregnant women and continue to gather the evidence on safety and efficacy to potentially support the use of the vaccine by important sub-populations,” said William Gruber M.D., senior Vice President of Vaccine Clinical Research and Development, Pfizer, in February of 2021. “Pregnant women have an increased risk of complications and developing severe COVID-19, which is why it is critical that we develop a vaccine that is safe and effective for this population. We are deeply thankful to the volunteers who are enrolling in the trial, and site investigators who are leading this work.”

“It is time to take the next step and extend our clinical program to other vulnerable populations, such as pregnant women, to potentially protect both them and future generations,” added Oxlem Tureci, M.D., Chief Medical Officer of BioNTech.

The Phase 2/3 trial is designed as a randomized, placebo-controlled, observer-blind study in approximately 4,000 healthy pregnant women 18 years of age or older, vaccinated during 24 to 34 weeks of gestation … [with] two doses . . . administered 21 days apart. Each woman will participate in the study for approximately 7 to 10 months, depending on whether she was randomized to receive the vaccine or placebo. The study will assess safety in infants of vaccinated pregnant women and the transfer of potentially protective antibody to their infants ... through approximately six months of age. As established in the study protocol, after a participant’s infant is born, maternal trial participants will be unblinded and those who were in the placebo group will receive the vaccine.

There are so many problems with the design of this trial that it’s probably not even worth waiting around to get the results – which are not expected to be published before the end of July, 2022, giving Pfizer’s researchers around six months from the end of the trial to toy with the data and present it in its most flattering light (assuming that the trial started in February of 2021).

But it turns out that all is not as it seems. Pfizer was kind enough to provide a link to the ClinicalTrials.gov site where a quick search turns up the trial, last listed on May 19, 2022 as “active, not recruiting.”

This will be a Phase 2/3 randomized, placebo-controlled, observer-blind study … in approximately 350 healthy pregnant women 18 years of age or older … randomized 1:1.

What happened to the 4,000 women? Suddenly 350 are enough?

In fact, it’s not even 350.

The Phase 2 portion of the study will include approximately 200 pregnant women randomized 1:1 … at 27 to 34 weeks’ gestation … Phase 3 … women enrolled at 24 to 34 weeks’ gestation…

Maternal participants who originally received placebo will receive BNY162b2 at defined time points as part of the study.

Now we see that the trial ends not after the infants are born, but rather “at defined time points.” Who does the defining?

As for long-term follow-up, consider that it would not be ethical to deprive young women (or their newborn babies) of the opportunity of being vaccinated against such a dangerous disease, and therefore, once the trial is over, all women in the placebo group will be promptly vaccinated.