Study by Shimabukuro et al Lied Too, But Professionally, With Statistics
Guest post by Sasha Latypova
“But the plans were on display . . .”
“On display? I eventually had to go down to the cellar to find them.”
“That’s the display department.”
“With a torch.”
“Ah, well the lights had probably gone.”
“So had the stairs.”
“But look, you found the notice, didn’t you?”
“Yes,” said Arthur, “yes I did. It was on display in the bottom of a locked filing cabinet stuck in a disused lavatory with a sign on the door saying Beware of the Leopard.”
Douglas Adams, “The Hitchhiker’s Guide to the Galaxy”.
There has been a massive relentless campaign to get the needle into every arm over the past 2 years, but the group hunted with conspicuous vigilance by the government-pharma cartel from the start were pregnant women, followed by children and babies. An avalanche of (unlawful) direct to consumer ads screaming about tremendously “safe in pregnancy” Covid-19 shots started appearing on social media and other major platforms before these shots were even authorized for emergency use (December 2020). EUA does not permit advertising any drug as safe and effective. But the government is exempt from following laws, remember?
A side note for every over-zealous vaccinator out there: you were “following orders” from the HHS and coercing every pregnant woman in your care by lying about safety and efficacy of these injections. You were paid for lying to your patients, and you may have been promised a liability cover. You may still be held liable under state laws for not providing informed consent. Talk to your attorney.
Given the avalanche of “tremendously safe in pregnancy” messages out there, including from the top FDA and CDC officials, one may be surprised that as of today, these shots are officially NOT RECOMMENDED in pregnancy according to the product labels, that state there is no data to make these recommendations. Furthermore, maternal toxicity, skeletal abnormalities and accumulation of the potentially toxic injection substances in the ovaries have been documented by non-clinical studies for these products. Of course, to find this information, you need to descent into a dark cellar and find a locked file cabinet – i.e. know how to find the drug labels in the bowels of the FDA website, read sections buried deep in those labels, and in addition, sue the HHS for freedom of information, and wait months for the lawsuit to hopefully turn out in your favor. See, this is easy, you just have to follow the proper procedure!
I have written extensively about Pfizer’s and Moderna’s nonclinical studies that revealed clear harm for pregnancy and neonatal development. The studies were in FDA’s possession at the time the shots were authorized, yet the FDA chose to ignore the safety signals, and in case of Moderna’s product, they went even further and wrote an outright lie in the product’s summary document, stating that there was no vaccine related skeletal malformations in baby rats, while Moderna’s own documents admit that these were observed at a statistically significantly increased rate in vaccinated rats’ offspring. Additionally, Pfizer’s own published study in reproductive toxicology showed nearly 300% increase in skeletal malformations in babies and doubling of the pre-implantation embryo loss in injected female rats.
In standard, lawful, regulation and ethics compliant pharmaceutical development process (long gone now), novel medicines are never given to pregnant women or to women of childbearing potential until the risks to reproductive system and pregnancy can be excluded with confidence through both animal toxicology studies and clinical trials that exclude women who are pregnant or can become pregnant. For very novel technologies, the general rule was that the products would be tested first on healthy male volunteers, and if women need to be enrolled in early phase clinical studies, then the women are not of childbearing potential, e.g., surgically sterilized or post-menopausal.
These long-established safety and ethics practices were disregarded in the development of Covid-19 injections. The animal studies were not done prior to the initiation of the large-scale clinical trials, they were compiled much later and were both deficient and outright fraudulent in many aspects as discussed in my articles linked above. Exclusion criteria for pregnancy were written into the human clinical trial protocols, however, as is well known in clinical trial practice, pregnancy listed as exclusion is insufficient for prevention of enrolling subjects that subsequently become pregnant into the trial, especially with large populations such as 40,000+ subjects for each of these trials. Given that everyone involved in this activity is experienced in clinical trials, I believe Pfizer, Moderna and FDA knew that this would happen and in fact counted on getting pregnant women for experiments in this manner. The outcomes of those experiments are not yet clear, as the data from Pfizer’s clinical trials is still being delivered through FOIA, and has not been made available in Moderna’s case at all. At any rate, that experimental activity lasted only about 4 months, after which time the manufacturers unilaterally decided that their products are simply too wonderful to withhold from the placebo subjects and destroyed the experimental design that was supposed to deliver long term safety data by unblinding and injecting the placebo cohort. The FDA never found a single breaking of the regulation by Pfizer and Moderna that it did not wholeheartedly embrace, and they didn’t find this one objectionable either.
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The injections were swiftly pushed through EUA in December 2020, and the actual study of the safety in pregnancy was included as a “postmarketing commitment”, i.e. manufacturers’ promise to complete certain research by certain dates after a drug goes on the market. That postmarketing study was initiated in February 2021, but eventually it was simply abandoned. “The study enrolment was stopped with incomplete numbers because recruitment was slow and it became unreasonable/inappropriate to randomize pregnant women to placebo given the amount of observational evidence that the vaccine is safe and effective, coupled with increasing number of technical committees supporting immunization of pregnant women,” according to the email from Jelena Vojicic, Pfizer vaccines medical lead in Canada from April 4, 2022, as reported by The Epoch Times. Let me translate from pharmaspeak: “slow enrollment” means women are becoming increasingly aware of the danger to them and their babies posed by these insanely untested products and are not lining up to be injected while pregnant anymore; “unreasonable to randomize to placebo” = we desperately wish to not have a control group; “observational evidence that the vaccine is safe and effective” = we assert that these injections are safe, because we assert so.
This brings me to the part about lying professionally, with statistics. A retrospective analysis of a vaccine registry dataset was published by New England Journal of Medicine in June 2021. The study by Shimabukuro et al was called “preliminary” and called pregnant women “persons” in obedience to the woke jargon of their controllers in academia as well as the NEJM. This group reviewed data collected over about 10-week period, from December 14, 2020, to end of February 2021 by vSafe database, or mobile application which was distributed to the newly injected at the beginning of the rollout. The dataset that was reviewed in the study contained enrollment and outcomes data for 827 pregnancies, although it referred to a total of approximately 3500 pregnant women who got the app (but either did not enroll in the registry or did not supply the outcomes data). The number by itself is shocking to me. There was no data available for the injections’ safety in pregnancy at the time. The product was and still is entirely experimental. Pregnant women were excluded from clinical trials (sort of), and bad results in animal studies were known to the FDA but hidden from public. By February 2021, 3500+ women already fell for the lie and offered themselves for a very unethical experiment.
Of the 827 studied pregnancies, 700 received injections (and enrolled in the vSafe registry in the 3rd trimester of pregnancy. 127 women enrolled in the 1-2 trimester. The study concluded that there were no obvious safety signals for pregnancy. To find out the truth however, one would need to skip past the abstract, conclusions and all text of the paper and go to Table 4 and its footnotes:
It is not difficult to decipher the lie. The numbers are all there but presented in a manner designed to obfuscate. First notable omission is regarding the statistics for spontaneous abortions (defined as pregnancy loss <20 weeks of gestation). The total in the set was 104. While the “normal” incidence numbers (i.e. normal background rate of the event based on long-term statistical reference) are included for all other research parameters, for this parameter the authors do not include the normal incidence rate and instead declare it “not applicable”. The excuse given in footnote is amateurish – they state it is not because “only” 92.3% of these miscarriages occurred in women injected in the 1st trimester, and state that they need to wait for data from further 1224 participants. This makes no sense. Incidence is a background historical estimate, not derived from the current study dataset. In addition, the authors provide reference 15, a paper that states that the incidence rate for spontaneous abortions is 10% for clinically recognized pregnancies, and somewhat higher, up to 25% for very early pregnancies that are not yet recognized. Why did they include the reference, but pretended it was not applicable to include in the table?
I calculated the true approximate rates of the spontaneous abortions, and stillbirths (loss of pregnancy/baby after 20 weeks of gestation):
Since it is impossible to have a spontaneous abortion attributed to the 700 women injected and enrolled in the registry in the 3rd trimester, the 104 miscarriages can be all attributed to the 127 women from 1-2 trimester. There could be 31 women (127-96), who were injected in the 2nd trimester who ended up with a stillbirth in the 3rd, but none the other way around. That adjustment would not affect the results very much, and if anything would reduce the denominator for spontaneous abortions, making the rate even worse. When calculated correctly, removing 700 subjects that were not relevant for the spontaneous abortion denominator (but were included by the NEJM study authors to hide the horrendous result), the rate is a staggering 82%. Comparing to the 10% “normal” rate, this is an 8x increase! Furthermore, in the 700 group of 3-rd trimester pregnancies, the rate of stillbirth is ~1.5%, while a quick search of CDC data shows that the historical norm is around only 0.6%. The injected women experienced about 3x increased rate.
Alarming numbers for lost pregnancies are coming from a variety of sources now, from doctors and from safety surveillance databases. As of February 2022, the VAERS database contained over 2000 reports of loss of pregnancy before 20 weeks in injected women. For reference, the entire VAERS database, since its inception and for all products other than covid-19 injections (approximately 98 other vaccines) contained ~700 such reports. Below is the graph by Jessica Rose, PhD.
These injections are for nobody, but they are particularly harmful to the otherwise healthy population – pregnant women, children, babies. Government lies, coercion, gaslighting and other malignant policies must stop. Do not comply.
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