La prueba irrefutable de que el ARNm de las "vacunas" Covid se están extendiendo a la leche materna y de los daños causados a fetos y bebés.
Pero los psicópatas siguen recomendandola para mujeres embazadas...
■https://www.thelancet.com/journals/ebiom/article/PIIS2352-3964(23)00366-3/fulltext
https://twitter.com/Fa21519230/status/1705946241668911161?t=p31K8018B_jcl--8Mwymsw&s=19
CHILDREN`S HEALTH | EU- AFFAIRS | PUBLIC HEALTH | VACCINE SAFETY
La última entrega explosiva de datos condenatorios de la EMA confirma su fracaso: PSUR #3, los casos de embarazo y lactancia
By Sonia Elijah
May 15, 2023
Thanks to a Freedom of Information Act request, the EU’s Periodic Safety Update Report #3 (PSUR #3), covering the 6-month period of 19 December 2021 through to 18 June 2022, recently became available on the Austrian Politics and Science blog, tkp.
My analysis of PSUR #1 was published in Children’s Health Defense Europe, which covered adverse events reported over the first 6 months of 2021 for the Pfizer-BioNTech mRNA COVID-19 vaccine. At this current time, PSUR #2 and the appendices for PSUR #1 and #3 have not yet been released.
This specific article is part 1 of the analysis of PSUR #3, the third pharmacovigilance document requested by the European Union’s drug regulator, the European Medicines Agency (EMA), prepared by Pfizer/BioNTech and signed off by the Vice President of Worldwide Medical and Safety at Pfizer, Barbara De Bernardi MD, on 18 August 2022.
An overview of the data
508,351 case reports (individuals) containing 1,597,673 events
Three times the number of cases were reported for women than men
1/3 of all cases were classified as serious
3280 deaths reported
60% of cases were reported with either outcome unknown or not recovered
92% of cases did not have any comorbidities
Highest number of cases occurred in the 31-50 year age group
Germany had the highest recorded number of cases (22.5% of all reported worldwide cases)
This report focuses on the pregnancy and lactation adverse event cases in the 396-page bombshell report.
Breast-feeding infant cases
It is important to note that upon further review of PSUR #1, something extremely disturbing surfaced – adverse events were reported for breast-fed babies, indirectly exposed to the Pfizer-BioNTech mRNA shot, by their vaccinated mothers. The screenshot below is taken from page 165 of PSUR #1.
The fact that 2 cases from the post-marketing (PM) data involved babies who were indirectly exposed to the Pfizer-BioNTech mRNA vaccine (BNT162b2) via the trans-mammary route (through the breast milk) and consequently suffered a stroke (central nervous system haemorrhages and cerebrovascular accidents), is shocking.
Then, on page 149 (screenshot below), 3 more cases of babies suffering from neurological adverse events, for example, convulsions, from being indirectly exposed to the vaccine via their vaccinated mothers’ breast milk, were recorded.
This pattern was also observed in PSUR #3, the screenshot below is taken from page 80.
From the analysis of booster doses (> 2 dose primary series), a staggering 455 cases were recorded during the 6-month reporting interval (1 from the clinical trial data and 454 recorded from the post-marketing data) involved babies whose cases “were excluded due to indirect exposure (transplacental/transmammary) to BNT162b2”
A further example, shown in the screenshot below taken from page 239, reports 4 cases (babies) suffering from respiratory adverse events of special interest (AESI), which were “determined to be non-contributory and were not included in the discussion since these cases involved exposures to the vaccine during the mother’s pregnancy or through breastfeeding.”
In both PSUR reports the same reason is given by Pfizer/BioNTech for why these cases “are not included in the discussion” because they “were determined to be non-contributory” since they involved babies “who were indirectly exposed to BNT162b2.”
Given the gravity of this important safety signal affecting nursing babies, to brush over the fact that these infants’ adverse event cases were non-contributory because they were indirectly exposed to the vaccine via breast milk- is unconscionable.
Results from a ground-breaking September 2022 study by Hanna et al., published in JAMA Paediatrics, researchers found trace amounts of the COVID-19 vaccine mRNA in the breast milk of lactating women, as soon as one hour after vaccination. They went on to state, “We speculate that, following the vaccine administration, lipid nanoparticles containing the vaccine mRNA are carried to mammary glands via hematogenous and/or lymphatic routes.”
Remember the unwavering yet completely unsubstantiated claim made by drug regulators and health authorities across the globe that the mRNA vaccine just stays in the arm. Well, that couldn’t have been further from the truth.
In the recent leaked letter by the EMA, Executive Director, Emer Cooke, to the Chair of COVID-19 Special Committee, MEP Kathleen Van Brempt, Cooke begrudgingly admitted, “that the lipid nanoparticles can distribute rather non-specifically to several organs such as liver, spleen, heart, kidney, lung and brain, with the liver appearing to be the organ where the lipid nanoparticles distribute most.”
Her admission was made on the heels of the Therapeutics Goods Administrations (TGA) of Australia’s evaluation report on Pfizer’s nonclinical biodistribution study, raised by the MEP, Robert Roos, at the March 27, 2023, Special Committee hearing on COVID-19. The January 2021 TGA report, alarmingly revealed that the lipid nanoparticles which encase the mRNA, travel to the liver, spleen, brain, eyes, bone marrow, adrenal glands, ovaries and testes– nearly every organ tissue.
The pregnancy cases (cumulative clinical trial data)
The pregnancy cases arising from the cumulative clinical trial data in PSUR# 3, originated from Pfizer’s phase 1/2/3 clinical trial through to June 2022. Even though pregnant women were excluded from Pfizer’s pivotal trial, some of the female participants became pregnant. As part of the approval letter for the emergency use of COMIRNATY (marketing name for Pfizer-BioNTech mRNA vaccine), the World Health Organisation (WHO) requested that BioNTech, the marketing authorisation holder, monitor their outcomes.
There were 697 pregnancy cumulative cases reported, which comprised of 597 mother cases and 100 baby/foetal cases. ‘431 cases reported exposure to vaccine in utero without the occurrence of any clinical event’ in the mother cases. The following is a breakdown of the 166 mother cases which did report adverse clinical events. The numbers in brackets reflect the number of frequently reported events.
~ 1/5 of all mother cases reported serious adverse events (139)
spontaneous abortions (46)
Pre-eclampsia (7)
Cephalo-pelvic disproportion (6)
Abortion missed, Foetal death, postpartum haemorrhage, premature separation of placenta (4 each)
Abortion threatened, ectopic pregnancy, gestational hypertension, premature delivery, premature labour (3 each)
Abortion incomplete, hyperemesis gravidarum, maternal exposure via partner during pregnancy, miscarriage of partner, uterine disorder (2 each)
COVID-19 (9)
Anaemia (2)
From the list above, it’s note-worthy to point out that “maternal exposure via partner during pregnancy” and “miscarriage of partner” refers to cases of women being indirectly exposed to BNT162b2 by their vaccinated partners. This importantly relates to vaccine shedding, which was on Pfizer’s radar even before its clinical trial commenced but was later widely reported as a myth to the public. According to Pfizer’s own clinical trial protocol, cases of pregnant women who were indirectly exposed to the vaccine by their partners (who participated in the trial) were classified as ‘Exposure During Pregnancy’ and immediately reported to Pfizer Safety on the Vaccine Serious Adverse Event Form within 24 hours of the investigator’s awareness. The pregnancy was to be followed up by the investigator with Pfizer Safety being notified of the outcome.
The baby/foetal cases (cumulative clinical trial data)
What’s disturbing is that a staggering 98 out of the 100 baby/foetal cases were reported as serious. The screenshots below reflect their appalling outcomes.
For the 68 baby/foetal cases showing ‘live birth without congenital anomaly,’ the serious adverse event outcomes can be read in the screenshot below.
There was also one case of still birth without foetal defect during the reporting period, which was coded as Neonatal respiratory distress syndrome.
The pregnancy cases (from the post-authorisation data)
According to the post-authorization data, there were 3642 pregnancy cases with 1898 cases pregnancy outcomes provided during the reporting period (Dec 2021-June 2022). Germany had the highest number of pregnancy cases (837) in the reporting period, followed by the UK with 475 cases. The table of those 1898 outcomes can be seen below.
Significantly, a third of the pregnancy outcomes provided during the reporting period were negative.
Spontaneous abortion: 483
Live birth with congenital abnormalities: 52
Still birth with foetal defects: 26
Elective termination (because of foetal defects): 39
Out of the 3642 pregnancy cases, 322 were classified as baby/foetal cases and 3320 were mother cases.
The baby/foetal cases (post-authorisation data)
90% of the 322 baby/foetal cases were classified as serious. There were 39 cases of ‘live birth with congenital anomaly.’ The screenshots below, show the frightening range of those defects.
There were 37 cases of spontaneous abortion in the baby cases with reported events of ‘Foetal growth restriction (18) congenital anomaly (8), Foetal heart rate abnormal (3), Cytogenetic abnormality Foetal vascular malperfusion (2 each).’
In 4 cases the mother had an underlying medical history but for the remaining 33 cases, the report states, ‘there was limited information regarding obstetric history or co-suspect medications of the mother, which precluded meaningful causality assessment.’
There were 23 cases of reported elective termination of pregnancy. 22 out of the 23 cases ‘reported elective termination due to foetal defects.’ There were a further 21 cases of still births, with just over 70% of those cases reporting foetal defects.
In stark contrast to the damning data, the report concludes: ‘There were no safety signals regarding use in pregnant/lactation women that emerged from the review of these cases..’
Furthermore, throughout the ‘Use in Pregnant/Lactating Women’ section in PSUR #3, the following dismissive and recurring statement is made, ““There was limited information regarding mother’s obstetric history, which precluded meaningful assessment.”
My recent investigative report on Pfizer’s Pregnancy and Lactation Review, just released in April per court-order by the FDA, 2 years after it was signed off, contained similar damning adverse events, such a spontaneous abortion and preterm delivery of foetuses, exposed to the vaccine trans-placentally or trans-mammary (through the breast milk) after their mothers were vaccinated. Adverse events such as facial paralysis and lymphadenopathy were also reported in infants, indirectly exposed through the breast milk of their vaccinated mothers.
Earlier this year, a paper was published in the Journal of American Physicians and Surgeons by Thorp et al., which revealed an astonishing volume of global adverse event counts for COVID-19 vaccines reported over 18 months, compared to 282 months for influenza vaccines, (see screenshot of Table 1 below).
Given the abundance of damning evidence, it has become increasingly apparent that serious negative pregnancy outcomes observed post-vaccination can be seen as a contributing factor to the decline in the birth/fertility rate, reported in countries, which rolled out the mRNA vaccines.
In November 2022, shocking results were revealed in a working paper by the Federal Institute for Population Research, entitled, “Fertility declines near the end of the COVID-19 pandemic: Evidence of the 2022 birth declines in Germany and Sweden”.
The paper stated, “The seasonally adjusted monthly TFR of Germany dropped from 1.5-1.6 in 2021 to 1.3-1.4 in 2022, a decline of about 14 %. In Sweden, the corresponding TFR dropped from about 1.7 in 2021 to 1.5-1.6 in 2022, a decline of almost 10 %. There is no association of the fertility trends with changes in unemployment, infection rates, or COVID-19 deaths. However, there is a strong association between the onset of vaccination programmes and the fertility decline nine months after of this onset.”
What is noteworthy is that even in the EMA’s Risk Management Plan version 9.0, revised in November 2022 for COMIRNATY (both monovalent and bivalent versions), it states on page 111: “The safety profile of the vaccine is not fully known in pregnant or breastfeeding women due to their initial exclusion from the pivotal clinical study however, post-marketing experience in pregnant women is available.
So, we have on record that the EMA’s current position is that the safety profile of the vaccine is not fully known in pregnant and breastfeeding women.
Secondly, we know the EMA were fully aware of the alarming safety signals found in these Periodic Safety Update Reports (including clinical trial and post-marketing cases), first documented in PSUR #1 because Pfizer and BioNTech compiled these pharmacovigilance documents for the regulator. Yet, the agency shockingly went on to rubber stamp these experimental mRNA products as “safe and effective” for pregnant and lactating women and continue to this day to promote its use for this cohort.
All this culminates to a preponderance of evidence showing that the agency is not only culpable of failing to protect this generation of European citizens but aHow a false hydroxychloroquine narrative was created, and much more
September 21, 2023
Horowitz: The smoking gun of mRNA is spreading to breast milk
What’s worse than the likely deaths of millions of adults from the COVID shots? The increasing probability that the gene juice was passed on to the next generation of babies, including those who were never directly injected with the mRNA. That would mean the shocking body count of spike protein victims may continue for an entirely new generation long after the pandemic is over.
Consider the fact that the U.S. government is approving, recommending, and funding the dangerous vaccines for everyone — including pregnant and lactating women — even though we now know that officials knew from day one that the vaccine spreads everywhere in the body, including to the mammary glands of lactating women. Now, a brand-new study published in the Lancet, which is the Bible of the medical industry, concedes that the vaccine molecules percolate everywhere in the body and are present in the breast milk.
“Of 13 lactating women receiving the vaccine (20 exposures), trace mRNA amounts were detected in 10 exposures up to 45 [hours] post-vaccination,” observed the researchers from NYU Langone Hospital’s pediatrics department after examining breast milk samples from these women prior to and following vaccination.
The authors confirmed what those of us paying attention knew over two years ago, but many were gaslit into believing the opposite. “The COVID-19 vaccine mRNA is not confined to the injection site but spreads systemically,” they conceded as the logical conclusion of their broader experiment.
This study comes roughly a year after a research letter published in JAMA found traces of the mRNA shot in the breast milk of seven of 11 vaccinated nursing women researched.
So we now have two top medical journals confirming the presence of the vaccine in breast milk. Asserting this premise got me fact-checked and canceled from social media throughout 2021, even when I cited previous studies indicating exposure to the shot via lactation.
Of course, now that the authors of this study can no longer hide this disquieting fact, they adroitly get out ahead of the obvious implication by immediately asserting in the opening line, without evidence: “COVID-19 mRNA vaccines play a vital role in the fight against SARS-CoV-2 infection.” Additionally, after being forced to accept the obvious, they seek to downplay the effects on breast milk by noting that the traces of gene therapy found in the extracellular vesicles “neither expressed SARS-COV-2 spike protein nor induced its expression in the HT-29 cell line.” In other words, it’s innocuous and can’t affect the baby.
Problem solved? Not exactly.
As astute researcher Igor Chudov rightly observes, for some bizarre reason the samples from their control group never expressed spike protein to begin with! “However, positive control samples used in concentrations similar to those of BM EVs also failed to induce S protein expression,” acknowledge the authors as a confounding point to their implication about breast milk traces being biologically inactive.
So clearly the authors were using a cell line that was not expressing spike protein in any context, thereby rendering their secondary conclusion (traces found are inert) irrelevant. However, the primary conclusion of finding the mRNA in the breast milk is solid. The authors vividly explain how the breast milk is exposed to the vaccine: “The LNPs will release their mRNA content into the cytosol of the mammary gland cells, and a portion of this mRNA will be recruited, packaged, and released in the BM EVs (exosomes or microvesicles). This can be significant as the BM EVs act as natural LNPs, protecting the mRNA from degradation.”
This study cannot be examined in a vacuum, as if we have no other corroborating evidence of dangers to the baby from a vaccinated mother in lactation. Thanks to court documents, we now have an eight-page confidential document from Pfizer itself dated April 20, 2021 – before most pregnant women would have gotten the shot – acknowledging that the vaccine spreads transplacentally and via lactation. Furthermore, Pfizer was aware of and tracking adverse events in babies exposed to the mother’s vaccination. Clearly, the company suspected the mRNA was indeed biologically active.
While OB/GYNs all over the world were officiously and obnoxiously lecturing their patients to get the experimental shots, Pfizer was observing AEs in a whopping 20% of the 215 lactating women in its sample. The report chronicles 10 serious AEs, including facial paralysis, lymphadenopathy (swelling of lymph nodes that could be associated with cancer), and blurred vision, and six among the infants, including skin exfoliation, rashes, swollen skin, and unspecified sickness. That’s a high percentage of serious AEs for babies for any thereputic.
Let’s not forget that to this day, we still do not have a formal Pfizer study of the shot’s safety in lactating women, even as the CDC recommends more shots for all ages, despite the wealth of injuries across the board. The European database EudraVigilance is now reporting 46,999 fatalities and 4,731,833 injuries following injections of five mRNA COVID vaccines. Typically, we don’t allow pregnant and lactating women to take any experimental medication – even with no apparent signs of adverse events. In this case, we are well into the third year of observing widespread death and injury affecting every corner of the body – now buttressed by a litany of studies showing the lipid nano particles cross every blood barrier and can circulate in the body for at least six months. Yet the policies and recommendations fail to reflect any of this knowledge because the findings of these studies are suppressed.
In order for this lactation study to be published in the Lancet, the authors were forced to infer that the smoke they confirmed is absolutely no indication of a fire. Except we’ve already seen such adverse events in nursing mothers, including cases where it’s hard to dismiss the vaccine as the culprit. Here is one vivid VAERS entry:
There’s your fire to accompany the smoke of traces of mRNA present in the milk.
In addition to VAERs and Pfizer’s original documents, the European Union is publishing post-marketing pharmacovigilance of Pfizer’s own observations on serious adverse events, including in nursing babies. Investigative reporter Sonia Elijah has combed through the EU’s Periodic Safety Update reports and has discovered that Pfizer documented numerous cases of strokes, convulsions, and respiratory failure among nursing babies. Ironically, appallingly, and counterintuitively, Pfizer refused to investigate further because these AEs were automatically dismissed as unrelated to the vaccine. Why? Because Pfizer simply removed them from the analysis! In the words of the Pfizer investigator, these serious AEs were “determined to be non-contributory and were not included in the discussion since these cases involved exposures to the vaccine during the mother’s pregnancy or through breastfeeding.”
Nobody should be surprised that the presence of the vaccine, which itself caused tens of millions of adverse events in adults, would affect nursing babies. A study published a year ago in JAMA revealed that 3.5% of women reported a decrease in breast milk supply and 1.2% reported “issues with their breastmilk-fed infant after vaccination.” We see traces of mRNA, and we’ve seen a slew of undeniable anomalous injuries in nursing babies.
Does that incontrovertibly prove it as scientific law without further investigation? No. But is it tantamount to a Nuremberg Code violation to keep recommending the shots without first attempting to disprove the causation? No doubt.
Aside from the appalling revelation about breastfeeding exposure and how early on Pfizer knew about it, we are seeing a disturbing pattern of academic obfuscation emerge once again during this debate. Every time we find an ominous study, the high priests of the vaccine religion obdurately dismiss our concerns as “incomplete” findings or “speculative.” But we do have an entire array of concerning findings that cover the gambit of scientific research that, taken together, would be enough to convict the vaccines of murder if they were a human criminal defendant.
We are well beyond a simple rallying cry of “no mandates.” We need an immediate suspension of new vaccines, a commission to study the existing ones, and a new Nuremberg trial to convict those who knowingly pushed the shots, despite knowledge of widespread death and injury