Pfizer’s Pregnancy & Lactation Cumulative Review Reveals Damning Data!
In April 2023, while digging through numerous FDA-released documents concerning the Pfizer-BioNTech mRNA COVID-19 shot, I was among the first researchers to uncover and publicize Pfizer’s deeply disturbing Pregnancy and Lactation Cumulative Review document.
On REDACTED reporting on Pfizer's Pregnancy & Lactation Review
A big thank you to Clayton Morris of Redacted! The only news show, as of yet, to cover this bombshell report, which should be making headline news everywhere!
My article based on Pfizer’s report was first published in Trial Site News on April 22, 2023 and can be read below.
A damning 8-page document was recently released, as part of this month’s court-ordered Pfizer data dump. I have written many reports for Trial Site News on Pfizer’s trove of documents, which both the US Food and Drug Administration (FDA) and the pharmaceutical company wanted to remain hidden from the public until 2096. The links below are for all my analytical reports pertaining to Pfizer’s nonclinical and clinical trial documents, including its post-authorization safety report.
https://www.trialsitenews.com/a/fdas-forced-hand-drops-pfizers-bombshell-safety-document
https://www.trialsitenews.com/a/first-look-at-newly-released-pfizer-docs-part-2
The Pregnancy and Lactation Cumulative Review was signed off on 20 April, 2021, just around the same time when there was a strong push by health authorities around the world, including the US Centers for Disease Control and Prevention (CDC) and the UK’s National Health Service (NHS), for pregnant and lactating women to receive COVID-19 vaccines. The report is a cumulative review and summary of relevant (pregnancy and lactating) cases reported in Pfizer’s pharmacovigilance (Safety) databases from the time of drug development through to 28 February, 2021 and it contains disturbing data.
673 case (individual) reports were identified in total: 458 cases involved vaccine exposure during pregnancy (mother/fetus) and 215 cases involved exposure during breast feeding. Out of the 458 pregnancy cases, 248 (more than half) reported adverse events, see screenshot below.
The pregnancy cases
Of the 458 cases involving vaccine exposure during pregnancy, 51 events were reported for spontaneous abortion (miscarriage), abortion (1 event) and abortion missed (1 event).
According to Pfizer, 53 reports of spontaneous abortion were noted (see screenshot above) but 4 cases were excluded from the review because of COVID-19 (included suspected) and 13 cases were further excluded because of the women’s medical history- then there was "one patient" who had a medical history of COVID-19 and was also exlcuded- this should leave 35 remaining cases but Pfizer erroneously writes, "the remaining 39 cases are summarized.."
Of the '39' cases that were reviewed, 38 were actually listed, another reporting error, perhaps? What immediately stands out (where gestational age was known) that all the pregnant women in those cases experienced a miscarriage in their first trimester.
A further 6 disturbing cases out of the 458, involved babies being exposed to the vaccine transplacentally, leading to premature delivery. Their cases are described in the screenshot below.
In two of the premature delivery cases, the babies died because of severe respiratory distress and pneumothorax- both the mothers received the Pfizer-BioNTech mRNA vaccine in their second trimester. In another shocking case, a baby developed foetal tachycardia (heart rate over 160 beats per minute) where “the clinical outcome of the foetal tachycardia was unknown.”
This bombshell real-world evidence, was known back in early 2021 by the FDA and Pfizer/BioNTech, just before the big push to get pregnant women vaccinated- and it showed significant safety risks to the foetus due to indirect (transplacental) exposure of the Pfizer-BioNTech mRNA vaccine, with spontaneous abortion (miscarriage) being one of the known outcomes.
When I analysed Pfizer’s Cumulative Analysis of Post-Authorization Adverse Event Reports for TrialSite News, released via court order at the end of 2021, similar alarming data was also observed. Out of 270 post-authorization pregnancy cases, no outcome was provided for 238 cases. Of the remaining 32 cases where the outcome was known: 23 were reported as spontaneous abortion (miscarriage), 2 as premature birth with neonatal death and 2 cases of spontaneous abortion with intrauterine death.
In the biased, retrospective study by Lipkind et al., which formed the ‘evidence’ for many leading health authorities, such as the CDC, to assure the public that “COVID-19 vaccination during pregnancy is safe and effective,” only 1.7% of the roughly 10,000 women received the COVID-19 mRNA vaccine in their first trimester, compared to 61.8% who were vaccinated in their third trimester. This is a significant confounding factor, because 80% of miscarriages (spontaneous abortions) occur in the first trimester. It can be said this bias was an effective way to skew the study’s results, making it appear that the mRNA vaccines were safer than they actually were. It’s worth reading my report for TrialSite News, On what basis are pregnant women being encouraged to take the Pfizer vaccine?
The lactation cases
41 (~20%) of the 215 lactation cases reported adverse events in infants indirectly exposed to the vaccine via the transmammary route (through breast milk). The screenshot below shows an extensive list of adverse events reported in breast feeding infants, ranging from facial paralysis, lymphadenopathy and blurred vision.
Pfizer's report concludes that the “cases reviewed above are indicative of what is in the Pfizer safety database as of 28 February 2021. The sponsor (Pfizer/BioNTech) will continue to monitor and report on all pregnancy exposure and lactation cases.”
A study by Hanna et al., published in JAMA Pediatrics in September 2022, revealed that 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.”
However, this vitally important information was already known for quite some time by Pfizer and BioNTech, since it was observed in real-world data from Pfizer’s own review, signed off on 20 April 2021 and submitted to the Food and Drug Administration (FDA), where 3 days later the CDC began recommending it for pregnant women.
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Thank you for the digging and explaining you do.
I think the time will come that some influential person will realise they lost a baby and the news will be hard to keep quiet.
The last of the clinical trials for pregnant women finishes in August 2024, and then the final trial on the post vaccination myocardial effects finishes in 2027.
That is according to Dr Henry Ealy, when he went through the EUA agreements, when Comrinaty was being voted on by the FDA.
So strap in folks, we may be here a while.🤔😉🤦♀️