For nearly three decades, Periodic Safety Update Reports (PSURs) have been vital for the continuous safety evaluation of medicinal products, ensuring their risk-benefit balance stays favourable over time. Data from Post-Marketing Surveillance included in the PSURs showing a pattern of safety issues could potentially lead to the revocation of a medicinal product's authorization.
For instance, in 2021, the European Medicines Agency (EMA) recommended the revocation of the conditional marketing authorization for Ocaliva (obeticholic acid) due to concerns over liver injury risks. The review highlighted that the benefits of Ocaliva no longer outweighed its risks in treating Primary Biliary Cholangitis (PBC). This decision was influenced by safety data from PSURs and other pharmacovigilance information.
Initially granted marketing authorization in 2006, Acomplia (rimonabant), an anti-obesity drug, had its authorization revoked two years later. This was due to serious psychiatric side effects, including depression and an increased risk of suicide, which were identified through post-marketing surveillance and PSUR data.
Yet, for the experimental Covid shots- the disturbing pattern of safety issues gleaned from the PSURs have been ignored by the regulators, who have continually concluded that the risk-benefit balance remains “favourable.”
The PSURs submitted by Pfizer (with BioNTech as the marketing authorisation holder) to the EMA were part of their obligations associated with the conditional marketing authorisation for their Covid mRNA shot, first granted on December 21, 2020. The PSURs cover 6-month time-periods. Even after standard marketing authorisation has been granted, these reports are still required to be submitted to the agency for review.
It was not until a group, comprising of 130 European doctors called PSUR4doctors, who repeatedly sent FOIA requests to the EMA, demanding the release of thousands of pages of PSUR safety data for all the COVID-19 vaccines that these documents became accessible to the public. The PSUR4doctors initiative brought to light the EMA's extreme reluctance to make these documents available, despite legal obligations under EU transparency laws. Their actions are reminiscent of the lawsuit brought against the US Food and Drug Administration by Public Health and Medical Professionals for Transparency (PHMPT), a group of scientists, public health officials, and academics. After the FDA denied their FOIA requests for the release of all the documents the agency relied on to approve the experimental Pfizer/BioNTech mRNA shot, the group filed a lawsuit. The infamous trove of Pfizer/BioNTech documents, which were gradually released, exposed disturbing data the regulator and Pfizer/BioNTech wanted to remain hidden from the public until 2096.
One could argue that the safety data from the PSURs are even more damning, as they expose the extensive and ongoing post marketing surveillance data from around the world, collected not only by Pfizer but also downloaded from EudraVigilance.
Since January 2023, the EMA has slowly released these critical PSURs and their annexes (though not all), along with the assessment reports made by the Pharmacovigilance Risk Assessment Committee (PRAC) to PSUR4doctors. PSUR#1 (covering the period December 2020-June 2021) was first made publicly available after being published on the Austrian science and political blog, tkp.
In February 2023, I wrote an explosive investigative series for Children’s Health Defense Europe analysing both PSUR#1 and PSUR#3. The only ones available at the time.
EMA’s failure to pull COVID 19 jabs even though risk-benefit balance nullified
The Tragedy of the Child Deaths: EU’s 3rd damning vaccine safety report, Part 2
Clayton Morris of Redacted interviewing me about my first report.
Thanks to the relentless endeavours of Dr Silvia Behrendt, the PSURs and supplementary data released so far by the EMA, are accessible on her substack,
and tkp.The “big push”
Before I turn to PSUR#2, the second Periodic Safety Update Report compiled by Pfizer/BioNTech covering the period of June 2021 to December 2021, it is important to remember what the health authorities were saying at that time, in regards to pregnant women and the Covid shots. Notably, pregnant women were excluded from all the Covid vaccine clinical trials.
From April 2021, the following headlines appeared in UK newspapers like, The Daily Mail: “Pregnant women SHOULD get Covid vaccines: No10's jab advisory panel changes guidance for mothers-to-be because evidence shows they are safe.”
The Joint Committee on Vaccination and Immunisation (JCVI), the panel behind the decision based their opinion on the “data from 90,000 pregnant American women given either Pfizer or Moderna's jab.”
However, as previously reported, the US data was heavily skewed and far from reliable. It was based on a retrospective study, where over 60% of women were vaccinated in their third trimester, with only 1.7% of women being administered the jab in their first. This would have injected a significant confounding factor effecting the results as 80% of miscarriages (spontaneous abortions) occur in the first trimester.
Pfizer’s Pregnancy and Lactation Cumulative Review
Furthermore, around this time, on 20 April 2021, the US Food and Drug Administraiton (FDA) signed off on the infamous Pfizer’s Pregnancy and Lactation Cumulative Review, while there was a simultaneous 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 shots.
The cumulative review contained a summary of pregnancy and lactating cases reported in Pfizer’s pharmacovigilance databases from the time of drug development through to 28 February, 2021. I was one of the first investigative journalists to discover this damning document while digging through the trove of Pfizer papers back in April 2022, exactly a year after it was signed off. The following is an extract from my report, first published in Trial Site News.
Out of the 458 pregnancy cases, 248 (more than half) reported adverse events, see screenshot below.
I was interviewed by Clayton Morris of Redacted regarding this bombshell discovery.
Pfizer’s Cumulative Analysis of Post-Authorization Adverse Event Reports
Another damning document- one of the first released by the FDA at the end of 2021 was Pfizer’s “Cumulative Analysis of Post-Authorization Adverse Event Reports of PF-07302048 (BNT162B2) received through 28 February 2021.” My December 2021 report for Trial Site News exposed how in the first three months of the rollout, the following alarming data regarding vaccinated pregnant women was already well established.
Pregnancy outcomes for the 270 pregnancies were reported as spontaneous abortion (23), outcome pending (5), premature birth with neonatal death, spontaneous abortion with intrauterine death (2 each), spontaneous abortion with neonatal death, and normal outcome (1 each).
The early and ignored red flags from the animal studies
The preclinical DART (Developmental and Reproductive Toxicology) study conducted on rats by BioNTech, showed a dramatic increase in miscarriage (preimplantation loss) rate for BNT162b (the Pfizer/BioNTech shot rolled out to the public) compared to the control group. Below is a screenshot from page 55 of nonclinical evaluation report conducted by Australia’s drug regulator, the TGA.
Summer of persuasion
Despite the damning data that would have been known by the regulators- the relentless push to get pregnant women vaccinated continued. In August 2021, the pregnant Carrie Johnson, wife of former UK Prime Minister Boris Johnson, told the world she was “feeling great” after the second Covid jab and “urged all expectant mothers to get vaccinated.”
The positioning of Carrie as the “poster child” to persuade expectant mothers to get the Covid jabs, quickly gave way to seemingly systematic scare tactics.
On 11 October 2021, the NHS issued the following statement.
“The NHS is encouraging pregnant women to get the COVID-19 vaccine as new data shows that nearly 20 per cent of the most critically ill COVID patients are pregnant women who have not been vaccinated.”
On the exact same day, RCOG announced: “The Royal College of Obstetricians and Gynaecologists (RCOG) supports calls from the NHS, encouraging pregnant women to get the COVID-19 vaccine as new data shows that nearly 20% of the most critically ill COVID-19 patients are pregnant women who have not been vaccinated.”
This was promptly followed by the England's Chief Midwifery Officer, Jacqueline Dunkley-Bent, encouraging pregnant women to get vaccinated due to the risks highlighted by this data.
According to the statement issued by NHS England: “Since July, one in five COVID patients receiving treatment through a special lung-bypass machine were expectant mums who have not had their first jab.”
Notably, these figures have never been published in any academic journal for independent analysis but rather were part of an internal NHS data collection and analysis.
In my interview with obstetrician and gynecologist, Dr Kim Biss, she raised the argument that pregnant women were not at higher risk of hospitalization and mortality from COVID-19. This was observed first-hand from her practice, since 2020. Furthermore, a paper by Pineles et al., published in Obstetrics and Gynecology Journal in 2021 found ‘a substantially lower rate of in-hospital mortality in pregnant patients than nonpregnant patients hospitalized with COVID-19 and viral pneumonia.’
Dr Biss also revealed damning data with regards to miscarriage and fertility rates, seen at her practice, post mRNA vaccine roll-out.
“The average month to month miscarriage rate in 2020 was 4%. In 2021, it jumped 7-8%, roughly doubling in 2022 to 15%. By December of that year, it reached 25%.”
Pregnancy outcomes revealed in PSUR#2
Turning to PSUR #2, the following is a summary of the post-authorisation data regarding pregnancy outcomes related to the vaccinated pregnant women reported in the 6-month interval period (19 June 2021 through 18 December 2021). Where spontaneous abortion is reported, this refers to the unintentional loss of a pregnancy before the foetus is able to survive independently (otherwise known as miscarriage). A serious case is one that is considered: life-threatening, is a congenital anomaly/birth defect, or results in hospitalisation, a significant disability/incapacity, or death.
Total Pregnancy Cases: 5239 cases, representing 4896 unique pregnancies. This is an increase from 1661 cases noted in PSUR#1. The 5239 cases were split between 4796 mother cases and 443 baby/foetal cases.
The countries with over 100 reported cases included:
UK (1229)
Netherlands (654)
France (491)
Germany (372)
US (371)
Japan (226)
Canada (206)
Italy and Estonia (143 each)
Belgium (126)
Australia (124)
Sweden (103)
Of the 4796 Mother Cases:
Clinical Events were reported in 3740 cases, of which 2248 were serious (close to half of all mother cases) and 1492 non-serious, reporting various pregnancy and clinical events. Common pregnancy-related events included spontaneous abortion (1040 cases), vaginal hemorrhage (120), and fetal death (67). Other frequent clinical events included headache, fatigue, and vaccination site pain.
Of the Baby/Foetal Cases: 443 cases were reported with 389 classified as serious (roughly 88%) and 54 non-serious. The screenshot below is taken from page 295 of the report. It reveals the alarming live birth with congenital anomaly outcomes. 53 cases reported 75 congenital anomalies. Common anomalies included foetal growth restriction, congenital heart diseases, and trisomy 21.
Of the live births without congenital anomaly (218 cases), serious adverse events were also reported. Most common events included premature baby and foetal hypokinesia, with some cases showing perinatal complications.
There were 41 cases of still birth, 17 of which reported fetal defects. Common events included foetal hypokinesia and foetal death.
Notably, there were 30 cases of elective termination, mainly due to foetal defects, with anencephaly and foetal malformation reported frequently.
101 cases of spontaneous abortion were reported with the majority exposed during the first trimester, often reporting foetal growth restriction and heart rate abnormalities.
The miscarriage (spontaneous abortion) cases reported for both mother (1040) and baby cases(101) as a percentage of total pregnancy cases (5239) was close to 22% for vaccinated women.
The same dismissive statement was repeatedly used for all these alarming cases: “There was limited information regarding obstetric history/ medical history and co-suspect medications of mother which precluded meaningful causality assessment.”
The section on “use in pregnant/lactating women” was concluded by the statement: ”There were no safety signals that emerged from the review of these cases of use in pregnant/lactating women.”
Interestingly, buried on page 214 of the PRAC PSUR assessment report, MS4 (member state 4) raised a red flag concerning a potential “common pattern” and how spontaneous abortion was the most frequently reported outcome.
“PREGNANCY: Overall, we agree with the Rapporteur evaluation However, the foetal defects associated with stillbirths (17 cases), elective pregnancy termination (29 cases) together with those found in livebirth should be described in detail in order to rule out a common pattern. Since spontaneous abortion is the most frequently reported outcome, an analysis of O/E is expected.
However, this was followed by the dismissive comment made by Menno van der Elst, the Rapporteur for Pharmacovigilance Risk Assessment Committee (PRAC) at the time, which can be read below:
Rapporteur assessment comment: At the moment, the Comirnaty exposure in pregnant women is not known and therefore O/E analyses cannot be performed. However, the PRAC Rapporteur agrees that it is unclear if the frequency of AEs reported including spontaneous abortion is consistent with the expectation. This can however not be determined from spontaneous reporting. Future results from studies (including PASS addressed in the RMP) evaluating the safety in pregnancy should give more clarity regarding pregnancy outcomes in relation to Comirnaty exposure.”
Moms need to at least shut Wi-Fi off at night, as wireless radiation creates leakage in the blood brain barrier, and when off our cerebrospinal fluid is more likely to clear neurotoxins from the injections.
My daughter is due to deliver twins and has thankfully resisted all the vaccinations which are offered to her at every midwife appointment. She’s determined not to have them but even she says the suggestion that she’s not protecting her babies is a powerful coercive tool that’s very hard to fight against at a time when she’s so vulnerable. I weep for these poor women and their babies.