Why are New Zealand’s Medical Regulation bodies are not informing us of the harms?
In normal times in New Zealand, rigorous safety standards have meant that pregnant women are traditionally the last to receive a new pharmaceutical intervention. The Covid pandemic has unpicked the fabric of this safety blanket. As more information now comes to light, it’s crucial that we re-examine the messaging that pregnant women continue to receive.
Data contradicts claims that all pregnant women are at high risk of Covid. In fact, healthy pregnant women are at no more risk than the general population. Moreover, healthy people under 50 have a low risk of severe disease, hospitalisation or death from Covid.
With that in mind, is the push to vaccinate all NZ pregnant women with the Pfizer Comirnaty injection, a wise or proportionate response?
Obtaining the Pfizer Clinical Trial Data
Public Health and Medical Professionals for Transparency (PHMPT) comprise over 600 clinicians and academics who collaborated to obtain and disseminate Pfizer’s raw trial data. In this short video, Dr Peter Doshi explains the importance of independent scientific analysis of raw data.
After the US regulator, Food & Drug Administration (FDA), declined PHMPT’s request to access the trial data which was used to authorise the Pfizer product, a lawsuit was filed.
For reasons which are becoming obvious, and which are deeply concerning, Pfizer and the FDA requested a delay of 75 years for the data release.
The judge ruled in favour of PHMPT, ordering the release of the documents in monthly lots. Both PHMPT and their lawyers at ICAN are now publishing these documents as they are released.
Recognising that only skilled professionals could adequately scrutinise such extensive volumes of data, America’s Dr Naomi Wolf made a public call for assistance. Teams of highly qualified volunteers – including biostatisticians, clinicians, scientists and medical fraud investigators – are reviewing and analysing the data. Their summations are then published at Daily Clout.
Pfizer trials investigating pregnancy and breastfeeding outcomes
To date, there is only one completed Pfizer randomised control trial looking at healthy pregnant women. It has not yet been published. There are multiple limitations to this trial, including:
- small sample size,
- maximum follow-up time to six months after birth,
- and a plan to vaccinate the placebo arm, eliminating the possibility of comparing long-term outcomes.
Pfizer’s January 2021 Nonclinical Evaluation Report reveals highly concerning data related to experimentation on 44 pregnant Wistar rats, which were followed for 42 days. This research formed the basis for authorities to recommend, and even mandate, vaccination of humans. The best that can be said of this study is that it stands as a grim illustration of the annihilation of scientific ethics.
Regulatory standards have since diminished even further, with the bivalent product approved following research on only eight mice.
The report shows the distribution of mRNA-containing Lipid Nano Particles (LNPs) throughout the body. LNPs efficiently cross all human membranes, including the blood-brain and placental barriers, and into breast milk.
Pre-implantation loss (when a fertilised egg does not implant into the uterine wall) occurred in
- 4.1% of the Wistar rat control group, and
- 9.8% of Pfizer’s Comirnaty group.
The investigators – investors and employees of Pfizer-BioNTech – claimed this serious safety signal could be dismissed as a ‘normal effect’.
Twelve different foetal abnormalities were observed in the rat litters, and all occurred at much higher rates in the Comirnaty group.
No further relevant studies (e.g. developmental progress of the pups) were conducted. You can investigate more at The False Messaging on Vaccines Given to Pregnant Women.
Pregnancy and breastfeeding outcomes in other Pfizer trials
Although pregnant women are specifically excluded from all other Pfizer trials, unexpected pregnancies can, and often do, occur. Specific trial protocols define what constitutes Exposure During Pregnancy (EDP) and Exposure During Breastfeeding (EDB).
The protocols require immediate follow-up by investigators when an exposure is identified.
Two specific documents released so far have reported on data taken from the Pfizer safety database up to 28 February 2021 involving cases of EDP and EDB.
The outcomes are catastrophic.
The Cumulative Analysis of Post-Authorization Adverse Event Reports was released into the public domain in November 2021, with a reissue in April 2022.
An extraordinary breach of clinical trial standards occurred, namely, the absence of reportage about pregnancy outcomes for the majority of the EDP cases. There were 274 EDP cases identified during this trial, and yet 238 of them were totally excluded from the final report on the trial results.
Of the remaining 36 EDP cases, 28 women lost their baby to foetal and/or neonatal death.
Numerous clinical symptoms were experienced by women exposed during pregnancy, including
- chest pain and uterine contractions.
- Four baby cases experienced intrauterine growth restriction, premature birth, and neonatal death.
Of the 133 EDB reports, 17 clinical events were reported. Symptoms in women included
- breastmilk discolouration
- suppressed lactation.
This could significantly impact breastfeeding rates, which are an important factor in maternal and infant health outcomes.
Three serious infant cases of EDB were reported but their symptoms were not separated from the non-serious cases.
A case reported in VAERS describes the March 2020 death of a breastfed five-month-old. The baby’s mother had received her second Pfizer dose just the day before the symptom onset.
Pfizer Pregnancy and Lactation Cumulative Review
In April 2023 a Pregnancy and Lactation Cumulative Review was released. This has been reported on at Daily Clout, and by journalist Sonia Elijah.
Again, clinical trial standards are breached, with missing data and apparent calculation errors.
The report lists
- 53 spontaneous abortions, 15 of which were excluded due to other risk factors
- six premature births, including two confirmed neonatal deaths.
Six breastfeeding infants reportedly experienced serious adverse events, including illness requiring hospitalisation.
Other adverse events included facial paralysis, nose bleeds and blurred vision.
What does the NZ data show?
Medsafe New Zealand’s Centre for Adverse Report Monitoring (CARM) states that only 5% of actual side effects are reported.
This voluntary reporting scheme is woefully inadequate for post-marketing monitoring of a new product.
CARM initially published regular reports on the Covid vaccine, but have since stopped. The last report, published in December 2022, has 67 records of spontaneous abortion (miscarriage). These are tabulated as an adverse event of special interest (AESI), defined as “medically significant events that have the potential to be causally associated with the vaccine and must be carefully monitored”.
Two key questions arise from this:
- Is this highly-relevant information being conveyed to pregnant women?
- What is being done to investigate further?
The Medsafe database for the ten years Jan 2010 to Dec 2020, records a total of nine pregnancy adverse events for all influenza vaccinations administered in NZ, none of which were miscarriages.
Compare this to the 67 miscarriages recorded in less than 18 months for the Covid vaccine – a dramatic increase!
According to the Immunisation Advisory Committee (IMAC), data on the exact number of pregnant women in NZ who were injected with Pfizer is unavailable.
An Australian study claims 69% uptake amongst pregnant women. A similar number is likely in NZ given the similarities between our governments’ Covid responses.
Assuming a 5% adverse event reporting rate, the 67 miscarriages identified by CARM could represent a figure as high as 1340. Using this figure, the number of live births for 2022, and the uptake rate of 69%, we come to a possible 3% increased miscarriage rate associated with the Pfizer injection. It’s sobering to note that the increase in pregnancy loss was identified by Pfizer itself.
Overseas data paints a similar picture, as clearly delineated by Dr Tina Peers speaking on the UK’s deplorable safety standards.
Increased miscarriage rates are a safety signal for congenital abnormalities. The use of thalidomide to treat morning sickness in the 1960s resulted in 100,000 birth defects globally. What women didn’t know at that time, was that the drug was also responsible for an increase in miscarriages.
Loss of a baby is categorised as
- a spontaneous abortion or miscarriage up to 20 weeks
- a stillbirth, fetal death or perinatal death after 20 weeks.
The Perinatal Mortality and Morbidity Review Committee (PMMRC) administers a national database reporting on all perinatal deaths. Reports are usually published with a one-year delay, but with Covid restrictions interrupting workflow, there is currently a two-year delay. It will therefore be some time before any effects of the Covid injection rollout are reported.
There is no national database recording miscarriage rates in NZ.
The estimated background rate of miscarriages is 15.3% of all recognised pregnancies. The risk of miscarriage falls with gestational age, and most occur in the first 12 weeks of pregnancy. In the second trimester (12-20 weeks), the risk of miscarriage is between 2-3%.
Losing a baby at 5 weeks can be a very different experience from losing one at 18 weeks, yet they are both categorised as spontaneous abortion/miscarriage.
The CARM database does not stipulate the gestational age of the 67 miscarriages reported after the Covid injection. It is simply not acceptable to write them all off as early pregnancy loss, without this vital information.
As we have outlined, so far no safety studies have involved pregnant women. How then, did the official messaging claim that these injections were safe in pregnancy?
The Ministry of Health website states there are no safety concerns for pregnancy or breastfeeding, without providing a link to any supporting evidence. When you go digging, the Shimabukuru study is often cited. This observational study is significantly flawed, with inherent bias, because most participants were vaccinated in the third trimester.
Another frequently-cited study, Lipkind et al, uses statistical chicanery to assure us that miscarriage rates are not a safety signal. Almost half of the authors have declared financial associations with Pfizer.
In an updated study sponsored by US Centers for Disease Control, the same investigators admit that safety concerns are causing hesitancy among pregnant women. Product marketing appears to be a motivating factor for their research, especially when viewed alongside their conflict of interest disclosures which highlight their connections with Pfizer and other pharmaceutical giants.
Using American v-safe data, another study showed an 18.8% miscarriage rate associated with the Covid injection, which at the very least warrants further investigation.
The current government-led messaging to pregnant women is that being vaccinated means they are far less likely to fall seriously ill. This is in direct contrast to data showing the number of hospitalisations is higher in the fully vaccinated and boosted population.
Informed consent is a bedrock in pregnancy care, and most interventions and procedures are discussed at length. For example, if a woman is offered amniocentesis (an extraction of amniotic fluid from around the baby in utero, for genetic testing), then the small risk of miscarriage (1-3/per 1000 or 0.1-0.3 %) is discussed. What is considered an acceptable level of risk, and who defines this? The answer is that it differs for every woman, and a robust discussion is the least health professionals can offer.
Using the same logic, if there is a possible 3% increased risk of miscarriage with the Covid injection, then shouldn’t pregnant women also be told about this so that they can make an informed decision?
It is simply unacceptable to say that any conversation involving the unknowns, and risks, of the Pfizer injection is ‘misinformation’ or ‘antivax’ messaging.
Midwives were silenced during the pandemic by their regulatory body. The concept of informed consent that we usually hold sacrosanct was (and continues to be) relegated in favour of a zealous need to get ‘everyone to do it for their whānau’.
How is it ethical to force an experimental medicine on a pregnant woman?
It is not.
No-jab-no-job is the very definition of coercion, and pregnant women facing mandates had no option for exemption. The precautionary principle was discarded, and Dr Bloomfield deemed pregnancy and/or breastfeeding no reason for reprieve.
Was it proportional or even acceptable to deny pregnant women an exemption? Where was the bioethical advice to the government, and what happened to the guiding principles in the Health Act? Read this article for a thorough analysis of how normative principles were set aside during Covid.
J.R.Bruning Talking Risk
Covid-19 IN NEW ZEALAND. ETHICS & THE SETTING ASIDE OF NORMATIVE PRINCIPLES.
This discussion paper draws attention to the setting aside of ethical obligations in law, and moral dilemmas over the Covid-19 pandemic, of 2020-2022. I suggest that in the absence of such considerations, a weakening of democratic and ethical norms occurred, excluding important …
Medical professionals daring to ask questions, or suggest precautions, were demonised and threatened. Highly qualified and experienced midwives who questioned – faced a painful witch hunt mostly from within our own profession.
Disciplinary action was threatened against anyone reported as spreading ‘misinformation’. We were to provide women with ‘evidence-based information and advice’. The problem was that with Comirnaty, there was no evidence -because there are no good-quality safety studies!
Now, the Bivalent booster is recommended for pregnant women, with no Medsafe reports available. These reports were our last vestige of safety monitoring.
Recent communication to midwives recommends Pfizer as the preferred choice during pregnancy ‘due to the lack of safety data for Novavax’.
Do we laugh or cry? —
Chris Walker said:
These evil deluded people will never be forgiven for their work for pharma…