The miscarriage of medicine – Pfizer and the regulators had data by June 2021 showing a serious safety signal for miscarriage. They not only ignored it but suppressed access to the documents.

Dr Ah Kahn Syed

Much of this relates to the pregnancy data from the Pfizer “vaccine” study. You know, the one where they showed how “safe and effective™” the investigational gene therapy vaccine (GTV) products were, particularly in pregnancy.
 
In fact they are so safe and effective™ in pregnancy that Viki Male – the pharma industry’s go-to for pushing the vaccines on pregnant women – keeps telling us this over and over again. As it happens, Viki is probably not old enough to remember the thalidomide scandal which was one of the many times in history that the pharma lobby has lied to pregnant women about how safe their drug was. The result was a generation of babies that had no limbs, yet this doesn’t stop Viki and the OBGYN establishment (including Kevin Ault, a recent member of ACIP) demonstrating an abject lack of care regarding this completely untested novel therapy.
 

 

 
So why am I bringing this up again? Because there are three pieces of information that have come to my attention this week and I need to briefly go over them to show you that the mRNA gene therapy vaccines have had a huge pregnancy safety signal since the beginning of the rollout that should have stopped it in its tracks, but it didn’t.
 

#1 Pfizer’s PSUR document

 
This is the Periodic Safety Update Report number 1 (PSUR) which I believe was released under a freedom of information request and was brought to my attention by Sonia Elijah. The safety update report was based on follow up of the Pfizer clinical trial participants as well as separately recorded adverse event reports.
 

 
The report itself is 286 pages long but for the purpose of this article we are just going to focus on the pregnancy data pages 234 – 244 (tables 38 – 40). There are a few sources of data quoted but mainly they relate to the C4591001 clinical trial (the “95% effective” study that never was).
 
This is table 38
 

 
As you can see there were 144 pregnancies recorded prospectively. This is really important because without recording pregnancies prospectively (i.e. from the start) you will miss the pregnancies that miscarry the most – that is those in the first 6 weeks. The V-safe pregnancy registry was meant to have adopted this model but the CDC have chosen not to release that data. I have discussed this previously and for anybody that doesn’t understand how we assess miscarriage rates this article (and the one that it links to) is a must
 
Now, table 38 and its accompanying data gives us a really useful piece of information that we do not have from any other source – that is the proportion of adverse pregnancy-related events. In this prospective data set 94/145 (65%) of the pregnancies (termed mother cases to avoid the issue of multiple pregnancies) had no adverse event recorded.
 
In terms of the actual proportion of miscarriages we have the following information

17 of 144 pregnancies (11.8%) miscarried altogether
12 of 73 pregnancies (16.4%) miscarried where the mother received the vaccine in the first trimester
21 of 73 pregnancies (28.7%) miscarried or underwent termination of pregnancy, including those having a termination for fetal defects, where the mother received the vaccine in the first trimester

Now these are shocking figures despite what the pharma companies have told you. What is more they are entirely consistent with what I have written in the previous reports and whichever way you look at it these rates are at least double what you should expect following diagnosis of pregnancy by ultrasound.

Remember as well that it is the first trimester recipients that we are interested in because (a) you can’t miscarry after 20 weeks, a different term is applied and (b) very few drugs have an adverse impact after 20 weeks, even this one.

Just to reiterate also, this data is from the clinical trials and therefore represents a cohort monitored from the time that a pregnancy is declared. Only pregnancies where the outcome was known are included, so the event rates might be higher.
 
Another shocking figure is this one:

Of the pregnancies recorded, only 76% made it to delivery without a congenital anomaly. 24% ended either in pregnancy loss or congenital anomaly.

It’s also worth noting that in this prospective data set, where “a rigorous assessment was undertaken” as we have been told multiple times, 54 of the 109 live normal births did not have a trimester of exposure recorded. That means that they did not know when the vaccine was given to the pregnant woman.
 
Now let’s look at table 40.
 

 
In this table the pertinent figures are these:

Total pregnancies = 1089
Miscarriages* = 232 (21.3%)
First trimester exposure pregnancies = 215
Miscarriages* = 92 (42.7%) [this is an overestimate – see below]
 
*miscarriages and terminations. Note that 90% of the elective terminations in this cohort were for foetal defects – a very high rate. They have therefore been amalgamated with the miscarriages for the purpose of this article.

Now these rates are elevated because the pregnancies recorded in this cohort were from the wider population who reported an “adverse event” as a pregnancy exposure associated with vaccination. So in order to try to ascertain how this population compares to a prospectively evaluated population (where you start off with a known pregnant cohort, give the therapy and then follow them up to completion of pregnancy, just as in V-safe or the table 38 cohort) we need to adjust the denominator upwards.
 
We can get an estimate of our adjustment factor by using the prospective cohort provided (thanks Pfizer!) in whom the number who reported adverse events (irrespective of the outcome) are recorded. It’s 51/145 (35%). Note that these are the those other than the adverse event of “pregnant on the trial”.
 

 
Because this is a prospective cohort we can now use this rate (35%) to reverse engineer the denominator for the larger group in the PSUR, which is in table 40 (the “incremental review” cohort) and is made up of those who reported an adverse event associated with pregnancy relating to receipt of the vaccine – the kind of report you would get in VAERS for instance.
 

 
Because this is a selectively reporting cohort, the adverse event rate is higher. This is because some people don’t report (it’s a pain, so why bother?). 659/1604 is only 41% whereas it should be 65%, giving an under-reporting of about 1.5x. So we can predict the denominator such that the reporting rate is 35% to match the clinical trial (“cumulative review”) cohort.

There were 945 reported events (“mother cases”) which should be 35% of the total so the estimated denominator becomes 945/0.35→ 2700
 
The 1089 total quoted in table 40 was derived from 1607 unique pregnancies (the remainder had not reported) and therefore represents 67.8% of the cohort.
 
The estimated denominator for table 40 therefore would be 2700*.678→ 1831

On this revised denominator we would then have

Total pregnancies = 1831
Miscarriages* = 232 (12.6%)
First trimester exposure pregnancies (estimated) = 215 *1831/1089 = 361
Miscarriages* = 92 (25.5%)

Note that the calculation is somewhat skewed by the “retrospective cases” in table 40 giving a first trimester miscarriage rate of nearly 100%. This is the same kind of problem that we have seen in previous reports where groups have quoted the adverse event reports with miscarriage rates of nearly 100% – basically because all the reports are of miscarriages after vaccination (this also applies to pretty much every report of a miscarriage rate of over 50%).
 
Leaving off the “retrospective cases” and only adjusting the “prospective cases” in table 40 (the incremental cohort) gives us

Total pregnancies 841
First trimester exposure miscarriage* = 28/148 = 18.9%
Estimated prospective pregnancies in first trimester = 148*(2700/1609) = 248
Estimated miscarriage rate in first trimester (conservative) = 11.3%

Bear in mind that this is a conservative estimate yet it does come in around the lower limit for the previous estimates of miscarriage rate that we have discussed, and fits in with the Zausche estimate of around 12-14%. The true rate is probably somewhere between the 11% and the 25% calculated. This is up to double that a normal miscarriage rate, whatever Pfizer and the CDC say.
 
The problem is that, on the basis of the data presented, you would need a much bigger denominator than that seen in the PSUR and this was not provided.

On the basis of the data provided in the PSUR, with miscarriage estimates over 20%, this product should have been halted for pregnant women in the first trimester.

Another way of looking at this is using the text descriptors of the numbers of adverse events
 

 
Summarising:

945 pregnancy events. If this is 35% of the population this gives us a revised estimate of 2700 pregnancies
 
Of the events, 275+21+9+16+7 = 328 are miscarriages (early fetal loss) = 12.1% of the estimated total pregnancies
 
There is a wide variation in the estimated miscarriage rate, because the data is seemingly deliberately designed to confuse.

There are 9 (not 6) still births reported in the PSUR here. This gives 0.33%, which is the (lower limit) rate expected for a Western population. This would confirm that the denominator estimate here is probably the upper limit estimate of the correct number.
 
Assessing the background rate of miscarriage in a normal pregnancy is no mean feat. This is because most early pregnancies and early pregnancy losses are not reported. In order to assess a truly comparative pregnancy cohort you need to recruit participants early and the earliest you can do this is usually around 6-7 weeks of gestation (2-3 weeks after a missed period). “Historical” miscarriage rates always overestimate the miscarriage rate because they include “self reported” pregnancies – which are those not confirmed by ultrasound. Here is an example from a well-touted Lancet review. You can see even from this that the only study that has a miscarriage rate less than 10% is the Andersen study which is a hospital registry. All the other rates are far higher.
 

 
This highlights the difference in comparator when using a prospective cohort. That is, one where you confirm a pregnancy. In a trial situation this is ideally by early ultrasound in order to assess gestational age. Ultrasound is standard practice for dating of pregnancies in most Western countries now, although it wasn’t 20 years ago from which many of the “historical miscarriage rates” are quoted. So the question must be – what is the background rate of confirmed pregnancies now? Papers on this are surprisingly sparse but other than the Naert paper quoted there are two others that show a similar miscarriage rate of 5-6% for ultrasound confirmed pregnancies based on prospective (i.e. women register early in pregnancy, at the latest 6 weeks, and are followed up) – the Wang study here (6/108 miscarriages = 5.6%) and the Bae study here (52/820 miscarriages = 6.3%). If you’re running a trial where you prospectively evaluate patients early on, you need to have a good reason why you aren’t comparing to these rates instead of an inflated rate from 30 years ago.

We now have multiple sources giving us a (conservatively estimated) post-vaccination miscarriage rate of at least 12-16% (prospectively calculated) and multiple sources giving us a pre-vaccination era miscarriage rate of 5-6%. Because a comparative cohort was not provided for V-safe nor for the Pfizer vaccine studies, it is now impossible to confirm that the product does not increase the risk of miscarriage.

I’ll just repeat that and put it in a box for the TLDR peeps

Multiple sources demonstrate that, when prospectively assessed (i.e looking at a cohort of women from the point at which a pregnancy is conclusively demonstrated) the miscarriage rate of a normal cohort is historically 5-6%.
 
Following the mRNA COVID vaccinations multiple sources, presumably using the same criteria, demonstrate miscarriage rates around 12-16%.
 
This represents a potential doubling of the miscarriage rate associated with vaccination in pregnancy.

So now we have the difficult stuff out of the way, we can look at the clues that Pfizer and the regulators (TGA, MHRA, FDA, EMA) knew that there was a problem with fetal loss following the administration of the mRNA products.

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