Are Vaccines safe for Pregnancy?

A close look at the NZ Ministry of heath website advice to expectant mums

If you are pregnant and want to know if the Covid Vaccine is safe for pregnant women to take, you might have visited the NZ Ministry of Heath website Where Dr Nikkie Turner states; that Covid 19 carries a ‘higher risk of miscarriage’, that ‘[the vaccine has] got a really good safety profile’; that we’ve ‘got lots of international data now showing that the vaccine works really well with pregnant women’ etc. Sounds reassuring.

What is the data supporting these statements? In relation to the health of baby, the MoH lists only 2 studies. The first is the Shimabukuro study that formed the basis of the CDC approval of the vaccine for pregnancy (and shortly thereafter most countries followed suit). The second is the Kharbanda et al study. Let’s take a look at them both...

Shimabukuru et al

Published in the New England Journal of Medicine (NEJM) in April 2021, the study, led by Dr Tom Shimabukuro from the CDC (is that a conflict of interest? Just asking.), is entitled ‘Preliminary Findings of mRNA Covid-19 Vaccine Safety in Pregnant Persons’. From the abstract we read:

From December 14, 2020, to February 28, 2021, we used data from the “v-safe after vaccination health checker” surveillance system...

December 14 to February 28, that’s not quite 11 weeks to study what normally takes 9 months. Right out of the starting gate we have an issue!

The title states it is ‘preliminary’ findings, but I waited in vain for the final results. There weren’t any and we shall see why. Are ‘preliminary findings sufficient to justify the vaccine rollout? Not even the authors seem to think so:

However, more longitudinal follow-up, including follow-up of large numbers of women vaccinated earlier in pregnancy, is necessary to inform maternal, pregnancy, and infant outcomes.

I don’t think Ashley Bloomfield read that.

But the study itself was faulty. Within weeks of the study’s publication letters were being sent to the NEJM editor pointing out an egregious mistake where the wrong denominator was used to calculate that the miscarriage (spontaneous abortion) rate was no higher than normal.

Nothing was done even though these letters came from many sources. I was in correspondence with a Canadian team of authors who were actively discussing this issue with NEJM in June 2021 (first letter here, final letter here). Despite the error being too obvious to be denied, it took until September 7 to finally correct the paper. Why did it take so long?

Here’s a timeline. On Sep 05 the original article had not been changed or corrected. None of the letters sent to NEJM had been published. On Sept 08 a letter from a Doctor Sun (a good one too) was published pointing out the mistake, and also on Sep 8 a response from the Authors acknowledging the mistake but redirecting to their new study results (Zauche et al) published also in the NEJM on September 8^th as a letter to the editor.

Nothing was done by the NEJM until the authors had figured out another way to present the data and only when they had, was the correction made. Everything happened on September 8... nothing suspicious about that eh?

Meanwhile, all around the world’s pregnant women were encouraged to get the shot when there was actually no evidence that it was safe because the claims made in this rush job study turned out to be false.

But did the Zauche ‘correction’ do anything to prove safety? I’ll come back to that shortly.

First let’s take a peek at the other part of the Shimabukuru study, that is not part of the controversy, and not subject to the retraction. Here it was claimed that there was no increase in other pregnancy outcomes for the vaccinated:

The problem with all these claims is that none the mums in this study who had completed their pregnancies were exposed to the risk of the vaccine for the full 40 weeks of pregnancy. In fact, by my reckoning, the average exposure time was about 6 weeks only! This fact on it’s own renders the findings useless for drawing any conclusions. But, as we shall see with my analysis of the ‘Zauche correction’, there is an alarmingly clear signal of a problem for pregnancies exposed to the vaccine in the early weeks of pregnancy yet none of the children in the above denominators (apart from the miscarried ones) would have been exposed to this danger zone. It is well established that children in early pregnancy have a much higher miscarriage rate. What is the effect of vaccine exposure early in pregnancy? What is the effect on those that survive miscarriage during the period? The data in the study that informed table 4 can’t possibly tell us.

So it can’t possible tell us the vaccine is safe.

Lets look a the ‘Zauche Correction’.

The authors, many of whom were part of the Shimabukuru study, did not complete the Shimabukuru study by following the mums to the end of their pregnancies and then calculating the outcomes. Instead they used a different methodology and removed 1500 participants (which ones?). Nothing at all suspicious about this either so let’s take the data at face value.

In their new methodology they compared the miscarriage rate of the vaccinated women at each week of gestational age with those of women in two other historical studies and then used this to calculate an over all rate. The Covid vaccinated women fell within the range of the two baseline study so therefore: nothing to see here- vax is safe.

Here’s the graph to prove it- Comparative studies are the orange line (top of range) and blue line (bottom of range). The 2 covid vaccinated lines are grey (primary analysis), and yellow (sensitivity).

I’m not comfortable with the yellow line barely keeping below the upper limit when there are many other studies that show a much lower miscarriage rate (in addition to the Goldhaber study). This on it’s own does not say ‘safe’, but instead ‘please study me more’. But take a close look at weeks 7 to 9. Note how the vaccine lines rise sharply compared to the two comparative studies. This indicates a much higher miscarriage rate for those weeks. Below I have added guidelines to the graph and figures for the weekly miscarriage rates for all 4 lines.

Here’s the weekly rates side by side:

And in Graph form:

This is a considerable hike. (Note also the high starting point of the Murkerkee study. If it wasn’t for this very high start the Murkerkee study would not be the upper limit any more.)

What is the effect on overall miscarriage numbers? In the Zauche correction, once again the mums were only exposed to the 14 week miscarriage risk period for a very short time and only a few of those would have been exposed to weeks 7 to 9 which appear to be the problematic ones. I modelled the outcome for these weeks by starting with the 2456 mums in the study, ‘exposed’ them all to these problematic weeks, and compared the outcome to both of the background rate studies:

As you can see the result is a considerable increase compared to both background studies. This increases the relative risk of miscarriage between 54% at the low end to 77% at the high end. To put this into context, if all pregnant mums in New Zealand were vaccinated in this vulnerable zone we would have expected between 2000-4000 additional babies dying during these weeks. Thank God (truly!!!) not all got the jab at this crucial time! But how many did, following the advice of Nikkie Turner and the MoH?

So much for Shimabukuro’s ‘preliminary’ study that was abandoned by the authors after it was used to justify vaccinating pregnant women all over the world. What a fiasco!

Kharbanda et al

The Kharbanda et al study is the other study referenced by the MOH to justify Covid vaccines as ‘safe and effective™’.

The purpose of this study was to determine whether there was an increased risk of miscarriage within 4 weeks of taking a jab, not the whole pregnancy. But because, historically speaking, more reactions occur closer to the jab time (called temporal association) you could make a case that if there is no increase in the first 4 weeks, then the assumption can be made that the vaccine is safe throughout pregnancy. Fair enough, I’d be happy to accept that as evidence.

Overall the study found only a very small increased risk (about 2%). So the conclusion is ‘safe’.

But not so fast.

Taken even at face value, the data (and results table) indicates that young vaccinated mums under the age of 25, who made up only 3.6% of the total group, account for 4.8% of the miscarriages- a 33% increased risk. That’s one safety signal that needs further investigation.

But if we dig a little deeper we find that the methodology used results in vaccinated mums also being used in the baseline comparison group, albeit mums who have been vaccinated outside the 4 week period. So if the vaccine does cause a negative effect outside of 4 weeks, the result will be skewed in the vaccines favour and the effect covered up. The baseline would also include mums who were vaccinated around the time of conception or in the peri-conception period. These mums would have been exposed to the early weeks where miscarriage rates were highest. They’re newly conceived babies might have been effected by the vaccine, or the vaccine effected their ovulation etc, resulting in a less viable pregnancy and a subsequent higher miscarriage rate. They would be counted in the baseline group hiding the actual effect of the vaccine.

The supplemental appendix from the study (below), which give examples of various scenarios included in the study (very helpful), gives a clear example of this. Example number 6 received dose 1 just after week 1 gestation, and dose 2 at 6 weeks. She was monitored for 4 weeks and this period was counted as miscarriage free in the vaccinated group, but she lost her baby 4 weeks later and this miscarriage was counted instead with the unvaccinated in the baseline group. She had received 2 shots early in pregnancy, did this damage the baby and cause, or contribute to, the later miscarriage? One can think of various other scenarios that will fall into the same category.

Then there would be the mums who got vaccinated around conception time or just before (one dose or two) and lost their baby before getting to week 6. These mums may not be recognised as pregnant yet, and so excluded from the study altogether. But what was the effect of the vaccine on pregnancies like this? The study is not designed to find out.

It would have been very easy to overcome this problem by simply excluding vaccinated mums from the baseline comparison group. Then the study would have been robust, at least as an indicator of what is happening in the 4 weeks post vaccine. It is a great shame they didn’t do this, but as it is, we would be foolish to draw any conclusions from the study apart from identifying that safety signal for young mums that needs further investigation.

Summary

In summary, the ‘Science™’ backing up the MoH’s claim for the safety of the Vaccine during pregnacy do nothing of the sort. On the contrary both provide red flags indicating more study is needed. The shenanigans surrounding the Shimabukuru study, on the back of which the vaccine was approved all over the world, reveal it to be shambolic fiasco, hastily put together.

One wonders why?