sept 30, 2021
In my own community, the most prominent concern on the minds of many of the vaccine hesitant, especially young women of childbearing age, is the fear of an adverse effect on fertility. Possibly because of this, fertility concerns have also been derisively dismissed by the doctors with more passion and vengeance than for any other type of adverse effect being attributed to the vaccines. Thus, it seems to me that compiling a list of reasons to legitimately worry that these vaccines maybe negatively affect fertility is something that would be useful to people. What follows is a simplified, straightforward explanation in layman language of a few of the more reasonable arguments why these vaccines might affect fertility.
Failure of the FDA to require vaccine manufacturers to conduct standard tests on the genetic therapy part of the vaccines
The vaccines currently in use in the US all utilize what is known as a “genetic therapy”, in the sense that it utilizes a host cell to translate genetic material into a protein. Gene therapies are supposed to be rigorously tested in ways that standard vaccines are not, in order that we understand how the gene therapy part works in real life and make sure that there isn’t any unanticipated action going on.
These tests include assessing the toxicity (ie does it interact with anything in the human body in a harmful way) of the genetic material delivery vehicle, where they end up in the human body (distribution), the duration of protein production, the quantity of protein production, the distribution of the protein in the human body, and the toxicity of the produced protein.
Critically, this also includes a special battery of tests to specifically assess reproductive toxicity. None of these tests were conducted in human subjects, and some don’t seem to have been done in animals either, a deeply troubling failure that goes well beyond “cut corners”. Remember, a test is only as good as its design, and to my knowledge, there is no official documentation of rigorous testing for these things available in the public domain, implying that they don’t exist.
A further concern is that pregnant women were excluded from all of the vaccine trials, so there has not yet been a proper study with a control group to see if there are any differences in pregnancy loss or congenital defects between vaccinated and unvaccinated people. Additionally, the trials were irreversibly terminated after just a few months when the control arms were vaccinated, ending the possibility (threat?) of any long term data emerging from the trials. Fertility is something that by definition requires a long term study to properly assess.
So right off the bat, the trials never established that the vaccines didn’t affect fertility, the “experts” just assumed that they didn’t. Expert opinion is not considered evidence of drug safety for good reason, namely that experts are usually wrong when it comes to predicting things, especially regarding novel drugs (for a variety of widely ranging reasons). Regrettably, experts seldom recognize the limits of their own expertise, and vis a vis covid seem unaware that any exist altogether. Were expert opinion a valid method of adjudicating safety concerns for new medical products, the FDA could be retired, as experts always assume that new drugs won’t have any unanticipated side effects. Thus this contention is an empty and meaningless pile of nonsensical drivel.
One note before getting to the more granular part: pretty much all of the following points, even if true, would only be true within certain parameters – for example, you’d need a minimum amount of spike proteins to cause any damage. But since they skipped the tests, we don’t really have a good idea of these numbers, hence the concern.
LNP’s (Lipid Nano Particles)
Both mRNA vaccines utilize a mixture of lipid compounds as a “delivery vehicle” to transport the mRNA itself into a host cell where the mRNA can then “hijack” the cell to produce spike proteins. There are a few potential concerns with these LNP’s:
- The biodistribution report in Pfizer’s pharmacokinetic pre-clinical animal study submitted to the Japanese government found that LNP’s were accumulating in the ovaries in significant numbers.Obviously, the presence of accumulating foreign material in the ovaries, which are also a particularly sensitive organ, is cause to wonder just what the actual effects are on ovarian function. Maybe there aren’t any. And maybe the LNP’s only go to the ovaries in rats but not in humans. Thing is, this was never tested in human subjects, so we just don’t know.
- By necessity, positively charged lipids – cationic lipids – were needed to make the LNP vehicle work (such as ALC 1035). Cationic lipids are known to have toxicity in humans. One of the earliest and most persistent hurdles in developing mRNA technology was the lipid toxicity. While the vaccine manufacturers (of course) think that they have solved this problem, there was never any proper testing to see if the “fix” used holds up everywhere in the body where the LNP’s can accumulate. And there definitely isn’t a long track record of public use of the mRNA platform that we could see shows no signs of LNP toxicity. Again, this particular one maybe it isn’t toxic at all, maybe they succeeded in suppressing any toxic property of this lipid enough to avoid toxicity issues, but this would require testing.
- Nanoparticles in themselves have been previously thought to be possibly causing a decrease in fertility – such as what is documented in the study Potential adverse effects of nanoparticles on the reproductive system.
All of these vaccines cause host cells to produce a piece of the covid virus known as the spike protein. The function of the spike protein for the covid virus is to bind with a surface protein on cells, which would enable the covid virus to “break into” that cell. When the vaccines were designed, conventional wisdom was that the spike protein was just a sort of “key”, nothing more. Unfortunately, in the intervening months a lot of new research came out that showed very clearly that the spike protein was the piece of the covid virus that did most of the damage, which is relevant because the same mechanisms largely apply to reproductive organs too. We know that the spike protein circulates all over the body, so it is plausible that some make it to the ovaries.
- Spike protein, by merely binding with the ACE2 receptor, can trigger cellular dysfunction and even kill the cell. (Interestingly, one of the modifications made to the spike protein that the vaccines produce is to lock the S1 into an open conformation with the RBD exposed (very short sort-of-layman version), something that is virtually guaranteed to enhance the binding affinity of the S1 with cellular receptor proteins.) ACE2 receptors are ubiquitous throughout the human body, including reproductive organs/tissues, thus the reasonable fear that binding with ovarian ACE2’s might be deleterious to fertility.
- Spike proteins trigger immune system overreaction, leading to very harmful inflammation. Spike proteins accumulating in the ovaries would therefore potentially cause an immune reaction against ovarian tissues.
- If any of the LNP’s with mRNA still inside end up in the ovaries, ovarian cells would produce spike proteins, precipitating an immune response against ‘infected’ ovarian cells, with potentially dire consequences for the ovaries.
Decreased Fertility in Animal Trials
Moderna’s EMA from the EU included the admission that rats lost 14% of pregnancies in the vaccine group vs only 7% in the control group. Pfizer’s reported a limited reproductive toxicity study that found a “~2x increase in pre-implantation loss – ~9.77% vs 4.1% in controls”, and “among fetuses […] there was a very low incidence of gastroschisis, mouth/jaw malformations, right sided aortic arch, and cervical vertebrae abnormalities, although these findings were within historical control data”. These should have merited follow up studies to determine if this effect was vaccine induced or just a statistical artifact. Being within historical control data doesn’t mean that the result has to be a product of random chance, and a clear signal that certain abnormalities were more prevalent in the vaccine arm compared to the placebo is a legitimate concern to adjudicate.
Much has been made over the allegation that the spike protein was similar enough to a protein critical to pregnancy called syncytin-1, that antibodies produced to bind with the spike protein would “accidentally” bind with syncytin-1. I initially thought that this claim was unpredicated. However, the only study that I am aware of that attempted to look into this found a clear increase in what they were measuring as a proxy for anti-syncytin-1 antibodies between pre-vaccination and post-vaccination (Addressing anti-syncytin antibody levels, and fertility and breastfeeding concerns, following BNT162B2 COVID-19 mRNA vaccination, Figure 2B). (This study is a particularly messy wreck of poor methodology and wildly unpredicated claims by the authors, something way beyond the scope of this essay.) I think that this result should be investigated further to make sure that this is not the case.
Clinical Outcomes, Especially Widespread Menstrual Irregularities From Vaccines
Whatever the merit of any of the aforementioned propositions individually, there has been an undeniable avalanche of vaccine side effects that implicate fertility:
- Menstrual Problems – This is probably the most widespread serious side effect. A University of Chicago survey that hoped to get 500 women who had experienced post-vaccination menstrual irregularities has so far eclipsed 140,000! The UK has more than 30,000 official reports in their version of VAERS (Yellowcard). Remember, this is something that to many if not most women is an intensely private matter, meaning that the underreporting might be even more pronounced than for other vaccine side effects. And some of these reports went well beyond things like missing or extra heavy/uncomfortable periods. It is axiomatic that anything affecting menstruation is automatically noteworthy concerning fertility unless proven otherwise.
- Lost Pregnancies – Over 1,000 in VAERS so far, which grossly underreports everything. I have heard or seen a number of individual cases of weird (and on occasion horrifying) placental damage where the treating OBGYN thought that the vaccine was the most likely indication. We need a proper massive control study that is honestly designed and executed to see if there are more pregnancy losses in the vaccine arm than in the control arm.
We Don’t Know What We Don’t Know
We have no idea what we may discover down the line in a year, or maybe 5 or even 10 years. We don’t even know about things that we might’ve caught had there been proper rigorous testing. For all we know, there might be a secondary or tertiary consequence of some other vaccine interaction that impacts fertility. This is why new drugs are subjected to long term testing, spanning at least a few years, so we can see if there are unexpected results that the genius expert scientists weren’t quite brilliant enough to foresee.
Young people, especially women – in other words, those who become pregnant – carry a practically insignificant risk from covid itself. The “pregnancy is a comorbidity” trope is just one of a litany of absurdly exaggerated claims disseminated as a fearmongering tactic, so even a miniscule risk to fertility is a significant consideration.
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