A few days ago, I came across Dr . Viki Male, qualified with a science PhD in pathology rather than a medical degree, who lectures in reproductive immunology at Imperial College Greater london. Dr . Male, cocooned within a white coat to provide the necessary medical gravitas, was the celebrity of an NHS video promoting COVID-19 ‘ vaccinations’ (more properly experimental gene-based therapies) to pregnant mothers.
Now it is a fact that pregnant moms were deliberately excluded through the clinical trials of all the COVID-19 vaccines. It follows that we get no data on the protection of these experimental medications from properly designed trials by which outcomes for treated and untreated pregnant women are in comparison. Neither do we have any long-term data on the effects of these experimental medical treatments on mothers and their unborn children. Without this proof to support her case, Doctor Male’s strident promotion from the COVID-19 vaccines to expectant mothers could only have been based on a belief they do no harm, rather than on any scientific proof.
However , Dr . Male did seem quite sure of herself, despite the girl exposed position. I therefore determined to look at the quality of the data that she utilized to shore up her belief system. Like Dr . Man I am qualified with a Ph level. D. in biology, and throughout my career I have been involved in the peer review procedure, assessing the scientific high quality of papers to determine whether or not they meet the standards required for publication. Dr . Male, in response to critique of the NHS video on her Twitter feed, gave great prominence to a recently published papers from a group led simply by Professor Sarah Stock on Edinburgh University entitled “ Early pregnancy outcomes following COVID-19 vaccination and SARS-CoV-2 infection: a nationwide population-based matched cohort study “. I consequently determined to review this paper myself, and assess whether or not the analyses that it presented backed the conclusions that had been attracted, and whether the manuscript has been worthy of publication.
My verdict is that easily were a reviewer of the paper, I would unequivocally deny it on the grounds which the data on which it is dependent are unsound, that it fails to analyse the crucial interaction between vaccination status and SARS-CoV-2 infection, and that the findings drawn are not supported by results presented. Indeed, the only real significant result to emerge in the study is that there were increased odds of early miscarriage among women receiving the AstraZeneca vaccine when compared to historical controls (17% higher: adjusted odds ratio 1 . 17; 95% CI: 1 . 03-1. 34). I outline the full reasons for my verdict below.
The paper retrospectively compares matched cohorts associated with vaccinated and unvaccinated females to assess whether they differed in the frequency of either pregnancy loss in the initial 20 weeks or ectopic pregnancy. Comparisons in the frequency of these deleterious outcomes had been also made between cohorts of pregnant women who do, or did not, test good for the SARS-CoV-2 virus. To be able to assess the overall quality from the research, it is first crucial to determine the quality of the data where it is based.
The research is critically dependent upon unambiguous classification of individuals to the categories vaccinated or unvaccinated, infected or uninfected. The particular authors concede that there might be significant problems here:
We had to rely on imputed gestation in end of pregnancy to get a high proportion of pregnancies ending in early loss, which may have led to misclassification associated with vaccination or infection status.
Particularly, if the total length of the maternity was not known it was assumed to be uniformly 10 days for miscarriages or eight weeks for ectopic pregnancy. Making these assumptions could lead to misclassification of the vaccination or infection status of individuals.
Secondly, the research depends upon accurate recording of rates of miscarriage. Again, you can find problems with these data:
We could not really include early miscarriages where the woman did not seek healthcare advice.
Finally, the distinctive stage of this study, that it entails matched cohorts that do not really differ for confounding elements, is thrown into doubt by the admission that three key factors, well known in order to influence pregnancy outcomes, are not matched:
We were not able to adjust regarding body mass index (BMI) or smoking; or consist of diabetes in clinical vulnerability scores.
The next area for overview is how these jeopardized datasets were analysed. 2 features of the treatment of the data are usually concerning. Firstly, before comparison of the vaccinated and unvaccinated cohort was performed, many women with a positive SARS-CoV-2 test during the study period were excluded. Secondly, just before pregnant women with and without the SARS-CoV-2 positive test were compared, all vaccinated individuals were excluded.
The effect of these exclusions is that the interaction between vaccination status and presence or lack of SARS-CoV-2 on pregnancy results is ignored. This is a serious omission because vaccination happens in the presence of SARS-CoV-2 in the community (the whole cause that vaccination is being promoted). Therefore , we need to study the result of vaccination in the existence of SARS-CoV-2 infections, not in their complete absence. A significant reason for doing this is that recent data suggest not only that vaccination does not prevent infection simply by SARS-CoV-2, but that shot recipients may have a higher possibility than unvaccinated of tests positive for SARS-CoV-2 plus suffering from COVID-19. If we disregard this effect by not including individuals who are SARS-CoV-2 positive, we have been not obtaining a true assessment of the real-world effects of vaccination on pregnancy outcomes.
Notwithstanding these serious flaws in the analysis, we are able to now look at the results which were obtained and the conclusions which were drawn from them by the writers. Looking across all the information presented, no significant effect of SARS-CoV-2 infection on early pregnancy outcomes was discovered in this study. The only substantial result to arise from the study was that there were higher likelihood of early miscarriage among females receiving the AstraZeneca vaccine when compared to historical controls (17% higher: aOR 1 . seventeen; 95% CI1. 03-1. 34). Therefore , the conclusion that should be drawn from this study is that there is absolutely no evidence that SARS-CoV-2 infections poses a risk in order to early pregnancy outcomes, but that vaccination with the AstraZeneca vaccine increases the risk associated with early miscarriage.
Curiously, this is the inverse associated with what the authors actually determined in their manuscript:
Overall, our studies found no evidence of an increased risk for miscarriage or even ectopic pregnancy after COVID-19 vaccination, supporting current suggestions that vaccination remains the safest way for pregnant women to protect themselves and their babies from COVID-19.
So , Dr . Male, this is the standard of scientific evidence upon which you foundation your advocacy of the COVID-19 vaccines for pregnant women. The only real significant result that comes from the research suggests that at least one of the vaccines increases the risk of early miscarriage. I believe the only honourable thing for you to do is forthwith to withdraw from further promotions of the COVID-19 vaccines for pregnant women. There is over your scientific reputation on the line. There is the future happiness of all pregnant women who place their own trust in you because you are actually put forward as a scientist and individual of integrity.