Reading the above text: "In response to my questions, today I can reveal . . ." I thought that you - Joel Hirschhorn - had contacted and received a response from Pfizer on this important matter. However it was Maryanne Demasi PhD. I think you should have made this very clear, with the full title of her article and a link to it, at the start of this page, with a note that what follows is almost the full text what she wrote. I think you should have obtained her permission to do so first. Substack has a mechanism for cross-posting articles.
You left out Maryanne Demasi's final links to the TGA (Australian Therapeutic Goods Administration) FOI responses.
The final section links to and quotes from an article by y Dr. Priyom Bose, Ph.D "Can COVID-19 vaccinations cause miscarriage in pregnant women?" https://www.news-medical.net/news/20230219/Can-COVID-19-vaccinations-cause-miscarriage-in-pregnant-women.aspx in which she discusses Rimmer et al. 2023 "The risk of miscarriage following COVID-19 vaccination: a systematic review and meta-analysis" Human Reproduction 2023-02-16 https://academic.oup.com/humrep/advance-article/doi/10.1093/humrep/dead036/7043098 which is a systematic review and meta-analysis which analysed the data from "21 studies (5 randomised trials 43 and 16 observational studies) reporting on 149,685 women" - a subset of a larger number of studies they considered. "Limitations, reasons for caution: Our analysis was limited to observational evidence with varied reporting, high heterogeneity and risk of bias across included studies, which may limit the generalisability and confidence in our findings."
"All of the RCTs in this review excluded 179 pregnant women at the time of recruitment but reported on those who became pregnant during the trial.".
They reported a 7% higher (1.07) Relative Risk ratio of miscarriage in the women who had received one or more quasi-vaccines and vaccines (I think that Sinopharm and Sinovac are vaccines), but did not regard this as significance since their 95% confidence range was 0.89 to 1.28. This means a 7% higher rate of miscarriage for women who were treated with the (quasi-)vaccines.
I looked through the article and the supplementary data (link to zip file at bottom of the page) and could not find the raw or aggregated data for miscarriages or ongoing pregnancy / live birth, other than in Fig 3 and Fig 4. In the top part of Fig 3, as best I understand it, there are 422 miscarriages from 2589 (quasi-)vaccinated women = 0.163 and 4698 from 20975 women who were not so treated = 0.224. The headings of these figures are blanked out. On the basis of these ratios, it seems they found only 0.163 / 0.224 = 72.8% the rate of miscarriages in the treated women with respect to miscarriages in the untreated women.
I don't understand how they arrived at their RR figure of 1.07, which shows more miscarriages in the treated women. "1.07" appears at the bottom of this top section, below the individual estimates for each trial. However it is not the average for those estimates - nor should it be, since some trials were very small. 1.07 is evidently the outcome of their elaborate statistical analysis system which I have not tried to understand. I assume that the 1.07 figure is represented by the dotted red line in the top part of Fig 3, slightly to the right of a marker for 1.02. The size of the black boxes represents something about the weighting given to the results reported from each study, which would be a function of number of participants and perhaps risk of bias (Supplement Fig S1)
The bottom part of Fig 3 refers to ongoing pregnancies and live births. They find a RR of 1.0 with a 95% confidence range of 0.097 to 1.03. The totals for the (quasi-)vaccinated women were 1992 / 2876 = 0.693 and for the untreated women 16685 / 22688 = 0.735, showing much *more* risk for the (quasi-)vaccinated women.
I don't understand how their analysis system works - and I don't have time to find out. Can anyone explain it?
The raw figures I quoted and the ratios I calculated above are in Fig 4, to the left of the RR effect sizes. For the miscarriage results they rate the certainty as "low" and for the ongoing pregnancy / live birth figures, "very low".
This survey was unable to analyse differences in other variables such as measures of health of the women, due to the widely divergent reporting methods in the various studies. Since they worked from pregnancies, they were not in a position to judge any ill effects on the rate at which women became pregnant, either for any given level of sex, or by overall intention - with potential pandemic and fear-induced effects reducing how often they had sex in settings which could result in pregnancy.
Reading the above text: "In response to my questions, today I can reveal . . ." I thought that you - Joel Hirschhorn - had contacted and received a response from Pfizer on this important matter. However it was Maryanne Demasi PhD. I think you should have made this very clear, with the full title of her article and a link to it, at the start of this page, with a note that what follows is almost the full text what she wrote. I think you should have obtained her permission to do so first. Substack has a mechanism for cross-posting articles.
You left out Maryanne Demasi's final links to the TGA (Australian Therapeutic Goods Administration) FOI responses.
The final section links to and quotes from an article by y Dr. Priyom Bose, Ph.D "Can COVID-19 vaccinations cause miscarriage in pregnant women?" https://www.news-medical.net/news/20230219/Can-COVID-19-vaccinations-cause-miscarriage-in-pregnant-women.aspx in which she discusses Rimmer et al. 2023 "The risk of miscarriage following COVID-19 vaccination: a systematic review and meta-analysis" Human Reproduction 2023-02-16 https://academic.oup.com/humrep/advance-article/doi/10.1093/humrep/dead036/7043098 which is a systematic review and meta-analysis which analysed the data from "21 studies (5 randomised trials 43 and 16 observational studies) reporting on 149,685 women" - a subset of a larger number of studies they considered. "Limitations, reasons for caution: Our analysis was limited to observational evidence with varied reporting, high heterogeneity and risk of bias across included studies, which may limit the generalisability and confidence in our findings."
"All of the RCTs in this review excluded 179 pregnant women at the time of recruitment but reported on those who became pregnant during the trial.".
They reported a 7% higher (1.07) Relative Risk ratio of miscarriage in the women who had received one or more quasi-vaccines and vaccines (I think that Sinopharm and Sinovac are vaccines), but did not regard this as significance since their 95% confidence range was 0.89 to 1.28. This means a 7% higher rate of miscarriage for women who were treated with the (quasi-)vaccines.
I looked through the article and the supplementary data (link to zip file at bottom of the page) and could not find the raw or aggregated data for miscarriages or ongoing pregnancy / live birth, other than in Fig 3 and Fig 4. In the top part of Fig 3, as best I understand it, there are 422 miscarriages from 2589 (quasi-)vaccinated women = 0.163 and 4698 from 20975 women who were not so treated = 0.224. The headings of these figures are blanked out. On the basis of these ratios, it seems they found only 0.163 / 0.224 = 72.8% the rate of miscarriages in the treated women with respect to miscarriages in the untreated women.
I don't understand how they arrived at their RR figure of 1.07, which shows more miscarriages in the treated women. "1.07" appears at the bottom of this top section, below the individual estimates for each trial. However it is not the average for those estimates - nor should it be, since some trials were very small. 1.07 is evidently the outcome of their elaborate statistical analysis system which I have not tried to understand. I assume that the 1.07 figure is represented by the dotted red line in the top part of Fig 3, slightly to the right of a marker for 1.02. The size of the black boxes represents something about the weighting given to the results reported from each study, which would be a function of number of participants and perhaps risk of bias (Supplement Fig S1)
The bottom part of Fig 3 refers to ongoing pregnancies and live births. They find a RR of 1.0 with a 95% confidence range of 0.097 to 1.03. The totals for the (quasi-)vaccinated women were 1992 / 2876 = 0.693 and for the untreated women 16685 / 22688 = 0.735, showing much *more* risk for the (quasi-)vaccinated women.
I don't understand how their analysis system works - and I don't have time to find out. Can anyone explain it?
The raw figures I quoted and the ratios I calculated above are in Fig 4, to the left of the RR effect sizes. For the miscarriage results they rate the certainty as "low" and for the ongoing pregnancy / live birth figures, "very low".
This survey was unable to analyse differences in other variables such as measures of health of the women, due to the widely divergent reporting methods in the various studies. Since they worked from pregnancies, they were not in a position to judge any ill effects on the rate at which women became pregnant, either for any given level of sex, or by overall intention - with potential pandemic and fear-induced effects reducing how often they had sex in settings which could result in pregnancy.