ORLANDO, FL — A recent analysis by two researchers clearly questions the conclusions of a so-called “study” performed by the Centers for Disease Control and Prevention (CDC) and published in The New England Journal of Medicine (NEJM) and now cited to support the use of the COVID shots in pregnant women.
In their analysis, “Spontaneous Abortions and Policies on COVID-19 mRNA Vaccine Use During Pregnancy,” Dr. Simon Thornley, a senior lecturer in the University of Auckland’s Section of Epidemiology and Biostatistics, and Dr. Aleisha Brock, a researcher in New Zealand, reveal that the CDC “study” “presents falsely reassuring statistics related to the risk of spontaneous abortion in early pregnancy, since the majority of women in the calculation were exposed to the mRNA product after the outcome period was defined (20 weeks’ gestation).” In fact, their analysis found that the “Preliminary Findings of mRNA Covid-19 Vaccine Safety in Pregnant Persons” actually indicates an increased incidence of miscarriages seven to eight times higher than the authors’ results.
The limitation and inaccuracies of this “study” are many. The authors Shimabukuro, et al., analyzed data from December 14, 2020, to February 28, 2021 (an 11-week span). That’s less than one trimester of a nine-month pregnancy. Data was collected from three U.S. vaccine safety monitoring systems: the v-safe after vaccination health checker, the v-safe registry, and the Vaccine Adverse Event Reporting System (VAERS). The CDC’s v-safe registry is a smartphone app which sends text messages to participants to prompt them to complete an online survey to assess their health status and encourage reporting of adverse reactions post-vaccination. Therefore, since participants communicated through a phone app, it is impossible to know whether they are actually women, pharmaceutical employees, or even pregnant.
Thornley and Brock draw attention to the errors and recalculate the risk of pregnant women taking the COVID injection. The CDC “study” presents falsely reassuring statistics related to the risk of miscarriage in early pregnancy since the majority of women in the calculation were exposed to the injection after the outcome period was defined (20 weeks’ gestation). It also states that the sample population is a “total of 35,691 v-safe participants 16 to 54 years of age identified as pregnant.” However, the authors only followed 827 people who identified as pregnant. Yet Thornley and Brock found that a closer inspection reveals that between 700 and 713 women were exposed to the injection after the time frame for recording the outcome had elapsed (up to 20 weeks of pregnancy).
Thornley and Brock also refute the safety of the COVID shots for pregnant women, give the many research limitations in this “study” such as when an incorrect denominator was used in calculating pregnancy loss in the first 20 weeks and the authors did not disclose essential descriptive statistics required to critique their recommendations.
Following the submission of Thornley and Brock’s analysis, a correction was published to the “study” resolving some of the questionable calculations. The CDC scientists acknowledged they should have made clear that they could not accurately calculate a risk estimate for miscarriages because follow-up data was not yet available for most of the women. Shimabukuro, et al., admit that “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.” However, there are still more inaccuracies, according to Thornley and Brock.
SOURCE Liberty Counsel
Related study mentioned in the Epoch Times:
Using data from the study and several estimates, the New Zealand researchers calculated that spontaneous abortions occurred in 81.9 percent to 91.2 percent of the women who were vaccinated before 20 weeks of gestation.
“We question the conclusions of the Shimabukuro et al. study to support the use of the mRNA vaccine in early pregnancy, which has now been hastily incorporated into many international guidelines for vaccine use, including in New Zealand,” the researchers said.
“The assumption that exposure in the third trimester cohort is representative of the effect of exposure throughout pregnancy is questionable and ignores past experience with drugs such as thalidomide. Evidence of safety of the product when used in the first and second trimesters cannot be established until these cohorts have been followed to at least the perinatal period or long-term safety determined for any of the babies born to mothers inoculated during pregnancy,” they added.
Their study’s title and abstract is:
Spontaneous Abortions and Policies on COVID-19
mRNA Vaccine Use During Pregnancy
Aleisha R. Brock, Simon Thornley
The use of mRNA vaccines in pregnancy is now generally considered safe for protection against
COVID-19 in countries such as New Zealand, USA, and Australia. However, the influential CDCsponsored article by Shimabukuro et al. (2021) used to support this idea, on closer inspection, provides
little assurance, particularly for those exposed in early pregnancy. The study presents falsely reassuring
statistics related to the risk of spontaneous abortion in early pregnancy, since the majority of women in
the calculation were exposed to the mRNA product after the outcome period was defined (20 weeks’
In this article, we draw attention to these errors and recalculate the risk of this outcome based on the
cohort that was exposed to the vaccine before 20 weeks’ gestation. Our re-analysis indicates a
cumulative incidence of spontaneous abortion 7 to 8 times higher than the original authors’ results
(p < 0.001) and the typical average for pregnancy loss during this time period. In light of these findings,
key policy decisions have been made using unreliable and questionable data. We conclude that the
claims made using these data on the safety of exposure of women in early pregnancy to mRNA-based
vaccines to prevent COVID-19 are unwarranted and recommend that those policy decisions be
Copyright © The Authors — Published Under the Creative Commons License
Comments are closed.