Research Calls Into Question CDC Study Assuring Safety of COVID-19 Vaccine in Pregnancy

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 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 Dec. 14, 2020, to Feb. 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 that 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. {eoa}

This article originally appeared at lc.org.

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