Are COVID-19 Vaccines in Pregnancy as Safe and Effective as the Medical Industrial Complex Claim? Part I
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Abstract
Introduction: In Part I of this three-part series, we report a retrospective, population-based cohort study assessing rates of adverse events (AEs) in pregnancy after COVID-19 vaccines compared to the same AEs after influenza vaccines and after all other vaccines.
Methods: Data were collected from the U.S. Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA). The CDC/FDA Vaccine Adverse Event Reporting System (VAERS) database was queried from January 1, 1990 to April 26, 2024, for adverse events (AEs) involving pregnancy complications following COVID-19 vaccination. The time-period included 412 months for all vaccines except COVID-19 vaccines, having been used for only 40 of the 412 months (December 1, 2020 to April 26, 2024). Proportional reporting ratios (PRR) by time compared AEs after COVID-19 vaccination to those after influenza vaccination, and after all other vaccine products administered to pregnant women. In cases in which the PRR was not applicable, Chi-square analysis and Fisher’s exact tests were used according to CDC/FDA guidance. CDC/FDA stipulate a safety concern if a PRR is ≥ 2 or if a Chi-square is ≥ 4.
Results: The CDC/FDA’s safety signals were breached for all 37 AEs following COVID-19 vaccination in pregnancy including miscarriage, chromosomal abnormalities, fetal malformations, cervical insufficiency, fetal arrhythmia, hemorrhage in pregnancy, premature labor/delivery, preeclampsia, preterm rupture of membranes, placental abnormalities, fetal growth restriction, stillbirth, newborn asphyxia and newborn death. All p values were ≤ 0.001 with the majority being <0.000001.
Conclusions: We found unacceptably high breaches in safety signals for 37 AEs after COVID-19 vaccination in pregnant women. An immediate global moratorium on COVID-19 vaccination during pregnancy is warranted. The United States government, medical organizations, hospitals, and pharmaceutical companies have misled and/or deceived the public regarding the safety of COVID-19 vaccination in pregnancy. The promotion of the COVID-19 vaccines in pregnancy by The American College of Obstetricians and Gynecologists (ACOG), The American Board of Obstetrics & Gynecology (ABOG), and The Society for Maternal Fetal Medicine (SMFM) must cease immediately.
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Introduction
The “Golden Rule of pregnancy” has remained unchanged throughout millennia: Novel and/or potentially harmful substances are never used when new human life is being formed and nurtured within the womb. Even foods and beverages normally considered safe for most people are ill-advised during pregnancy such as unpasteurized milk, fermented foods (such as kombucha, yogurt, and certain cheeses), as well as some preparations and types of fish. Experts agree that small amounts of alcohol could potentially cause harm to the developing embryo and fetus and should therefore be avoided in pregnancy. The foregoing list is hardly exhaustive. Many other foods and beverages are avoided during pregnancy for the same reason – they have the potential to cause harm during pregnancy.
The Golden Rule of pregnancy was emblazoned on the collective consciousness of the global community after the thalidomide and diethylstilbestrol (DES) pregnancy disasters of the 20th century. Novel and untested medical interventions introduced during any stage of pregnancy are avoided, due to their high potential to cause short- and long-term multigenerational harms that may not be discoverable for years or even decades. The thalidomide and DES disasters demonstrate how easily delicate and intricate processes in the developing embryo/fetus can be catastrophically damaged when a novel teratogenic agent is given during pregnancy. During the vulnerable embryonic stage, the intricate blueprint for a new human life is created, including formation of all major systems and structures. During the fetal development stage, critical growth and development of all the major organ systems takes place. Because of the graphic nature of severe birth defects caused by thalidomide, it is perhaps better remembered than DES. Yet thalidomide (which we discuss in Part II) caused far less morbidity and mortality in pregnancy than did DES.
DES was widely prescribed to pregnant women for several decades with as many as 10 million exposed globally [1]. All physicians, especially obstetricians, know that DES was associated with cervical malformations in the daughters exposed in-utero. This tragically resulted in infertility, recurrent pregnancy loss, ectopic pregnancy, miscarriage, cervical insufficiency, preeclampsia, premature delivery, stillbirth, and neonatal death [2].
Ironically, the pharmaceutical industry marketed DES in pregnancy as a novel method to avoid pregnancy loss. Yet DES also caused clear cell adenocarcinoma of the cervix and vagina, as well as breast cancer [2]. DES complications were multigenerational and not limited to reproductive disasters in women. DES caused multiple complications in both sexes including autoimmune disease, neurodevelopmental alterations, psychosexual disorders, depression, immunologic complications, pancreatic disorders, early menopause, and cardiovascular problems [1,2]. Epigenetic alterations have been detected, and generational effects are observed in both DES daughters/sons, and DES granddaughters/grandsons [1,2]. As the data in this study demonstrates, the carnage caused by DES was unrivaled in history until administration of COVID-19 vaccines during pregnancy. Results of this study, as well as reports of adverse event data following COVID-19 vaccination in pregnancy prior to this study, similarly point toward the possibility (if not probability) of long-term, multigenerational harms [3-8].
The purpose of Part I presented here is to assess the effects of COVID-19 vaccines on pregnancy outcomes through the Vaccine Adverse Event Reporting System (VAERS) database. VAERS is a national early warning system for vaccine safety established in 1990 as an outgrowth of the National Childhood Vaccine Injury Act signed into law in 1986 [9]. VAERS is co-managed by the U.S. Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA).
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