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Are COVID-19 Vaccines in Pregnancy as Safe and Effective as the Medical Industrial Complex Claim? Part I
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.
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