Preprint Article Version 1 This version is not peer-reviewed

Are COVID-19 Vaccines in Pregnancy as Safe and Effective as the U.S. Government, Medical Organizations, and Pharmaceutical Industry Claim? Part II

Version 1 : Received: 29 June 2024 / Approved: 1 July 2024 / Online: 1 July 2024 (10:20:29 CEST)

How to cite: Thorp, J. A.; Benavides, A.; Thorp, M. M.; McDyer, D. C.; Biss, K. O.; Threet, J. A.; McCullough, P. A. Are COVID-19 Vaccines in Pregnancy as Safe and Effective as the U.S. Government, Medical Organizations, and Pharmaceutical Industry Claim? Part II. Preprints 2024, 2024070069. https://doi.org/10.20944/preprints202407.0069.v1 Thorp, J. A.; Benavides, A.; Thorp, M. M.; McDyer, D. C.; Biss, K. O.; Threet, J. A.; McCullough, P. A. Are COVID-19 Vaccines in Pregnancy as Safe and Effective as the U.S. Government, Medical Organizations, and Pharmaceutical Industry Claim? Part II. Preprints 2024, 2024070069. https://doi.org/10.20944/preprints202407.0069.v1

Abstract

Introduction: In Part II of this three-part series, we expose techniques that can be used by the U.S. Centers for Disease Control and prevention (CDC) and Food and Drug Administration (FDA) to manipulate and throttle the Vaccine Adverse Event Reporting System (VAERS), a vaccine safety monitoring system open to the public. The U.S. government’s recommendation of COVID-19 vaccines during pregnancy was more a product of propaganda than of science and plagued with conflicts of interest. The extreme breach of COVID-19 vaccine pregnancy complication safety signals documented in VAERS cannot be disregarded or concealed. As a result, CDC/FDA are moving to closed, government captured platforms, including V-safe, Vaccine Safety Datalink (VSD) system, and the Biologics Effectiveness and Safety (BEST) system. Public transparency of adverse events following COVID-19 vaccination in pregnancy should be increased, not thwarted. Methods: In Part I 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 vaccination. In Part II we investigate tactics discovered in VAERS that concealed vaccine injuries and deaths. Conflicts of interest, as well as specific communications and publications from the CDC/FDA and the New England Journal of Medicine (NEJM) are analyzed. Results: Of all VAERS AE reports, 8.47% (138,983) of COVID-19 reports had no vaccination date and thus were missing from the data presented in Part I of this series. We unconcealed data presented in Part I of this series to include VAERS case reports that were excluded when using standard queries because of an “unknown vaccination date”. The unconcealed data in the 37 AE cases reported in this study (Part II) ranged from 0 - 38% with a mean of 8.2% (standard deviation 9.7%) and the significant breaches of VAERS safety signals in Part I of this series were largely underestimated. Another method of concealing vaccine associated AEs is to exclude the specific vaccine type rendering it as an “unknown vaccine type”. “Unknown vaccine type” has logarithmically increased since the rollout of the COVID-19 vaccines in 2021, ranging from 1 to 400 cases between 1990 to 2018 to 11,461 cases in 2021. CDC/FDA granted $67 million via a Cooperative Agreement grant to Massachusetts Department of Public Health (MDPH) between July 1, 2019, to June 30, 2025. MDPH then made subawards under this grant to 21 influential public and private health and civic organizations, including NEJM’s owner, Massachusetts Medical Society (MMS). As one of the subawardees under the grant, MMS as owner of NEJM received over $426,000 in federal HHS/CDC grant money from 2019 to 2020 for “public health and medical emergency preparedness projects”. Conclusions: CDC/FDA has failed to capture and account for a significant number of AE case reports following COVID-19 in VAERS by a variety of techniques in an apparent attempt to sanitize the data. CDC’s Rochelle Walensky and NEJM’s Editor-in-Chief Eric Rubin pushed novel untested COVID-19 vaccines in pregnant women despite clear evidence from multiple sources that safety signals had been breached.

Keywords

COVID-19 Vaccines; Pregnancy Complications; Cervical Insufficiency; Miscarriage; Stillbirth; Preterm Delivery; Preeclampsia; Fetal Growth Restriction; Fetal Malformations; Premature Newborn Death; Newborn Complications 

Subject

Medicine and Pharmacology, Obstetrics and Gynaecology

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