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

"Abstract

Methods: ... [W]e investigate tactics discovered in VAERS [Vaccine Adverse Event Reporting System] 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...

Conclusions: CDC/FDA has failed to capture and account for a significant number of AE [adverse event] 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.

Introduction

... The purpose of Part II of this three-part series is to explore techniques that appear to 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) to limit adverse event data that we published in Part I. We also review the systematic discrediting of VAERS in favor of other federal vaccine safety surveillance systems that do not allow voluntary reporting of adverse events and/or are closed to independent scrutiny and public view. These include V-safe, Vaccine Safety Datalink (VSD) system, and the Biologics Effectiveness and Safety (BEST) system. Finally, we explore potential conflicts of interest between:

• CDC/FDA
• Then-CDC Director Rochelle Walensky MD MPH
• NEJM’s Editor-in-Chief, Eric Rubin MD PhD
• NEJM’s Managing Editor, Stephen Morrissey PhD
• CDC vaccine safety officer Tom Shimabukuro MD MPH
• Massachusetts Department of Public Health (MDPH)
• Owner of the NEJM – the Massachusetts Medical Society (MMS)...

Results

... All 37 AEs in pregnancy far exceed the CDC/FDA safety signal: a PRR of ≥ 2 or a Chi-square of ≥ 4. Summary statistics for the 37 AEs mean (n, range) are as follows: PRR 69.2 (46, 5.37 - 499); z statistic 9.64 (46, 3.29 - 27.0); and Chi-square was 74.7 (26, 28.9 - 148)...

Discussion

The findings in Part II document that pregnancy associated AE safety signals in Part I are underestimated because of a variety of intentional or unintentional omitted data missing from some VAERS fields. Danger signals in Table 1 are significantly underestimated because 'unknown vaccination date' and 'unknown vaccination type' exclude case reports submitted to VAERS from appearing in standard search results. Moreover, these two fields can be manipulated by VAERS administrators to conceal injuries and deaths and to sanitize unprecedented breaches in safety signals...

Many independent experts have documented large numbers of VAERS cases which were dropped, deleted, and never published...

In conclusion, COVID-19 vaccine safety mechanisms utilized by the CDC/FDA have insurmountable conflicts and biases. The CDC/FDA appear to have unsuccessfully attempted to sanitize VAERS case reports of AEs following COVID-19 vaccination in pregnancy by a variety of techniques described in this study. CDC/FDA attempted to conceal V-safe data that has now been exposed, much to the credit of attorney Aaron Siri and ICAN."