German Researcher Concerned about Number of COVID-19 Associated Vaccine Deaths and AE in EMA Database
https://trialsitenews.com/germ…s-and-ae-in-ema-database/
Recently, a German researcher investigated, reviewed, and analyzed spontaneously reported fatalities and adverse events associated with COVID-19 vaccines in Europe. Conducted by Dresden-based Karla J Lehmann, this analysis probed the number of recorded adverse events and fatalities. It assessed the cardiovascular adverse events up to a specified data in European countries. The study inquired into the EudraVigilance web reports originating from the European Medicines Agency (EMA) and some data from the German PEI safety system. Ms. Lehmann emphasized an “alarming” rate of COVID-19 vaccine-associated suspected side effects as well as potential deaths. The German researcher also pointed out large volumes of cardiovascular reactions associated with the databases—in many cases of a life-threatening nature. For example, what she refers to as cardiac and heart circulatory triggered deaths represented nearly a third of vaccine-related deaths associated with the Pfizer-BioNTech vaccine called Comirnaty.
The subject of COVID-19 vaccine-associated adverse events and deaths is most certainly controversial, and this recent study uploaded to preprint is no exception. She notes that in the past, with other vaccines, the level of fatalities or cardiovascular events associated with vaccines were uncommon. While few researchers delve into this controversial subject, possibly due to intense societal pressure to accept the dominant risk-reward narrative in much of the developed world, Lehmann takes the plunge, undoubtedly making herself controversial in the process.
Not Recognized Thus Far
Ms. Lehmann reminds the reader that, to date, many sizable numbers of cardiovascular adverse events and deaths aren’t accepted as necessarily causally linked, and many are overwhelmingly justified by the risks of not executing the mass vaccination program.
One exception, of course, has been for vascular and thrombotic as well as embolic side effects, which can lead to serious consequences. Lehmann declared that in these cases, “the mechanism of action suggests that downregulation of ACE2 by non-neutralized spike proteins may have cardiovascular effects.”
Vascular thrombotic/embolic events represent the second most prominent side effects associated with the COVID-19 vaccines. The scholar suggests that to better understand why sinus vein thrombosis and other thrombotic/embolic events are associated with AstraZeneca’s Oxford vaccine known as Vaxzervia. The author suggests that cardiovascular side effects are of real concern. Yet, systematic and rigorous study shows limitations associated with the nature of how these reports are filed, the lack of adequate recording procedure, and the lack of specific case information or ability to compare to a select population.
Discussion
First, Lehmann notes that the “EudraVigilance database is more comprehensive and differentiated compared to the German safety reports. Those vaccinated were predominantly between the ages of 18-64 years (66-81.6%). Among them, 67%-74% were women and 24%-31% men.”
She reports 525,907 total cases (about 0.2% of all vaccinations by June 5, 2021) for all vaccines and any side effects. In a table, the German author reports that 13,867 fatalities (2.64%) were recorded. Put another way, on average, “1.1 % of vaccinated persons with ADRs in Germany and 2.64T% of Europeans died in connection with ADRs.” Lehmann found that this high number represents an anomaly for any vaccine product.
Lehmann shares an average annual rate in Germany totaling 3.8 reports/day and 0.028 deaths per day for adults. The report declares, “There was a 50-133 fold increase in reported side effects in temporal relation to COVID-19 vaccinations and a 187-200 fold increase in vaccine ADR -related fatalities.”
The German author concluded that “The quantity and quality of the analyzed general side effects of COVID-19 vaccines and the specific cardiovascular side effects of Comirnaty and Vaxzervia are a matter of concern.”
Lead Research/Investigator
Karla J Lehmann
Ms. Lehmann is a specialist in pharmacology and toxicology, an author of 55 scientific publications and manual contributions, as well as numerous lectures, drug reports for initial and post-registration as well as for Periodic Safety Update Reports (PSUR).
Call to Action: TrialSite provides a link to the study.
https://osf.io/gh9u2/