The Pharmacovigilance Betrayal of the COVID-19 Era

Abstract

A vaccine clinical trial phase 1 and 2 involve up to a few hundred very healthy people, to make sure the vaccine is safe enough for phase 3 involving a few thousand very healthy people - all of it orchestrated by the pharmaceutical company that stands to profit.  By the time it is approved by the Food and Drug Administration (FDA), if a bad reaction is uncommon we’re not going to see it in a few-thousand person study - but, like how not every single cigarette causes cancer, the dangers are still real.  We simply do not know what adverse events will look like in a diverse large population until vaccines are administered to a diverse large population.  In essence, the clinical trial never ends, it’s just that our children become the subjects of the uncontrolled experiment.  We had better be watching awfully closely - that is pharmacovigilance.

For the COVID-19 shots, pharmacovigilance through the Vaccine Adverse Events Reporting System (VAERS) is described in the CDC’s 2021 VAERS SOP for COVID-19 Vaccines 1 . The VAERS SOP stated that the CDC and the FDA would each use a different data-mining method to look for “safety signals” in VAERS, and would collaborate to investigate any detected signals to determine whether there is a causal relationship between the shots and the adverse event with the signal.