Prof dr Veterinary Tropical Diseases
INCREASE OF ALL-CAUSE MORTALITY IN HUMANS FOLLOWING CORONA VACCINATION
The safety and efficacy studies are the core of vaccine development. These require the use of representative product, which means that raw materials used for production, production technology, internal and final product control, the dose of the active ingredient, presentation, and thus the final product, are a close representation of the product for which a marketing authorization is requested. The outbreak of the SARS-CoV-2 virus caused a sense of urgency that initiated a series of changes to formal registration requirements to shorten the time to market. These comprised changes to the use of genetically modified organisms, broad interpretation of what a vaccine is (which allowed skipping of biodistribution studies), in the absence of a validated experimental animal model of COVID-19 allowing immunogenicity studies and in vitro virus neutralization as efficacy studies, compressing phase 1, 2 and 3 studies in humans, and lack of medium and long term safety and efficacy data. As a result, the corona vaccines received an Emergency Use Authorization that allowed the use of the products and required reporting efficacy and safety data obtained from the field. Because it was regarded unethical not to offer vaccine to people that were potentially at risk of severe disease, ongoing registration studies were jeopardized by unblinding and vaccination of the subjects that had received placebo. As a result, only retrospective cohort studies and observational studies can be used to detect possible adverse events. Here we report the temporal association of waves of excess mortality in the population and vaccination campaigns in the Netherlands, and discuss immunopathological mechanisms that could explain these findings.