The following was produced by Steve Kirsch. TrialSite’s Op-ed exists to provide point of view and perspective, not necessarily the view of this media platform. But diversity of opinion and perspective during a crisis such as this is of utmost importance. Steve Kirsch, a drug development philanthropist, regular contributor to the TrialSite, and founder of the COVID-19 Early Treatment Fund (CETF), is actively funding research into generic repurposed drugs such as fluvoxamine that evidence efficacy targeting COVID-19. Kirsch, a trained engineer from Massachusetts Institute of Technology (MIT), made a fortune in Silicon Valley, inventing notable technologies such as the optimal mouse. The Silicon Valley entrepreneur turned drug development philanthropist now studies the novel COVID-19 vaccines, with a particular interest in ensuring that the public is sufficiently safe. He recently focused his attention on the Centers for Disease Control and Prevention (CDC) Vaccine Adverse Event Reporting System (VAERS), comparing and evaluating the past ten (10) years of safety data associate with the influenza vaccine versus the brand new mRNA-based COVID-19 vaccines now authorized under emergency use for COVID-19. TrialSite notes that there is overwhelming evidence that these vaccines are effective, and, in fact, recent studies indicate that most people that end up in the emergency room today are those that haven’t been vaccinated. But the Silicon Valley entrepreneur turned drug development philanthropist makes some discoveries.
TrialSite’s focus on research transparency and accessibility over time contributes to a greater overall trust in biomedical research, which leads ultimately to greater patient and volunteer participation, critical in the advancement of medicine. Kirsch recently ran a comparison of the influenza and COVID-19 vaccines. TrialSite must qualify that the data reported on in VAERS isn’t necessarily associated with the actual vaccine. In fact, the U.S. government repeatedly declared that deaths reported in association with the vaccine have been systematically declared not directly associated with the jab.
The CDC operates a vast nationwide safety monitoring program that includes not only VAERS but also v-SAFE, as well as other Vaccine Reporting Systems and the COVID-19 Vaccine Safety Monitoring Systems for Pregnant People.
About 42% of the U.S. population has been vaccinated, to date, representing one of the vastest mass vaccination programs in history. About 296 million people have received at least one dose and about 136 million people have been fully vaccinated. From one point of view, the probability of any safety incident is indeed very low. That’s one reason why the CDC recently changed the mask mandate and how, from state to state, normalcy appears on the horizon. With such an important mission, the proper recording, tracking, and analysis of safety incidents represents a key input for ongoing continuous improvements to the next wave of vaccine products.