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Three COVID-19 vaccines in the US have been released for sale by the FDA under Emergency Use Authorization(EUA) based on a clinical trial design employing a surrogate primary endpoint for health, severe infections with
COVID-19. This clinical trial design has been proven dangerously misleading. Many fields of medicine, oncology
for example, have abandoned the use of disease specific endpoints for the primary endpoint of pivotal clinical
trials (cancer deaths for example) and have adopted “all cause mortality or morbidity” as the proper scientific
endpoint of a clinical trial. Pivotal clinical trial data from the 3 marketed COVID-19 vaccines was reanalyzed
using “all cause severe morbidity", a scientific measure of health, as the primary endpoint. “All cause severe
morbidity” in the treatment group and control group was calculated by adding all severe events reported in the
clinical trials. Severe events included both severe infections with COVID-19 and all other severe adverse events
in the treatment arm and control arm respectively. This analysis gives reduction in severe COVID-19 infections
the same weight as adverse events of equivalent severity. Results prove that none of the vaccines provide a health
benefit and all pivotal trials show a statically significant increase in “all cause severe morbidity" in the vaccinated
group compared to the placebo group. The Moderna immunized group suffered 3,042 more severe events than
the control group (p=0.00001). The Pfizer data was grossly incomplete but data provided showed the vaccination
group suffered 90 more severe events than the control group (p=0.000014), when only including “unsolicited”
adverse events. The Janssen immunized group suffered 264 more severe events than the control group (p=0.00001).
These findings contrast the manufacturers’ inappropriate surrogate endpoints: Janssen claims that their vaccine
prevents 6 cases of severe COVD-19 requiring medical attention out of 19,630 immunized; Pfizer claims their
vaccine prevents 8 cases of severe COVID-19 out of 21,720 immunized; Moderna claims its vaccine prevents
30 cases of severe COVID-19 out of 15,210 immunized. Based on this data it is all but a certainty that mass
COVID-19 immunization is hurting the health of the population in general. Scientific principles dictate that the
mass immunization with COVID-19 vaccines must be halted immediately because we face a looming vaccine
induced public health catastrophe.
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