US COVID-19 Vaccines Proven to Cause More Harm than Good Based on Pivotal Clinical Trial Data Analyzed Using the Proper Scientific Endpoint, “All Cause Severe Morbidity”
Classen Immunotherapies, Inc, 3637 Rockdale Road, Manchester, MD
J. Bart Classen, MD*
Trends in Internal Medicine
Research ArticleCitation: Classen B. US COVID-19 Vaccines Proven to Cause More Harm than Good Based on Pivotal Clinical Trial Data Analyzed
Using the Proper Scientific Endpoint, “All Cause Severe Morbidity”. Trends Int Med. 2021; 1(1): 1-6.
J. Bart Classen, MD, Classen Immunotherapies, Inc, 3637 Rockdale Road, Manchester, MD 21102, Tel: 410-377-8526, E-mail: Classen@vaccines.net.
Received: 24 July 2021; Accepted: 25 August 2021
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.
Clinical trial data show there were actually few very “severe” cases of COVID-19 in either the vaccinated or the placebo group.
This fact is ignored by our corrupt public health ‘authorities’ who are pushing a continual narrative of fear, aided and abetted by a bought out media. According to Doctors for COVID Ethics, these injections are “needless, ineffective, and dangerous.”
Also important from the study:
- Moderna data shows that only one of 15,166 unvaccinated patients required admission to an intensive care unit for COVID-19.
- Data provided by Janssen shows that only a few of the “severe” COVID-19 infections required medical intervention, yet the vaccinated group had 595 severe Grade 3 or 4 events in the first 28 days post immunization.
- Table S10 in the appendix published in the New England Journal of Medicine  , shows only 2 of 19,514 patients immunized with the Janssen vaccine needed medical intervention for severe COVID-19
infections starting 14 days after immunization, while only 8 of 19,544 controls needed medical intervention for severe COVID-19 infections starting 14 days after placebo, where the infection was confirmed by a central lab. This benefit, reduction in 6 case of COVID-19 requiring medical intervention, in 19,630 vaccinated patients is simply statistically insignificant in a population that has a hundred fold more severe events of any cause.
Reductions in infection rates, hospitalization rates and even death with COVID-19 are poor surrogate markers for health and are not proper primary endpoints for a vaccine clinical trial.
Science thus does not support a health benefit with COVID-19 vaccines. All arguments for immunization are purely philosophical and based on false, discredited, assumptions.
Earlier this week I posted this article which methodically goes through the data and math required to understand “vaccine” efficacy. Again, as with the article above, in order to have good data, you must “count things and divide things which matter.” Regarding efficacy, it’s imperative to know how many infected people went on to die in each group. The author states that while “vaccine” manufacturers proclaim “vaccine” efficacy of 90% or better, no information is available to suggest that the death rate (what truly matters) is any different in the vaccinated vs the unvaccinated. Further, for certain age groups, the number actually leans towards a higher death rate among the “vaccinated.”
And then there’s the important issue of absolute risk. Go here to read an important article that explains how “vaccine” manufacturers are purposely using a statistical trick to make the injections look far more protective than they are.
In a July 1, 2021, commentary in The Lancet Microbe,3 Piero Olliaro, Els Torreele and Michel Vaillant also argue for the use of absolute risk reduction when discussing vaccine efficacy with the public. They too went through the calculations, coming up with the following:
- Pfizer/BioNTech — Relative risk reduction: 95%
- Absolute risk reduction: 0.84%
- Moderna — Relative risk reduction: 94%
- Absolute risk reduction: 1.2%
- Gamaleya (Sputnic V) — Relative risk reduction: 91%
- Absolute risk reduction: 0.93%
- Johnson & Johnson — Relative risk reduction: 67%
- Absolute risk reduction: 1.2%
- AstraZeneca/Oxford — Relative risk reduction: 67%
- Absolute risk reduction: 1.3%
It’s abundantly clear that when you actually utilize endpoints that matter, these injections are not only worthless – they are dangerous.
For more of Classen’s work: