I have repeatedly written—and stated in many discussions—that vaccine efficacy has never been tested in patients, which is the only scientifically valid way to establish a drug’s (including vaccines) relevance and efficacy. Each time I raise this point, the reaction is often hostile. People respond as if I am ignorant, claiming I do not understand virology or medicine, that this subject is outside my expertise, and that there are “hundreds of studies” proving vaccine efficacy that I have supposedly failed to read or understand.
My position is not based on opinion, stubbornness, or a refusal to engage with the literature. It is based on logic, scientific reasoning, professional expertise, and careful reading of virology and medical publications. When examined critically, what many people assume has been proven has not been directly demonstrated in the way efficacy is established for real medicines.
From a scientific standpoint, efficacy can only be established by testing a drug in patients who actually have the disease. That requires a clearly defined and validated patient population. In the case of vaccines, the illness is claimed to be caused by a viral infection. Therefore, a mandatory prerequisite is the ability to establish and confirm viral infection in patients analytically.
This is where the framework collapses. A valid analytical test cannot be developed or validated without reference standards. For viral diseases, the required reference standard would have to be the virus itself—isolated, purified, and fully characterized. Without that reference standard, a properly validated diagnostic test for viral infection cannot exist in the scientific sense. Without a valid diagnostic test, it is impossible to define, confirm, and validate a true patient population.
As a result, vaccines are not tested in patients. They are tested in healthy human volunteers. Logically and scientifically, that means true efficacy against a viral illness cannot be established, because there is no validated way to identify infected patients and no validated patient population against which to measure real-world disease prevention.
What, then, does virology and medical practice call “vaccine efficacy”? An arbitrarily developed vaccine is given to one group of healthy volunteers. Another group receives either an inert substance labeled as a placebo or a comparison product. Both groups are then evaluated using surrogate laboratory tests—most commonly the PCR test or antibody assays.
However, these are not valid endpoints for establishing efficacy. If the underlying tests cannot be properly developed and validated without viral reference standards, then the outcomes derived from those tests cannot serve as scientific proof of efficacy. Despite this, relative differences between the two groups are treated as “evidence.” If fewer “positive” results occur in the vaccinated group than in the control group, the vaccine is declared effective.
In many cases (in fact, mostly), the absolute numbers are small—sometimes extremely small—yet the results are converted into impressive-sounding percentages. For example, if there are zero positives in one group and one or two positives in the other, efficacy can be reported as extraordinarily high, even approaching 100%. That is not a demonstration of real-world protection against a confirmed disease; it is a statistical outcome produced by surrogate definitions and surrogate tests applied to healthy volunteers.
The conclusion is unavoidable and unequivocal. Vaccine efficacy has not been tested in patients. This is not a semantic dispute, a philosophical disagreement, or a matter of interpretation—it is a factual consequence of how vaccine studies are actually conducted. Without a validated method to identify infected patients, there can be no patient-based efficacy testing. What is called “efficacy” in virology and medicine is therefore not efficacy in the real or scientific sense, but a constructed outcome derived from surrogate measurements applied to healthy volunteers.
What follows is not science, but a manufactured scenario: hypothetical disease definitions, unvalidated diagnostic proxies, relative comparisons, and statistical inflation presented as proof. Virology and modern medical practice have built an internally consistent narrative, but one that is detached from real, testable, physical verification. The appearance of rigor is maintained through publications, models, and repetition—not through validated analytical demonstration.
The issue, therefore, is not a lack of reading or understanding. It is a fundamental disconnect between what is labeled as “scientific evidence” in medicine and virology and what constitutes real, testable, and validated science in analytical chemistry. For this reason, I am correct in stating that vaccine efficacy has not been tested in patients. Until efficacy is demonstrated against a clearly defined disease in a validated patient population using scientifically valid reference standards, claims of vaccine efficacy remain assumptive, model-based, and unproven—regardless of how often they are repeated or how forcefully they are defended.
To further address this point, I asked ChatGPT to provide a summary of how vaccine efficacy is reported in the literature. The response below is fully consistent with what I have described. I hope you find it helpful.