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COVID-19 Vaccine Efficacy Grossly Overestimated from Non-Randomized Studies
Multiple Sources of Bias Created Illusion that Vaccines Worked as they Failed in the Real World
By Peter A. McCullough, MD, MPH
Proponents of COVID-19 mass vaccination will admit the products are not perfect yet claim they saved “millions of lives.” Major therapeutic claims such as mortality reduction with a single novel product can only be made on the basis of large, prospective, randomized, double-blind, placebo-controlled randomized trials with proper primary endpoints. Non-randomized studies have threats to validity that cannot be overcome.
Fung et al in a recent paper just scratch the surface in addressing this complex issue. They point out that background infection rates and cross-overs from unvaccinated to vaccinated early in the campaign were sources of bias that led to inflated vaccine efficacy.
There are two major determinants of hospitalization and death that have not been handled in every paper claiming the vaccines worked: 1) early treatment for COVID-19 at home that would prevent a hospitalization or death, 2) natural immunity from a prior infection. When analyzing any study of COVID-19 vaccine efficacy, look for these variables in Table 1 of baseline characteristics—you wont find them. It is my experience that vaccinated persons are so worried about COVID-19 they are the first to get on early treatment. Additionally, so many COVID-19 recovered were forced to take vaccines under the mandates, they work to make the “vaccinated” group look better in observational studies.
Most studies conducted in the US do not have access to the CDC vaccine database, hence we cannot verify vaccine status. To make matters worse, electronic records used in hospitals default to “unvaccinated” so unless a sick COVID-19 patient can find and produce their vaccine card and be sure its corrected in the computer, they are counted as unvaccinated when indeed they were jabbed. This is certainly true for those in respiratory isolation where family members are not prompted and or cannot bring in the vaccine card.
Almost all the observational studies rely on PCR or antigen test positive to determine cases as opposed to clinical adjudication. Since COVID-19 tests are intermittently positive for many months after infection, the cause of a hospitalization or death could be another illness in many patients who are test positive, hence without adjudication we cannot know if the vaccine is impacting COVID-19 pneumonia.
Finally, the issue of investigator funding bias cannot be understated. Since the CDC and FDA are the named cosponsors of the COVID-19 vaccine campaign, they cannot be trusted sources of data or analysis on vaccine efficacy. They have been given marching orders to get a needle in every arm as a national security operation—so propaganda is widely used by the agencies. Additionally, the NIH co-owns an mRNA vaccine patient, thus they cannot be unbiased. Investigators, company employees, or scientists at institutions that have received funding from CDC, NIH, vaccine suppliers, or HHS COVID-19 counter-measure programs also have to be held in suspicion of being biased to promote vaccination even it is has failed.
For all of the above reasons, claims that the COVID-19 vaccines worked to reduce spread of infection, hospitalization, and death must be rejected. The burden of proof has not been met and threats to validity have not been overcome. All of the COVID-19 vaccines should be removed from the market and we should begin the investigative phase into how this massive program failed to stop COVID-19.