Overview

Medical journals and textbooks are clear that the only way to accurately determine the life-or-death impacts of medical treatments is by measuring “all-cause mortality” in “randomized controlled trials.” Clinical lingo aside, this is simply the number of deaths in studies where people are randomly assigned to receive or not receive a certain treatment.

Though widely ignored in media coverage of COVID-19 vaccines, medical journals describe all-cause mortality in randomized controlled trials (RCTs) as:

• “the most objective outcome” (Journal of Critical Care)
• “the most relevant outcome” (The Lancet Respiratory Medicine)
• “the most significant outcome” (JAMA Internal Medicine)
• “the most important outcome” (PLoS Medicine)
• “the most important outcome” (Journal of the National Medical Association)
• “the most important outcome” (International Journal of Cardiology)

Beyond the fact that death is the most severe and clearest health outcome, the reason why this measure is more vital than any other is because RCTs control for every possible confounding factor, including those that are not obvious. Thus, a clinical research methods guide states that RCTs are the “gold standard” for research because they provide “a rigorous tool to examine cause–effect,” which “is not possible with any other study design.”

Combined with the use of a placebo so that people don’t alter their mindsets or behaviors as a result of knowing they received the treatment, quality RCTs ensure that any significant difference in the total number of deaths among the people who receive and don’t receive a treatment is, in fact, caused by the treatment. This eliminates subjective judgments about the root causes of death, which is a major point of contention with COVID-19 vaccines.

Unlike other data which can be easily manipulated through statistical tampering, all-cause mortality in RCTs is straightforward and solid. If an RCT is large enough and properly conducted, a simple tally of all deaths among people who receive and don’t receive a treatment proves whether the treatment saves more lives than it takes.

Underscoring all of the above facts, medical textbooks and journals explain that:

• RCTs are “the pinnacle in clinical design.”
• RCTs are “the best way to study the safety and efficacy of new treatments.”
• “the act of randomisation in a large” RCT “balances participant characteristics (both observed and unobserved) between the groups, allowing attribution of any differences in outcome to the intervention.”

In this case, the “intervention” is FDA-approved COVID vaccines, and the “outcome” is death. That vital data was gathered in RCTs involving 72,663 adults and older children for the Moderna and Pfizer vaccines. However, the FDA presented these results in a place and manner likely to be overlooked, and no major media outlet has covered them.

The results reveal that 70 people died during the Moderna and Pfizer trials, including 37 who received COVID vaccines and 33 who did not. Combined with the fact that half of the study participants were given vaccinations and the other half were given placebos, these crucial results provide no indication that the vaccines save more lives than they take.

Accounting for sampling margins of error — as is common for medical journals and uncommon for the media — the results demonstrate with 95% confidence that:

• neither of the vaccines decreased or increased the absolute risk of death by any more than 0.08% over the course of the trials.
• the vaccines could prevent up to two deaths or cause up to three deaths per year among every 1,000 people.

Importantly, those results:

• apply to adults and older children averaged as a group, and the vaccines’ benefits and risks can vary considerably for each individual.
• don’t apply beyond the timeframes of the studies, which were limited to several months.
• don’t apply to people who were excluded from the studies, including those who are severely ill, previously had COVID-19, or have an immune disorder like HIV.
• don’t apply to the currently dominant SARS-CoV-2 variant (Omicron).

Just Facts asked four Ph.D. scholars with contrasting views about COVID vaccines and who specialize in the disciplines addressed in this research to critically review it. Among those who did so, they assessed it as follows:

• Jessica Rose, Ph.D. in Computational Biology, Postdoctorate in Molecular Biology, Postdoctorate in Biochemistry: “I rarely have nothing to say when I read something with regard to corrections, but this is accurate and well written.”
• Rodney Sturdivant, Ph.D. in Biostatistics, Director of the Statistical Consulting Center at Baylor University: “The facts, so well laid out in this article, are a call for a very careful review and more study before future shots are recommended. All statisticians and scientists should be demanding better from the FDA.”

For more details, continue reading the full research here.

James D. Agresti is the president of Just Facts, a think tank dedicated to researching and publishing verifiable facts about public policy issues.