How Much Harm Is Too Much for a Vaccine? We Already Have the Criteria

Lightspring/Shutterstock

There's evidence that suggests that aluminum is a neurotoxin.

There's evidence that shows that glyphosate is a cause of infertility.

Many vegans contend that a plant-based diet is positively associated with healthy aging.

There's a traditional Chinese belief that sweeping with a broom on New Year’s brings bad luck.

But how do we know if these things are actually linked or if they're just randomly associated?

How do public health officials, medical doctors, and patients themselves determine if there's a cause-and-effect relationship between aluminum and brain decline or glyphosate and fertility challenges?

This isn’t just a philosophical debate. Figuring out the answers to cause-and-effect questions has the potential to impact many of our health and lifestyle choices.

Correlation or Causation?

Sir Austin Bradford Hill was a medical statistician in Great Britain. In 1965, Hill established a set of nine “viewpoints” to determine when data demonstrated causation.

Hill’s work is still the foundation of showing cause and effect in epidemiology, as well as of showing statistically valid causation across the sciences.

You have heard the caution that “correlation is not causation.” This is a phrase repeated many times over, especially by industry spokespeople trying to defend the safety of pharmaceutical medications or other products.

The idea behind insisting that correlation doesn't equal causation is that just because two things happen together, it doesn’t mean that one caused the other.

A quick example: Let’s say a lot of people named Ashley drive Priuses. That doesn’t mean that Prius drivers must be named Ashley or that people named Ashley necessarily prefer Priuses. The observation can be true without there being any real connection between the name Ashley and Priuses beyond simple random chance.

However, when data show a correlation of any kind (whether it be sudden deaths among healthy young people who have recently had COVID-19 vaccines or Prius drivers named Ashley), Hill points to nine ways of proving causation.

The Bradford Hill Criteria

In 1965, long before cigarette manufacturers acknowledged there was any connection, Hill applied his criteria to smoking and cancer.

While everyone now recognizes the connection, it’s important to remember that smoking and lung cancer don't have a 1:1 correlation.

Many people, including Jennifer’s grandfather, are able to smoke like chimneys all their lives without getting lung cancer.

However, the Bradford Hill criteria point to smoking as a cause of lung and other cancers, including rare cancers that are found more frequently in smokers.

The Bradford Hill Criteria

1. Strength: The more two things occur together, the more likely the causality, even for rare events.
2. Consistency: Studies find the same correlation in different places and populations.
3. Specificity: A single cause produces a specific effect. (True of diseases like tuberculosis, for example, which is caused by a bacterium called “Mycobacterium tuberculosis”; not so simple for cancer, which appears to have multiple causes.)
4. Temporality: The cause must come before (precede) the effect.
5. Biological gradient: More exposure leads to more frequent consequences.
6. Plausibility: Is there a plausible mechanism for how one thing causes the other?
7. Coherence: Is the same effect found in both epidemiological studies of the population and in laboratory work?
8. Experiment: Can the correlation observed in the population be reproduced in a laboratory experiment?
9. Analogy: Is this cause-effect relationship similar to others we already understand?

Meeting Even One Criterion Enough to Show Causation

According to Hill, you don't need to satisfy all of his criteria in order to show a clear cause-and-effect relationship between two things.

In fact, satisfying any one of the Bradford Hill criteria is enough to suggest causation. But if several of the criteria are found, the causation is more likely. Many well-understood causes do not meet all of Bradford Hill’s criteria. The only one you must have in order to prove causality is temporality. In other words, the cause must come before the effect.

If any pharmaceutical product—including a prescription or over-the-counter medication or a vaccination—meets even just two of the criteria, caution would suggest that the possibility of causation be vigorously investigated.

Myocarditis in Young Men Post-COVID-19 Injection

Cases of myocarditis in young men who had received mRNA COVID-19 vaccines made UK health officials concerned that the risk of myocarditis may be as great or greater to young men than the risks of COVID-19 itself. Because of a risk-benefit analysis that showed that cases are higher in men who get the Pfizer vaccine, the UK's National Health Service now recommends young men get the Moderna injection.

When Florida public health officials did an extensive review of the existing data, they came to a very different conclusion. Florida Surgeon General Dr. Joseph Ladapo now recommends that adult men under 40 don't get vaccinated against COVID-19.

In a statement released on Oct. 7, 2022, Ladapo said:

“This analysis found that there is an 84% increase in the relative incidence of cardiac-related death among males 18–39 years old within 28 days following mRNA vaccination. With a high level of global immunity to COVID-19, the benefit of vaccination is likely outweighed by this abnormally high risk of cardiac-related death among men in this age group. Non-mRNA vaccines were not found to have these increased risks.

“As such, the State Surgeon General recommends against males aged 18 to 39 from receiving mRNA COVID-19 vaccines. Those with preexisting cardiac conditions, such as myocarditis and pericarditis, should take particular caution when making this decision.”

How does looking at the data lead to rescinding the recommendation that males aged 18 to 39 get vaccinated? The data showed the Bradford Hall criteria of strength—there is an increased incidence of myocarditis in more vaccinated populations; consistency—incidents of myocarditis post-vaccination have been found worldwide; temporality—young men (and many other people) are developing myocarditis following the COVID-19 vaccines; and perhaps specificity—until the rollout of the vaccination program, myocarditis in young men was extremely rare.

Research is now being done to look at plausible biological mechanisms to explain why the mRNA vaccines are causing heart inflammation.

In April 2021, the Centers for Disease Control and Prevention (CDC) temporarily paused the use of the Johnson & Johnson vaccine, after several women developed thrombosis and thrombocytopenia within two weeks of being vaccinated.

Since this specific condition was virtually unheard of before the vaccines, six cases in women between the ages of 18 and 48 were enough to get the attention of the public health authorities. Several Bradford Hill criteria were fulfilled, including temporality and strength. The CDC recommends using other vaccines against COVID-19. As they explain on their website:

“There is a potential cause-and-effect relationship between J&J/Janssen COVID-19 vaccine and a rare and serious adverse event. It is blood clots with low platelets (thrombosis with thrombocytopenia syndrome, or TTS). TTS occurs at a rate of about 4 cases per million Janssen’s Johnson and Johnson doses and has resulted in deaths. Because of this risk, vaccination with COVID-19 vaccines other than J&J/Janssen vaccine is preferred.”

Pharmaceutical Expert Weighs In

A former pharmaceutical executive, Sasha Latypova, spent her career founding several companies focusing on clinical trial reviews.

In a recent interview with UK Column, Latypova pointed to data that show—using the Bradford Hill criteria—it's clear that the harms of the COVID-19 injections outweigh the benefits.

Among other things, Latypova pointed to a Pfizer-funded rodent study that showed that pregnant rats had poor health outcomes. Pfizer dismissed the findings of skeletal abnormalities, feeding disturbances, and pregnancy loss in the vaccinated rodents as “incidental.”

But Latypova also mentioned that we know that there have been significantly more miscarriages and stillbirths in countries where large numbers of women have been vaccinated.

“The birth rates have declined in perfect correlation with the vaccination rates” in these countries, she said. "At the same time, we haven't seen a similar decline in poorer countries where pregnant women have not been getting COVID-19 injections. In those countries, birth rates have risen.

“What else do you need as proof?” Latypova asked rhetorically. “All the Bradford Hill criteria have all been met for all of this.”

There's a definite correlation between COVID-19 injections and adverse events, including declining birth rates, stillbirths, and other poor health outcomes. In most cases, if a drug is shown to cause harm by meeting just two Bradford Hill criteria, it would no longer be recommended. In this case, all nine Bradford Hill criteria are met.

It’s time for public health officials, along with medical doctors, epidemiologists, and everyone else, to reappraise the contention that these injections are safe.