Safe and Effective?

An appeal to the medical orthodoxy.

Photo by Sander Sammy on Unsplash

People feel very differently about the Covid-19 mRNA inoculations. Should we be so surprised? I’m not. People are different. We have different experiences. We listen to different sources. We have varying knowledge bases and capacities to synthesize information.  We have different biases.

What surprises me is that so many folks on both sides of the issue are shocked and frustrated that everybody is not in agreement.

Before delving into this further, let us take a few steps back and get a broader perspective on this quagmire we are all in. We should be able to see that:

• Both sides believe that they are absolutely correct

• Both sides believe that the other is hopelessly gullible and has been taken in by a false narrative

• Both sides believe that the other is causing harm to the population

In other words, both sides mirror each other except for two crucial differences: 

1. Only one side is pleading for an open debate while the other feels that such an exercise would not only be futile but dangerous. 

2. Only one side is advocating for uncensored expression of all opinions while the other, though acknowledging that censorship is anathema in most situations, believes that we are in an unprecedented time that calls for a selective gagging of certain opinions for the greater good.

Without debating “the science”, what does this fundamental difference between the two sides tell us? We should be able to agree that if they were wrong, the side calling for the gagging of the other will take a lot longer to realize it. How exactly would a group that censors dissenting opinions ever be able to see that they were mistaken to begin with?

Also notice that the Covid vaccine skeptics who are calling for open debate are advocating for freedom of expression for both sides, not just theirs. Of course, their magnanimous position doesn’t prove that they have the correct understanding of “the science”. Likewise, just because vaccine proponents believe that they have the exclusive right to propagate their ideas doesn’t mean they are wrong.

“Misinformation” is coming from both sides

First, I would like to demonstrate how both the skeptics and the proponents are responsible for spreading misinformation.

In February of 2022, the UK Expose ran this story:

Could the mortality rate of fully vaccinated 10-14 year old kids really be 51 times higher than unvaccinated kids of the same age? The authors of the piece cited data from England’s Office of National Statistics (ONS) and plotted it here:

The mortality rate of the fully vaccinated 10-14 year olds in England at the time was indeed 51 times larger than the unjabbed. What is not directly conveyed is that the pool of fully vaccinated kids was only about 1,600, whereas the pool of unvaccinated kids of that age was over two million.

What does this mean? Given the low mortality rate of children of this age to begin with, all it takes is a handful of deaths to cause a dramatic increase in the mortality rate in the tiny, fully vaccinated group. What was the cause of death in these four kids? Was it Covid-19? Was it homicide? Was it a car crash? We are not told.

Moreover, the two groups of kids were not matched by health status. Chronically ill and immunocompromised kids were being urged to vaccinate at that time.

The point here is that although the UK Expose accurately cited the ONS data, the article was misleading, especially to those who read no further than a headline.

Alternative media platforms are not the only ones that are guilty of disingenuous reporting. Take this piece from the Associated Press from the end of June, 2021:

Were nearly all Covid-19 deaths occurring in the Unvaccinated? Drs. Fauci and Walensky parroted this headline on numerous platforms. Strangely, the CDC at that time was not reporting the vaccination status of those who were perishing from Covid-19. Where was the data that supported these claims? If there was any, it wasn’t being shared publicly

A few weeks later, local publications ran similar headlines like this one from The Denver Post:

Unlike the AP article, the Denver Post cited their data source, in this case reports from the Colorado Department of Health.

There are two points to make here. The first is that the headline mentions deaths but not mortality rates like the Expose did. The second is that this is over a six month time period starting at the beginning of January 2021.

I downloaded the data from the Colorado Department of Public Health and plotted it here:

Can we see the problem here? We are not given the denominator, i.e. the number of person-years in each group. Most Coloradans were unvaccinated during this period of time as the plot on the right demonstrates. It was only during the last week of June when half the population was vaccinated.

Most of the monthly Covid-19 deaths occurred in January and February, a time where less than a few percent of the Colorado population was fully vaccinated. Over the six month reporting period, approximately 83% of the population in that state was unvaccinated.

To put it another way, if the Covid vaccines offered zero benefit, 83% of the deaths should have occurred in the unvaccinated.

Based on this data, the vaccines did in fact offer a temporary benefit in preventing Covid-19 deaths, but it wasn’t anywhere near the 96% effectiveness that the headline implied.

Was this an honest mistake? It’s up to you to decide. Nevertheless we can’t escape the fact that some people who were undecided in the summer of 2021 chose to get vaccinated based on headlines like these.

Both the UK Expose and the Denver Post were accurately citing data, but neither publication was accurately explaining the data. In fact, it is fair to say that both publications were intentionally misleading their readers.

This is the problem we have been having. How is the average person supposed to proceed? Are we to expect that everyone should “do their own research” and download data sets from the Office of National Statistics or State Departments of Health to cross check what appears in the media?

The point here is that those who subscribe to the “mainstream” position, those who believe these mRNA products are safe and have saved many lives are quick to label any information coming from outside their trusted sources as suspicious, unreliable or dangerous. The idea that their own sources could ever deliberately mislead anyone is too hard (or too scary) to accept.

Of course we could be equally critical of the vaccine skeptics, those that may have spread the UK Expose headline (and those like it) on their social media pages in an effort to warn their tribe of the potential danger of the jabs. 

Where Can We Agree?

At this time, there are very, very few sources we all can agree are valid. I suggest that to get the clearest picture of the safety and efficacy of the Covid-19 mRNA vaccines we should begin with the published and peer-reviewed findings of the Pfizer/BioNTech trial from November 2020 because:

• It is one of the few data sets that offers randomized, placebo control outcomes in two matched cohorts

• It was the largest of the vaccine trials

• It was the first formulation to be authorized for use in adults and adolescents

• The results of the trial form the lens through which we regard all subsequent findings

The last bullet point cannot be emphasized enough. Covid-19 vaccine proponents are resistant to the possibility that these products are unsafe because the Pfizer trial purportedly demonstrated that they were not only safe but wildly effective. The results were hailed as a triumph of modern medicine; the cavalry that arrived just when things were the darkest.

The ubiquitous lawn signs that urge us to “trust the science” may seem like a reminder to be objective, but in truth there is a significant emotional component to the messaging. It is a rallying of the troops, a call to solidarity and a reminder that the rational portion of society delivered on their promises and provided us with the protection that was needed to reclaim our lives. All that was left was to do our part and get in line.

Is it even possible to be objective about these things anymore?

What did the Pfizer Trial tell us about risk and benefit?

Here I want to take a hard look at how and why we initially concluded that the Pfizer/BioNTech SARS-COV2 mRNA vaccine was safe and effective. In order to do that, we must examine the results from the trial. The study was peer-reviewed and published in the New England Journal of Medicine in November, 2020.

The mRNA vaccines were granted emergency use authorization in December of 2020 because of their purported efficacy in preventing Severe Covid-19. How good were they exactly?

I am going to assume readers have some fluency in basic math and scientific terminology. 

Here’s how we unpack the study:

1. What is the reduction in absolute risk of getting Severe Covid if vaccinated?

2. Use that to calculate the Number Needed to Vaccinate (NNV)

3. How many Serious Adverse Events will result for every Severe Covid-19 Case avoided?

Absolute Risk Reduction

From NEJM:

RESULTS

A total of 43,548 participants underwent randomization, of whom 43,448 received injections: 21,720 with BNT162b2 and 21,728 with placebo... Among 10 cases of severe Covid-19 with onset after the first dose, 9 occurred in placebo recipients and 1 in a BNT162b2 recipient.”

There were approximately 21,720 participants in each wing of the trial. Nine cases of Severe Covid occurred in the placebo wing, only 1 in the therapy (vaccine) wing.

Thus, the vaccine offered an absolute risk reduction of (9 - 1)/(21,720) = 0.037%.

In other words, the risk of getting severe covid was 9/21,720 = 0.042% during the observational period if you got the placebo. It was 1/21,720 = 0.0047% if you got the vaccine. The vaccine conferred a 0.037% (0.042 - 0.0047) reduction in risk.

There are two big takeaways here. The first, the risk of contracting severe disease was tiny to begin with, regardless if you were “protected” by vaccination or not. Contrast that with the endless series of daily Covid deaths that were prominent in the corner of every CNN broadcast. Note, that at the time these results were published in the NEJM, there were no Covid deaths in either wing of the trial.

Second, it was these 10 outcomes that ultimately sold the vaccine to the public and the 250 million individuals that dutifully lined up for the primary series in this country alone. Yes, we inoculated billions of people based on what happened to these ten trial participants. Think about that…

Number Needed to Vaccinate

The reason why the absolute risk reduction is important is because it allows us to calculate the Number Needed to Vaccinate (NNV). The NNV is perhaps the most vital metric when evaluating the safety and efficacy of a preventive therapy like a vaccine. How many people have to get vaccinated to prevent a single case of severe disease?

The calculation is straightforward. For every 21,270 people inoculated eight cases are prevented. Inoculate 2659 (or 21,270/8) people and we prevent one case.

Is that number high, low or just right? It depends. It depends on the risk of getting vaccinated. Risk of vaccination has been rarely mentioned in the mainstream media which has been dominated by memes and PSAs from the CDC that assure us that these products have been thoroughly tested for safety.

But what was the risk exactly? Here we are not going to refer to PSAs from our trusted agencies of public health, nor are we going to cite others who claim that a depopulation agenda is in place and that everyone who got jabbed will die in a year. We are sticking with the published trial data. What did the trial tell us? Was there a risk? Yes there was.

Vaccination Risk: Serious Adverse Events

In order to make an apples to apples comparison we must weigh the risk of severe covid, the kind of covid that will put you in the hospital, with an adverse event that will do the same. We are not told how many people in the vaccine group were hospitalized for something other than Covid. We are, however, told how many of them ended up with a Serious Adverse Event (SAE).

“Serious” is not a subjective term. It means something specific to the FDA and to the Pfizer investigators. SAEs are:

• Death

• A period where your life was threatened

• The need for medical or surgical intervention

• Hospitalization (initial or prolonged)

• Permanent Disability

• Birth Defect

Were there SAEs suffered by the vaccinated pool in the trial? Yes there were. 

126 of 21,270 people had an SAE (see Table S3 below). This is about 0.6% or six per thousand.

The key question here is, how many SAEs will result from every case of severe Covid prevented?

This is where we need the NNV. 2,659 vaccinations will result in approximately 16 SAEs (2,659 x 0.006 = 16).

For every severe Covid case prevented 16 Serious Adverse Events will occur.

That’s what the trial demonstrated. The question should be, how could such a product be authorized by the FDA in the first place?

The answer is given here:

111 SAEs occurred in the placebo group!

This was about 0.5%. That’s almost the same as in the vaccine group, so the FDA advisors shrugged it off and focused only on the vaccine’s efficacy.

Vaccine Efficacy (VE) is a function of relative risk reduction. The VE in preventing severe Covid was 90%. This means that trial participants who received the experimental vaccine had a 90% less chance of contracting severe Covid-19 than those who got the placebo during the several months period of observation. The 90% VE comes from the fact that nine times more people in the placebo group got severe disease than in the vaccine group.

Hence, the public was told that the product had a remarkable ability to protect while having a risk that was negligible.

This is what the results showed.

Why were there so many SAEs in the placebo group?

The investigators assure us that the placebo was in fact saline, a safe and inert solution that is widely used. As an anesthesiologist I have personally given saline to about 20,000 patients in my career. Not one of them had ever had one of those SAEs occur soon after getting saline.

Is it possible that the placebo was not saline but some other substance that is potentially dangerous? We are not going to speculate. We are sticking with the official trial as our “truth”. The investigators assure us that the placebo was saline.

The reality is that 0.5% of the placebo group who had an SAE did not have the event as the direct result of the saline they received. This number represents the background rate of these events in the population.

Is this possible? Do five out of a thousand people end up with those kinds of things every six weeks (that was the average period of observation)?

It depends. It depends on which kind of SAE we are talking about. Is it death or permanent disability? Or is it a “medical intervention” in the form of a trip to the urgent care clinic? Pfizer does not tell us which of these events were occurring. Neither did they tell us who among the placebo group succumbed to these things. Was it mainly the octogenarians in the trial (very few of those)? Was it the ones with comorbidities (only 1 in 5)?

We are now faced with a lot of uncertainty because we also cannot compare the kinds of SAEs that occurred in the vaccine group with the ones that occurred in the placebo group.

Is it more prudent to shrug this off like our regulators did or should we look a little harder? I vote for the latter.

Brook Jackson and the proof of her allegations

Brook Jackson was a trial coordinator with 15 years of experience who was working at Ventavia, a Clinical Research Organization (CRO) that Pfizer had hired to conduct parts of their trial.

She was shocked to see that things were handled in very sloppy ways at her facility. She immediately notified the FDA of several of her concerns. She was fired from her position within 24 hours.

Among her allegations was the unblinding of investigators. She is saying that the investigators at her facility knew which participant was getting the vaccine and which were getting the placebo.

This is a massive accusation. If what she is saying is true, this would invalidate the entire trial and its findings. We can see that if the investigators knew who was getting what, it would be very easy to manipulate the findings, especially around SAEs. 

All one has to do is recommend that any minor symptom reported by a placebo recipient be treated with some kind of “medical intervention” and the incidence of SAEs in the placebo group will be artificially exaggerated, thus hiding the difference between the two groups. In order to pull this off, the investigators would have to know which participants got the placebo. They would have to be unblinded.

Could this have happened? Maybe. How could we know without trusting Ms. Jackson? Is she an authentic whistleblower who is courageously bringing light to medical fraud in the interest of the public? Or is she an unhinged anti-vax nut job seeking attention and remuneration?

Why should we trust her?

It turns out that we don’t have to trust her at all. There was unequivocal evidence of fraud, including investigator unblinding, in official communiques between Pfizer and the advisory committee for the FDA. It’s a matter of how close we are willing to look…

This is a table from an official memorandum sent from Pfizer to the Vaccine and Related Biological Products Advisory Committee (VRBPAC) of the FDA in support of their application for Emergency Use Authorization (EUA) for their product.

Table 2. Efficacy Populations, Treatment Groups as Randomized indicates how many participants in the trial remained at each stage of the trial. We do not expect that every participant enrolled at the beginning of the trial will complete it and contribute to the study’s results.

People leave for various reasons. They may not show up for their appointment. They may move or choose not to continue for personal reasons. They may have forgotten to sign a consent form. There could be mistakes in administering the therapy, etc.

The point here is that if the investigators were blinded and the identical protocol was applied to every participant, we would expect that roughly the same number of participants will be dropped from the trial at each stage. Looking closely, that is exactly what happens until one crucial point.

Highlighted in red is something extremely suspicious that occurred “on or within 7 days of the second dose”. At that late stage in the trial 60 placebo recipients were dropped while 311, or five times more vaccine recipients were dropped.

Why?

Pfizer says it was due to “important protocol deviations”. What protocol deviations? They do not say.

We are now faced with another important question. Could this have happened coincidentally? The answer is, absolutely. Coincidence can never be completely ruled out. However, we can be more rigorous in our investigation. What are the chances that this could have happened by coincidence alone?

This is a common question that can be answered using a standard tool in statistical analysis called the Fisher Exact Test. This calculation requires us to know the size of each group and the incidence of an event occurring in each group.

Here’s what we get:

The chance that this magnitude of a difference between the number of placebo and vaccine recipients who dropped out dropped out because of protocol deviations by coincidence alone is less than 1 in 100,000.

Stated a different way, the chance this this disparity occurred by coincidence if the same protocol was applied to both groups is less than 1 in 100,000.

In other words, there is a greater than 99,999 out of 100,000 chance that one group was subject to a different protocol than the other.

If the investigators were blinded, how could different protocols be applied to the two groups?

To be thorough, we must also consider the high likelihood that some, if not all of the 251 extra participants who received the vaccine were yanked from the trial because they suffered serious adverse events that the investigators did not want to acknowledge in the results for obvious reasons. There is no proof of this; all we can say is that mathematically it is nearly impossible that the disparity between the two groups was from a “serious protocol deviation”.

In my mind, it doesn’t matter what kind of proof Brook has. This finding demonstrates, beyond any reasonable doubt, that the trial was fraudulent. If I were her lawyer this would be my EXHIBIT A.

If we choose to hold on to the slim possibility that the investigators were blinded and this peculiar disparity occurred by a highly improbable but possible coincidence we then must contend with this (EXHIBIT B):

This is the equivalent table, sent from Pfizer to the FDA months later, this time in support of their application for EUA for their pediatric formulation (kids aged 5-11). This time, at the same point in the trial, 7 days from the second injection, more than six times more children were dropped from the trial (3.1% of the vaccinated group vs 0.5% of the those who got the placebo). Once again, this was due to “important protocol deviations”.

Is it fair to label those who believe these products are not safe “conspiracy theorists”? Or are those who maintain they are extremely safe “coincidence theorists”?

Yet again, the FDA chose to not question the investigators further.

This last point is more disquieting to me than the fraudulent nature of the trial. Our regulatory agencies were not doing their job. They didn’t do it with the adult trial. They didn’t do it with the pediatric trial. There’s no reason to believe they ever did or ever will fulfill their mission to protect the public.

This is not something that is easy to accept. We are forced to look beyond the illusion of scientific integrity and regulatory processes and see this for what it is.

Someone is responsible for hiding the injurious effects of these products in these trials knowing that they would be eventually given to billions of human beings. Was it the investigators employed by a multi-billion dollar pharmaceutical corporation or the “experts” on the FDA’s advisory committee? It was both. Pfizer gave the FDA the numbers and the FDA looked the other way.

It’s unimaginable to me. Perhaps this is why so many people won’t accept what is right in front of our eyes.