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Editor’s note: Dr. Madhava Setty, senior science editor for The Defender, presented his views on how to discuss COVID-19 vaccines during an Aug. 22 interview with Joe Martino of The Pulse. Below is part 1 of the interview.
How can we have respectful conversations with people who are not on the same page about COVID-19 vaccines?
In a video presentation for The Pulse, an independent Canadian media platform, Dr. Madhava Setty, senior science editor for The Defender, shared the approach he uses when talking to other medical professionals.
Setty said he was inspired to create the presentation by the many people, especially parents, who asked his advice on how to discuss the potential dangers of vaccinating children with their spouses, ex-spouses and primary care physicians.
“These parents were desperate and woefully ill-equipped to penetrate the highly biased and incurious attitude of a medical juggernaut,” said Setty.
The best place to start a conversation about COVID-19 vaccines is with Pfizer’s clinical trial data, Setty said.
In the video, Setty shows how mainstream and independent media can distort the facts.
Then he breaks down the Pfizer clinical trial results and demonstrates how the data should have brought the U.S. Food and Drug Administration (FDA) to conclude Pfizer’s mRNA shot was not safe to deploy on hundreds of millions of people in the U.S.
How media can distort data
To illustrate how media distort the facts, Setty began with the example of a provocative Feb. 7 headline in The Exposé: “Pfizer Covid-19 Vaccine increases Children’s risk of Death by 5100% according to the Office for National Statistics.”
According to The Exposé, “Children between 10 and 14, who had at least one shot of the Covid-19 vaccine, were 10 times more likely to die between January and October 2021, while children who had the second dose were 52 times more likely to die.”
Looking at the raw data used to generate the graph in the article, Setty pointed out there were far more unvaccinated 10- to 14-year-old children (over a million) at the time the data was collected than vaccinated children (around 4,000).
The groups being compared are very different in size, and a small number of deaths in the relatively tiny group of vaccinated children “will have an enormous effect on the rate of mortality” in that group, said Setty.
The data also did not indicate the cause of death of the children. Therefore, the four deaths in the children who received two doses could have been completely unrelated to the vaccine, the result of car accidents or suicide.
“This is an example of how independent media has been misleading with those kinds of headlines, but they’re not the only ones,” said Setty. “Now, let’s look at what the mainstream has done.”
Setty turned to an example of the mainstream media distorting the data — in June 2021, when The Associated Press (AP) ran this article: “Nearly all COVID deaths in US are now among unvaccinated.”
“I think we all remember this because this was being echoed on mainstream platforms by Rochelle Walensky, who was the director of the CDC [Centers for Disease Control and Prevention] and … Anthony Fauci, the director of the NIAID [National Institute of Allergy and Infectious Diseases],” said Setty.
“They were precise, they were saying 96 to 99% of COVID deaths were happening in the unvaccinated, and we have to understand that this was the beginning of a messaging campaign that said, it’s going to be a ‘pandemic of the unvaccinated.’”
Setty noticed this was a large increase from Pfizer’s clinical trial data, which reported 90% efficacy against severe COVID-19.
Walensky and Fauci claiming that 99% of COVID-19 deaths were among unvaccinated people was “a huge statement about the vaccine’s efficacy. It is incorrect to say, ‘well, 90 versus 99 — that’s only a 9% difference.’
That’s actually not the way to interpret those numbers because the efficacy of the vaccine is a matter of comparing the ratio between who is succumbing to these outcomes in the unvaccinated versus the vaccinated.”
Given that efficacy is a ratio, Setty explained, the efficacy increasing from 90% in the Pfizer clinical trial — which is 9 times more effective than the placebo in preventing severe COVID-19 — to 99%, according to Walensky and Fauci … this makes it 99 times more effective in preventing death.
“That is a factor of 11 times more than what the trial said, which is why I was skeptical of these kinds of comments.”
Setty asked what the public would assume when it heard 99% of COVID-19 deaths were in unvaccinated people.
We would assume — because we were told the total number of deaths and not the incidence rate of COVID-19 deaths by vaccination status — that the two groups of people being compared were about the same size, Setty said.
If the groups were the same size, then, “If 99% of the deaths are happening in the unvaccinated, that means the vaccine is working incredibly well.”
But the two groups were not the same size.
At the time, the CDC was not reporting the incidence rate of COVID-19 deaths by vaccination status. So where did the AP go to calculate that “nearly all COVID deaths in the U.S. were in unvaccinated people”?
The data came from the states. The reported deaths were not from the time the article ran — the states were adding up deaths over a six-month window, from Jan. 1, 2021, to the end of June 2021.
The AP was incomplete in its reporting, according to Setty, and when people read the article or heard the statements from Walensky and Fauci, “they were assuming that they were talking about what was happening then, like in the last couple of weeks, when approximately 50% of the population in this country at the time were fully vaccinated,” said Setty.
But the reality is that the majority of the deaths in the six-month window were in January and February, when a very small percentage of the U.S. population was fully vaccinated.
Setty showed the data from Colorado. The graph (below) on the left shows weekly COVID-19 deaths from January to June, and the graph on the right shows the percentage of the Colorado population that was vaccinated over that period.
Clearly, the group of unvaccinated people was much larger than the group of vaccinated people when the majority of the deaths occurred.
“What I am saying here is that if you add everything up, you will most certainly come up with a huge number of deaths in the unvaccinated,” Setty said. “Why? It’s because most people, when the most deaths were occurring, were unvaccinated.”
“So this is the problem that we run into,” Setty said. “When we’re not diligent in our inquiry and we just listen to what we’re being told.”
In this case, the incidence rate of COVID-19 deaths should have been reported per 100,000 people, then we could see what the incidence rate was in the unvaccinated group compared to the vaccinated group, Setty explained.
“There’s a lot of distortion happening here. The numbers are correct but look at how the Associated Press and Fauci and Walensky were presenting the data. They were not being clear, and I would expect more from our officers of public health.”
Start with Pfizer’s clinical trial data
The best place to start a conversation about COVID-19 vaccines is with Pfizer’s clinical trial data, Setty said.
The clinical trial data is detailed, widely cited and was published in the New England Journal of Medicine in December 2020.
The Pfizer-BioNTech COVID-19 vaccine was the most highly used in the U.S., and the first COVID-19 vaccine granted Emergency Use Authorization for adults, adolescents and then for children.
“This is the place to start because this is where our health authorities went to when they were cajoling and promoting us to get the vaccine,” said Setty.
Setty summarized how clinical trials are conducted. In this case, the 43,448 participants were divided into two equally sized groups similar in age and comorbidities. The treatment group received two shots of the Pfizer vaccine, the placebo group received two saline injections.
Investigators waited to see how many people in each group got COVID-19, and compared rates in each group.
“Based on that, you calculate what is called the ‘vaccine efficacy,’” Setty said, adding that it’s important to understand that “the vaccine efficacy is a function of relative risk.”
Examine relative risk versus absolute risk
To explain relative risk versus absolute risk, Setty used the example of the lottery.
Let’s say the chance of winning the lottery if you buy one ticket is 1 in a million. If you buy 2 tickets, your chance of winning is now 2 in a million.
How much greater is your chance of winning the lottery if you buy that second ticket? It is: 2/1,000,000 – 1/1,000,000 = 1/1,000,000 = 0.0001%.
This is the absolute advantage gained by buying a second lottery ticket.
“What is the ‘efficacy’ of buying a second ticket?” Setty asked.
It is: 1 – (chance of winning with 1 ticket/chance of winning with 2 tickets) = 1 – ½ = 50%. This is the relative advantage gained by buying a second lottery ticket.
“If you’re selling lottery tickets, are you going to talk about the absolute risk advantage or the relative risk advantage?” Setty asked. “It’s clear you would talk about the relative advantage of having a second ticket, not the absolute advantage.”
Responding to the analysis, Joe Martino, who hosted the podcast, said:
“There have been polls done, [asking] what are the chances of a vaccinated or unvaccinated person ending up in the hospital? So many people were saying anywhere between 30, 40, 50, 60, 70, 80% chance if you’re unvaccinated, you’ll end up in hospital.
“But the reality is, for both vaccinated and unvaccinated people, it’s less than a 1% chance. So there was a huge distortion.”
Setty agreed: “Those large numbers about efficacy, we attribute that to the risk of actually going to the hospital as opposed to the absolute risk, which is … what we want to know.”
How many clinical trial participants got severe COVID?
Setty shifted to the next topic, stating that we can all agree that the Pfizer shot’s efficacy against severe COVID-19 was 90%.
“But in order to dig deeper we have to ask, ‘How many of those 40,000 people in the trial actually developed severe COVID-19?’”
Setty said he posed that question to many practicing physicians. “Was it 10%, which would be 4,000 people? Was it 1%, which would be 400 people? Was it 0.5%?”
None of the physicians he asked knew the number, and when he told them, they were “at least mildly disquieted, to astounded.”
Ask yourself, how many people got severe COVID-19 in the Pfizer clinical trial?
The answer: 10.
Nine in the placebo group, and one in the vaccinated group.
True, that’s 90% efficacy against severe COVID-19, Setty said.
However, “We have to be a little bit more careful based on 10 outcomes,” he said. “We have decided to deploy this vaccine to hundreds of millions of people. Does that make sense?”
What’s ‘the number needed to vaccinate’?
To know “how good the vaccine is, we need to know how many people have to be vaccinated to prevent a single case of severe COVID-19,” Setty said.
Setty went over how to calculate this number and explained how, based on Pfizer’s clinical trial data, 2,500 people need to be vaccinated to prevent one case of severe COVID-19.
That means the unvaccinated group had a relative risk 9 times higher than the vaccinated group, but the reduction in the absolute risk for an individual is only 0.04%.
This is important, Setty said, because “when we’re trying to make our own personal decision about whether or not we should get vaccinated, we have to look at what the risk versus the benefit is.”
“Should you get vaccinated?” he asked. “It depends.”
If there were no risks associated with the vaccine, it would make sense to get vaccinated to get the tiny benefit.
But what is the risk of a serious adverse event compared to a serious case of COVID-19? Setty asked.
Is there a risk associated with receiving Pfizer’s mRNA vaccine? Setty dug into this, sticking only to Pfizer’s clinical trial data.
There are common adverse events from getting a vaccine, like a sore arm, fever or malaise for a few days, he explained.
But to get closest to “comparing apples to apples,” Setty considered only the severe adverse events. This way, the risk of getting a severe adverse event from Pfizer’s shot can be compared to the risk of getting severe COVID-19 if one declines to get Pfizer’s shot.
The definition of severe adverse event, as per the FDA (and followed by Pfizer in its clinical trial), is when the patient outcome is: death, a life-threatening event, hospitalization (initial or prolonged), disability or permanent damage and congenital anomaly/birth defect.
What was the risk of a severe adverse event in the vaccinated group in the clinical trial?
From Table S3 (in the Supplementary Appendix), there were 126 severe adverse events in the vaccinated group of 21,262. This 0.6%, or 6 in a thousand.
The number to vaccinate to prevent one serious case of COVID-19 is 2,500 people, which will result in 15 serious adverse events (6/1000 x 2500 = 15).
“If we’re comparing apples to apples, it clearly points to the fact that we should probably not get vaccinated,” Setty said. “I’m not giving you medical advice, I’m not spreading misinformation here, I’m just saying this is what the numbers showed: The risk of getting a serious adverse event is way higher than preventing severe COVID-19. Fifteen serious adverse events, versus one serious case of COVID.”
Martino asked, “Is it expected that this same ratio would turn up once it gets deployed on millions of people?”
Setty said it was impossible to answer that question because a clinical trial only approximates what will happen in the real world. This is “why we have a pharmacovigilance system in place, where the vaccine manufacturers are required to report these kinds of events to the FDA,” Setty said.
“The point here, which is excellent … is, given this number, should we have moved forward? I say no.”
Why so many serious adverse events in the placebo group?
Digging further into the trial data, Setty said, “We’re sticking with a document [the paper on the Pfizer clinical trial] that both parties should be able to agree upon as being valid.”
“How, then, was this product authorized?” asked Setty, given that 6 adverse events per 1,000 vaccinated is so high.
The reason is this: There were 111 serious adverse events in the placebo group, which is 0.5%. This is close to the 0.6% rate in the treatment group.
So the rate of serious adverse events in the treatment group was not much higher than that in the placebo group.
Setty questioned how the rate of severe adverse events could be so high in the placebo group. As an anesthesiologist, he said he personally injected at least 20,000 people with a saline solution without ever once seeing a serious adverse event.
“This has never ever happened,” he said, referring to the number of adverse events reported in the placebo group in Pfizer’s trial. “Maybe with an antibiotic, with a drug, but never saline. Not even once in my 20-year-long career.”
The placebo group is supposed to show the background rate in the general population of people having serious adverse events, as defined by the FDA.
“Is it possible that 5 of 1,000 people over a 6- to 8-week period ended up in hospital for whatever reason?”
There was not enough granularity in Table S3 to know the characteristics of the participants who experienced the severe adverse events to help explain this large number.
The trial was double-blinded meaning both investigators and participants were not supposed to know who received the vaccine, and who received the placebo.
Setty said it would be a “huge accusation” to claim the investigators may have fudged the numbers to hide the deleterious effects of the vaccine.
But that is the accusation made by Brook Jackson.
Pfizer unblinded participants, whistleblower alleges
Brook Jackson was a regional director employed at the research organization Ventavia Research Group, one of the companies conducting Pfizer’s clinical trial.
She told The BMJ “that the company falsified data, unblinded patients, employed inadequately trained vaccinators, and was slow to follow up on adverse events reported in Pfizer’s pivotal phase III trial.”
This was happening during the clinical trial but did not come to public attention until almost a year later, Setty said.
If the investigators were unblinded, then “they saw who was getting what,” he said. “Now, that is an enormous accusation, because that essentially invalidates the entire trial.”
If the investigators know who is getting the treatment, and who is getting the placebo, “it’s very easy to manipulate the data,” Setty said.
Should we believe Jackson? Setty asked. What do we have to go on besides the oddly high 0.5% rate of severe adverse events in the placebo group?
This is “an example of where we have to look harder, beyond a headline, and beyond what The New York Times is saying, or what Fauci is saying,” Setty said. “Let’s look harder at what we know.”
Emergency Use Authorization Memorandum — Pfizer-BioNTech
This leads us to Table 2. “Efficacy Populations, Treatment Groups as Randomized” (on page 18) of the Emergency Use Authorization Memorandum, submitted by Pfizer to the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC).
VRBPAC is the group that advises the FDA on whether to authorize the use of a new vaccine.
“This is an incredibly important piece of information that does not get wide recognition,” said Setty.
The table shows, as the trial proceeds, the evaluable population in the placebo group and in the treatment group (labeled “BNT162b2” in the table, the Pfizer shot), revealing how many people dropped out or were excluded from the trial at various points.
There are many reasons why a person may drop out from a trial, Setty explained. People can die, decide not to continue or not show up for an appointment.
Some people may be removed from a trial if there is an error in the administration of the placebo or treatment.
There are “so many different reasons why people will drop out, and we would expect that if the trial is blinded, if the investigators are blinded, about the same number of people in both the vaccine and placebo group will drop out of the trial,” Setty said. “Why? Because they’re being treated the same way.”
For most stages of the Pfizer trial, roughly the same number of people in each group dropped out or were excluded.
However, at a critical point in the trial, which is within seven days of getting the second dose, something changed.
“What we see here is, as opposed to all of the other stages of the trial, 311 people dropped out of the vaccine group compared to only 60 in the placebo group,” Setty said. “That means 5 times more people dropped out of the vaccine group.”
“Why?” he asked. “Pfizer says it was due to ‘important protocol deviations.’ What are these ‘important protocol deviations’? They don’t tell us,” Setty said.
“Did the FDA ask? They did not,” he added.
What are the chances this was coincidental?
Could coincidence account for the disparity in the number of people who left the vaccine group compared to the placebo group?
“The answer is, absolutely, yes, you cannot rule out coincidence,” said Setty. “But here’s where we need to be more careful … What are the chances that this could have happened coincidentally?”
To determine that, Setty used the Fisher Exact Test, the same test used to determine whether a medical intervention is having an effect, or whether effects observed are by chance.
From the Fisher Exact Test, “the chance that this could have happened coincidentally is less than 1 in 100,000,” Setty said.
“And if that wasn’t enough, look at what happened several months later in the pediatric trial.”
Setty referred to Table 12 (page 59) of the Emergency Use Authorization Memorandum, submitted by Pfizer in October 2021 to request authorization for children aged 5 to 11.
“It happened again in kids, and here we see at the same point in the trial, now there were 6 times more kids that were yanked from the study, after getting the second dose,” Setty said. “Within seven days of the second dose.”
Is it a coincidence, or did something happen? Were the investigators unblinded? What happened to the kids that got pulled out of the trial after the second dose?
What happened to the adults that got pulled out of the trial after the second dose?
“We don’t know,” Setty said. “We would expect the FDA to ask the question, ‘What happened?’ And they didn’t.”