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Months before emergency use authorizations (EUAs) were granted by the FDA for vaccines against COVID-19, starting with the Pfizer/BioNTech vaccine and then continuing with the Moderna and Johnson & Johnson (J&J) vaccines, those of us who’ve been following and trying to counter the antivaccine movement predicted that antivaxxers would publicize and weaponize reports of death and adverse events after COVID-19 vaccines to give the impression that the vaccines are dangerous. By the end of January, our predictions had come true even more blatantly than I had expected, as I discussed this technique three months ago and why it is deceptive. The first time I had noted this technique of antivaccine messaging was actually as far back as December, when antivaxxers were publicizing reports of Bell’s palsy and syncope within days after the Pfizer vaccine had been released under an EUA. It’s a technique that continued with claims based on VAERS that COVID-19 vaccines cause heart attacks and sudden cardiac deaths, with these sorts of claims being central to messaging by antivaccine activist Del Bigtree. None of these reports demonstrated causation, but that didn’t stop antivaxxers from publicizing them. Then, when the FDA issued a pause for the J&J vaccine based on (at the time) one-in-a-million reports to VAERS of a rare type of blood clot, reports that the FDA and CDC took very seriously, antivaxxers predictably went wild over it, even though the risk-benefit ratio of the vaccine was still deemed to be favorable.

So why am I addressing this topic again? Simple. It’s a narrative that hasn’t gone away. Worse, it’s grown in the three months since I last wrote about it. At the extreme end of the antivax hysteria is, as one might expect, Mike Adams at NaturalNews.com proclaiming, “VACCINE HOLOCAUST now accelerating: VAERS data show nearly 4,000% increase in vaccine deaths in 2021 (so far) vs. the entire year of 2020“. (I’ll give Adams credit for understanding that the word “data” is plural.) Another example of this particular antivaccine messaging comes from a recent article in The Liberty Sentinel, “COVID vaccines killing huge numbers, warns leading doctor“. The doctor is someone I hadn’t actually heard of before, Dr. Peter McCullough. On the more “reasonable” end of this narrative (in actuality, “reasonable”-seeming from an antivaccine activist who tries his best to deny that he’s antivaccine and portray himself ), there’s Robert F. Kennedy, Jr.’s “freelance reporter” Megan Redshaw proclaiming on his antivaccine “news” site The Defender, “Reported Vaccine Injuries Continue to Climb, Pfizer Seeks Full Approval for COVID Vaccine“.

Vaccine deaths are up nearly 4,000% over the year before!

Before I discuss why this narrative is deceptive, it helps to give you a taste of it, first from Dr. McCullough:

Under normal circumstances, 50 deaths reported to the CDC’s VAERS surveillance system would result in a drug being taken off market immediately.

In the case of the COVID shots, however, thousands of deaths have already been reported, and yet the mass vaccination programs continue to be pushed.

Dr. McCullough, a professor of medicine who developed a globally acclaimed and highly successful COVID treatment protocol, also emphasized that there have been many unnecessary deaths as a result of policy decisions made at various levels of government.

Naturally, there’s a video, and naturally it’s on Rumble:

I was curious about the claim in the article that Dr. McCullough is the “doctor with the most citations in the National Library of Medicine on these topics”. Which topics, I wondered upon first reading that, a question that was answered by the last paragraph regarding his allegedly having developed a “globally acclaimed and highly successful COVID treatment protocol”. A quick PubMed search revealed that he does indeed have 38 publications related to COVID-19 in the peer-reviewed literature. That jogged my memory a bit. It turns out that Dr. McCullough is a consultant cardiologist and Vice Chief of Medicine at Baylor University Medical Center and Principal Faculty in internal medicine for the Texas A & M University Health Sciences Center. (More on him in a moment.)

Now let’s hear Mike Adams’ version of it. He starts out, as he often does, trying to seem reasonable:

According to government data published at VAERS.hhs.gov, just 82 people died in 2020 after being vaccinated. But so far in 2021, there are 3,317 deaths that have been reported following covid-19 vaccinations.

That’s an increase of nearly 4000%, and we’re barely into the second quarter of 2021 (versus the entire year of 2020).

Less than half of the US population has been vaccinated so far, which means as that number increases, the deaths will increase, too. If this trend continues, we are likely to see somewhere between 12,000, – 15,000 post-vaccine deaths reported to the VAERS system by the end of calendar 2021.

Then, as Adams nearly always does, he goes right off the deep end:

My well-educated guess is that right now, covid-19 vaccines have likely killed around 50,000 Americans. This puts the covid vaccine on par with the number of Americans killed in the entire Vietnam War. That makes sense because the vaccine industry is waging war on humanity, and by the time they’re done, they hope to exterminate billions.

This number is likely to exceed 250,000 by the end of this year, putting vaccine atrocities in the category of being, as Tucker Carlson said last night, “The single deadliest mass vaccination event in modern history.”

We are witnessing a vaccine holocaust being inflicted upon humanity, and no one is allowed to say that anyone has suffered any harm whatsoever from the vaccine. To do so gets you banned, blacklisted and smeared. If you happen to be particularly effective at telling the truth about this vaccine holocaust, you will be named, doxxed and targeted by a complicit media that now works as the propaganda enforcement arm of the medical mafia.

He also mischaracterizes an article by vaccine researcher and advocate Peter Hotez:

As I just wrote about yesterday, NATURE has published an article by a deranged pediatrician in Texas who is essentially demanding United Nations shock troops hunt down and silence all “anti-vaxxers” around the world, using “counteroffensive” measures and anti-terrorism enforcement squads armed with weapons.

Unsurprisingly, Dr. Hotez wrote nothing of the sort, as his article, “COVID vaccines: time to confront anti-vax aggression” clearly shows. Basically, Dr. Hotez advocated countering online antivaccine disinformation with a combination of cyber security, law enforcement, public education, and international relations. In response, Mike Adams launched a campaign of harassment against him, including publishing his work email address and phone numbers:

Meanwhile, over at RFK Jr.’s antivaccine propaganda website:

The number of reports of injuries and deaths following COVID vaccines continues to rise, according to data released today by the Centers for Disease Control and Prevention (CDC). The data comes directly from reports submitted to the Vaccine Adverse Event Reporting System (VAERS).

VAERS is the primary government-funded system for reporting adverse vaccine reactions in the U.S. Reports submitted to VAERS require further investigation before a causal relationship can be confirmed.

Every Friday, VAERS makes public all vaccine injury reports received as of a specified date, usually about a week prior to the release date. Today’s data show that between Dec. 14, 2020 and April 30, a total of 157,277 total adverse events were reported to VAERS, including 3,837 deaths — an increase of 293 over the previous week — and 16,014 serious injuries, up 2,467 since last week.

So let’s take a look at this claim. Unsurprisingly, the answers to this particular antivaccine talking point will be similar to the ones I gave before three months ago, but with a somewhat different emphasis.

Dr. Peter McCullough: An MD/MPH who promotes quackery and doesn’t know how VAERS works

Let’s start with Dr. McCullough’s video. There are a number of red flags. First, it’s noted on the Rumble page for his video that the website he “mentions is AAPSOnline.org.” Regular readers will remember AAPS as, basically, the John Birch Society of “medical societies,” basically an astroturf right wing science denialist organization disguised as a legitimate academic medical society that has a long history of promoting antivaccine misinformation (including providing a platform for Andrew Wakefield) and, now, COVID-19 disinformation, that basically loves Dr. McCullough’s protocol, which, of course, involves hydroxychloroquine, the Black Knight of COVID-19 treatments that evidence just can’t seem to kill. Unsurprisingly, he is presented as a Brave Maverick Doctor speaking Truth to power. Similarly unsurprisingly, he cannot cite any randomized double blind clinical trials (RCTs) to support his protocol, instead relying on the excuse that all Brave Maveric Doctors (like Stanislaw Burzynski) use that they “can’t” do the RCTs. In his case, it was because the pandemic hit so fast. Oddly enough, there have now been quite a few RCTs of various COVID-19 treatments proposed early in the pandemic, and equally unsurprisingly, the vast majority of them have been negative. Similarly, he excuses those studies showing that single drugs don’t work, saying that you have to use “multiple drugs” as in HIV. Of course, what he neglects to mention is that in general multidrug cocktails contain drugs each of which does have some single agent activity. You can’t just throw together drugs that don’t work and expect that they will work, and, as Dr. Vincent Iannelli explains, they don’t work.

Of course, what Dr. McCullough claims to have done is to “leverage” small clinical trials and observational studies; too bad he didn’t do the RCTs of his cocktail, which, given the rapidly fatal course of severe COVID-19, would, contrary to his claim, not take “years” to get results from. Finally like all Brave Mavericks, Dr. McCullough claims that the reason his protocol isn’t widely accepted and publicized isn’t because it doesn’t work, but rather because the press and government regulatory agencies are either ignoring or “suppressing” news of it, even as he cited a “home treatment guide” published by—you guessed it!—AAPS. Basically, his protocol includes one FDA-accepted drug, Regeneron’s monoclonal antibody cocktail that was issued an EUA, followed by vitamins (of course!), steroids (another drug that works) and—also of course!—hydroxychloroquine, ivermectin, zinc, and azithromycin, none of which have been shown to work. Come to think of it, he’s very much like Stanislaw Burzynski, mixing the unproven with the weakly proven and claiming without evidence to have “saved thousands of lives” and claims he could have saved 50-85% of the lives lost to COVID-19. Again, there’s no solid evidence to support any of these claims. I will give him one point. He’s not entirely wrong that the US has decided to emphasize vaccination as the answer to the pandemic, but he also dismisses masking and social distancing as having been overemphasized.

Next up, Dr. McCullough resurrects a common trope about the COVID-19 vaccine clinical trials by pointing out the low percentage of patients who got COVID-19 in the trials, dismissing the trials because of that while ignoring that the studies had been powered with the expectation that a low percentage of participants would be diagnosed with COVID-19. Basically, in the video he’s rehashing the same dubious arguments made by Peter Doshi in January to claim that the actual efficacy of the Moderna and Pfizer vaccines is much lower than the clinical trials found. And, as antivaxxers often do, Dr. McCullough misunderstands VAERS.

He also invokes a comparison beloved of antivaxxers, the 1976 swine flu vaccine, which was associated with a rare incidence of Guillan-Barré syndrome, which is a canard. Basically, antivaxxers claim that the program was killed after 500 cases of Guillain-Barré syndrome and 25 deaths, except that the evidence of association with the vaccine was unclear and there was no transmission of H1N1, leading the CDC to end the program early. As noted by the CDC:

As of 1976, >50 “antecedent events” had been identified in temporal relationship to GBS, events that were considered as possible factors in its cause. The list included viral infections, injections, and “being struck by lightning.” Whether or not any of the antecedents had a causal relationship to GBS was, and remains, unclear. When cases of GBS were identified among recipients of the swine flu vaccines, they were, of course, well covered by the press. Because GBS cases are always present in the population, the necessary public health questions concerning the cases among vaccine recipients were “Is the number of cases of GBS among vaccine recipients higher than would be expected? And if so, are the increased cases the result of increased surveillance or a true increase?” Leading epidemiologists debated these points, but the consensus, based on the intensified surveillance for GBS (and other conditions) in recipients of the vaccines, was that the number of cases of GBS appeared to be an excess.

Had H1N1 influenza been transmitted at that time, the small apparent risk of GBS from immunization would have been eclipsed by the obvious immediate benefit of vaccine-induced protection against swine flu. However, in December 1976, with >40 million persons immunized and no evidence of H1N1 transmission, federal health officials decided that the possibility of an association of GBS with the vaccine, however small, necessitated stopping immunization, at least until the issue could be explored.

See the difference? In 1976, there was no transmission of H1N1 going on and a question of whether the H1N1 vaccine being used at the time had an association with Guillain-Barré syndrome. Under such circumstances, it was hard to argue for continuing the vaccination campaign. Fast forward 45 years, and we still have widespread community transmission of COVID-19, with the overall death toll approaching 600K in the US alone. It’s an entirely different situation.

Dr. McCullough is also shockingly ignorant of how VAERS works. He claims that only a health care worker can access the system and that a patient or a loved one has to contact a physician or health care worker to enter a report. That is completely wrong. Indeed, one of the complaints about VAERS is that anybody—and I do mean anybody—can enter a report. It is this openness that is simultaneously one of VAERS greatest strengths and weaknesses. It’s a weakness in that this openness allows for gaming of the system, as lawyers for parents seeking to sue vaccine manufacturers for autism as a “vaccine injury” did 15 years ago. Seriously, this is an error huge enough to make me wonder about everything else, in particular whether he got his MPH out of a cereal box. This guy has an MPH and doesn’t know (or didn’t bother to find out) how VAERS actually works and that there are other vaccine safety monitoring systems other than VAERS? The only reaction I can think of is:

When Godzilla gives you the facepalm, you know the failure is monstrous.

Naturally, there’s a conspiracy theory to go along with Dr. McCullough’s claims. Citing his experience on data safety monitoring committees, Dr. McCullough claims that it would have been “impossible” for the FDA and CDC to evaluate the first 1,600 deaths reported to VAERS and conclude that they were unrelated to the vaccines. As a result, according to him, there was a “scrubbing” of reports of death to VAERS. You’d think that someone with an MPH would understand the concept of rapid cycling analysis, which allows near real-time surveillance of possible adverse events after vaccination (or other medical interventions). Naturally, according to him, this “scrubbing” is taking place with the collusion of the press, specifically the Trusted News Initiative, which is in reality a program to combat the spread of harmful antivaccine disinformation.

The list of bogus claims and errors only accelerates from there. I’ll deal mainly with the ones unique to him and then in the next section deal with the claims common to the “Vaccine Holocaust” narrative. Here are just a few of the many bits of misinformation and disinformation spread by Dr. McCullough:

  • He claims that a vaccine trial in Australia was stopped because participants developed false positive HIV tests because “parts of the [mRNA?] code that were attempted to be used in an Australian vaccine turned HIV tests positive.” It turns out that antibodies generated by the vaccine did lead to some false positive HIV results but no HIV was ever found to be present. The reason for this is that short sequences coding for peptides that resemble peptides in HIV proteins are very common in genes coding for various other proteins, including in genes found in coronaviruses. This is basically a claim similar to that made by Nobel Laureate Luc Montagnier, who should know better but apparently does not.
  • If you really don’t want to be viewed as antivaccine, you really shouldn’t misinterpret the Nuremberg Code, as Dr. McCullough did. Antivaxxers love to claim that vaccine mandates violate the Nuremberg Code because they “violate informed consent”. They do not.
  • He also states that 60-70% of new COVID-19 cases occur in people who have already been vaccinated against COVID-19. Wrong.
  • And, of course, Dr. McCullough believes that SARS-CoV-2, the coronavirus that causes COVID-19, is an “engineered virus” that escaped from a lab, just as our Nobel Laureate turned antivaxxer and homeopathy believer Luc Montagnier does. There is no evidence that this virus was “engineered,” and this has been known for over a year now. This claim of a “plandemic” has been a conspiracy theory for a little over a year now, with claims of an “engineered” virus having arisen months before that.

You get the idea. Basically, Dr. McCullough should have stuck to cardiology and renal disease, the two areas for which he was known prior to the pandemic that led him, as he characterized it in the video, to completely reorient the focus of his academic career. I guess the opportunity for grift and conspiracy theories was too much for him to resist.

“Vaccine Holocaust,” or: How to frighten with large numbers

Let’s get back to a core claim in this narrative, namely that the number of deaths reported to VAERS since the mass vaccination campaign with COVID-19 vaccines began in mid-December means that the vaccines are causing a “vaccine holocaust”. Sure, Dr. McCullough didn’t use that word, but Mike Adams and others aren’t so reserved, and the article featuring the interview with Dr. McCullough was titled “COVID vaccine killing huge numbers, warns leading doctor“. The numbers used by different antivaxxers vary depending on the date of their publication and the dates of the specific VAERS reports they cite. The exact numbers aren’t as important as the understanding that antivaxxers are ignoring a very important aspect of any comparison like the “4,000% increase in deaths” narrative – a narrative found not just on NaturalNews.com, but on antivax social media and websites all over the internet.

So let me repeat what I said three months ago: Whenever you see these sorts of numbers, two questions should come straight to you mind right away. The first is: What’s the denominator? The second is: What is the baseline rate for such adverse events in the population studied? To that I would add a third question: How many deaths occur during the same span of time, absent the intervention? In other words, in a four and a half month period, how many people would normally be expected to die, regardless of the cause? Finally, if you want to get really granular, you can break it down by age. However, a simple, rough, “back of the envelope” calculation will suffice to show how innumerate antivaxxers are when they make this claim about VAERS. But before we do that, let’s take a look at another number. How many people have died of COVID-19 in the US in that same four and a half month period? According to Johns Hopkins, as of May 1, there were approximately 575,000 deaths recorded, compared with around 300,000 in mid-December, meaning that ~275,000 people have died of COVID-19 over the last 4 months.

So how many people die of all causes every year? The CDC states that the yearly number of deaths in the US in 2019 was 2,854,838, for a rate of 869.7 deaths per 100,000 population. In brief, less than 1% of the US population dies every year, and immediately before the pandemic around 7,821 people died each and every day. In a four and a half month period (137 days from December 14, 2020 to April 30, 2021), then, we’d expect there to be approximately 1.07 million deaths, or a rate of approximately 326 per 100,000 population. That’s a lot of deaths. Suddenly, the figure of ~4,000 deaths since mid-December reported to VAERS doesn’t seem like such a big number, does it?

Let’s continue, though. How many people got at least one dose of one of the vaccines during that time period? As of April 30, it was 144.9 million people. In any given random population of 144.9 million people in the US during a given four and a half month period, we’d expect to see ~472,374 deaths. Again, those are big numbers. If we divide by the 137 days encompassed by December 14, 2020 to April 30, 2021, then in such a population we would expect to see 3,448 deaths each and every day during that time period, leaving aside any other sources of excess death.

Of course, this is a “back of the envelope” calculation, and I know that the sharp readers out there will immediately point out that it can be misleading to average all these vaccines over the entire four and a half month period. After all, early in the period, relatively few vaccines were being administered compared to the latter part of the period, when the vaccination campaign had been ramped up to truly impressive levels, and then, more recently, falling off again as the average daily vaccination rate fell from its peak level. Naturally, as a result, one would expect that reports to VAERS would start out slowly, as vaccination started out slowly, and then accelerate as the pace of vaccination picked up. So let’s go back to RFK Jr.’s numbers, in particular this part:

Today’s data show that between Dec. 14, 2020 and April 30, a total of 157,277 total adverse events were reported to VAERS, including 3,837 deaths — an increase of 293 over the previous week — and 16,014 serious injuries, up 2,467 since last week.

I interpret this as meaning that, according to RFK Jr., there were 293 deaths reported to VAERS during the last week of April. That sounds like a large number, particularly when, averaged out, it translates to 41.9 deaths per day. But is it? How many people received COVID-19 vaccines that week? By subtracting the April 23 statistic from the April 30 statistic, I come up with 7.66 million people receiving a COVID-19 vaccine during the last week of April, or 1.1 million/day. How many deaths would we expect in a week in a population of 7.66 million in a week, based on the CDC’s pre-pandemic statistics? Using the aforementioned yearly incidence of death pre-pandemic of 868.7 per 100,000 in a year, we can say that in a population of that size there would be 66,619 deaths in a year, or 182.5 deaths per day or 1,278 deaths in a week.

However, this is not a random population. Remember who got priority for COVID-19 vaccines until very recently. First, there is as yet no COVID-19 vaccine approved or even with an EUA issued for children. The Pfizer vaccine’s EUA applies for people 16 years of age and older, while the EUA for the Moderna and J&J vaccines only applies to people 18 years of age and older. More importantly, the two main priority groups until recently were healthcare and frontline workers and older adults, starting with those 65 and older. If you look at the CDC statistics for death rates by age, you’ll see that death rates rise rapidly with age, which is no particular surprise to anyone. Of course death rates are highest among the elderly and low among the young. Unfortunately, that’s how nature works.

Think of it this way. Never before in the history of VAERS has there been a mass vaccination program like that for COVID-19. The population initially targeted vaccination was exactly the population that has the highest baseline death rate, meaning that by random chance alone we would expect to see a seemingly large number of deaths within days of vaccination.

But there’s yet another factor. Those who have received a COVID-19 vaccination know that all those who receive COVID-19 vaccines are given instructions to sign up for V-Safe, a monitoring system that works by text message. Basically, if you sign up for V-Safe, you will receive periodic text messages, starting as daily text messages that become less frequent over time. I note that, even though I completed my vaccination series in January, I still receive V-Safe texts periodically. This basically turns a passive surveillance system into a quasi-active surveillance system. And, remember, the more you look for something, the more you will find. Always.

The law of large numbers says that, whenever an intervention is administered to huge numbers of people, there will be large numbers of adverse events that happen after that intervention by random chance alone. The way scientists determine if there is a safety signal in those adverse events is by comparing them to the expected baseline rate of each adverse event. The bottom line is that, fear mongering articles by RFK Jr. and reports of a “vaccine Holocaust” to the contrary, there is no evidence of deaths above and beyond what one would expect based on known baseline rates of death in the US population. Although RFK Jr. might not be expected to know this, someone like Dr. McCullough, who has an MPH in addition to his MD, should really, really, really know better. That he promotes antivaccine disinformation based on fear mongering about reports to VAERS of deaths and adverse events tells me one of two things. Either his MPH education failed him, or he’s lying. Take your pick. As for Mike Adams, no one expects him to know anything other than grift and propaganda.

The law of large numbers plus intensive monitoring

I can’t resist ending, as I began this post, with simple observation.

Whenever large numbers are involved, it becomes all too easy to fear monger by pointing to numbers that appear large but, when compared to the baseline rate, are actually not that large at all. That is the entire basis of the latest antivaccine propaganda trope pointing to the seemingly huge number of deaths reported to the VAERS database.

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Posted by David Gorski

Dr. Gorski's full information can be found here, along with information for patients. David H. Gorski, MD, PhD, FACS is a surgical oncologist at the Barbara Ann Karmanos Cancer Institute specializing in breast cancer surgery, where he also serves as the American College of Surgeons Committee on Cancer Liaison Physician as well as an Associate Professor of Surgery and member of the faculty of the Graduate Program in Cancer Biology at Wayne State University. If you are a potential patient and found this page through a Google search, please check out Dr. Gorski's biographical information, disclaimers regarding his writings, and notice to patients here.