As the vaccines for COVID-19 continue to roll out and tens of millions more doses get into tens of millions more arms, I’m coming to the reluctant conclusion that I could, if I so desired, do nothing but blog about the antivaccine misinformation about these particular vaccines being spread by antivaccine activist Robert F. Kennedy, Jr. and his organization Children’s Health Defense through its online house organ The Defender. When last I visited RFK Jr. and his antivaccine disinformation machine, he was deceptively using the Vaccine Adverse Events Reporting System (VAERS) database to impute causation when there is not yet evidence of it to the reports of adverse events reported there. That time, he was trying to imply that the deaths reported to VAERS had been caused by COVID-19 vaccines, with, of course, plausible deniability that that’s what he was doing. Unsurprisingly, he soon followed up with another post that used updated figures for adverse events reported to VAERS in the same deceptive way. (They were just larger, because a wider range of dates were included.) It’s basically the same article, with the same obligatory cut-and-pasted anecdotes of specific cases of death after the vaccines that were probably not related. A computer could generate these posts, at least until yesterday, when RFK Jr. decided to drill down with an article entitled What VAERS Data Reveal About Cardiac-Related Reactions to COVID Vaccines. It’s the same schtick, just about one subtype of adverse event.
Actually, this article probably could have been generated by computer, with just a little bit of reprogramming. Still, let’s take a look at the claim:
We looked at the data we have so far to see if we could identify any emerging patterns. What immediately stands out is that the 12,697 reactions reported as of Feb. 4 are not limited to injection-site reactions. These appear to be serious reactions reported by medical personnel from all over the country.
One trend worth noting is the number of reported cardiological reactions, including myocardial and tachycardia disorders. We found 1,171 cases using the more common symptoms reported, including 134 cases where the patient died — or 21% of the total COVID vaccine deaths reported to VAERS.
According to VAERS data, of the 1,171 serious cardiac-related cases reported, 1,021 (87.2%) occurred within 48 hours of receiving the vaccine. Of the 134 cases where the patient died, 50% occurred within 24 hours and 60% within 48 hours.
Here, once again, we see the technique of providing numbers without context. This will become apparent when I go to the Bloomberg COVID-19 Vaccine Tracker, which, as of today, states:
The biggest vaccination campaign in history is underway. More than 181 million doses have been administered across 79 countries, according to data collected by Bloomberg. The latest rate was roughly 6.19 million doses a day.
In the U.S., more Americans have now received at least one dose than have tested positive for the virus since the pandemic began. So far, 56.1 million doses have been given, according to a state-by-state tally. In the last week, an average of 1.67 million doses per day were administered.
Using the interactive graphs on the Bloomberg site, I determined that by February 4, 2021 roughly 37 million doses of vaccine had been administered, or 11.2/100 people. Again, by now we’re vaccinating close to 1.7 million people per day. It’s not clear to me how many people have received both doses or just one, but what is clear is that, with a population of 328 million in the US, likely by February 4, over 20 million people, possibly as many as 25 million, had been vaccinated with the first dose of a COVID-19 vaccine by Pfizer/BioNTech or Moderna. I’ll use the lower number, to give RFK every bit of the benefit of the doubt that he doesn’t deserve. I also note that it is true that RFK Jr. did use a different site to come up with an estimate of 35 million doses administered by February 4, but that number was mentioned almost in passing, with no effort to do the calculations that show what a tiny number the VAERS reports represent. So I’ll do it.
From that perspective, 12,697 reactions of all kinds translates to 63/100,000 people, or 0.063%. Again, this is a rough calculation based on the estimated number of people vaccinated by February 4. In any event, that’s not a very big number, is it, particularly when it includes all adverse events, including less severe ones.
What about cardiac events? Again, RFK Jr. notes 1,171 serious cardiac-related cases reported to VAERS, with 1,021 within 48 hours of vaccination. Let’s do the math again, again with 20 million as the number of people vaccinated. (Again, if I used the total number of doses given, whether 35 million or 37 million, it would only look worse for RFK Jr.; as a benevolent cranky box of blinking lights I’m bending over to be nice to him.) That’s 0.0059% or 5.9/100,000 people. As for deaths, 134 deaths is roughly 0.7/100,000, a very tiny number. Of course, as is always the case, what is the comparator? How many people in the US die of cardiac events on a give day?
This is a little trickier because CDC death statistics show that heart disease claims around 650,000 people a year in the US, but that’s all heart disease, including heart attacks, congestive heart failure, etc. Let’s start with sudden cardiac death, defined thusly:
Sudden cardiac death (SCD) is a sudden, unexpected death caused by loss of heart function (sudden cardiac arrest). Sudden cardiac death is the largest cause of natural death in the United States, causing about 325,000 adult deaths in the United States each year. Sudden cardiac death is responsible for half of all heart disease deaths.
Sudden cardiac death occurs most frequently in adults in their mid-30s to mid-40s, and affects men twice as often as it does women. This condition is rare in children, affecting only 1 to 2 per 100,000 children each year.
Let’s translate that to the number of sudden cardiac deaths per day. 325,000 sudden cardiac deaths per year works out to around 890 deaths per day, each and every day, on average. That means, from December 14, 2020 (the first day COVID-19 vaccines were available outside of clinical trials in the US) and February 4, 2021 (a total of 53 days), we would expect roughly 47,710 sudden cardiac deaths just due to the natural baseline rate of this particular form of death. Here’s another comparator. In any two day period, we’d expect to see 1,780 (because I’m uncharitable right now, I’ll round up to 1,800) sudden cardiac deaths. Even if we counted all the sudden cardiac events within 48 hours of vaccination that were reported to VAERS, we don’t even come close to the baseline background rate of sudden cardiac deaths. I know I’m comparing apples to oranges here, all cardiac events to sudden cardiac death, but I’m doing it just to show that RFK Jr.’s numbers are not a concerning safety signal. He’s recording 134/53= 2.5 deaths from cardiac causes per day since the COVID-19 vaccination program began, and we know that just under 900 people a day die sudden cardiac deaths, considerably more if you count the “less sudden” forms of cardiac deaths.
Now here’s where RFK Jr. does something clever, something that tells me that he (or whoever wrote this article for him) knows he’s lying and misrepresenting statistics, rather than making an innocent error:
If we compare the 653 COVID-19 vaccine death reports to flu vaccine deaths reports, a shocking statistic emerges. There have been only 20 flu vaccine-related deaths so far in the 2020/21 flu season when more people received the flu vaccine than ever before — 193.6 million doses, and only one of those reported deaths was related to a cardiac disorder.
This means that so far, with only 35 million COVID-19 vaccine doses administered (as of Feb. 4), numbers of total reported deaths and also cardiac-related reported deaths are already exponentially higher than deaths reported following flu vaccines.
Did you see what they did there? No? Consider again that VAERS is a passive reporting system, as RFK Jr. loves to repeat over and over again. Also consider that the flu vaccine has been around for decades and has been recommended on a yearly basis for a long time. It’s in the background. People don’t even think much about it when they get it. Compare that to COVID-19 vaccination, and the unprecedented scale of the vaccine rollout in the middle of a pandemic. Consider also that everyone who receives a COVID-19 vaccine is given literature that explains how to report an adverse event to VAERS, as well as a pamphlet telling them how to sign up for V-Safe, a system that sends a text message periodically to ask vaccine recipients about their health and how they are feeling. I’m still getting weekly V-Safe texts two months after my first dose of the Pfizer COVID-19 vaccine. Basically, RFK Jr. is comparing apples to oranges in terms of reporting, given how much more intense the safety monitoring has been for COVID-19 vaccines.
Then, of course, RFK Jr. can’t resist going on in the same deceptive vein:
The U.S. is not the only country to report these symptoms following the vaccine. The UK government’s “Yellow Card” system has so far reported 590 cardiac disorders for Pfizer and 12 fatalities, and 212 reports for the Astra Zeneca vaccine, including one death.
The World Health Organization’s (WHO) vaccine injury reporting system, “Vigiaccess” has recorded 3,234 reports relating to cardiac disorders. Vigiaccess is a database of reactions of reports from 142 countries, but so far the 67,277 COVID 19 reports are mostly from Europe (81%), the U.S. (19%) and Asia (1%). It is unclear if there is duplication with VAERS and Yellow Card system.
Both the UK’s and the WHO’s systems are not accessible by the public, so further scrutiny is difficult without assistance from the respective agencies. As with VAERS, there is always a causality disclaimer which usually serves to dismiss all reactions despite temporality or association between exposure and disease.
Again, these are small numbers in comparison to the now 180 million doses of COVID-19 vaccines that have been administered worldwide. One can almost sense the desperation in the last paragraph, where RFK Jr. includes the grudging disclaimer that a report to VAERS does not imply causation, characterizing that observation as an excuse for the CDC to dismiss all reactions as “coincidence.
Then there’s this passage, which brought me back to a topic I first wrote about a couple of weeks ago:
Is it possible that the Pfizer or Moderna vaccine contribute to heart problems?
Some doctors think so. We know that the mRNA vaccines program cells into producing the spike protein to arm the immune system against an infection. What if the spike protein the body generates is also contributing to heart problems the same way that the virus would?
We know from recent research that the COVID-19 spike protein alone, without the virus, appears to be the culprit that triggers a cascade of events that results in inflammation and the formation of microthrombi (small blood clots) in vessels throughout the body. So it makes sense that many of the adverse reactions that we will see from the mRNA vaccines will parallel the injuries we also see from the COVID-19 infections.
When RFK Jr. says “some doctors think so,” what he’s really saying is that one doctor does. (Actually, there’s a doctor named Dr. J. Patrick Whelan who’s been making similar claims, but I’ll have to deal with him in another post at some point.) And who is that doctor? I’m referring to Dr. Hooman Noorchashm. whose idée fixe is that it’s dangerous to vaccinate those who have COVID-19 or have recently recovered from the disease because in patients who have been infected before there could still be spike protein in the endothelial cells lining blood vessels that could be the target of the immune reaction provoked by a vaccine based on the coronavirus spike protein, the protein used as the antigen in both the Moderna and Pfizer/BioNTech vaccines. It was a hypothesis that I didn’t consider totally unreasonable when I first heard it but that I now consider quite implausible, both from a basic science standpoint and from the lack of a safety signal predicted by it after 35-37 million doses of COVID-19 vaccines administered.
Unfortunately, Dr. Noorchashm has been utterly resistant to disconfirming studies and evidence and is still out there using anecdotes as evidence for his idea and getting increasingly annoyed that people other than antivaxxers are no longer paying attention to him:
He’s even looking for adverse events to use to promote his idea:
Have you or a loved one recently undergone vaccination with one of the COVID-19 vaccines from Pfizer or Moderna, currently being administered across the nation?
Have you or a loved one experienced any health problems, complications or death following such vaccination?
If so, please write me to report your problem at [email protected].
As a physician, immunologist and public health advocate I am very seriously concerned that the FDA and CDC’s surveillance systems are not capturing vaccine associated problems, complications and deaths with sufficient clarity and detail.
Basically, Dr. Noorchashm is still out there doing what antivaxxers have been doing, looking for reports of adverse events after COVID-19 vaccination. At this point, no matter how “pro-vaccine” he proclaims himself, he is continuing to help antivaxxers do their dirty work spreading fear about vaccines.
Finally, RFK Jr. tries to sound all “science-y”:
Temporality and strength of association are major contributors to causality according to the most robust diagnostic criteria used by doctors, the Bradford Hill Criteria:“Temporality is perhaps the only criterion which epidemiologists universally agree is essential to causal inference.” and “the larger an association between exposure and disease, the more likely it is to be causal.”
Here’s the problem. The numbers cherry picked by RFK Jr. don’t even show an association, much less a strong association, between COVID-19 vaccination and cardiac events, including sudden cardiac death, nor do they even come close to showing a temporal association. For that to hold, at the very least one would have to demonstrate that cardiac events occur well above the expected baseline rate within a certain timeframe after vaccination, and certainly the numbers used by RFK Jr. don’t even come close to showing that people receiving the COVID-19 vaccination are suffering cardiac events at anywhere close to the expected baseline rate. True, some of this could well be underreporting, but, even so, there isn’t even a whiff of a safety signal from these numbers.
Antivaxxers gonna lie, and grifters gonna grift, and RFK Jr. is nothing if not an antivax grifter.