Later today, the CDC will convene a meeting of the Advisory Committee on Immunization Practices (ACIP) to discuss, among other things, reports of myocarditis in young people after COVID-19 vaccination. This meeting was originally scheduled for June 18, but was delayed after President Biden signed a bill into law making Juneteenth a federal holiday. Because June 19 was Saturday, June 18 became the observed holiday this year.
Certainly antivaxxers and the right wing media have been weaponizing VAERS reports of myocarditis after COVID-19 vaccines, even though VAERS reports cannot establish causation, because that is what antivaxxers do. Pre-pandemic, they routinely used this tactic for VAERS reports of autism and sudden infant death syndrome, among other things, even though high quality epidemiological studies failed to find an indication of causation—or even correlation. Since COVID-19 vaccines were distributed under an FDA emergency use authorization beginning last December, antivaxxers have been doing the same thing, exactly as I (and many others who have followed the antivaccine movement for a long time) warned that they would, weaponizing reports of heart attacks, death, syncope, and Bell’s palsy by strongly implying causation and ignoring baseline rates of these events. One antivaxxer has even gone so far as to state that COVID-19 vaccines are killing lots and lots of people in a veritable “holocaust.” So, naturally, when reports of myocarditis in young people started showing up, antivaxxers did the same thing, but, worse, Fox News pundits amplified these reports:
That’s Dr. Peter McCullough, by the way, the same person who was claiming, in essence, a “holocaust” due to the vaccines. More recently, he’s been featured by Mike Adams on his podcast claiming that COVID-19 vaccines contain nanoparticles that self-assemble to build a biocircuitry “operating system” to control your moods and thoughts.
Of course, just as I have said for all the adverse events reported to VAERS, I must concede that it is possible that some COVID-19 vaccines might trigger myocarditis. What’s important is to look at the evidence, which ACIP will do. What is that evidence?
Myocarditis and COVID-19 vaccines in VAERS
At the June 10 meeting of the Vaccines and Related Biological Products Advisory Committee, a report was made regarding myocarditis after vaccination with mRNA-based COVID-19 vaccines. At that meeting it was reported that:
- Out of 3.26 million doses administered to children 12-15 years old (May 10 thru May 31, 2021), there had been 1,497 reports of non-serious adverse events (AEs) and 48 reports of serious AEs.
- Out of 19.84 million doses administered to 16-25 year olds (December 14, 2020, thru May 31, 2021), there had been 9,439 reports of non-serious AEs and 656 reports of serious AEs.
Most commonly reported AEs included dizziness, headache, nausea, fever, and syncope. But what about myocarditis?
The CDC notes that 226 (of 475) case reports met the CDC working case definition and that followup and review are in progress for the remaining reports. At the time of the report, 270 had been discharged; 15 were still hospitalized, with three in the intensive care unit. Of these ICU patients, two had significant comorbidities (morbid obesity in one; a Campylobacter infection in another).
Of the 270 discharged:
- 246 (91%) went home
- three went to another facility (e.g., rehabilitation facility)
- 21 did not specify
Of 270 discharged, recovery status was known for 221:
- 180 (81%) had full recovery of symptoms
- 41 (19%) had ongoing signs or symptoms or unknown status
Basically, in VAERS, there did appear to be a possible signal in that more reports of myocarditis were observed than would be expected without the vaccine in the general population, but only in 16-24 year olds.
So the investigators went to another system to test the hypothesis.
Myocarditis after COVID-19 vaccination (VSD)
Antivaxxers love to portray VAERS as though it’s the be-all and end-all of vaccine safety and there are no other vaccine safety monitoring systems. It’s true, too, that VAERS has a lot of limitations, largely because it is is unique among US vaccine safety reporting systems in that it is a passive surveillance system. It relies on people to submit reports of adverse reactions to vaccines; it doesn’t actively look for them, as active surveillance systems do. Moreover, anyone can submit a report to VAERS, and they do, including parents of autistic children seeking compensation for their children’s autism as being due to “vaccine injury”. Indeed, I long ago discussed how lawyers have long gamed VAERS to support their litigation, reporting lots of cases of autism as supposedly an “adverse reaction” to vaccines. It’s not just vaccines and autism, either. The easily-abused nature of VAERS data is one huge reason why those of us who’ve been following the antivaccine movement a long time like to refer to the bad “scientific studies” published by antivaccine physicians and scientists that use VAERS as their data source as “dumpster diving.” Examples abound, including a study claiming to find a link between the H1N1 vaccine and miscarriages or one of the earliest examples that I ever encountered, Mark and David Geier’s epically bad study trying to link thimerosal-containing vaccines to autism. As an amusing aside, whenever I discuss VAERS, I like to recount the tale of how in 2006 Jim Laidler infamously reported to VAERS that the flu vaccine had turned him into The Incredible Hulk and VAERS accepted the report. True, someone did contact him to question it. If Laidler hadn’t been honest, he could have insisted that the report remain, and it would have.
You might wonder: Why would anyone set up a system like VAERS, which is co-managed by the Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA)? First, you must understand that, as I alluded to above, VAERS isn’t intended to give an accurate estimate of the frequency of various adverse events after vaccination. Rather, it was always intended to serve as an early warning system, a “canary in the coalmine”, so to speak. Consequently, even though antivaxxers like to harp on how passive surveillance systems generally capture only a small fraction of adverse reactions, one thing VAERS does do is capture severe reactions. Practically no one is going to report an adverse reaction like a sore arm or transient fever to VAERS, but you know damned well they’ll report more serious ones, such as a seizure. The problem is that the natural human tendency to seek patterns, coupled with the way antivaccine lawyers game VAERS by having their clients report all sorts of spurious “adverse events” to the database after vaccination, means that VAERS is a very noisy, distorted, and unreliable database.
That’s why there are other systems, including the Vaccine Safety Datalink (VSD), which is an active surveillance system with nine participating integrated healthcare systems that covers 12 million people a year:
The Vaccine Safety Datalink (VSD) is a collaborative project between CDC’s Immunization Safety Office and eight health care organizations. The VSD started in 1990 and continues today in order to monitor safety of vaccines and conduct studies about rare and serious adverse events following immunization.
The VSD uses electronic health data from each participating site. This includes information on vaccines: the kind of vaccine given to each patient, date of vaccination, and other vaccinations given on the same day. The VSD also uses information on medical illnesses that have been diagnosed at doctors’ offices, urgent care visits, emergency department visits, and hospital stays. The VSD conducts vaccine safety studies based on questions or concerns raised from the medical literature and reports to the Vaccine Adverse Event Reporting System (VAERS). When there are new vaccines that have been recommended for use in the United States or if there are changes in how a vaccine is recommended, the VSD will monitor the safety of these vaccines.
So, given the findings in VAERS, the more reliable VSD was used to ask the same question: Is there a correlation between COVID-19 vaccination with mRNA-based vaccines and myocarditis? To do this, patients receiving the COVID-19 vaccines were compared to those in the database who didn’t receive these vaccines during the period in question but received other vaccines on the same calendar days. The data suggest no, at least in aggregate:
Drilling down, however, we see that the confidence intervals are very wide:
There does, however, appear to be a potential signal for an increased risk of myocarditis in young adults after the second dose of Moderna.
More concerning were these data from people 16-39 years old:
Given the increase after the second dose, even if there aren’t more cases of myocarditis after vaccination than might be expected in the general population, this is the suggestion that there might be a signal, leading to the conclusion:
- Early VSD data also suggest more cases after dose 2 vs. dose 1; rate ~16 cases per million 2nd doses.
Again, currently, even after the second dose of vaccine, myocarditis appears to be a rare event. Skeptical Raptor currently doesn’t think that there is a link between these vaccines and myocarditis while I am a little more concerned, but we both leave our minds open to the possibility as more data come in.
What does this all mean?
Even if this signal seen in VAERS and possibly hinted at in VSD turns out to be real and further investigation finds an elevated risk of myocarditis after vaccination in teens and young adults, it is important to make this comparison:
There are a couple of considerations here. First, even if there is a correlation between mRNA-based COVID-19 vaccines and myocarditis in the young, it remains a rare event and serious disability from it is even rarer. Second, as the article cited by Dr. Hotez found, there is a much higher risk of myocarditis after COVID-19 infection itself.
There’s a third consideration as well. It’s a rule in medicine that, whenever you look for something you will find more of it. More than that, though, you will find more of it in a subclinical or milder form that was not picked up before screening. I’ve discussed this before in the context of screening mammography, for instance, and the increasing prevalence of autism. Now that doctors are keyed in to the possibility of a link between COVID-19 vaccination and myocarditis in young people, I would expect increasing reports even if there isn’t a link, which will make sorting this whole thing out even more difficult.
In the meantime, I can’t help but refer to a post I did about a rare form of clotting disorder observed at an even lower frequency after vaccination with the Johnson & Johnson vaccine (for which, by the way, no reports of myocarditis have yet surfaced the last time I checked) and Tweets about the FDA and CDC’s actions at the time that make observations applicable to myocarditis and COVID-19 vaccines:
The bottom line is that safety monitoring of COVID-19 vaccines has been, contrary to the way that antivaxxers portray it, namely as ignoring and downplaying AEs in order to push vaccinations, incredibly intense, serious, and robust. The rapid investigation of cases of myocarditis after vaccination with the Moderna and Pfizer vaccines is just one more example of this. Although I won’t be able to watch it on livestream because I’ll be at work, I will look forward to seeing what sort of discussion occurs at ACIP later this morning.
Here are some updates on the ACIP meeting about myocarditis, as discussed on Twitter. I’m using a Twitter feed because all the figures are already there, and I don’t have to make them myself:
The evolving bottom line appears to be that there does seem to be a small but real increased risk of myocarditis from the mRNA-based COVID-19 vaccines, but the risk-benefit profile still favors vaccination.