COVID19 update, July 1, 2021: mRNA vaccines and myocarditis revisited

[Apologies in advance for formatting issues]

So the CDC has now issued a warning that myocarditis may be a rare consequence of Pfizer and Moderna mRNA vaccines.  https://www.medscape.com/viewarticle/953647 A comment from the British Medical Journal here: https://www.bmj.com/content/373/bmj.n1635

As we have covered here on April 27 https://spinstrangenesscharm.wordpress.com/2021/04/27/covid19-update-april-27-2021-india/,  the first country to report a potential problem was actually Israel — the first to vaccinate the majority of its population (and over 90% of people age 50 and over) with Pfizer. 

Yet the response has been much slower than in the case of the rare blood clotting disorder found among Oxford/AstraZeneca vaccinees — almost exclusively women of child-bearing age. [See our previous coverage here https://spinstrangenesscharm.wordpress.com/2021/04/11/covid19-mini-update-april-11-2021-clues-about-rare-oxford-astrazeneca-thrombotic-events-israel-has-reached-a-form-of-herd-immunity-pfizer-and-south-african-variant/ and herehttps://spinstrangenesscharm.wordpress.com/2021/04/11/covid19-mini-update-april-11-2021-clues-about-rare-oxford-astrazeneca-thrombotic-events-israel-has-reached-a-form-of-herd-immunity-pfizer-and-south-african-variant/

Several European countries actually suspended O/AZ, others switched to Pfizer for women and O/AZ for men.

So why the much slower response? Two reasons: signal-to-noise ratio and severity.

If a severe complication is either unheard of normally, or [in the case of O/AZ’s thromboleucocytopenia], does exist but is “one in a million” rare in ‘nature’, then it takes quite few cases to raise the alarm. This is doubly true if we’re talking about life-threatening complications.

In contrast, myocarditis (inflammation of the heart muscle) is a much more common ailment: a 2016 article in the journal Circulation Research

https://www.ahajournals.org/doi/10.1161/CIRCRESAHA.115.306573 speaks of 22 cases annually per 100,000 people. Patients skew heavily male — in fact, a 1999 article reports 98 cases of myocarditis diagnosed among 670,000 Finnish military conscripts 1977–1996, during their intake checkups. https://doi.org/10.1053/euhj.1998.1444

At least one guy (early twenties, athletic) in my daughter’s social circle has had a bout of viral myocarditis — and yes, this was in the BC era, Before COVID ;).

Myocarditis can be caused by a wide variety of pathogens: the Merck Manual explains:

Infectious myocarditis is most often viral in the US and other developed nations. The most common viral causes in the US are parvovirus B19 and human herpes virus 6. In developing nations, infectious myocarditis is most often associated with rheumatic carditis, Chagas disease, or AIDS. Direct myocardial injury due to SARS-CoV-2 infection, with symptoms ranging from mild chest discomfort to fulminant myocarditis, may occur in COVID-19 cases.

Noninfectious causes include cardiotoxins, certain drugs, and some systemic disorders. Myocarditis caused by drugs is termed hypersensitivity myocarditis.

Merck Manual of Diagnosis and Therapy, Professional Edition, accessed July 1, 2021: https://www.msdmanuals.com/professional/cardiovascular-disorders/myocarditis-and-pericarditis/myocarditis

The vast majority of clinical cases are self-limiting (medico-speak for: “the patients will get better on their own”), with NSAIDs like ibuprofen for inflammation and pain, and (important!) rest. (Going long distance-running or iron pumping during a bout of myocarditis, thinking “rest is for wusses” can kill you — think of it as trying to go racing in a car with an engine working at half-capacity.) A good cardiologistshould be able to tell the small minority of cases that take a more sinister turn.

You get the idea: if myocarditis is a side effect of vaccination, it needs to have a fairly high incidence rate to generate a signal that statistically rises above background and the noise thereon. When back in late April I raised the subject with the Infectious Diseases chief at [name of major hospital redacted], (s)he was convinced the incidence among vaccinees was just that among the general population.

Meanwhile we have more data, as pretty much every adult who’s ever going to have the shots has gotten them. Between January and May 2021, Israeli hospitals nationally saw 275 cases of myocarditis, of which 27 shortly after a first Pfizer dose, 121 shortly after a second Pfizer dose, the remaining 127 clearly unrelated. Even if we attribute all 148 temporally related cases to the vaccine (itself a post hoc ergo propter hoc fallacy), that is 148 out of 5.17 million doubly vaccinated — about 29 per million, or one in 35,000. Cases were overwhelmingly, but not exclusively, young men.

The vast majority of these cases resolved over several days with nothing more than bed rest, NSAIDs, and hospital observation. In one (1) highly publicized case (link to a Channel 13 documentary  segment in Hebrew 

a 22-year old girl named Shir-El Hallel [z”l] died a few days after being admitted to Sieff Hospital in Tzfat (or Safed for Arabic speakers), the regional medical center for the Upper Galilee. The deceased’s sister, being interviewed in the video, is herself a nurse and gives a fair amount of medical detail. Apparently, the admitting physician in the ER looked at her ECG suspected correctly it was myocarditis, had a blood panel done and found extremely high levels of troponin  https://en.wikipedia.org/wiki/Troponin (10,000 ng/l, compared to 20-40 normally) upon which he referred her to the cardiac ICU for observation.

The family (and their attorney) now argue the doctor and nurse there “fell asleep on watch” and ignored the young woman’s deterioriation, and are now suing them and the hospital for rashlanut refu’it [medical negligence]. (It is also alleged that the night nurse, who saw “readings that didn’t make sense” on the cardiac monitor, simply shut it off rather than to wake up and alert the doctor.) The Channel 13 interviewer spoke to two senior cardiologists on camera (one from Ichilov Hospital, the other from Sheiba/Tel Hashomer — two of the “Big Four” academic hospitals in the country. Both are saying a competent colleague should have caught this and would have been able to prevent her death.

Speaking as a somewhat informed layman, it seems the family has a prima facie case[*]. On the other hand, a recently retired cardiologist abroad I talked to said this was a murky situation and no physician’s judgment calls will bat 100% accuracy in such a situation. “Medicine is not an exact science.”

So is the risk of one (1) death worth it? [Assuming, for the sake of argument, it were not preventable.] We had a total of 6,429 documented “of, not with, COVID” deaths.[**] According to the website of the Clalit HMO, in the group ages 0 to 30, there were 42 deaths total from COVID (0.65% of overall COVID mortality), plus 51 ages 30-39, 123 ages 40-49, and then the numbers rise rapidly with age.

These are the facts as we know them. When assessing them, it behooves us to steer clear of three fallacies:

• misleading vividness: a very vivid and newsworthy, but extremely rare “man bites dog” event is perceived to be much more common than it actually is
• Nirvana fallacy: rejecting any solution that is not 100% successful.
•  180ism (thanks to center-leftie Yasha Mounck for this priceless neologism): whatever one’s ideological opponent favors, one must take the 180 degrees opposite position — a fallacy related to “reductio ad Hitlerum” . Remember that even the most incompetent and/or evil regime can get something right sometimes, if only because of the Law of Broken Clocks.

[Many thanks to reader “Yves not-Cohen” for some background info.]

[*] There is the additional thorny ethno-religious complication here that made thorny here by an ethnic issue — the doctor being accused of malpractice is Arab, like, BTW, many respected physicians here. To its credit, the family has not raised this issue.

[**] Thank G-d, this is now largely behind us. According to the Ministry of Health dashboard, the last COVID death was a week ago, the one before  that ten days earlier.