Full disclosure, I was heading into this week NOT expecting to do an update, and focus on some other writing projects in my “writing time.”

Then I got inundated by reader questions around what is clearly another swell of “mRNA vaccines are unsafe” narratives out there this week, likely heavily prompted by the very public collapse of the NFL player we mentioned last week.

Damar Hamlin has been released from the hospital this week, with no reported adverse effects, and is looking more and more likely to be a case of commotio cordis. Regardless, I have still seen -absolutely nothing- about his vaccination status, what vaccine he got, and when. I know the assumption is that since he is in the NFL, he is vaccinated, because the league tried to force the players to do that and most did. If so, he was vaccinated awhile ago, but even that is not “proof” of his vaccination. After all, I’m old enough to remember quarterback Aaron Rodgers creating a preseason press firestorm just this year when discussing on Joe Rogan that he is known to be allergic to one of the vaccine components, and thus was not vaccinated, playing anyways, and went through his understanding of an alternative immunization protocol that he worked on with his doctor.

I’m not sure I understood what Aaron was talking about, but that’s a bit of a game of telephone, since it merely reflects what he understood of what his doctors were telling him about what they were doing. So no knock on anyone involved–I don’t expect Aaron to be an expert immunologist.

Getting back on track though, there is no evidence, for or against, the cardiac collapse of Damar Hamlin being remotely COVID related. Preponderance of evidence, including video of the incident, his treatment, and recover, all still suggest commotio cordis to me as the lead candidate, and that has little to do with myocarditis, be it vaccine or infection associated.

But that was a high profile, highly watched, and high news coverage event like an elite 20 something athlete keeling over and needing CPR in the middle of the game. “There’s been like a billion of those though, lately, right? I mean, this was something that was happening and being commented about all throughout the pandemic. Isn’t this just like all those European soccer players who were collapsing and needing CPR just a season or two ago?” I hear you say Rememberin’ Recent History Hypothetical Reader.

“Shouldn’t this prompt debates on COVID mRNA vaccine safety if all of these young, healthy athletes are having these scary cardiac events?”

I hear you say that too, Hypothetical Reader.

And I get it. I mean, I did five minutes of Google just now, and stuck to just the first page of results, and look at all these stories about young athletes dying from sudden cardiac collapses. And they all have a common theme–I’ll tell you what that is after I list them out here:

–You have a thirteen year old who died after collapsing during football practice in Texas.

–You have the preliminary report of a 26 year old NBA G-league player who died after collapsing during a game, which showed “cardiac abnormalities” that will need further investigation. Yeah–I bet you don’t even remember hearing about this, right?

–There’s a high school football player this time who collapsed and died during a recent game. If you read the article, he’s one of at least 9 similar cases in the previous 8 months! Bet you don’t recall hearing about that either.

–Finally, we have a good news write up a New England Journal of Medicine study on adolescent soccer players found that the rate of sudden cardiac death was three times higher than estimates from previous years, and recommended changing who and how we screen for risk factors and early diagnosis of possible cardiac problems. That’s right! A full on, peer reviewed, top tier journal study of sudden cardiac death in soccer players–and it found a MUCH higher rate of cardiac risk than expected!

“See?!?!?! This is what we’re talking about! All these scary reports are everywhere; this NEVER happened before or at least was NEVER this common; and it’s only since COV-“

No. No, no, no, no. Let me stop you RIGHT THERE, Hypothetical Reader.

Because I can assure you that NONE of those four links I just gave you, all on similar scary stories of young elite athletes, collapsing and dying during games, including enough young soccer players to warrant a specific study of them, have -anything- to do with COVID. In fact, I’ll repeat that in all bold and all caps.

THOSE FOUR LINKS I JUST GAVE YOU, ALL OF THOSE COLLAPSES AND DEATHS, AND THE SOCCER STUDY, HAVE -NOTHING- TO DO WITH COVID.

Nothing at all.

“But-“

No. No COVID at all. And I am 100% confident of that, Hypothetical Reader.

Because those four stories? The common link? It’s not COVID.

That’s 5 minutes of Google and the links from the first page of hits for a search of athlete cardiac death in 2018.

That’s right–all four of those links, and the soccer study, predate COVID by two years.

You may recall we said at the time when European soccer players were keeling over that it wasn’t clear if COVID vaccination was playing a role (considering many of those players were less likely to be vaccinated than you might have thought) or COVID infection itself or if it was merely just a statistical blip.

This is why. Every year, every single year, a few elite athletes will go down unexpectedly for cardiac reasons. Usually genetic. Could by myocarditis that wasn’t picked up (either COVID or other causes). Commotio cordis in the right setting. Heat stroke was a thing for a few years too. While those genetic causes are rare, there are enough athletes out there that a few will “win” that lottery.

Don’t confuse the increase in media coverage incidence with epidemiological incidence, as the former is volitional, and the latter is biological.

Since the coverage incidence has clearly resuscitated some of the debates on vaccine safety (pun intended), let’s shoot for a quick discussion.

Alright. Let’s start with the following stipulations, what we all know, and can agree on.

1. The mRNA COVID vaccines have a known, but small, risk of myocarditis as a vaccine associated adverse event.
2. The FDA, and other regulatory agencies, believe they have this known risk as well. No really! They make them list it as a known adverse event, and have required both Pfizer and Moderna to do Phase 4 studies specifically to better understand the incidence, severity and duration of vaccine associated myocarditis.
3. Those Phase 4 studies, for Pfizer at least, are actually about a week over due. This is NOT conspiratorial. The FDA, I am sure, is working the language on these HARD, because no matter what they say when they release them, both narrative sides will claim victory. One side will say “see? Myocarditis CONFIRMED! VACCINES UNSAFE!” The other will say “Rare!” and downplay severity. The truth will be in the middle. The FDA knows they will be crucified from both sides, pretty much no matter -what- they say.
4. The risk of myocarditis is HIGHER from infection by SARS-CoV-2 than the vaccine. We estimated about 10 fold previously; I have seen meta-analyses that suggest it may be as high as 1,000 fold. Suffice to say, the risk of myocarditis from COVID infection is 1 to 3 -orders of magnitude- HIGHER the same risk from the vaccine.
5. This is because a SARS-CoV-2 infection will produce more spike protein than the vaccine in total, for longer, and yes, also distribute it throughout the body through the virus’ known ability to get into the blood stream and infect endothelial cells.
6. The real question, as SARS-CoV-2 mutates to -less severe- strains, revolves around how the risk of myocarditis from severe infection is changing relative to the risk of myocarditis from vaccines and boosters. For kids, as we mentioned at the time, this is already kind of close–they don’t get severe COVID very often, and thus have the lowest rates of myocarditis from SARS-CoV-2. In fact, this is why some countries stopped giving the vaccine below a certain age range.
7. It is absolutely legitimate to monitor risks of myocarditis from circulating strains of SARS-CoV-2 and the vaccine to better understand the risk:benefit ratio, and when the risk of the vaccine myocarditis might outweigh its benefits from viral strains unlikely to cause severe disease. Especially since we also have effective acute treatments to reduce the rate of severe COVID.
8. To that point, just this week, one of the advisors to the FDA’s external expert board for vaccines published an op-ed in the NEJM that gives an excellent overview of the bivalent “boosters” that were approved this summer. The op-ed concludes with the following, which should sound very familiar (although I am neither the expert nor the author of this conclusion): “Although boosting with a bivalent vaccine is likely to have a similar effect as boosting with a monovalent vaccine, booster dosing is probably best reserved for the people most likely to need protection against severe disease — specifically, older adults, people with multiple coexisting conditions that put them at high risk for serious illness, and those who are immunocompromised. In the meantime, I believe we should stop trying to prevent all symptomatic infections in healthy, young people by boosting them with vaccines containing mRNA from strains that might disappear a few months later.” You can find the entire op-ed here. That entire committee will meet at the end of this month to update recommendations for necessity of boosters and in which populations, and will undoubtedly debate the risk:benefit of them vis a vis the phase 4 studies on myocarditis risk.
9. It is unknown, but at least probable, that taking anti-inflamamtory medication around the second vaccine dose and/or boosters may reduce the risk of myocarditis. That said, there are studies that show that patients who get vaccine associated myocarditis have detectable free spike protein in their blood that is NOT bound by antibodies, while those who get the vaccine, but NOT myocarditis, have wrapped up spike protein in their blood with antibodies. So it may come down to the kind of antibodies your immune system “chooses” to make that determines your risk of myocarditis, and MOST, indeed, the GREAT MAJORITY of people, have immune systems that make the “right” antibodies to avoid myocarditis from the vaccine.
10. Which is to also say that we might better understand who is at higher risk for vaccine (or infection) associated myocarditis and perhaps ways to reduce that risk in the near future.

To very briefly address some of the coverage of specific papers we were sent, one was an article taking a stance on a small study of 9 adolescents with vaccine associated myocarditis that was significant for showing cardiac MRI changes consistent with at least some scarring a few months later. However, the study is small and lacked control groups for comparison to put the findings into appropriate context. Did not stop the over-interpretation of the study in the article I was sent. Fortunately, there are better studies, such as the one covered well in a lay report here, which had control groups of myocarditis from COVID infection itself and another group of non-COVID but viral infection associated myocarditis. The TL;DR version is that the vaccine associated myocarditis was less severe in effects on the heart versus infection associated myocarditis, and generally cleared over time. Again, you are 10 to 1,000 times (depending on who you read/believe) more likely to get myocarditis from a case of severe COVID than from the vaccine–even though yes, Virginia, the vaccine can cause myocarditis too.

There was a pre-print article whose lead author is a well-known and vocal COVID vaccine critic, whose default is they are dangerous and unsafe. I don’t say that to be ad hominem, but just that I was reading the pre-print with an eye towards the bias of the author. This pre-print article was sounding alarm about a large increase in menstrual irregularities and still births associated with the mRNA COVID vaccines based on the VAERS reporting results. They looked at the VAERS data and compared the rates of reports for these conditions to rates of similar reports for flu vaccines, and in fairness, they cite the correct “safety signal” metric that is used to generate hypotheses from the VAERS data. Because that is all the VAERS data does–generate possible safety signals for more definitive studies to analyze. In general, a possible safety signal worth following is when a given condition is twice as commonly reported with a new vaccine versus an older one. The challenge with interpreting VAERS for COVID vaccines specifically is the nature of VAERS reporting and potential confounding variables. There has been a real, and public, push to blame ALL THE THINGS on COVID vaccines. You have never had the level of VAERS reporting as you have had with COVID vaccines as a result, and anyone can make a VAERS report if they think there is even a remote chance that the vaccine could be associated with the condition they are reporting. So a HUGE number of different conditions associated as possible adverse events for the COVID vaccines in VAERS (and I saw other articles highlighting the long, long list of other possible conditions that were reported twice as often per dose versus flu vaccines elsewhere) could happen for two different reasons.

–1. The COVID vaccines really are one of the most unsafe products ever, and have just enormous amounts of wildly different side effects.

Presumably, those who believe that the vaccines are wildly dangerous due the varied and severe consequences of SARS-CoV-2 spike proteins are also big believers in long COVID. They should believe that not only does long COVID exist, but it is common and causing wide ranges of very severe long term symptoms in patients all over, as viral infection causes higher “doses” of spike protein over a longer period than the vaccine. When I draw the Venn diagram of those who believe the vaccines are super dangerous and causing all kinds of varied problems, and those who believe long COVID is common, super dangerous and causing all kinds of varied problems, I don’t see much overlap. Conversely, I don’t find that those who believe fervently in long COVID overlap much with believers in common and widespread severe side effects from the vaccines.

I find the psychology and sociology of that fascinating.

Aside over.

–2. The higher level of reporting on all those conditions in VAERS is a reflection of the higher number of reports submitted because a larger segment of the population believes that these vaccines -may- be very unsafe and is reporting ALL possible side effects, no matter how improbable the causation.

When they have done controlled studies (and we’ve covered a few just for menstrual irregularities with the vaccines, because that cropped up specifically earlier), the incidence and severity has NOT matched the VAERS signal in the current pre-print report on VAERS safety signals that I received via a reader this week. And those studies we reported earlier were controlled, and far and away better evidence.

For things like birth defects and still births, other analyses of the same VAERS data!!!! have come to completely different conclusions than the preprint article. One can be found here. Notice they call these findings “preliminary” as well, precisely because to be definitive, focused and controlled studies need to be done.

VAERS is a hypothesis generating tool, and is not, by itself, definitive of anything.

In fact, for birth defects and still births, when those studies have been done, they have also NOT seen the signal the preprint article was all worked up over. Here is good lay coverage of a study in Australia, although the results may be confounded as the non vaccine group has other socioeconomic reasons for higher levels of defects and still births.

So that pre-print article will need to survive some peer reviewer moderation of its conclusions, I think, and even then, is just “cool story, bro” until some of the potential signals get tested with a more rigorous and focused study.

–I think what will be proven out of VAERS will likely share an inflammatory mechanism of action. The symptoms of the Pfizer flu and Moderna malaise are consistent with a really solid, and inflammatory reaction, generating dose in that vaccine.

–Again, kudos to the readers and your spidey sense about articles that seem like they might be just a little alarmist, and want a sanity check on how worried they really should be, or if the science really says what is being claimed in the article.

You guys -really are- good bullshit detectors. Really!

–Real quick XBB variant update… It is indeed better at avoiding immune protection from vaccines and prior infection, and is contagious. It’s also far better than previous omicron cousins at binding the ACE receptor–however, still no sign that it is more severe than its omicron cousins. For the most part, it and a few other new generation cousins are pushing out the last vestiges of omicron BA.5, and it may again be more that BA.5 is running out of hosts it can infect than anything else.

–Around the horn, transmission is still quite brisk in China and nearby neighbors, with Japan and Thailand for example seeing solid upticks. In the US, cases are flat to declining and leading indicators are actually trending DOWN (I know–this despite XBB headlines).

–At some point, we’ll come back to some inexpert pontificating the intersection of narratives, government and social media, and how to judo narratives when friends and family have been caught in a moment and gone tribal on you. At some point. But not today. I’m out of time. : )

Your chances of catching coronavirus this week are equivalent to the chances that this was a live shot of your author when enough texts and emails on vaccine safety, signals, and media coverage of those had rolled in that an update this week probably made sense…

<Paladin>