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I listened to a lot of the ACIP hearing yesterday re the mRNA vaccines and the myocarditis concern. (The part about boosters was also very interesting!)
As soon as that risk/benefit analysis was shown, I had no doubt that the vaccines would continue. without even the pause that the J&J vaccine got. But Iām not clear if they will take a vote (like they do at the other meetings Iāve listened to parts of ā when the J&J was first granted EUA and when the pause was lifted) at some point. The other meetings were only re the J&J vaccine, whereas this meeting was a 3-day event to discuss other vaccines, also. The mRNA presentations/discussion was only added to this weekās meeting because the original meeting was cancelled because of the Juneteenth holiday.
They do not believe the spike protein is the problem as the spike protein antibody was negative in some patients.
The young men affected by myocarditis, which in itself appears not to be fatal and largely appears to be easily treatable, may in fact also be hospitalized or die of covid. What makes you think that the numbers must be āothersā? The numbers might just as easily include these same young people.
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To me, the way to think about the myocarditis risk is: what are the odds of getting myocarditis from the vaccine? The risks of an equally/more serious adverse event from covid? Which number is bigger? Avoid that.
A few people may not generate antibodies to the spike protein after vaccination or natural infection. But the spike protein could still adversely affect them in whatever way in that case.
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I think you have to weigh the odds of getting myocarditis from the vaccine against ALL the possible adverse events from COVID, not just the same condition.
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One of the biggest challenges with Covid is it doesnāt impact everyone the same. Certain groups of people are more at risk for worse outcomes than other groups. No groups are without risk though. But its clear some groups are much more at risk overall and for worse outcomes.
Risks of unknowns in terms of vaccines are also not equally distributed. Obviously any long term effects of vaccine will be endured longer for someone in their 20s versus someone in their 80s. Effects are also more likely to impact younger people (more active) than the elderly. Same is true of long term impact of Covid though.
Different people will weigh the risks differently. There is a tendency here for people to think everyone elseās experience is the same as theirs. That just isnāt the case though.
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Iād tend to view the relative risk of adverse outcomes from any vaccine vs adverse outcomes from the disease, as suggested, and avoid the more risky path. One should look at all outcomes from Covid as well and the data is still forthcoming on that. So a lot of unknowns.
It seems the risk/benefit trade-off is more defined at this point, although no doubt those figures will update over time. As someone pointed out, it wouldnāt be clear who those āothersā are whose deaths or hospitalizations are prevented; however, in general those who are hospitalized due to Covid skew older and less healthy than 18-24 year old men. The data are pretty clear there. We know that the subject 18-24ās were healthy prior to the heart inflammation (ie no underlying reason to have heart inflammation). So it seemed an odd trade-off to potentially give someone who is healthy a treatment that could make them sick in order to prevent maybe twice the number of ICU admissions and a few deaths. While several hundred hospitalizations are also avoided, we donāt know the cost or resources of those vs. the heart-inflammation hospitalizations and medical follow-up. Myocarditis and pericarditis - even mild cases - means no exercise for six months upon recovery. And only 79% seem to recover; another 21% may need pacemakers, heart transplant, etc.
Still, we are talking small numbers. Iām just wondering how this analysis compares to other risk/benefit trade-offs that the medical community sees when assessing the impact of a new drug or therapy. For instance, would they recommend that this age group refrain from taking it, or continue? The conclusions are pretty broad, given the very different predicted outcomes by age and gender.
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I wonder how this all fits in with the long haulers like my son who have experienced chest pain (and fatigue - even from walking or playing frisbee) for up to a year, then got better after being vaccinated to where he said he has no side effects now. 57% of long haulers got better after Moderna (13% worse), but I donāt know if all of them had chest pains - probably not. My guy did. Heās glad to be rid of them.
I wish he had had health insurance and they had done more tests on him along the way instead of just a chest x-ray when he was sick. I am incredibly curious how this whole puzzle fits together.
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Agree. That risk/benefit analysis kind of does that by looking at hospitalizations, ICU admits, death, etc but doesnāt touch on long-Covid issues. Data is probably still developing there and of course there are varying degrees of severity. Some long-Covid is under-the-radar, too, which complicates matters. Myocarditis and pericarditis are very specific side effects with a known course of treatment.
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Short answer is yes.
For a stark reminder of this, take a look at the meeting documents and assessment of the TTS risk associated with the JNJ vaccineā¦there is a slide with the risk of all thrombotic type events with oral contraceptives (spoiler alertā¦much greater than that of the JNJ vaccine), see slide 20 here: https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2021-04-23/04-COVID-Mammen-508.pdf
A few clues in this presentation:
Look at the āAdditional considerations for direct benefit and riskā, which are on slide 35 of the deck that evergreen5 linked to above (which apply to all age groups, not just the 12-17 year old data shown along side these additional risk factors):
-Prevention of MIS-C (has a 1%-2% fatality rate in those under 21, per slide 16)
-Prevention of prolonged symptoms
-Protection against variants
You can see the authorās conclusion re: risk/benefit analysis on slide 37:
Direct benefit-risk assessment shows positive balance for all age and sex groups
Further, on slide 39, the recommendation in people with a history of myocarditis or pericarditis is to get the vaccine in all age groups, with the exception of those who had Myocarditis after the 1st dose of an mRNA COVID-19 vaccine but prior to 2nd dose. And even then, in some instances, if the heart has healed, the recommendation is to get the 2nd vaccine.
Defer 2nd dose of mRNA COVID-19 vaccine until more information is known
However, if heart has recovered, could consider proceeding with 2nd dose under certain circumstances. Discuss with patient, guardian, and clinical team
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Completely agree ā thatās what I thought I said. 
Probably posted too early (not enough caffeine).
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My husband just got a physical and his doctor suggested doing a heart test (Canāt remember which one) out of an abundance of caution. It still doesnāt compare to the numbers with heart problems and more from Covid itself.
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When Covid first started spreading, there was a study (out of Germany as I remember) that it caused myocarditis in athletes at a very high rate.
Doctors, researchers and young healthy athletes were very concerned. Then it was looked into, there were additional studies. It was found that myocarditis was a rare complication of Covid.
So again, itās a complication of getting Covid and a rare complication of the vaccine. Pick your poison. I suspect that they are seeing it in the vaccine at a lower rate than if you got Covid. I donāt know that for sure but seeing as they have seen 1200 cases out of millions of vaccinated. You decide.
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We know the risk factors for the disease (old age, diabetes, obesity etc.) I havenāt seen anything about real risk factors for the vaccine - except that they seem totally different. J&J hit some young females, the myocarditis issues with mostly young males. It seems very counterintuitive to me.
If there are ~1200 reports of myocarditis among the 177 million people whoāve been vaccinated how would we know whether they got it from the vaccine or from having Covid? If people had an asymptomatic or low symptom case of Covid could it have affected their organs? How do scientists know whatās a side effect of the vaccine and what was caused by the virus?
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In part, I assume it is the temporal relation. See slides 26-29 the rates for dose 1 and dose 2 (there is a clear dose dependent relationship), and the difference (or lack thereof) between 7 and 21 days post vax.
But, this is still all passive data. For the life of me, I cannot see why they do not want to do an actual prospective study. VAERS data is not a study; it is a signal for further investigation.
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I suspect there is, but studies take time. Why would you think there wouldnāt be?
Because someone asked that exact question at the meeting yesterday, and CDC straight up said no, they were relying on VAERS. Presumably Pfizer still has some studies ongoing as they work toward full approval, though that wasnāt part of their answer (my understanding is that Pfizer never found myocarditis in the small studies on young ages, their n was too small).
Adding, CDC mentioned that some in academic circles may be kicking around the idea of doing a study, but none are happening at this time.
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