Study-vaccine induced myocarditis risk by vaccine type, age, gender, and dose--Moderna higher risk

[tall73]

Risk of Myocarditis After Sequential Doses of COVID-19 Vaccine and SARS-CoV-2 Infection by Age and Sex

Some selections:

DISCUSSION In a population of >42 million vaccinated individuals, we re-port several new findings that could influence public health policy on COVID-19 vaccination. First, the risk of myocarditis is substantially higher after SARS-CoV-2 infection in unvaccinated individuals than the increase in risk observed after a first dose of ChAdOx1nCoV-19 vaccine, and a first, second, or booster dose of BNT162b2 vaccine. Second, although the risk of myocarditis with SARS-CoV-2 infection remains after vaccination, it was substantially reduced, suggesting vaccination provides some protection from the cardiovascular consequences of SARS-CoV-2. Third, in contrast with other vaccines, the risk of myocarditis observed 1 to 28 days after a second dose of mRNA-1273 vaccine was higher and similar to the risk after infection. Last, vaccine-associated myocarditis was largely restricted to men younger than 40 years with 1 exception; both younger men and women were at increased risk of myocarditis after a second dose of mRNA-1273.

Vaccination against COVID-19 has both major public health and economic benefits. Although the net benefit of vaccination for the individual or on a population level should not be framed exclusively around the risks of myocarditis, quantifying this risk is important, particularly in young people who are less likely to have a severe ill-ness with SARS-CoV-2 infection.

The risk of vaccine-associated myocarditis is small, with up to an additional 2 events per million people in the 28-day period after exposure to all vaccine doses other than mRNA-1273. This is substantially lower than the 35 additional myocarditis events observed with SARS-CoV-2 infection before vaccination. Furthermore, vaccination reduced the risk of infection associated myocarditis by approximately half, suggesting that the prevention of infection associated myocarditis may be an additional longer-term benefit of vaccination. The risk of vaccine-associated myocarditis is consistently higher in younger men, particularly after a second dose of mRNA-1273, where the number of additional events during 28 days was estimated to be 97 per million people exposed. An important consideration for this group is that the risk of myocarditis after a second dose of mRNA-1273 was higher than the risk after infection. Indeed, in younger women, although the relative risks of myocarditis were lower than in younger men, the number of additional events per million after a second dose of mRNA-1273 was similar to the number after infection. These findings may justify some reconsideration of the selection of vaccine type, the timing of vaccine doses, and the net benefit of booster doses in young people, particularly in young men.

It should also be noted that only the first occurrence of myocarditis in the study period is used in this analysis. Therefore, the results found for the risk of myocarditis after a third dose do not include repeated instances of myocarditis in the same individual.

A comparison of rates of death with myocarditis between those infected with SARS-CoV-2 or vaccinated was not possible, given that for this analysis, we have included only people who had been vaccinated. Therefore, a patient with COVID-19 who died after myocarditis before receiving a vaccination will not be included, and rates of myocarditis death after SARS-CoV-2 will be underestimated

Be sure to note the last paragraph for an important caveat. I wish they had separately calculated the total risk for those never vaccinated from the same database for comparison. But it still has helpful info overall.

This is not new info, in that the preprint was released some months back. However, it was now published, etc.

 

[KCfromNC]

From the conclusion of the paper :

In summary, the risk of hospital admission or death from myocarditis is greater after SARS- CoV2 infection than COVID-19 vaccination and remains modest after sequential doses including a booster dose of BNT162b2 mRNA vaccine.​

 

[tall73]

From the conclusion of the paper :

In summary, the risk of hospital admission or death from myocarditis is greater after SARS- CoV2 infection than COVID-19 vaccination and remains modest after sequential doses including a booster dose of BNT162b2 mRNA vaccine.​

There is only one sentence more in the abstract conclusion so we can include it also. It relates to the higher risk among young men, especially when receiving Moderna.

CONCLUSIONS: Overall, the risk of myocarditis is greater after SARS-CoV-2 infection than after COVID-19 vaccination and remains modest after sequential doses including a booster dose of BNT162b2 mRNA vaccine. However, the risk of myocarditis after vaccination is higher in younger men, particularly after a second dose of the mRNA-1273 vaccine.

 

[stevil]

There is only one sentence more in the abstract conclusion so we can include it also. It relates to the higher risk among young men, especially when receiving Moderna.

CONCLUSIONS: Overall, the risk of myocarditis is greater after SARS-CoV-2 infection than after COVID-19 vaccination and remains modest after sequential doses including a booster dose of BNT162b2 mRNA vaccine. However, the risk of myocarditis after vaccination is higher in younger men, particularly after a second dose of the mRNA-1273 vaccine.

Myocarditis is a condition. But it doesn't talk about the severity, or longevity of the condition.

What is the risk of hospitalisation, long term injury or death for young men after the vaccine vs after SARS-CoV-2 infection?

 

[tall73]

Myocarditis is a condition. But it doesn't talk about the severity, or longevity of the condition.

What is the risk of hospitalisation, long term injury or death for young men after the vaccine vs after SARS-CoV-2 infection?

This study was actually looking at hospitalization or death resulting from myocarditis. So the rate of events is for either hospitalization or death.

We included all people ages 13 years or older who had received at least 1 dose of ChAdOx1 (AstraZeneca), BNT162b2 (Pfizer), and mRNA-1273 (Moderna) vaccine and were admit-ted to hospital or died from myocarditis between December 1, 2020, and December 15, 2021.

Also, it only looked at the first incident if someone had to be hospitalized more than once after another dose or infection.

 

[jayem]

From the public health standpoint, the issue is not whether a vaccine (or any therapeutic measure) has a risk of side effects. Of course, they all do. The far more important measure is the risk/benefit ratio. The evidence is solid that the benefit of mRNA vaccines in preventing serious SARS-CoV-2 infection requiring hospitalization and intensive care is far greater than the risk of vaccine side effects.

BTW: I’ve been a subject in the Pfizer BNT162b2 clinical trial for the last 2 years. I have regularly scheduled blood draws to check antibody levels. I had the 1st booster last Sept, but I have to wait until after my next blood draw to receive a 2nd booster. A major part of the study is determining antibody levels one year after vaccination. And anyway, I want to be boosted with the new vaccine that is augmented to cover the Omicron BA.4 and BA.5 subvariants. It should get EUA status very soon.

 

[tall73]

From the public health standpoint, the issue is not whether a vaccine (or any therapeutic measure) has a risk of side effects. Of course, they all do. The far more important measure is the risk/benefit ratio.

Risk profile for different age groups is part of the risk/benefit calculation.

For instance, if you are one of the young men at higher risk, you might want to think twice about Moderna, as compared to Pfizer, by this data.

Although that may change as you get into higher age groups if Moderna has better effectiveness but shows less risk for that age group.

It is also a reminder that each dose could potentially carry risk, which is part of the calculation when considering a booster.

 

[KCfromNC]

This study was actually looking at hospitalization or death resulting from myocarditis. So the rate of events is for either hospitalization or death.

Just so we're keeping this in perspective, the rate after covid vaccinations was something like 0.007%.

 

[ThatRobGuy]

While it's important to note that the myocarditis risk is bordering what I would call negligible for either scenario (infection vs. vaccination)

There was some "creative" metrics being used in order to somewhat downplay some of the risks present for vaccinations specifically with regards to myocarditis.

For full disclosure: I'm pro-vaccine on this one, have received 3 Pfizer jabs, and heavily recommended vaccination.

The reports showing that the myocarditis risk was greater for natural infection vs. vaccination could largely be attributed to just a low threshold they were setting.

From my understanding (and I'm not a medical professional, so perhaps someone who is can chime in and correct me if need be), the tests they were heavily relying on for the diagnosis was a blood test to check for the elevation of troponin - which is an indicator of cardiac damage.

According to NIH studies, irrespective of anything covid-related, nearly half of all ICU patients have elevated troponin. As do a third of regular inpatients. However, the magnitude of the elevation is really what determines whether or not it's an indicator of something very mild that will resolve on its own vs. an indicator of potential serious heart problems or irreversible long-term damage.

For instance, if you look at some of the case studies of younger men who did have severe reactions (which again, isn't many...I would still call the vaccine risks near negligible)

Troponin levels were > 2.5 ng/ml (normal range < 0.03 ng/ml)

(as a point of reference, as result of 0.4 would be in benchmark for indicating a probably heart attack)

For actual covid infections, troponin levels were 0.03 to 0.09 ng/mL for most those who experienced it with a natural infection. And for the ones who did have levels above 0.09, the majority were older patients who had preexisting heart conditions and not younger healthy people.



A hypothetical comparison
Let's say one were trying to calculate the risk of blood sugar increases across 2 scenarios.

Scenario A) a 3 out of 100 risk of your blood sugar raising to 160 mg/dL for a few days and then normalizing on its own, but only 10% of that subset of people will have elevation levels higher than
Scenario B) a 1 out of 100 risk of your blood sugar raising to 270 mg/dL for weeks before normalizing


The two ways of presenting the data would be
"Under scenario A, you're 3 times as likely to experience and elevation in blood sugar" (which makes A sound worse)
"Under scenario B, you're more likely to have a severe elevation in blood sugar that could do serious damage" (which makes B sound worse)

 

[jayem]

It was just announced that the FDA has given EUA status to the Pfizer/BioNtech and Moderna booster vaccines that cover the BA.4 and 5 subvariants. The CDC still has to sign off on them, but that’s a formality. Vaccinations might be given as early as this weekend. It should be noted that the vaccines’ efficacy is based on animal studies. Human data is needed for full approval.

FDA authorizes Covid booster shots that target omicron BA.5 variant

 

[tall73]

The reports showing that the myocarditis risk was greater for natural infection vs. vaccination could largely be attributed to just a low threshold they were setting.

From my understanding (and I'm not a medical professional, so perhaps someone who is can chime in and correct me if need be), the tests they were heavily relying on for the diagnosis was a blood test to check for the elevation of troponin - which is an indicator of cardiac damage.

Medical folks can weigh in. But since the study is looking at only hospitalized cases or deaths the blood tests would usually be used to investigate initially for suspected cardiac damage, but imaging tests might be done to determine the extent and risk once it is found to be likely.

 

[jayem]

Medical folks can weigh in. But since the study is looking at only hospitalized cases or deaths the blood tests would usually be used to investigate initially for suspected cardiac damage, but imaging tests might be done to determine the extent and risk once it is found to be likely.

I’m a retired physician. It’s true that myocarditis can result from SARS-CoV-2 infection. But—unlike vaccine associated myocarditis—it usually occurs in older patients. The linked article cites an average age of 56. The diagnosis is suggested when a middle-aged, or older Covid patient reports severe chest pain in addition to cough and shortness of breath. The diagnosis can be confirmed by cardiac MRI or echocardiogram. Fluid accumulation around the heart may show up on a plain chest X-ray. EKG abnormalities are likely present, and blood tests for cardiac inflammation will be positive.

Q&A: COVID-19, Vaccines, and Myocarditis | NIH COVID-19 Research.

 

[tall73]

I’m a retired physician. It’s true that myocarditis can result from SARS-CoV-2 infection. But—unlike vaccine associated myocarditis—it usually occurs in older patients. The linked article cites an average age of 56. The diagnosis is suggested when a middle-aged, or older Covid patient reports severe chest pain in addition to cough and shortness of breath. The diagnosis can be confirmed by cardiac MRI or echocardiogram. Fluid accumulation around the heart may show up on a plain chest X-ray. EKG abnormalities are likely present, and blood tests for cardiac inflammation will be positive.

Q&A: COVID-19, Vaccines, and Myocarditis | NIH COVID-19 Research.

Thank you for the review of the process of confirmation of the diagnosis. It looks like it does involve imaging, etc.

Q&A: COVID-19, Vaccines, and Myocarditis | NIH COVID-19 Research


Wanted to give the quote you referenced and another as well from the article:

Some groups have a higher risk of developing myocarditis from COVID-19. An analysis of 51 patients with possible or confirmed myocarditis showed that 70% were male, and the average age was 56. Most had other health conditions, such as high blood pressure, diabetes, or obesity, that raised their risk for serious COVID-19 illness.4

Men and boys between the ages of 16 and 29 have been most often affected by COVID-19–vaccine-related myocarditis, usually a few days after their second dose.5 Myocarditis may be due to their strong immune response to the vaccine.

 

[tall73]

Myocarditis - Diagnosis and treatment - Mayo Clinic

Diagnosis
Early diagnosis of myocarditis is important to preventing long-term heart damage. To diagnose myocarditis, a health care provider will typically examine you and listen to your heart with a stethoscope.

Blood and imaging tests may be done to check your heart health. Imaging tests can help confirm myocarditis and determine its severity.

Tests to diagnose myocarditis include:

• Blood tests. Blood tests are usually done to check for signs of a heart attack, inflammation and infection. A cardiac enzyme test can check for proteins related to heart muscle damage. Antibody blood tests may help determine if you had an infection linked to myocarditis.
• Electrocardiogram (ECG or EKG). This quick and painless test shows how the heart is beating. Your health care provider can look for signal patterns on an ECG to determine if you have irregular heartbeats (arrhythmias). Some personal devices, such as smartwatches, offer electrocardiogram monitoring. Ask your health care provider if this is an option for you.
• Chest X-ray. A chest X-ray shows the size and shape of the heart and lungs. A chest X-ray can tell if there's fluid in or around the heart that might be related to heart failure.
• Heart MRI (Cardiac MRI). This test uses magnetic fields and radio waves to create detailed images of the heart. A cardiac MRI shows the heart's size, shape and structure. It can show signs of heart muscle inflammation.
• Echocardiogram. Sound waves create moving images of the beating heart. An echocardiogram can show the heart's size and how well blood flows through the heart and heart valves. An echocardiogram can help determine if there's fluid around the heart.
• Cardiac catheterization and heart muscle biopsy. A health care provider threads a thin tube (catheter) through a blood vessel in the arm or groin to an artery in the heart. Dye flows through the catheter to help the heart (coronary) arteries show up more clearly on X-rays. A tiny sample of heart muscle tissue (biopsy) may be taken during this test. The sample is sent to a lab to be checked for inflammation or infection.

 

[ThatRobGuy]

It was just announced that the FDA has given EUA status to the Pfizer/BioNtech and Moderna booster vaccines that cover the BA.4 and 5 subvariants. The CDC still has to sign off on them, but that’s a formality. Vaccinations might be given as early as this weekend. It should be noted that the vaccines’ efficacy is based on animal studies. Human data is needed for full approval.

FDA authorizes Covid booster shots that target omicron BA.5 variant

You mentioned you're a retired physician, so I'd like to get "the doctor's opinion"

A) Will these BA.4/BA.5 boosters have a significant net positive impact given how those two subvariants have been spreading like wildfire? I've seen some estimates as high as >70% with regards to how many people in the US have had some flavor of Omicron. Should these variant specific boosters be reserved for elderly and at-risk...given that most young healthy people aren't at a huge risk from this (and most likely have some level of immunity anyway), any real value in a 18-25 year old racing out to get one?

B) For people in my situation -- 38 year old healthy male, healthy bodyweight, no co-morbidities -- had an infection with either the wild type or alpha back in November 2020. (I believe those were the circulating variants at the time), 2 pfizer jabs in April 2021, a Pfizer booster right before Thanksgiving 2021, and then caught the dreaded Omicron in Mid-December right around a month after the booster. ...any real value in getting this one? (apart from avoiding a stuffy nose and sore throat?)

I've been somewhat diligent with getting semi-quantitative antibody tests that provide the info on what titers score benchmarks I'm hitting throughout Covid. Unfortunately, they're not variant specific (not even sure if that's available??). Got one back in May before my cousin's wedding, was still hitting the 720 benchmark (which at least indicates some level of protection), although, I caught Omicron when the titers score was still high as well, so who knows...but the December omicron infection was extremely mild, drank beer and played video games while isolating with that one.

 

[Ana the Ist]

Myocarditis is a condition. But it doesn't talk about the severity, or longevity of the condition.

What is the risk of hospitalisation, long term injury or death for young men after the vaccine vs after SARS-CoV-2 infection?

There's no long term studies....


Obviously.
.
I can't believe I let my government do this to me. I had to choose 2 shots of Moderna or my job

 

[stevil]

There's no long term studies....


Obviously.
.
I can't believe I let my government do this to me. I had to choose 2 shots of Moderna or my job

I find it strange that (without evidence) you are frightened by the potential for long term side effects of the vaccine.
But for some reason you don't seem frightened by the potential for long term side effects of Covid. And seemingly you don't care that the death rate is proven to be 6-10 times higher for unvaccinated vs vaccinated. If noone in USA were vaccinated you would have had 3 million dead. If everyone was vaccinated you would have had only 300,000 dead.

 

[ThatRobGuy]

I find it strange that (without evidence) you are frightened by the potential for long term side effects of the vaccine.
But for some reason you don't seem frightened by the potential for long term side effects of Covid. And seemingly you don't care that the death rate is proven to be 6-10 times higher for unvaccinated vs vaccinated. If noone in USA were vaccinated you would have had 3 million dead. If everyone was vaccinated you would have had only 300,000 dead.

I would suspect that the partisan nature of the conversation caused some public discourse to be skewed from the normal type of conversations society would have about a medical intervention, in that:

A) It's always been pretty well understood that there's no such thing as a 100% risk-free drug (but in the case of this one, we all had to pretend it was...or risk catching a ban for saying otherwise)

B) The number of medical interventions that are mandated are few and far between, so when that does arise, and it's something perceived to be "brand new", that's going to put some people off


For instance, certain cholesterol and blood pressure meds have a much higher side effect rate than covid vaccines do, and everyone's allowed to acknowledge that they exist, and many people still come to the rational conclusion of "Hey, I'm 60, a little overweight, and heart attacks run in my family...the pros outweigh the cons...it's a no brainer"

However, if there was an entire public health messaging campaign build around the narrative that "these are the most perfect amazing heart drugs in history, and side effects are so much of a non-issue, that you shouldn't even be bringing it up...and we're going to do everything we can to make sure you take them"...there would probably be a lot of people who otherwise would gladly take them now, who would instead be stand-offish about taking them, and may even refuse to as some sort of act of defiance.


I've often wondered if, instead of mandates, and cramming a "everyone needs to do this ASAP" down on everyone, had it just been presented the same way we always talked about meds, if that would've actually improved vaccine uptake rates.

Those of us who are pro-vaccine would've still gotten it regardless, and for those who ended up being defiant and refusing to get it just to dig their heels in, many of them may have ended up taking it just like they take many things prescribed by their family doctor at their doctor visit.

I think of my uncle, who refused to take the covid vaccine (and got extremely sick when he caught it last year) on the grounds that "we don't know what this does, why are they so eager to make me take this new drug, etc...". He has pill caddy full of drugs that he has no clue what they do or how they work, and can't even pronounce half of them, that he took without objection simply because his family doctor recommended and prescribed them to him. I imagine that, instead of seeing that messaging coming from polarizing people, had it just been a visit with his GP saying "I'm recommending that all my patients over 50 get this", he likely would've rolled up his sleeve without so much as a question.

 

[Nithavela]

If you want to post studies that discourage people from getting the vaccination, you need to keep looking. This one only serves this purposes if one doesn't read the sentences you haven't bolded.

 

[stevil]

A) It's always been pretty well understood that there's no such thing as a 100% risk-free drug (but in the case of this one, we all had to pretend it was...or risk catching a ban for saying otherwise)

I'm thinking that you remember things very differently to me.
I'd never heard anyone say that the vaccine is 100% risk free, nor 100% effective, and I certainly hadn't seen that people were forced to pretend it was.
Initially before a vaccine was developed, Faucci was saying that we would be lucky if the forthcoming vaccines were better than 60% effective.
When they did get produced Faucci was saying that it was better than the 60%, but he never ever said it was 100% effective.

Personally I think the scientists and the experts did a great job of informing us every step of the way. Even at that taskforce brief they were saying that there were some treatments that were being investigated and were looking promising. HCQ was mentioned. When Trump got to the microphone, he then oversold HCQ, and Faucci had to bring him back and say that it is unknown, had not yet been proven whether HCQ was effective or not. I think at that point Trump's base then hooked onto HCQ and started to hate Faucci.
At one of the taskforce briefs, Pence and the rest of the team were telling people to wear masks, but then Trump got to the microphone and said "I won't be wearing a mask". From then on, his loyal base decided it was a show of loyalty and solidarity to their beloved leader that they would fight to not wear masks too. Many of Trump's loyal collegues also took up this culture fight. There is a clip of DeSantis ridiculing some boys for wearing masks. And of course Fox News (never one to let a culture war pass them by) started to ridicule mask wearing. With Carlson saying it is like wearing a diaper on your face.
While other leaders got vaccinated on camera to show people that they too are taking this, that it is safe etc, Trump took his vaccines in secret, not on camera and not willing to tell media or anyone that he took it.

In my view the MAGA movement acted absolutely disgraceful during the pandemic and probably caused 100's of thousand more people to die than would have otherwise been the case.

B) The number of medical interventions that are mandated are few and far between, so when that does arise, and it's something perceived to be "brand new", that's going to put some people off

Yes, and good leaders will take it on camera, and promote it, and have the proper information published, and good social media sites will look to take down misinformation which was going around saying lies about the vaccine and scaring people off.

However, if there was an entire public health messaging campaign build around the narrative that "these are the most perfect amazing heart drugs in history, and side effects are so much of a non-issue, that you shouldn't even be bringing it up...and we're going to do everything we can to make sure you take them"...there would probably be a lot of people who otherwise would gladly take them now, who would instead be stand-offish about taking them, and may even refuse to as some sort of act of defiance.

A pandemic of a highly contagious disease is very different from heart disease as it is catchy. Unvaccinated people put other people's lives at stake.

I've often wondered if, instead of mandates, and cramming a "everyone needs to do this ASAP" down on everyone, had it just been presented the same way we always talked about meds, if that would've actually improved vaccine uptake rates.

You haven't wondered what would have happened if Trump himself had worn masks and promoted masks, had publicly taken the vaccine and gotten his prominent leaders to also take the vaccine on camera and had gotten Fox News to promote mask wearing and vaccines?