Finland joins Sweden and Denmark in limiting Moderna Covid-19 vaccine

Without a more detailed case behind this it feels like "just trust us".

I'd really like some trust but verify. The lack of ability to verify many of these directions, especially with some of them from different organizations contradicting each other, is bothersome.

But the risk of getting COVID in any time period is less than 1 (based on % of population that has actually had it, possibly less than 0.1 or 10% per year), so it's worth waiting for the safest vaccine for certain groups.

They looked at 25 "averse events", and only half of them (12 of the 25) had higher prevalence with the vaccine than in the control group, which is what "no difference" looks like. The normal way you protect against this is by adjusting for the fact that you're doing multiple tests (one for each of the 25 adverse events), but "As is standard practice for studies of safety outcomes, no adjustment for multiple comparisons was performed.". Am I missing something?

Or to put it differently, if the vaccine puts you at risk for intracranial hemorrhages, does it also protect you against acute kidney injury (irrespective of Covid)? The difference is just as big in the other direction.

I dont know Swedish. Does it provide any numbers for Spikevax?

Because if normal figures showed 145 cases of myocarditis out of 177M people, that would be embarrassing as fuck.

A message from the Swedish state epidemiologist, as quoted in context (https://tt.omni.se/vaccinering-med-moderna-pausas-for-yngre/...):

> Det här är väldigt osäkra data från en preliminär studie, så vi har inte pekat på någon särskild nivå. Vi har fått ta del av den här studien från Läkemedelsverket och ser att det finns en skillnad mellan de vaccin som finns tillgängliga och då menar vi att det i nuläget är bättre att vi använder det vaccin där man inte ser de här signalerna, säger statsepidemiolog Anders Tegnell till TT.

Translation (my own): These are highly insecure measurements from a preliminary study – there is no established certainty. This study was recieved from Läkemedelsverket [translation: Medical Products Agency] which acknowledges there is a difference between available vaccines. Our opinion is that we currently should use a vaccine where we cannot correlate these types of indications [personal remark: relations to myocarditis], says Swedish state epidemiologist Anders Tegnell to TT [ref: media]

First need to know what the risk of myocarditis is when being vaccinated and having covid, and how much lower the risk of covid-infection is when having been vaccinated.

I don't think all of that data is available right now, so I would hesitate coming with certain conclusions about the right thing to do for young people. (Especially boys)

Also I would be a little careful using the 6x estimate for myocarditis caused by covid infection for these age groups, as in these age groups there may be quite a few undetected/asymptomatic covid infections. (That is it may be that: P(detected infection | covid, myocarditis) >> P(detected infection | covid) in young people)

https://www.science.org/news/2021/06/israel-reports-link-bet...

> Inclusion criteria were a first COVID-19 diagnosis during the April 1, 2020 - March 31, 2021 time period, with an outpatient visit 1 month to 2 years before, and another 6 months to 2 years before that

To actually compare fairly against vaccination, you need to compare the infection myocarditis rate, not the case myocarditis rate. (Technically you should really compare infection myocarditis rate * chance of actually getting infected w/ SARS-2 [while very slightly adjusting for time decay], but let's ignore that especially since the chance of getting COVID over a 2-3 year window is quite high)

So the study you linked will give an unfairly high estimate of the rate of myocarditis. This is the same principle as the fact that looking at hospitalized COVID-19 patients will show much worse effects than looking at rates of bad effects for all PCR+ individuals, and even moreso if extrapolating from serology.

This is probably also the reason the health authorities stopped recommending the Moderna vaccine for that demographic. Since the Pfizer vaccine is available, and AFAIK it's not in short supply, it's pretty much just a question of which vaccine to use for that demographic.

When I got the second (Pfizer) shot, I was also given a leaflet saying that extreme physical exertion should be avoided for a few days afterwards as that might increase the risk of myocarditis.

Also, since the vaccine doesn't prevent contraction of Covid, does it really make sense to frame this as though the two risks are mutually exclusive?

EDIT: The alternative is not stopping vaccinations. Men under 30 are given Pfizer.

Your risk of myocarditis from COVID is 10x-20x your risk of myocarditis from a vaccine.

(One of many many sources: https://twitter.com/awong37/status/1444825498018795521)

No: Absolutely not worth it to take that particular shot, as there are others available which don't have that side effect.

The comparison isn't moderna vs no vaccine (in which case moderna would win the risk trade-off). The comparison is moderna vs pfizer.

My cardiologist says that without an MRI he can't diagnose me and my insurance did not cover it. It's quite likely imo that there is a relevant diagnosis not being made because it's inaccessible.

But hey, the good thing is, we also have data. And the data, shows no correlation between vaccination and these problems you're referring to, and yet a VERY HIGH correlation (and some good reasons to say causation) between getting covid and having these issues.

Fortunately our understanding of statistics has advanced somewhat since the time of the caveman.

Obviously the parent was not referring to the entire development history of mRNA tech, any more than one would include the initial work on inventing the internal combustion engine when talking about how much safety testing had been carried out for a new model car.

The usual safety trials were not carried out for these vaccines, full stop.

1. That only uneducated 'researchers' have concerns, and ill-formed ones. Petrovsky, as a leading vaccine developer, outlines a clear, educated position on why it's still reasonable to have concerns over the current options [1]

2. That because billions of doses have been administered, there are no serious problems. You can certainly make a very sound case that Covid side effects are worse in defence of using these current options. But they are irrefutably far less safe and effective (relatively) than any other vaccines authorised and widely used over the last few decades. Considering this it's understandable why there is still concern over overdone claims around the safety of the current options. Even in a pandemic numerous regulatory authorities have had to add additional warnings and modify use of the current options.

3. Your last cited point on Covid deaths is very wrong. You just need to look at UK statistics (and other countries) to realise there is something very, very odd about the claimed US stats from the CDC.

[1] https://www.youtube.com/watch?v=yL_2Rq1zoRg&t=3063s

If you want to listen to a bunch of well meaning morons and take their experimental treatment, have fun. The rest of us will appreciate your sacrifice up until the point you try to drag us into your suicidal cult.

I'm not against vaccination but I would not recommend it to anyone after what it did to my body. Whatever it is.

Give me anything else and I'll take it, all I need is COVID risk reduction and due to where I am it will likely be one of the Chinese alternatives.

An economist steps over a $20 bill asserting it must be fake; someone else would have picked it up if it were real.

My family is sending me videos and articles about people who are claiming side effects and being ignored, and I'm wondering if there are some $20s laying on the ground.

Listen, this sort of argumentation creates mistrust. If this is how seemingly rational people argue (and dear god i hope it's not) then no wonder there is a lot of mistrust in society around these matters. Or maybe you were sarcastic, and in that case, you got me!

My responses:

1: I agree. You really have to dig deep.

2: I agree. But you can at least assess risk vs other vaccines.

3: My point is that people should not be mandated to take that risk. The technology is good and fine but let people choose. This boils down to a collectivist vs individualist argument. Largely western culture is born of prizing the individual over the collective. We have seen the horrors in the past of where collectivism leads.

4: I agree, it has to be an economic solution.

5: This is a complex statement to unwrap. I don't know anyone who isn't maybe a fervent Atheist Hedonist that thinks that unfettered selfishness is a virtue. Only sociopaths think that way by design and will justify it with whatever means necessary, be in intellectual or anti-intellectual. I will say that I don't like the fact that being against a mandate for ethical reasons as I pointed out automatically = anti-vax.

6: I agree. I don't like that fact that my opinion gets lumped in with people who think Bill Gates is a lizard trying to chip everyone. I do however think the "conspiracy" here is that the US public health authorities are going out of their way to squash any answer to this pandemic that is not a vaccine for the sake of reducing "vaccine hesitancy", the magic word. I would not be surprised if this was primary motivator and is admitted to years down the line, and its not necessarily the same as a "conspiracy" if this is the key term behind closed doors. Fauci already did the same with masks, first being anti-mask to protect the supply, then pro-mask once supplies were ample. He admitted to this himself. He also slowly creeped up the herd immunity % from 60% to 85%. When asked about this, he said he did it deliberately because "the American public couldn't handle the truth". That sort of logic is bad for public trust. Vaccine Hesitancy mitigation explains why any discussion of repurposed drugs, natural immunity, etc is shut out of the conversation. Look at how they are treating Mercks announcement of a new drug, with constant reminder that its no replacement for a vaccine. Why? In a "war" situation against a virus, why are not all options on the table? Why would you give a vaccine or even boosters to people with natural immunity when there are still entire countries waiting on theirs? This idea that the pandemic will end when 95% of the USA is vaccinated is ridiculous. You need global immunity. Its why Norway and Denmark have already accepted the disease and endemic, never going away.

7: Adenovirus vector technology (JJ, Astro-Zen shots) has only been recently adapted into a vaccine, same as mRNA. You cannot say there are no long term side effects based solely on a "drug vs immune response" durations. Trials of adenovirus vector based technology have failed in past trails. HIV vaccine based on this was a miserable failure. They tried using adenovirus based gene therapy on children on single gene mutations in in children, 40% got leukemia within 4 years. We dont even have 4 years of data for the current vaccine. I would agree they have somewhat passed the initial stages, albeit with with way worse VAERS profiles then any other vaccine in the last 50 years. Good enough though safety to give to people who want it, not force it on those who don't. The risk calculus is different for everyone especially given age and health.

8: Evidence where? Again, VASER is all we have because they opted to keep it as all we have. Like how they just banned Moderna for under 30 year olds in scandanavian countries and totally banned it in Iceland.

9: EUA has specific rules defined well before Covid. There cannot be any alternative treatments: Monoclonal antibodies, repurposed drugs, etc. Saying it went through "phase 3" trials means nothing when they cut out tons of checks in those trials. Cross-reactivity, Carcinogenic studies, to name a few.

10: Agreed VAERS is bad, but we have no other mechanism is my point. Really no issues identified? Not clots, not mycarditis, not nervous system issues, not GBS, nothing? I dont see how you can make that statement, its not true. Look at what just happen with Moderna in Europe. Go watch the FDA's publicly broadcast meeting regarding booster authorization. Every single doctor on the panel hammers the mycardidits point for boosters, and now we see Moderna getting pulled for it. The data is still trickling in. VAER is only between 1-5% of reported issues they estimate because it takes 30 minutes just to fill out the forms and most doctors wont bother, and its still abysmally bad for these vaccines.

I have a STEM degree in Physics and work in simulation. My wife is an ICU nurse. She also won't take it, along with 50% of the staff including the doctors at each hospital she floats to (more then 5 per week). Why? Because they witness the adverse events first hand, especially the mycarditis and clots. you can't just collectively dismiss their witnessed experience. I have made the point to her that she is at the epicenter aggregator of all those people but once you see it happen first hand you start to realize its not as rare as they say given that in a small enough town, there should only be a handful according to the CDC/FDA.

I think the rights of individuals to make their own choices should be upheld no matter the cost, otherwise we fall into this collectivist mindset that can justify anything it wants for "greater good". What if 5 years in we find out that the mRNA causes arterial and heart damage as some claim to have evidence for, and that some express the pulmonary conditions more immediately then others with mycarditis but everyone has some long term damage that will come back to haunt them. We would all be lamenting at how dumb we were to blindly trust a new technology adapted for a new use just because someone put the word "vaccine" on it and we all unquestionably trusted that. What if the intellectual objectors were the smart ones in the end? Careful that Darwins selection doesn't end up reversed in this case.

This argument would be stronger if a) People who wanted to be vaccinated couldn't get the vaccine that protects them and b) if vaccinated people themselves weren't able to spread the virus too.

All in all you are cramming down a rushed vaccine down peoples throat at the risk of their livelihoods for marginal impacts in the virus's ability to spread and little significant risk to those who are already vaccinated.

"Back when it was plausible to get to herd immunity with 60% of adults vaccinated".

That was never possible with these series of vaccines which don't prevent transmission, don't give full protection, and don't last very long. It's frankly stunning to me someone would make such a statement at this point in time.

Why have pediatric ICU beds been near or at capacity and care as a whole on the brink of failure from months of completely fucked working conditions for the doctors and nurses?

Along with other kids not dealing with COVID having life saving medical procedures/treatments indefinitely delayed until beds are back down below a certain fill for some amount of time? I've personally had to see effects this in my extended family.

Seriously - what is wrong with you? What makes you have to say things/come to conclusions like this when you're very clearly factually incorrect?

https://www.nbcdfw.com/news/coronavirus/pediatric-hospital-b...

https://www.beckershospitalreview.com/patient-flow/number-of...

https://www.webmd.com/lung/news/20210816/u-s-reports-record-...

https://www.nbcnews.com/news/us-news/kids-sick-covid-are-fil...

https://www.cnn.com/2021/08/24/health/covid-hospitalizations...

https://www.baltimoresun.com/coronavirus/bs-md-pediatric-cov...

https://www.washingtonpost.com/opinions/2021/09/02/picu-hosp...

In general, sure, but that's a bit like arguing people should be able to drive drunk because drunks are more likely to survive a car accident.

https://www.scientificamerican.com/podcast/episode/odds-favo...

> A retrospective study of nearly 8,000 trauma patients found that seven percent of people who came in sober died of their injuries, while those who were hurt while drunk only died one percent of the time. A positive blood alcohol level seemed to increase the likelihood of survival, even after the researchers took into account the age of the patient and the severity of the injury. Trauma patients who came in to the hospital drunk were discharged sooner, too.

The impact on others can be significant, and important.

I would only make that guess if you brought up car accidents and were opposed to driving test requirements, wearing seat belts, car safety regulations, etc.

There is one very important difference - reducing risk of death because of COVID-19 can be done very easily. Not so with driving.

Seems like most people in this thread hear "Scandinavian authorities are stopping the vaccination program", when the recommendation is rather to switch vaccines for men under a certain age.

The ethical consideration is not particularly complicated, and Scandinavian health authorities are not risk-averse idiots. They simply care about an equation that might lead to a couple of saved lives in total. I think this level of care speaks highly of the intentions of the healthcare systems in Scandinavia.

"As a general rule, the ICU cardiac injury described in COVID-19 illness is subclinical and largely reflected by a minor elevation of cardiac troponin, whereas CIRM is characterized by a clinical syndrome often warranting hospitalization, dramatic ECG changes, and very large elevations of cardiac troponin that are sustained over time. " "Again, children are not a high-risk group for COVID-19 respiratory illness, and yet they are the high-risk group for CIRM." Source : https://www.sciencedirect.com/science/article/pii/S014628062...

The correct answers to hospitalization risk can be calculated using data from the Department of Health and Human Services (via HealthData.gov) and the U.S. Centers for Disease Control and Prevention (CDC). One needs only the following figures: 1) the population of vaccinated and unvaccinated people 2) total hospitalizations resulting from COVID-19 3) hospitalizations of vaccinated people. We used data through August 9, 2021, one week before the survey was fielded. At that time, total hospitalizations from COVID-19 were estimated to be 2.6 million, with 7,608 vaccinations found among vaccinated people. The size of the vaccinated and unvaccinated populations was nearly equal on August 9 (with 168 million vaccinated and 163 million unvaccinated).

A simplistic analysis of these numbers would yield hospitalization rates of 0.005% for the vaccinated population (1 case in 22,118) and 1.6% for the unvaccinated population (1 case in 62), but those numbers exaggerate the benefits of the vaccine because the unvaccinated population confronted many more days of risk, since vaccination was gradually rolled out starting in December of 2020. For that reason, we take the average population totals over the relevant periods for each population (March 1, 2020-Aug. 9, 2021 for the unvaccinated population and Dec. 15, 2020,-Aug. 9, 2021, for the vaccinated population). The adjusted population of vaccinated people comes to 83 million and 295 million for the vaccinated population, since the entire U.S. population was unvaccinated -- except a small number of participants in clinical trials --up until December of 2020.

Using these adjusted figures, we calculate that the hospitalization rate for the vaccinated population is 0.01% (or 1 in 10,914), and the rate for unvaccinated adults is 0.89% (or 1 case in 112 people). In both cases, therefore, the correct answer is less than one percent, but the implied efficacy rate of vaccination is 99% at preventing hospitalizations. This is calculated as the hospitalization rate for the unvaccinated minus the hospitalization rate for the vaccinated, divided by the unvaccinated rate. In other words, it is the percentage decrease in hospitalization risk. This high rate of protection -- even against Delta -- is consistent with a recent article published in the Lancet, which reviewed large-scale empirical data from the United States and around the world.

Some may argue that patients may have been hospitalized as a result of COVID but not diagnosed as such. We think this is highly unlikely to result in significant downward bias in the rates of hospitalization risk since testing at hospitals became widespread after only a few weeks at the start of the pandemic, and the vast majority of hospitalizations would have occurred since May of 2020, given data on deaths, which are more comprehensively documented. Nonetheless, using various modeling assumptions, CDC epidemiologists estimate that the actual number of hospitalizations may be 1.8 times higher than the reported number. If these estimates are accurate, the true rate of hospitalization risk for the unvaccinated population is 1.6% and as high as 0.2% for the vaccinated population. In either case, the public's misunderstanding of risk is roughly just as inaccurate. One criticism of these inflated estimates is that they assume that many people were hospitalized while asymptomatically carrying the SARS-CoV-2 virus, leading to an undetected case. The problem with this reasoning is that it would count people admitted to the hospital for non-COVID reasons who coincidentally had an asymptomatic infection. These cases were correctly omitted from official statistics since the absence of symptoms cannot cause hospitalization.

A more serious limitation is that we count each admission from COVID-19 into a hospital as a unique person. In fact, we know from scholarly research that some patients are readmitted multiple times. One paper estimates that 9% of COVID-19 patients were readmitted to the hospital. This implies that, at minimum, our hospitalization estimates should be multiplied by 0.91 to capture only hospitalizations of unique individuals. Doing so would shrink both hospitalization risk estimates, and they would still both be well below 1%.

I think a better assessment of risk comes from the UK data https://assets.publishing.service.gov.uk/government/uploads/...

From Table 3, we learn that somebody unvaccinated in their 20's has a chance of 10/100,000 to end up in the hospital over a period of 28 days. So something like .1% per year. Vaccination reduces the risk by a factor of O(10), old age increases it by a factor of O(10). These data refer to a recent snapshot of a 28-day period, and I'd feel safer to assume that the next month looks more like the previous month than March 2020.

> Risk numbers are totally useless when not stating the time over which the risk is incurred. A 1% lifetime risk is very different from a 1% daily risk.

In this specific case the timeframe is not relevant. The metric here was "probability that you will be hospitalized IF you are infected with COVID-19". That means the timeline is "however long it takes to get better from Covid". Adding "lifetime risk" to that doesn't make sense, and "daily risk" makes even less sense (for example, someone who is sick for 130 days, is admitted to a hospital, and dies, would be counted as adding 1 "positive day" and 129 "negative days", making it an awful metric).

You are absolutely correct: if the only reason for not getting the vaccine is concern over vaccine side effects, then take the vaccine.

Or pedestrians or cyclists, or anyone that goes near a car. And since roads are everywhere, that is every single person.

Point is that the absolute risk matters too: If it's low enough you can just shrug and do whatever.

Maybe convenience is the highest priority (prefer single dose).

Maybe effectiveness against delta is the highest priority (prefer Moderna).

Maybe minimizing risk of myocarditis is a priority (say you have a history of autoimmune over reaction).

Ultimately, not only do we have the choice to get vaccinated, we also have the choice of which vaccine to get and this new data allows the population to make more informed choices about which vaccine is right for them.

So even if the risks of hospitalization were lower, which is 80 per 100k in that age group [2], it still doesn't make sense to conclude that the vaccine is a bigger danger than Covid.

Also don't forget this quote from the article:

> The risk of myocarditis is substantially increased for those who contract COVID-19

Given how easily COVID spreads, you'll be exposed to a risk vector for myocarditis whether you get vaccinated or not.

[1] https://www.statista.com/statistics/1191568/reported-deaths-...

[2] https://www.statista.com/statistics/1122354/covid-19-us-hosp...

Definitely not when you take the speed of Delta into account. For example Scotland (as the rest of the UK) did not vaccinate 12-15 year old children. When the school year started, about 10% of this population got infected in 5 weeks. So during first 5 weeks you had 1:10 change of getting COVID-19. About 27:100000 of them got hospitalized when in comparison CDC assumption was 38:100000 in 4 months.

So they are wrong as were UK officials. UK started vaccinating 12 year old and older since 20th September.

In addition. If you are going to develop myocarditis after vaccine induced immune reaction, changes are that it will happened to you when you get the infection. People are getting it after flu shot but it is given only once so it is not really comparable.

I would guess they do no such thing.

People don’t understand basic math and threat modeling. How likely you are going to get covid and how serious it can be (for you and others)? How likely you get something serious from vaccine (only you) but most likely avoid serious covid (and spread it less to others)?

Of course, forced vaccine might look bad from very selfish perspective, but benefits from bigger picture are obvious even with side effects.