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Culture War Roundup for the week of January 9, 2023

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CDC has released a report today finding preliminary association between the Pfizer vaccine and stroke for those over 65 years of age.

Another drop in the bucket - or is the bucket spilling out the top now?

https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/bivalent-boosters.html

Following the availability and use of the updated (bivalent) COVID-19 vaccines, CDC’s Vaccine Safety Datalink (VSD), a near real-time surveillance system, met the statistical criteria to prompt additional investigation into whether there was a safety concern for ischemic stroke in people ages 65 and older who received the Pfizer-BioNTech COVID-19 Vaccine, Bivalent.

Pfizer is associated significantly with strokes - CDC is keeping us in the dark about the exact data.

This preliminary signal has not been identified with the Moderna COVID-19 Vaccine, Bivalent. There also may be other confounding factors contributing to the signal identified in the VSD that merit further investigation. Furthermore, it is important to note that, to date, no other safety systems have shown a similar signal and multiple subsequent analyses have not validated this signal:

They then list multiple studies that did not replicate this finding for the BIVALENT vaccine - well of course, this vaccine was testing on mice, and then deployed without long term testing. Do they have monovalent data they are not mentioning?

EDIT: Is it possible monovalent risk benefit analysis is simply using a different pathogen, and now with the advent of Omicron, this is a medical update saying this level of strokes is no longer worth the benefit vs the current pathogen? Food for thought.

No change in vaccination practice is recommended.

This contradicts what Paul Offit's opinion is, which was posted in the NEJM. Paul Offit believes we should not give bivalent boosters to young healthy patients.

https://www.nejm.org/doi/full/10.1056/NEJMp2215780

It would be much more shocking to announce a chance to the vaccine campaign, than to keep the current inertia the same. I think we are seeing a communication strategy developing to deliver the population into accepting yearly mRNA vaccines - instead, they will be directed to other worthwhile candidates for vaccination - IF pharma companies can even deliver those.

In my eyes: mRNA vaccines are dangerous, so you need to determine how dangerous the pathogen presenting is. I see a great use case for mRNA developing for Airborne Ebola Zaire strains (90% mortality) or other disease of similar magnitude. Simply put: your vaccine should not significantly increase cardiovascular risk. It should be absolutely negligible. 1 in a million, whereas these vaccines might be 1 in 100,000.

What we need to compare this to is the pre-existing risk of stroke in people over 65 before getting any vaccines or treatment of any sort for any condition, and that appears to be high already:

About 75 percent of strokes occur in people 65 or older. In other words it is an increasing problem the older we get. It has been estimated that the chance of having a stroke double every decade after 55.

Stroke afflicts about 800,000 people a year and is estimated to occur at the rate of one American every 40 seconds. About three-fourths of the annual strokes are first-time strokes and the other quarter are recurrent. In other words most strokes are first-time episodes.

Stroke is the third leading cause of death among Americans. It kills about 140,000 people a year.

So this is the same question as the one about miscarriages etc. - are they directly attributable to the vaccine, or are they being noted and recorded as vaccine-related/Covid-related, just because a lot of people are being vaccinated/contracting Covid? Which came first, the chicken or the egg?

Now, if you pull up a link about 30 year olds getting strokes at the higher than normal rate, great, that's something to be addressed. But "population already at high risk of having strokes are getting strokes" is not, not unless "the rate is usually 75% but now has increased to 90%".

CDC has released a report today finding preliminary association between the Pfizer vaccine and stroke for those over 65 years of age.

That is not what it says, upon reading. It says that there was a signal which "met the statistical criteria to prompt additional investigation into whether there was a safety concern for ischemic stroke in people ages 65 and older who received the Pfizer-BioNTech COVID-19 Vaccine, Bivalent".

They investigated, and found nothing of concern. This is because:

Often these safety systems detect signals that could be due to factors other than the vaccine itself. Although the totality of the data currently suggests that it is very unlikely that the signal in VSD represents a true clinical risk, we believe it is important to share this information with the public, as we have in the past, when one of our safety monitoring systems detects a signal. CDC and FDA will continue to evaluate additional data from these and other vaccine safety systems. These data and additional analyses will be discussed at the upcoming January 26 meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee.

So you leading off with "Guys, guys, CDC found the vaccine booster causes strokes!" is incorrect.

Now, if you pull up a link about 30 year olds getting strokes at the higher than normal rate, great, that's something to be addressed. But "population already at high risk of having strokes are getting strokes" is not

I think this is totally wrong. If two people get strokes instead of one, that's not a worry. If two thousand people get strokes instead of a thousand, that is way more of a worry, the absolute amount of people being affected is much higher. I get the logic. Strokes happening to old people is Normal and to young people is Scary. But often Scary problems are Scary precisely because they're uncommon, while we shut our eyes to bigger problems precisely because we decide they're Normal.

met the statistical criteria to prompt additional investigation into whether there was a safety concern for ischemic stroke in people ages 65

You think that the CDC's statistical criteria don't involve exceeding the base rate in a statistically significant manner?

What's the base rate, what are the criteria for reporting?

So what we have is this: CDC did additional investigation, found nothing. Two conclusions:

(1) There is nothing there, the initial system that triggered the investigation was just picking up usual numbers

(2) There is something there, and the CDC, Pfizer, and other countries are all lying and covering up

Original post is trying to incline us to number (2). I want to know what is the base rate and how was it exceeded, if it was exceeded, before I throw ni with "it's all a cover-up".

Even if it is a real risk, how many of us are over 65? OP is using "risk of strokes in over 65" as an argument not to get any boosters, on the grounds that "if this is happening to them, what is happening to younger people?" and that's where the link needs to be demonstrated.

For instance, stroke is increasing among younger adults. Down to the vaccine? No, this is the conclusion of a 29 year study looking at data from 1990-2019:

Overall, in 2019 in the U.S., there were an estimated 460,000 strokes (of those, two-thirds were ischemic), 190,000 stroke-related deaths and 3.83 million stroke disability-adjusted life years.

From 1990 to 2019, the change in the prevalence of stroke in the general population increased by about 60%. Incidence, death and disability-adjusted life years also increased by about 20%.

However, the age-standardized rates of stroke incidence, death and disability-adjusted life years declined by 20% to-30% in that same period, and the prevalence of stroke did not change. These decreases have plateaued in the last 10 years of the study period.

Since 1990, stroke incidence among older adults (age 50 and older) decreased nationwide, yet increased in younger adults (ages 15 to 49) in some geographic areas, including certain states in the South (Alabama, Arkansas) and the Midwest (Minnesota, North Dakota).

So the reporting system may well be picking up something to do with strokes, but that it's down to the Covid vaccine alone has not been proven. Apparently, globally the incidence of stroke is going up, due to increased risk factors like obesity, high blood pressure, smoking, etc. And the rate of brain hemorrhage amongst younger adults, due to uncontrolled high blood pressure, is also increasing:

In the new study, lead researcher Abdulaziz Bako, a postdoctoral fellow at Houston Methodist Hospital, and colleagues used aggregated nationwide data from 803,230 ICH hospitalizations. They calculated the rate of ICH over five consecutive three-year periods from 2004 to 2018. People were divided into four age groups: 18-44 years; 45-64 years; 65-74 years; and 75 years and older.

Overall, researchers found an 11% increase in the rate of ICH among U.S. adults over the 15-year study period. ICH increased at a faster rate for adults under age 65 compared to those 75 and older. The rate of increase also varied by region, climbing faster in the South, West and Midwest than it did in the Northeast. ICH stroke rates were 43% higher for men than women.

Among those who had ICH strokes, the percentage of people who had high blood pressure also rose, from 74.5% to 86.4% over the study period.

The vaccine debate has to be the least productive of any topic. has anyone on either side ever had their minds changed on this issue despite all the ink spilled? Given how many people have taken the vaccines (billions worldwide) if there was even a small uptick in deaths and other complications, it would be a huge deal and unavoidable. You would not need to comb through huge troves of data to find maybe a tiny uptick in deaths for some small cohort

Don't regret the first two shots, regret the booster and don't think the vaccine should be taken by people <50 years of age.

I had my assumptions challenged. I thought the vaccines would be fine (ie a net benefit across all age cohorts), but when they were being recommended to children and young men I found myself to opinions other than the vaccines are the best/worst thing ever.

if there was even a small uptick in deaths and other complications, it would be a huge deal and unavoidable.

In a bunch of countries there is newish data indicating increased excess deaths not attributable to Covid. The confounders are myriad, but there is allegedly an unattributed signal to analyse.

I also changed my opinion after researching it. I was happy to get the first 2 jabs knowing what I did then, but the case for boosters in a post-Omicron world seems weak at best. Agree, however, that the magnitude of vaccine-related deaths is very small at this point.

Raising my Hand. My mind was changed on vaccine. Never a mandate fan. And I do think one dose of vaccine is useful if you haven’t had COVID but I’m solidly against jabbing every 6 months.

I think a lot of people on this camp

An easy way to falsify 'has anyone on either side ever changed their minds' is to ask: "where did all the anti-covid-vaccine people come from"? There are many more of them than there were vocal antivaxxers in 2016. It's not really productive as it stands though, few involved (I'm not one of them) understand enough about immunology, pharmaceutical development, epidemiology to really add anything .

It's not really productive as it stands though, few involved (I'm not one of them) understand enough about immunology, pharmaceutical development, epidemiology to really add anything .

I'm having a hard time seeing how even experts are adding much here. The subject matter is too complex. It's like trying to describe the flight of a baseball by the interactions of the atoms within the baseball. Theoretically possible, but not likely to be useful. That's why we need to take an outside view. Group A takes the vaccine. Group B doesn't. What are the outcome differences of those groups (taking into account externalities as much as possible)?

We can talk about spike proteins until we're blue in the face, but that's just theory, compared to the results which can be measured from a vaccine given to billions of people.

Yes? Many people took the first round and adamantly refuse to take any boosters.

I took the first round and then later got COVID. And then later got COVID yet again. My understanding is that getting COVID gives immunity around as good as the shot. I'm not sure if boosters would significantly help me.

Almost all those not taking boosters - which is more than half of those who've had a shot - do so because they think they're already vaccinated and protected / the pandemic's over / don't see the point, but are still happy about the first shots.

How do you know it's almost all? The first booster was out before the pandemic was "over" (the mask/test/recovery/vax mandates were still in effect, and the propaganda was still in full force). Me and my wife took the first 2 shots, and now regret it, several of our friends are in the same situation, and some even took the boosters against their will.

Both from talking to people IRL in a variety of walks of life, casually browsing many parts of the internet - probably 10% of the population at least has some form of vaccine-concern, but at least >75% of the vaccinated-non-boostered are content with the initial vaccines, probably.

Glancing at a study here - data from june/july 2022, published a week ago - seems to agree.

... okay, more than glancing, I downloaded the data, and filtered for the US (idk maybe i messed something up, but it matches with the figures):

\3. The risks of COVID-19 disease are greater than the risks of the vaccine

{ 'Strongly Agree': 507, 'Somewhat Agree': 202, 'Unsure/no opinion': 157, 'Somewhat disagree': 64, 'Strongly disagree': 70, Unanswered: undefined}

\4. The COVID-19 vaccines available to me are safe

{ 'Strongly Agree': 470, 'Somewhat Agree': 238, 'Unsure/no opinion': 156, 'Somewhat disagree': 60, 'Strongly disagree': 76, Unanswered: undefined}

And when filtered for answered anything other than 'no' on 'have you received a dose' q7

\3. The risks of COVID-19 disease are greater than the risks of the vaccine

{ 'Strongly Agree': 493, 'Somewhat Agree': 172, 'Unsure/no opinion': 94, 'Somewhat disagree': 27, 'Strongly disagree': 20, Unanswered: undefined}

\4. The COVID-19 vaccines available to me are safe

{ 'Strongly Agree': 465, 'Somewhat Agree': 224, 'Unsure/no opinion': 89, 'Somewhat disagree': 20, 'Strongly disagree': 8, Unanswered: undefined}

Open access data is really nice.

On the other hand, here's a rasmussen poll - https://www.rasmussenreports.com/public_content/lifestyle/covid_19/concerns_about_covid_19_vaccines_remain_high . Polling is hard.

has anyone on either side ever had their minds changed on this issue despite all the ink spilled?

I used to do vaccine research for a living and when the Covid vaccines rolled out, I advised people that asked me that they should take them because they'll probably work just fine. The couple years of evidence that we now have has led me to switch over to saying that the Covid vaccines are comically bad, the authorities saying otherwise are ridiculous liars, and the retconning to "it was never supposed to prevent infection" undermines the credibility of all future vaccines. So yeah, I'd say that my mind has changed.

I’m not sure we haven’t. Look at this. https://boriquagato.substack.com/p/another-look-at-uk-all-cause-mortality

Where is the author wrong?

I'm thinking of doing a top-level post on this next week, but it seems like this data doesn't necessarily jive with results in other countries. For example, in France, in a country with high vaccination rates, 2022 excess deaths in the 15-64 age category are actually down considerably from normal levels:

https://mpidr.shinyapps.io/stmortality/

England and U.S. mortality is up however. Perhaps its obesity or fentanyl related?

It would be interesting. And maybe there are just abnormalities in country by country numbers but given the high excess deaths in 20-21 you’d expect a large drop in excess deaths in 22.

Would also be interesting to see data on births. I’ve seen some series suggesting there has been a large drop in births and there was the Israeli data on sperm motility. It’s frustrating that we don’t get this info easily since a lot of country possess this info.

Well, let's say you did not want to take the vaccine, and you were mandated to take it. You could choose either J&J, mRNA, Novavax, or even fly overseas to get Covaxin. You may begin debating at that point.

mRNA vs. Other vaccines is a very difficult topic, because defanging a countries ability to give mandated vaccines is bad, but mandating vaccines that are bad isn't good. In fact, perhaps extreme caution should be taken based on the prior.

Why should a state even have the ability to mandate medical treatment when that's a very clear bright line violation of natural rights?

I care much more about the ethics of mandates than I do the specifics of efficacy. The individual must make the informed decision on this, not the state, and any mandates are tyranny that must be defended against to the death.

There is certainly a debate to be had about mRNA, a very necessary one, which was poisoned by the will to impose without discussion as we now know for a fact, but the idea that we should assume from the beginning that the State has to retain tyrannical powers in the name of public health is insane.

As an observer of the vaccine debates, its not useful to me on the specifics of the vaccine. I didn't take it and probably wont have to ever, had covid, its over.

But the meta-debate does allow me to calibrate my opinion of who to trust. Whose predictions panned out, who lied, who was okay with lying for the "greater good", etc. Im predicting in the coming years, a lot of people will be vindicated and a lot of people will have pies on their faces. The rhetorical stakes are too high for it to be any other way now.

If anything, atleast now I know who (almost everyone) is totally okay with me being a second class citizen on the premise of refusing certain medication. Some masks are off permanently. Them denying this in the future wont change my opinion of them.

its over

Unfortunately, there are a whole bunch of people for which it's not yet over. The federal gov't is still litigating at least two of their mandates, a mandate is now firmly implanted in immigration law, and there may well be state mandate battles still going on to boot. I probably cannot capture the absurdity of it, either, because what they are still trying to force on people is the original vaccine. Not even updated vaccines that are tailored to the current strains. They're still fighting in courts for the ability to force people to take shots now that are essentially useless (especially since most non-vaxxed folks have almost certainly had some strain of COVID by now), under threat of firing them, taking away their contracts, or prohibiting them from entering the United States.

In the Fifth Circuit's en banc oral argument, the fact that the vaccines don't do a great job at preventing infection or transmission came up, and the gov't said that their position could still be sustained on the grounds that it reduces the risk of severe cases/death. When pressed on whether the gov't could, on the same grounds, require everyone to get below a certain BMI, as obesity brings severe risks which are endemic in our society, they basically just said, "Yeah, we wouldn't do that tho."

If anything, atleast now I know who (almost everyone) is totally okay with me being a second class citizen on the premise of refusing certain medication. Some masks are off permanently. Them denying this in the future wont change my opinion of them.

This is why it's still so important. If there is not enough anti-authoritarian energy to form a hard consensus that the gov't should not even have the option to do such things, those people will go beyond the mask of "we won't force you to take certain medication". There will be more masks to come.

the absurdity of it

I am fully aware that the "real fight" is far from over given that many questionable laws are put into place and there is no precedent that all that was done for covid would not be repeated in the future. If anything the probability that it would be repeated is not infinitely higher. So that is a new CW battlefront in the making.

However, this seems to be mostly a (country with high state capacity) problem. Many countries have really left covid in the past and anything associated with it altogether.

As an observer of the vaccine debates, its not useful to me on the specifics of the vaccine. I didn't take it and probably wont have to ever, had covid, its over.

same here. i got it twice. the first time it was like a cold, second time only very mild. it's over .

Isn't there some worry that repeated Covid infections (or boosters) could cause long-term damage? I've definitely heard this claimed. Not sure how much of this is crackpot.

Agreed. I personally have a high esteem for many people on both sides of the issue - that's what makes this query so incisive and important.

You forgot this part:

When one system detects a signal, the other safety monitoring systems are checked to validate whether the signal represents an actual concern with the vaccine or if it can be determined to be of no clinical relevance.

and this part:

Although the totality of the data currently suggests that it is very unlikely that the signal in VSD represents a true clinical risk, we believe it is important to share this information with the public

which is probably why they said

No change in vaccination practice is recommended

Seems pretty reasonable.

And, you are being dishonest when you say:

They then list multiple studies that did not replicate this finding for the BIVALENT vaccine - well of course, this vaccine was testing on mice, and then deployed without long term testing.

The evidence they cite is:

● A large study of updated (bivalent) vaccines (from Pfizer-BioNTech and Moderna) using the Centers for Medicare and Medicaid Services database revealed no increased risk of ischemic stroke

● A preliminary study using the Veterans Affairs database did not indicate an increased risk of ischemic stroke following an updated (bivalent) vaccine

● The Vaccine Adverse Event Reporting System (VAERS) managed by CDC and FDA has not seen an increase in reporting of ischemic strokes following the updated (bivalent) vaccine

● Pfizer-BioNTech’s global safety database has not indicated a signal for ischemic stroke with the updated (bivalent) vaccine

Other countries have not observed an increased risk for ischemic stroke with updated (bivalent) vaccines

None of which seems to have anything to do with mice.

Yes, they say it's unlikely - but it's possible. SO now that we've established, it is unlikely, but possible that the vaccine can cause harm (which is occult and being undetected in other countries - if this possibility fleshes out).

No change in vaccination practice is recommended

The vaccination process will still be based heavily on a paradigm that humans MUST avoid circulating respiratory pathogens, yet if they must get infect, their best course of action is to take EUA vaccine (of which options are limited and you still cannot acquire an FDA approved and labelled vial of vaccine), at any age. They have said, the possibly the vaccine has a problem is not worth their time changing their public health campaign goal.

The evidence they cite is:

They do not submit any evidence regarding the monovalent vaccine. Yet the bivalent has the same synthetic mRNA transcripts as monovalent. Do we even know if bivalent mRNA is transcribed as a single strand, or seperated into two seperate mRNA molecules?

Not seeing any reason to get vaccinated for omicron, at almost any age or health, with an mRNA vaccine. We need a diversity of vaccines in this country, since efficacy is going to eventually drop for each mRNA boost.

SO now that we've established, it is unlikely, but possible that the vaccine can cause harm (which is occult and being undetected in other countries - if this possibility fleshes out).

No, from reading the report, they have a system which records symptoms in people who have received the vaccines and report side effects. There was a blip which they are required to investigate. The blip was "population at high risk of strokes are getting vaccinated and reporting strokes". So what has to be established is "does the vaccine cause, or elevate, a risk of having strokes?", and that was not established.

You could do a trial recording people who are in that age range (over 65) and do they report colds, sickness, arthritis flare-ups, gastro-intestinal problems and so forth after being administered a placebo, and see if that is reported. But we don't do that, because we expect people to have more health problems as they get older. Strokes and heart attacks are some of those problems. I'm sure that after getting the yearly flu vaccine, people also report first time strokes. But that doesn't mean the flu vaccine caused it, it means "you're over 65 and this is the risk of health problems you are going to have from now on".

Your own phrasing gives it away - hidden harm which is not detected in other countries, but you're sure it's happening anyway, because your prior is "The vaccine is dangerous" and you're grasping at straws to find anything to support that. So invisible danger nobody can find is there and that means the vaccines should be banned!

The vaccines are dangerous precisely because we are analyzing and looking for hidden harm, after we already administered a billion doses without fully understanding the consequences and outcomes.

mRNA cardiovascular toxicity is a severe problem and if it's at all likely, the hammer should drop. This "blip" is an 18 year old about to get mandated with mRNA bivalents before going to a community college.

of which options are limited and you still cannot acquire an FDA approved and labelled vial of vaccine

... do you think there's a meaningful chemical difference between a 'FDA approved and labeled vial' and earlier vials? Imagine a hippie liberal who refuses to buy fruit that's not labeled "non-gmo", even though the alternative fruits aren't crispred anyway.

No there's a meaningful legal, judicial, and regulatory framework surrounding those vials. And the public health vaccination campaign.

Simply put: your vaccine should not significantly increase cardiovascular risk. It should be absolutely negligible. 1 in a million, whereas these vaccines might be 1 in 100,000.

Why? This seems to me like you picked "an order of magnitude safer than what it allegedly is" and if the alleged rate of danger were different, you would have picked a different goal. Unfortunately I can't easily find the serious side effect rate for various common medicines, but https://www.medsafe.govt.nz/consumers/Safety-of-Medicines/Medicine-safety.asp says that a "very rare" side effect means one that happens to 1/10,000 people or less.

I find these numbers to be particularly confusing in light of how dangerous COVID itself is. https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)02867-1/fulltext#seccestitle140 says that at age 65, the IFR for COVID is about 1.7%, 1,700 times higher than your alleged risk of the vaccine and 17,000 times higher than what you claim the risk should be.

And according to https://www.cdc.gov/stroke/facts.htm, the baseline rate of ischemic stroke in the US is slightly over 2 per 1,000 people, again much higher than the alleged risk of the vaccine. For those of age 65, it seems to be slightly higher, increasing quickly with age: https://www.ahajournals.org/doi/full/10.1161/STROKEAHA.120.031659

For additional context, to have a 1 in 1 million risk of dying while driving, you would have to drive less than 100 miles (overall rate is about 1.5 deaths per 100 million vehicle miles in the US, according to https://en.wikipedia.org/wiki/Transportation_safety_in_the_United_States, although I think that number is outdated and is even higher now).

No medicine is completely safe, but this seems like a real no-brainer to me.

Vaccines have to be more good than bad. Almost all of them are. The covid vaccines get a wee bit murky in that regard when you get to younger age cohorts - especially younger male cohorts. There's a lot of good evidence that for young males in particular the virus carries fewer side effects than the mRNA vaccines, especially the 2nd dose of said vaccines. For older age groups I think you'd have to show pretty awful side effects for vaccination not to be worth it - so, for instance with over 65s you'd have to really have some bad frequency of side effects since they're so vulnerable to covid.

The other issue at hand here is efficacy, however. If the bivalent booster has risks but doesn't ultimately protect anyone any better than the 2x shots they already had (or 3x with the original booster) then there's really no good argument for them. The FDA lost two of its most experienced vaccine regulators over the Biden admin's "boosters for all" push, which wasn't based on any data whatsoever - we don't have any data showing that a 30 year old vaccinated woman will have further reduced mortality and morbidity with a booster shot or a bivalent booster. Most other countries, where their medical systems are more tuned towards cost and efficacy, have only authorized boosters for elderly people and those with severe immunocompromise (cancer patients). The US chose to push a one-size-fits-all policy with boosters, with zero evidence, and so...when a safety signal like this bubbles up it looks even worse than it would have if they'd pursued more evidence based recommendations.

Why? This seems to me like you picked "an order of magnitude safer than what it allegedly is" and if the alleged rate of danger were different, you would have picked a different goal.

https://www.nature.com/articles/s41467-022-35653-z

Here's one estimate. I would never base policy on one study, usually that's something the CDC would do.

I find these numbers to be particularly confusing in light of how dangerous COVID itself is. https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)02867-1/fulltext#seccestitle140 says that at age 65, the IFR for COVID is about 1.7%

This is data from a year ago. We are talking about how the bivalent booster is associated with ischemic strokes, especially held against the risk of omicron.

And according to https://www.cdc.gov/stroke/facts.htm, the baseline rate of ischemic stroke in the US is slightly over 2 per 1,000 people, again much higher than the alleged risk of the vaccine.

Let's stick to relative risk? This is not useful.

Driving is dangerous.

Agreed. But we have to go places, like schools, small business, and our places of worship. So no one proposes stopping driving. I'm proposing stopping the EUA novel biotechnology vaccination campaign.

We are talking about how the bivalent booster is associated with ischemic strokes, especially held against the risk of omicron.

Which it is not by the very report you are using. You've jumped from "The CDC reported a signal which they investigated and found nothing" to "The vaccine is associated with strokes" as though that were proven and established.

Why not go the whole hog and say the vaccine causes women to ride broomsticks to the meeting with the Devil? You are determined the vaccine is bad and then go looking for straws to build your house with, instead of looking at established risks and then forming an opinion.

Definite side-effects of getting the vaccine that have been established: muscle pains, fever, diarrhoea, mild allergic reaction.

Possibility of more serious side-effects: anaphylactic reaction

Very rare side effects

Very rare side effects may affect up to 1 in 10,000 people.

These include:

myocarditis

pericarditis

Myocarditis and pericarditis are inflammatory heart conditions.

The risk of these very rare conditions is higher in younger men.

These conditions are more likely to occur after the second dose and mostly happen within 14 days of getting the vaccine.

2 European studies have estimated the risk of myocarditis, after the second dose of the vaccine as:

1 additional case for every 7,600 men aged 12 to 29 (within 7 days)

1 additional case for every 5,320 men aged 16 to 24 (within 28 days)

We do not know the risk of myocarditis or other rare side effects after a booster dose yet.

If you want to argue that the risk for young men is too high as compared to the risk of contracting Covid and the effects of that illness, you have a valid case there. You do not have one for general scare-mongering.

Fair, I'm not going to rip off my wallpaper over elderly and at risk people receiving bivalent vaccines - precisely because I have a calculation of their quality life years remaining, that is very different from younger healthy people.

The exact people who benefit from a covid vaccine have less quality life years to live than those who do not.

The vaccine has a novel, not totally understood method of mRNA translation, and then goes through another not completely understood process of protein folding, and then enters the immune system (not completely understood). The pharmacokinetics of the nano lipid particle are not characterized or understood. And there is a concerning signal of a blood clot appearing in patient's brains.

I am not scare mongering, I am being highly critical, since I'm not the one defending the novel RNA transfection vaccines.

When they run trials for new vaccines, they will compare them to the harms that the RNA transfection vaccines caused, and the new vaccines are going to look amazing. My guess is they will use protein-adjuvanted methods.

Here's one estimate. I would never base policy on one study, usually that's something the CDC would do.

I didn't ask for an estimate, I asked why 1 per 1 million is the higher tolerable level of risk.

This is data from a year ago. We are talking about how the bivalent booster is associated with ischemic strokes, especially held against the risk of omicron.

Why does it being a year old matter? Even if the IFR is a few times lower, it's still much, much, much higher than what you're talking about.

Let's stick to relative risk? This is not useful.

Do you plan on explaining why or are you just going to make assertions?

But we have to go places, like schools, small business, and our places of worship. So no one proposes stopping driving.

It's entirely possible to build towns and cities that don't require you to drive literally everywhere, but no one seems to care about the risk from driving when designing cities or choosing where to live. At least, not at the magnitude you're talking about: 100 miles could be saved in 2 months by moving 1 mile closer to work, but does anyone care about that? Not in the slightest. A minuscule improvement in civil design would save orders of magnitude more lives than eliminating all risk from vaccines, with lots of other positive side effects to boot.

This entire post of yours is just one big isolated demand for rigor.

1 in one million, compared to 1 in 100,000, in our current data collection environment, is a good signal to keep track of if you are considering your options to receive a covid-19 vaccine. Perhaps you can take J&J, Novavax, or Covaxin and maintain protection against SARS-2.

The IFR is lower and vaccines are not denting hospitalization or death rates as they plummet from their previous heights (mass naïve infection). Most people have had a much better inoculation than a monovalent vaccine - they've had a SARS-2 infection.

Do you plan on explaining why or are you just going to make assertions?

Well, because a stroke as a cardiovascular event, I'm interested in the dynamic between mRNA vaccination and your cardiovascular system. A stroke, downstream of pathology, will offer valuable information when it goes above the baseline.

It's entirely possible to build towns and cities that don't require you to drive literally everywhere....A minuscule improvement in civil design would save orders of magnitude more lives than eliminating all risk from vaccines, with lots of other positive side effects to boot.

Well, you are demanding rigor, and yet I feel like this is a complex claim. Even a city would involve having people driving to bring supplies and transportation towards these centers - a mandatory risk.

We should be paving our public serology with only the best, most well understood vaccines that we are capable of developing and testing and passing on in our limited lifetimes. There is a broader umbrella of rigor that I am requesting to be frank.

A lot of the rigor I'm demanding will also take time, more time than has been allotted for these Bivalent updates. The first injectable, multi-transcriptional (unknown if combined or separated) mRNA vaccine to market has shown an unexpected safety signal.

1 in one million, compared to 1 in 100,000, in our current data collection environment, is a good signal to keep track of if you are considering your options to receive a covid-19 vaccine. Perhaps you can take J&J, Novavax, or Covaxin and maintain protection against SARS-2.

...why? What makes it a good signal? Again, compared to the baseline number of strokes, you probably would not ever be able to detect these increases. If you wouldn't seriously consider the risk of driving 1000 miles, why would you seriously consider this risk?

The IFR is lower and vaccines are not denting hospitalization or death rates as they plummet from their previous heights (mass naïve infection). Most people have had a much better inoculation than a monovalent vaccine - they've had a SARS-2 infection.

Do you have some data for these claims? I've seen them, but I've also seen the opposite (e.g. that vaccine provides a better immune response than previous infection). Case and hospitalization rates are certainly nowhere near their high of a year ago (https://www.cdc.gov/coronavirus/2019-ncov/covid-data/covidview/index.html) but if the virus is mutating to become more contagious and less severe over time, and vaccines aren't actually effective, you should still see a high case count.

A stroke, downstream of pathology, will offer valuable information when it goes above the baseline.

What valuable information? How does this answer my question?

Well, you are demanding rigor, and yet I feel like this is a complex claim. Even a city would involve having people driving to bring supplies and transportation towards these centers - a mandatory risk.

I'm not really sure what you are trying to say. There are plenty of alternatives to using large motor vehicles in city centers, near pedestrians. Also, deliveries of goods represent a tiny fraction of all trips taken in populated areas, so you can still have those while reducing personal car trips. Urban design is a complex topic, but so is medicine. Do you want me to recommend you some urbanist sources?

has shown an unexpected safety signal.

This seems like a much weaker conclusion than:

Another drop in the bucket - or is the bucket spilling out the top now?

mRNA vaccines are dangerous

your vaccine should not significantly increase cardiovascular risk. It should be absolutely negligible

Absurd safety standards for medicine are the norm. Lots of things with side effects and uncertain cost-benefit profiles (like lockdowns themselves!) are acceptable when if they happened to take the form of a pill or injection they'd be ten different kinds of illegal.

It is the norm, but even by those standards it feels inconsistent. I agree that many other policies are handled too cavalierly, but that's not really a good argument against what appears to be a legitimately safe vaccine.

I'm arguing in favour of the vaccine. It has a much better safety profile than a lot of things - it's just because it happens to take the form of medicine that we want a frankly ridiculous safety standard.

It's an EUA vaccine approved for an emergency. I think if you want to say "legitimately safe vaccine," it would be easier if Pfizer or Moderna could actually distribute an FDA approved and LABELLED as approved "Comirnaty" or "Spikevax" vial of vaccine.

if Pfizer or Moderna could actually distribute an FDA approved and LABELLED as approved "Comirnaty" or "Spikevax" vial of vaccine

Isn't this what they are already doing, or are you engaging in legal hair-splitting of the type about "the FDA issued approval labels for the original vaccine but the boosters are only recommended"? So if they're only "recommended" or "authorised" but not "approved" this means they're dangerous? There's a whole article about the difference between "approved" and "authorised" here.

If EUA is essentially the same process, only faster, what’s the benefit of the full FDA approval process?

It’s not really an “apples-to-apples” comparison.

In public health emergencies, the development process may be a little different. The world experienced—and is still experiencing—a global pandemic, which means there was an outpouring of resources and energy on one goal: developing vaccines and treatments against COVID-19.

To that end, early on the FDA provided clear communication to the pharmaceutical industry about the scientific data and information needed to ensure the timely development of vaccines. And among other efforts, the government developed a coordinated strategy involving its own agencies, academia, nonprofit organizations, and pharmaceutical companies to prioritize the development of the most promising vaccines.

That focus—and the resources applied to it—isn’t typically available for every vaccine or medical product, especially those that fall outside of a public health emergency.

Also, the processes are not designed to be nimble. They’re designed to give people confidence—and peace of mind—that products receiving FDA approval continue to be viewed as the gold standard of scientific rigor.

You may have a point somewhere buried beneath all the scare-mongering, but it's hard to discern. Maybe less "The vaccine has been proven to cause strokes!" when no such thing has been established would make your case better.

The irony here is that people have been complaining the full FDA approval process takes too long and a modified version (say, where drugs are trialled for a shorter period and the FDA approves them but you take them at your own risk, or that drugs legal in the EU shouldn't have to go through the same process in the USA for approval) would be better to get drugs to market and treating patients faster.

You can't please everyone!

Your response didn't address the crux of FDA and EUA labelling. The entire power structure of our country, legal recourse and all, rests along these lines. Sorry to bring Foucault into the mix, but he's the ultimate nightmare of a public health pandemicist.

https://www.comirnaty.com/

There are no data available on the interchangeability of COMIRNATY with COVID-19 vaccines from other manufacturers to complete the vaccination primary series. Individuals who have received 1 dose of COMIRNATY should receive a second dose of COMIRNATY to complete the vaccination series.

Is this not VERY different from the medical advice given to people getting the EUA? Mix and match the first vial you can even get your hands on?

I am much more worried about real, physiological implications of nanoparticle technology uptake. Not simple safety standard concerns (those already seem tattered).