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Culture War Roundup for the week of January 9, 2023

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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according to https://en.wikipedia.org/wiki/Transportation_safety_in_the_United_States, although I think that number is outdated and is even higher now).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).