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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.

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.

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.

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