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naraburns  nihil supernum  1yr ago (text post)   31226 thread views

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.

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.

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?

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