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Abundance of Caution??? WTF?

Abundance of Caution??? WTF?

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sh76
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This basically sums it up.

https://twitter.com/JesseOSheaMD/status/1382015600831172611?s=20

Risk-aversion myopia can go little farther.

sh76
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The utter contempt the authorities seem to have for the risk assessment and decision making abilities of the plebs is mind-blowing.

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@sh76 said
https://www.nbcnews.com/news/us-news/johnson-johnson-vaccine-should-be-paused-u-s-after-extremely-n1263898

The Food and Drug Administration and the Centers for Disease Control and Prevention issued a statement saying they were "recommending a pause in the use of this vaccine out of an abundance of caution."


Let's assume, arguendo, that ALL 6 clotting episode ...[text shortened]... VOLUNTARILY assume a risk that is less than 1 in 1,000,000???

Somebody defend this. I'm curious.
Kim Iversen said more people got a rare blood disease from the mRNA gene therapy treatments. She suspects a buy off or something like that.

The first time I saw this article I didn't read much of it because I didn't think the numbers of infected people after full vaccination was a big deal. After all, none of the vaccines are 100% effective. If you vaccinate enough people that is expected. Then I read that the vaccines take 6 weeks to work!

https://healthimpactnews.com/2021/cdc-admits-5800-fully-vaccinated-people-became-infected-with-covid-19-and-74-died/

Hey, that is a significant problem!
Now Pfizer says after you get fully vaccinated you still have to get a shot every 6 to 12 months for the rest of your life. There you have it, gene therapy for life.

Still ready to roll up your sleeve for a shot of gene therapy treatment?

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@shavixmir said
Yah, that’s what the Indians said too.
Yeah... look what happened to them!

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@sh76 said
The utter contempt the authorities seem to have for the risk assessment and decision making abilities of the plebs is mind-blowing.
Individual responsibility is a thing of the past...sit back and enjoy the ride...you are now in the hands of the all powerful state.
Welcome to the Twilight Zone.

The Obsolete Man!



" This is not a new world, it is simply an extension of what began in the old one. It has patterned itself after every dictator who has ever planted the ripping imprint of a boot on the pages of history since the beginning of time. It has refinements...technological advancements...and a more sophisticated approach to the destruction of human freedom. But like every one of the super states that preceded it, it has one iron rule: logic is an enemy and truth is a menace"

no1marauder
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@sh76 said
The utter contempt the authorities seem to have for the risk assessment and decision making abilities of the plebs is mind-blowing.
The whole idea of having a public health agency making science based decisions on how the handle a deadly pandemic is offensive; why can't such decisions be left to individuals? It's like having all those silly generals making military decisions in war rather than letting the individual soldiers do what they think is best.

Good point, sh.

Despite your Chicken Littleish assessments, the number of vaccinations since the "pause" have averaged well over 3.5 million per day, reaching nearly 4 million by Friday. https://www.cnbc.com/2021/04/16/covid-19-cases-deaths-vaccinations-daily-update.html

At that pace, we should hit 70% fully vaccinated by mid-June.

IF the J & J vaccine can't pass FDA muster, it shouldn't be used but there are adequate substitutes making this whole thread another exercise in internet posters blowing smoke on subjects they have little knowledge of.

no1marauder
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@sh76 said
This basically sums it up.

https://twitter.com/JesseOSheaMD/status/1382015600831172611?s=20

Risk-aversion myopia can go little farther.
From your link:

"J&J vaccine will only comprise of 5% of the overall vaccination campaign per the Biden Administration."

I stand by my assessment that such a quantity can be easily substituted by the other vaccines already in use. Your own source refutes your claim to the contrary.

sh76
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@no1marauder said
The whole idea of having a public health agency making science based decisions on how the handle a deadly pandemic is offensive; why can't such decisions be left to individuals? It's like having all those silly generals making military decisions in war rather than letting the individual soldiers do what they think is best.

Good point, sh.

Despite your Chicken Little ...[text shortened]... thread another exercise in internet posters blowing smoke on subjects they have little knowledge of.
It's great that Pfizer and Moderna are able to shoulder 95% of the work, but there are certainly individuals who either did not get the vax or delayed their vax due to the sudden J&J halt. For those people, they were refused the opportunity to get vaccinated based on a risk that is quite literally less than 1-in-a-million.

BTW, since you quote Nate Silver quite a bit, it might (or might not) interest you to note that he has been trashing the J&J halt on almost a daily basis. e.g., https://twitter.com/NateSilver538/status/1383424650290483212

Saying that it can't pass FDA muster is a circular argument. The FDA muster was based on a very public calculation. There has been no indication that the risk is any greater than the 6-in-7-million publicly reported.

Essentially what you're arguing is that lay people should never question any FDA decision, a proposition that I disagree with.

Edit: In case anyone doesn't like Twitter links, here is Nate's Tweet:

I don't really understand the endgame. Wait 2 more weeks (!) to gather more data. Let's say (as seems likely) the data shows there IS a link, but it's very rare. What then? We keep J&J banned because our regulators are insanely risk-averse?

no1marauder
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@sh76 said
It's great that Pfizer and Moderna are able to shoulder 95% of the work, but there are certainly individuals who either did not get the vax or delayed their vax due to the sudden J&J halt. For those people, they were refused the opportunity to get vaccinated based on a risk that is quite literally less than 1-in-a-million.

BTW, since you quote Nate Silver quite a bit, it migh ...[text shortened]... 's very rare. What then? We keep J&J banned because our regulators are insanely risk-averse?[/quote]
I follow Nate on Twitter and have read his recent stuff.

He's wrong.

You don't really know what the risk is; we know how many people have gotten the high risk blood clots already in the few weeks the J & J vaccine has been used but we don't know if that is the full extent of the problem. We need ................... guess what? More detailed study which you apparently think is worthless.

J & J is a less effective vaccine anyway and if it can be easily substituted by existing or soon to be existing stocks of Pfizer and/or Moderna vaccines, then the vaccinated population will be better protected with less risk.

sh76
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@no1marauder said
I follow Nate on Twitter and have read his recent stuff.

He's wrong.

You don't really know what the risk is; we know how many people have gotten the high risk blood clots already in the few weeks the J & J vaccine has been used but we don't know if that is the full extent of the problem. We need ................... guess what? More detailed study which you apparentl ...[text shortened]... zer and/or Moderna vaccines, then the vaccinated population will be better protected with less risk.
I don't think further study is worthless; I just don't think stopping people from getting it now when the risk of COVID is far higher than the risk of blood clotting is appropriate risk analysis.

As for J&J being less effective than the mRNA vaccines, that's probably true, but it has advantages. First, it's easier to store due to being able to tolerate warmer temps in storage. Second, it requires only one dose. Third, it's not based on new technology that's never been used in vaccines before. I believe the mRNA vaccines are safe and effective (I got the Pfizer one myself, as did my 16 yo daughter; and my wife got Moderna), but I can't really blame people for hesitating on the mRNA ones given that we don't know for certain that there are no long term effects of this technology.

All that is part of each person's risk calculation. By taking away the option from people, the FDA has narrowed people's options and probably caused many people to go unvaccinated (for at least the time being) based on a risk that is so negligible that people ought to be able to decide for themselves whether they want to take it.

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@sh76 said
I don't think further study is worthless; I just don't think stopping people from getting it now when the risk of COVID is far higher than the risk of blood clotting is appropriate risk analysis.

As for J&J being less effective than the mRNA vaccines, that's probably true, but it has advantages. First, it's easier to store due to being able to tolerate warmer temps in storage ...[text shortened]... is so negligible that people ought to be able to decide for themselves whether they want to take it.
What is the risk of getting the severe blood clotting? You keep pretending you know, but you don't. We can say that there have been six reported cases soon after the J & J vaccination, but does that mean that there is no possibility of the condition appearing weeks or months after? Given that the experts don't even know why this condition has appeared, it is premature to conclude, as you have done, what the risk is. More research is clearly needed.

It's the FDA's job to assess the risks and advantages of any new drugs. "Narrowing people's options" is their SOP. Your objection is essentially an objection against the entire regulatory system.

Again, I believe your claims that this pause will cause "many people to go unvaccinated" (even for a short period) to be unfounded. The stats say since the pause more than 3.5 million vaccinations a day are being done in the US. I see no indication that the pause will have the dire effects you claim.

sh76
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@no1marauder said
What is the risk of getting the severe blood clotting? You keep pretending you know, but you don't. We can say that there have been six reported cases soon after the J & J vaccination, but does that mean that there is no possibility of the condition appearing weeks or months after? Given that the experts don't even know why this condition has appeared, it is premature to ...[text shortened]... y are being done in the US. I see no indication that the pause will have the dire effects you claim.
Nobody really knows the risk of any new drug. Certainly we don't "know" whether there are long term effects of the mRNA vaccines. We hope not. We think not. But we don't really "know." We can only go on the evidence we have, not what we might become aware of in the future. People who don't want to take that slight risk are welcome to stay unaccinated.

Based on what we "know," the risk of blood clotting is tiny. Possibly a much more narrow measure, like recommending that young women (who seem to be the demographic in which the blood clotting is occurring) get Pfizer of Moderna, would be justifiable. But taking the vaccine down across the board is plainly not warranted by the facts on the ground.

I don't recall predicting "dire effects" on the scale of the vaccine rollout for the country as a whole. I'm talking about the individual level. Certainly there were sites that we set up for the J&J vaccine that had to go empty for at least a few days and certainly there are some people who are not going to take the mRNA vaccines that would have taken the J&J (I know two such people).

That the rollout is going well otherwise is not the point. Maybe the 3.5 million would be 3.6. That would be 100,000 additional people per day who are at risk of COVID based on a danger for which the evidence is extremely scant.

sh76
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@metal-brain said
Kim Iversen said more people got a rare blood disease from the mRNA gene therapy treatments. She suspects a buy off or something like that.

The first time I saw this article I didn't read much of it because I didn't think the numbers of infected people after full vaccination was a big deal. After all, none of the vaccines are 100% effective. If you vaccinate enough peo ...[text shortened]... gene therapy for life.

Still ready to roll up your sleeve for a shot of gene therapy treatment?
Pfizer speculated that you might need a yearly booster to get full protection.

Hmmm. Where have I heard of yearly boosters before?

Oh, right. The flu shot.

no1marauder
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@sh76 said
Nobody really knows the risk of any new drug. Certainly we don't "know" whether there are long term effects of the mRNA vaccines. We hope not. We think not. But we don't really "know." We can only go on the evidence we have, not what we might become aware of in the future. People who don't want to take that slight risk are welcome to stay unaccinated.

Based on what we "know," ...[text shortened]... people per day who are at risk of COVID based on a danger for which the evidence is extremely scant.
The evidence regarding the scope of this documented problem (not the speculative "problems" that may or may not exist regarding other vaccines) should be assessed by public health experts, not internet posters. Whether that risk is "slight" as you constantly claim is actually unknown. And the "facts on the ground" you are relying are based on nothing more than media reports usually written by laymen.

Simply put, the FDA and CDC were created expressly to make such medically based decisions and the fact that Nate Silver thinks they are being too "risk adverse" isn't as impressive to me as it is to you.

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