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by oldgradstudent 1125 days ago
> This feels like the kind of thing to include citations with, no?

I assumed this was well known.

https://www.npr.org/sections/health-shots/2021/02/19/9691430...

Edit: note that the NPR piece missed the more important problem. While some people in the placebo group decided to continue the study and not to take the vaccine, blinding was irrecoverably broken, and what is worse, they are self selected, so randomization is gone as well.
1 comments
kadoban 1125 days ago
That link says that after the FDA authorized the shots, the study participants were offered them. Not that something was skipped _before_ authorization.

Not giving these people the shots would have been immoral, it was already clear that they were effective and safe.

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logicchains 1125 days ago
>Not giving these people the shots would have been immoral, it was already clear that they were effective and safe.

It was not clear that they were long-term safe; there was not enough long-term data yet to discover this. And by unblinding, they made it very hard to gather such data.

Now that we have some such data, we see that indeed there are some non-trivial long term risks, such as doubling the risk of blood clotting in the eyes: https://www.nature.com/articles/s41541-023-00661-7 .

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kadoban 1125 days ago
> Now that we have some such data, we see that indeed there are some non-trivial long term risks, such as doubling the risk of blood clotting in the eyes

Doubling a miniscule risk. Even if true, this is orders of magnitude less consequential than the benefit gained by giving people the vaccine, instead of maintaining the blind group.

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oldgradstudent 1125 days ago
> That link says that after the FDA authorized the shots,

Yes, important steps were skipped or shortened for the unprecedented approval of these vaccines.

> Not giving these people the shots would have been immoral, it was already clear that they were effective and safe.

How can it be clear that they were safe if you haven't done any type of longer term followup?

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kadoban 1125 days ago
> Yes, important steps were skipped or shortened for the unprecedented approval of these vaccines.

If true, this link doesn't say it.

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oldgradstudent 1124 days ago
It says they stopped after authorization. They mean Emergency Use Authorization. Which can only be given to unapproved modalities.

That is, they stopped blinding half a year before the vaccine was actually approved.

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