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by dmurray 2018 days ago
> It seems almost impossible that the vaccines pose a greater risk than the risk of not using them.

While this is a reasonable conclusion from what we've read in the media, it's worth noting that this is at odds with the official opinions of the EMA and the FDA.

They both believe more data is needed, or that the agencies need more time to analyze the data, before they can decree that the benefits most likely outweigh the risks. Otherwise, they'd have approved the vaccines already.

2 comments

There's also a strong political reason for the US to not approve the vaccine as fast.

Fauci had to walk back[0] comments about the UK "rushing" the approval, stating

"The point that I was really trying to make [...] in the United States there is such a considerable amount of tension of pushing back on the credibility of the safety and of the efficacy that if we in the United States had done it as quickly as the UK did [...] that if we had for example had approved it yesterday or tomorrow there would have been push-back on an already scrutinising society that has really in some respects in the United States too much scepticism about the process."

[0] https://www.bbc.co.uk/news/world-us-canada-55177948

> already scrutinising society that has really in some respects in the United States too much scepticism about the process

Such politeness :-))

Most people outside the US don't call what's happening in the US "scepticism" :-(

Neither do "most" in the US, technically. Lotta ignorant people nonetheless.
The FDA set a meeting date for December 10th, that was at least somewhat arbitrary. They reportedly had no one working for 4 days during Thanksgiving break, so It's likely they could have just worked through Thanksgiving and had that meeting last week if they'd wanted to.
AFAICR, they're required to put a minimum two week period between the emergency use authorization request and the meeting.
Yeah, the real reason the agencies haven't approved it is closer to "the wheels of bureaucracies that big turn very slowly", but the official reason is still that the data they've seen so far is inconclusive.
"the data they've seen so far is inconclusive" has connotations that I don't think the FDA has implied officially or unofficially.