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by karmelapple 1777 days ago
Reading this, I wondered what might be keeping it from being fully FDA approved. I found this article explains it well: https://www.forbes.com/sites/leahrosenbaum/2021/07/30/why-ha...

A few quotes I thought were noteworthy:

> For emergency authorization, the FDA required two months of safety data versus six months for full approval, he explains.

> Pfizer submitted its application on May 7 and was granted special priority review status on July 16. In a press release, the company said the decision whether to fully approve the vaccine should come by January 2022. Other reports suggest Pfizer’s approval will likely be sooner, possibly as early as the start of the school year.

> As you might expect, clinical trial data is scrutinized, but the process involves more than just experts reading data. The FDA also inspects manufacturing facilities and meets many times with company executives.

> "I think a lot of us are baffled why the FDA is taking so long.” - Ashish Jha, dean of the Brown University School of Public Health

> To that end, the agency has reportedly expedited the process, even deprioritizing other projects in order to accelerate the timeline.

That last sentence struck me strangely, seeming to imply reprioritizing other projects was a big deal. We're still in a global pandemic, people are still dying here in the USA, and the economic realities still actively happening... yeah, I think deprioritizing other things is about the least surprising thing imaginable.