Did they start the approval process before the FDA did?

The UK regulatory agency is known for being fast. Also it appears in this case they really, really wanted to be first.

Part of the big Brexit push was arguing that they could do things better than Europe. Boris not only has a Covid crisis on his hands, but he was also the driving force behind Brexit.

guess they are just better/smarter when it comes to getting through the 100k pages of data

kinda sad for us

Again, the UK wanted to score some points off of Europe.

Note all the shade being thrown at the bottom of this article:

https://www.washingtonpost.com/world/europe/britain-pfizer-coronavirus-vaccine/2020/12/02/90f7276e-3470-11eb-9699-00d311f13d2d_story.html

Yeah, it's notable that the EU said their decision might not come until Dec 29. Each agency has their standards and procedures, but still, this has to put some pressure on them.

okay so it's political and not about saving the lives/preventing the deaths that might be associated with the lag in approval

because i'm just curious why the US didn't really really really want to be first given that 2000 people are dying every day from this here and we're no where near herd immunity

$$$$$$$$$

Everything is political in one way or another.

Buried at the bottom of the article I linked, you will see what public health officials are worried about. Germany has a huge antivax movement. The vaccine won't save many lives if no one gets it.

Drug approval is always about trying to do the most good for the most people. Lots of people die from cancer while drugs that could help them are awaiting review. Without that review however, many more people would die.

The initial doses of vaccine will cover a small percentage of the population, and be exhausted weeks after approval. Whether the FDA approves today, on the 10th, or even Jan 1st will have no effect on when most people get the vaccine.

The UK wanted a PR victory, and they got one. I don't think that will lead to problems, but I also don't think it's a good reason to rush our review beyond the extreme speed it's already moving at.

so the UK didn't do due diligence?

negligent compared to the US?

or are you saying they're subcontracting the real checking to the US, to where if the US denies EUA then the UK would then backtrack?

I'm just curious how they were able to go faster, regardless of why they were motivated

also even though the initial doses are small in availability aren't they earmarked at least in part for the most vulnerable populations in LTC

I don't think the delay you are mentioning is insignificant in that respect given those are the people dying by and large

but we can reasonably disagree on how important that is compared to the optics that you mentioned

I think they'd absolutely pull it if the FDA didn't approve.

Different countries do things differently. My wife works in reg, and a lot of her day is trying to navigate all the different national agencies.

Just to note, when AZ had an SAE in their trial a couple of months ago they had to pause in the UK for a couple of days. The FDA kept them on hold a lot longer. I don't know if that was the FDA being extra cautious, the UK taking more risk (or favoring a local company), or both.

amercer said:

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The UK regulatory agency is known for being fast. Also it appears in this case they really, really wanted to be first.

Part of the big Brexit push was arguing that they could do things better than Europe. Boris not only has a Covid crisis on his hands, but he was also the driving force behind Brexit.

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Interesting. Makes sense

I always thought U.K. and their socialized medicine wrote off those over 70. I guess the calculation is more expensive to treat an old person with Covid then to just give them the vaccine.