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Pfizer Covid vaccine approved for use next week in UK

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Re: Pfizer Covid vaccine approved for use next week in UK

#62
post #55

Earlier quoted context omitted.

I thought I saw a comment explaining the narcolepsy thing and showing how it had been debunked? I think a comment on HN from about a week or so maybe?

https://www.sciencedirect.com/science/article/abs/pii/S10870... > In our paper, we show that the risk appears to be limited to only one vaccine (Pandemrix®). During the first year after vaccination, the relative risk of narcolepsy was increased 5 to 14-fold in children and adolescents and 2 to 7-fold in adults. The vaccine attributable risk in children and adolescents was around 1 per 18,400 vaccine doses. Studies fr…

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Re: Pfizer Covid vaccine approved for use next week in UK

#63

Earlier quoted context omitted.

There's thousands and thousands of pages of trial data, and if there's a significant screw-up, it would destroy public trust in all vaccines for decades. https://en.wikipedia.org/wiki/Dengvaxia_controversy

It's been almost two weeks. That's more than enough time to read thousands of pages if they are literally the most important thousands of pages in the world right now.

What makes you so confident? If someone gave you the source code to a major software project, even with a large team of highly qualified engineers working as fast as they could, how long would it take to read over the entire thing and be absolutely sure that there were no serious mistakes?

Re: Pfizer Covid vaccine approved for use next week in UK

#64

Earlier quoted context omitted.

Happy beta testing to all Brits then!

My 85 year old grandparents are excited, they get to hold their great grand children again. They’d be first in line if they could be.

Aside from hospital workers they're likely to be pretty high on the list, if my understanding is correct.

Re: Pfizer Covid vaccine approved for use next week in UK

#65

In terms of rollout. UK is the ideal country to be the first: 1. Heavily impacted by Covid-19. 2. Centralised health care system makes it easier to compare results and efficiency. E.g. it's UK which figured out that dexamethasone is efficient against Covid https://www.who.int/news/item/16-06-2020-who-welcomes-prelim... 3. Developed country with great logistics.

Happy beta testing to all Brits then!

The 'beta' test already happened. Tens of thousands of people have proven it safe and effective. Haven't you been following the news?

Selfishly, I guess we should be happy that there is an anti-vaxxer sentiment; it means the rest of us will get our vaccines faster.

Re: Pfizer Covid vaccine approved for use next week in UK

#66
post #38

In terms of rollout. UK is the ideal country to be the first: 1. Heavily impacted by Covid-19. 2. Centralised health care system makes it easier to compare results and efficiency. E.g. it's UK which figured out that dexamethasone is efficient against Covid https://www.who.int/news/item/16-06-2020-who-welcomes-prelim... 3. Developed country with great logistics.

We also have a fairly old, fat, and alcoholic population so if this doesn't work we're probably not getting out of this lightly (even relative to where we are now)

I am not old.

Re: Pfizer Covid vaccine approved for use next week in UK

#68

Earlier quoted context omitted.

It looks like the FDA approval will probably follow in eight days (December 10th). I'd guess the UK just has the edge on administrative efficiency.

Pfizer concluded their trial and filed for approval with the FDA almost two weeks ago. People are dying. Why is it not approved yet?

Approval is like code review. They go over the work and make sure it is sound. Just giving an OK without doing the approval work would be called "rubber-stamping".

Re: Pfizer Covid vaccine approved for use next week in UK

#69

Pfizer submitted an emergency use authorization request to the US FDA on Nov. 20. Why was it not approved within a day or two? Is it merely a matter of reading the submitted paperwork and scheduling a committee meeting? There better be a damn good reason, because people are dying out here. I understand that trials take time, but we already have trial results now, so what's the hold up?

Pfizer only submitted the data package on Nov 20th, with a review on Dec 10th. That's 20 days to review what is likely hundreds of pages of data, if not thousands. It will be reviewed by hundreds of people, all with different expertise, who will need to talk to each other, dig into the data, re-run analyses, etc. You certainly don't want to just take the drug manufacturers word that everything checks out.

Plus, how the FDA approves it (including the speed) will create an impression on people's minds of how safe the vaccine is. Fast is good. "Too fast" is bad.

Re: Pfizer Covid vaccine approved for use next week in UK

#70

Earlier quoted context omitted.

It's been almost two weeks. That's more than enough time to read thousands of pages if they are literally the most important thousands of pages in the world right now.

What makes you so confident? If someone gave you the source code to a major software project, even with a large team of highly qualified engineers working as fast as they could, how long would it take to read over the entire thing and be absolutely sure that there were no serious mistakes?

If a team from the UK had already done it, I would just go ahead and accept their analysis. The US should give emergency approval now, based on the UK approval.
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