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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

#52

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?

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

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

#53
post #43
post #20

Not sure why the posts asking for vaccine risks are getting downvoted. Pandemrix, the vaccine for swine flu, caused a notable amount of narcolepsy cases in recipients here in FIN (notable here meaning the amount of yearly cases spiked by 3-4x) and as with anything that's taken quick to market there has to be some risk of overlooking some tail events somewhere. It's not an anti-vaccine attitude, just healthy skepticis…

The UK has a vaccine rollout plan that involves starting with health workers and over 80s. Due to supply issues, only those with the highest risk of death from COVID will get this vaccine.

UK health care workers were one of the main groups affected by Pandemrix-related narcolepsy. It was a bit of a scandal over here, though perhaps not the most well-known one.

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

#54
post #5

How did they approve it that fast? Is the approval process so different and so much more efficient than the one in the EU or USA? Was it extremely rushed to make sure to get doses before they have to compete with other countries for limited supply? I'm pretty curious now. Let's hope for the best, i.e. a good vaccine, a good process and no trust problems, the latter because at least it feels rushed.

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?

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

#55
post #20

Not sure why the posts asking for vaccine risks are getting downvoted. Pandemrix, the vaccine for swine flu, caused a notable amount of narcolepsy cases in recipients here in FIN (notable here meaning the amount of yearly cases spiked by 3-4x) and as with anything that's taken quick to market there has to be some risk of overlooking some tail events somewhere. It's not an anti-vaccine attitude, just healthy skepticis…

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 from Finland and Sweden also appear to demonstrate an extended risk of narcolepsy into the second year following vaccination, but such conclusions should be interpreted with a word of caution due to possible biases.

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

#56

Serious question: if you're a young person with no health issues, should you even get the vaccine?

Yes, There are two primary things to consider the Risk/Benefit to yourself and the Risk/Benefit to those around you.

The answer is still yes for both cases, long term covid damage is bad at any age and so is taking out a grandparent, co-worker you like.

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

#57
post #20

Not sure why the posts asking for vaccine risks are getting downvoted. Pandemrix, the vaccine for swine flu, caused a notable amount of narcolepsy cases in recipients here in FIN (notable here meaning the amount of yearly cases spiked by 3-4x) and as with anything that's taken quick to market there has to be some risk of overlooking some tail events somewhere. It's not an anti-vaccine attitude, just healthy skepticis…

You have to compare the risks to the risks of the disease and the likelyhood of contracting that disease. And for COVID-19 the risks are very high. It doesn't make much sense to me to trade the very high known risks of COVID-19 against the relatively low risk of rare side effects in a vaccine. These vaccines have been tested in ~40,000 people each, so we do know quite a bit about their safety.

The fatality rate of COVID-19 and the rate of serious complications is high enough that it easily dwarfs the chance of any potential rare side effects of the vaccines.

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

#58
post #37

Amazing that people will be getting vaccinated against coronavirus before the year is out. Is there any evidence of whether these vaccines prevent transmission of the virus yet? Or so far do we just know that they protect the person who is vaccinated?

If you're not actually infected, i.e. you're protected, you don't spread the virus. I'm not aware of a disease for which this isn't true, that vaccinated people can be carriers.

What I remember but cannot currently find a source for, is that there are three levels of protection that vaccines can provide. First is to protect patients from developing the sickness (but not from being infected!), second is to even prevent them from spreading it and best outcome is to prevent them getting infected at all. Only the second and third level prevent spread.

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

#59

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?

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.

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

#60

Serious question: if you're a young person with no health issues, should you even get the vaccine?

Yes, some young people with health issues can’t get vaccines of various kinds and they rely on herd immunity. One of the really sad things about the anti-vaccine movement is the people who are now at risk for things that they can’t get vaccinated against through normal fault of their own because herd immunity is reduced.
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