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Pfizer Covid vaccine approved for use next week in UK

bbc.com

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

#151

Post by modeless »

refurb wrote: post #69
modeless wrote: post #49

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 t…

Pfizer had FDA Fast Track approval in July which means they could start reviewing it early as the trial progressed. In a sensible process all those hundreds of people should have reviewed and discussed nearly everything but the final numbers prior to Nov. 20 and been ready to plug in the numbers as soon as they came out.

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

#152

Post by pfranz »

shusson wrote: post #71

Out of curiosity, how do people on HN rate the risk of long term side-effects?

I'm curious for an actual expert to answer, but when I've heard this question presented they would point out that the risk of long-term side effects from a vaccine must be compared relative to the unknown, long-term side effects of a covid infection and continuing to live in a society that's locked down.

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

#153

Post by Arkhaine_kupo »

Erlich_Bachman wrote: post #119
Arkhaine_kupo wrote: post #25

Earlier quoted context omitted.

Healthy skepticism belong in peer-reviews, in revisions of medical journals. Skepticism in the public space fosters anti-vaccine sentiments, adds to the already growing anti-vax movements and puts in risk the vulnerable in our society as they require shielding and for the rest of us to do our part.

That exact sentiment is the reason for this problem even existing. Peer review and medical journals are by no means exempt from usual human corruptions, and there is absolutely no rational way to say that certain concerns should only be allowed there, and that we should not be able to even discuss them outside of those closed circles.

> Peer review and medical journals are by no means exempt from usual human corruptions

Individual instances can be found, and errors do happen. However the idea that the biggest pharma companies, integrated by incredibly talented and hardworking people, and every safety institution (The american FDA, the EU security council etc) are all so compromised as to miss real problems and purposefully endanger the population is in my humble opinion absurd.

What is the societal advantage on letting a baker share his uninformed opinion on epidemiology? Why let software engineers discuss the safety standards of the medical field? A ton of the situations and problems are heavily skewed to high technical knowledge of narrow field.

I have no idea about how many volunteers are a good number to run a vaccine experiment, I have no idea what a good control group vaccine looks like or why use HepB and not measles. Me sharing my opinions on this topic only pollutes the conversation when I do not have the background knowledge to form an opinion on it.

If you look for information on this topics it would be much better for society if my blog is not there and there is information from actual doctors and epidemiologists talking about it.

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

#154

Post by throwaway_pdp09 »

string wrote: post #144
EliRivers wrote: post #126

Earlier quoted context omitted.

The infrastructure, absolutely. A serious road, rail and air network, lots of companies with lots of experience and all the right gear and so on. Where we fuck up is in the competency of the people in charge of awarding contracts. Be it Grayling giving millions of pounds to a ferry company with no ferries owned or leased, or indeed any experience at all with ferries (and, wonderfully, with a T&Cs on their website cop…

I know it's guaranteed internet points to deride the current government, and the ferry thing is/was despicable, but I think it's highly unlikely they're going to put KFC in charge of logistical operations for the vaccine rollout.

That's a deliberate misinterpretation of what was said.

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

#155

Post by stunt »

spaceman_2020 wrote: post #46

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

Even a doctor can't answer that without having access to your medical documents.

So get advise from your doctor. Perhaps it depends on your "health issues". And, don't look for an answer from the internet anytime soon.

I assume it depends on your condition. If you are lucky, they have tested it on people with similar conditions and there is data for it. Otherwise, they may still be able to measure the risk. If your doctor suggests that there is a risk because of your condition, then you have to calculate the risk of not taking it as well. How much risk is there for you with the vaccine? How long can you keep yourself safe from COVID19. That depends on your interactions with other people, your job, and people around you etc.

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

#156

Post by FractalParadigm »

string wrote: post #144
EliRivers wrote: post #126

Earlier quoted context omitted.

The infrastructure, absolutely. A serious road, rail and air network, lots of companies with lots of experience and all the right gear and so on. Where we fuck up is in the competency of the people in charge of awarding contracts. Be it Grayling giving millions of pounds to a ferry company with no ferries owned or leased, or indeed any experience at all with ferries (and, wonderfully, with a T&Cs on their website cop…

I know it's guaranteed internet points to deride the current government, and the ferry thing is/was despicable, but I think it's highly unlikely they're going to put KFC in charge of logistical operations for the vaccine rollout.

The point being made is that you have to give out the contracts to vetted companies who can actually deliver on it. Just because there's a cheapest option that, on paper, seems to tick all the boxes, doesn't mean said option is actually any good.

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

#157

Post by prodent »

string wrote: post #144
EliRivers wrote: post #126

Earlier quoted context omitted.

The infrastructure, absolutely. A serious road, rail and air network, lots of companies with lots of experience and all the right gear and so on. Where we fuck up is in the competency of the people in charge of awarding contracts. Be it Grayling giving millions of pounds to a ferry company with no ferries owned or leased, or indeed any experience at all with ferries (and, wonderfully, with a T&Cs on their website cop…

I know it's guaranteed internet points to deride the current government, and the ferry thing is/was despicable, but I think it's highly unlikely they're going to put KFC in charge of logistical operations for the vaccine rollout.

If they learned their lesson, shouldn't they be pretty much predestined for the job?

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

#158

Post by fsh »

School-Cotton wrote: post #91
newguy1234 wrote: post #81

Earlier quoted context omitted.

Yes we basically need everyone to get it who is willing to get it because we want to eradicate as much of the virus in the population as possible. Also as a society we need to encourage everyone to get the vaccine and do whatever possible to suppress anti-vaccine hysteria, you know the conspiracy theories are already going to go crazy over this I'm sure.

Is there any evidence that the vaccine reduces your risk of getting and spreading the disease? I’ve only heard that it decreases the severity.

The BioNTech/Pfizer press release mentions a reduction in confirmed cases (8 vs. 162), not in severity. There is no good reason why such an effective vaccine should not reduce the risk of spreading the disease. However, even a large phase 3 trial doesn't have enough statistics to answer this question.

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

#159

Post by sussexby »

jakozaur wrote: post #19

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.

And we have a really good spreadsheet for tracking who's been infected /s

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

#160

Post by tinus_hn »

polytely wrote: post #77
chrisvxd wrote: post #9

Earlier quoted context omitted.

My understanding is that they've been carrying out a rolling evaluation that has been going on for the duration of the trials, which has helped accelerate the normal process. Having said that, I believe the EMA (EU) also carried out a rolling evaluation, so I'm not sure what the differences are there.

From what I remember from the news yesterday the EMA will be done with the evaluation (if they don't find anything that causes concern) by the end of the month, so they aren't that far off

Yeah, there’s only about 5000 deaths extra for each day of delay. So no rush there!
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