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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

#281

Post by tinus_hn »

La1n wrote: post #273
tinus_hn wrote: post #253

Earlier quoted context omitted.

It’s not like they suddenly dumped a stack of papers on the regulators’ doorsteps. 99% of all the data they are going to get has been available for a long time and everything they are going to be able to check in their 20 days has been available for a long time. How are they going to check if the manufacturer fudged the report? Run the experiment themselves again in 20 days? Edit: by the way in the UK they were prepa…

>How are they going to check if the manufacturer fudged the report? Run the experiment themselves again in 20 days? Site and document inspections.

What site? Just pick one of the over 150 trial sites at random? What are they going to see that they couldn’t have seen a month ago?

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

#282

Post by cameronh90 »

mattmanser wrote: post #119
ascorbic wrote: post #11

Earlier quoted context omitted.

Unlikely to be the latter, because they've already prepurchased millions of doses. Unlikely to be the former either. The UK regulatory system is highly-regarded, and until January the EU medicines regulator was based in London. It may just be that they're particularly efficient.

Lets hope it's not not like our pandemic preparedness, that was highly regarded and turned out to be rotten.

It had actually been identified that our pandemic preparedness was overly focused on influenza. Still, I have no idea whether we'd have fared better in a flu pandemic - maybe the assumption was that we'd be able to get a vaccine quicker in that case?

In any case, it's still somewhat unclear why the UK has done so badly with Covid. There are some obvious things the government should have done better - and unless Brexit turns out to be a "titanic success", I can't see how Boris Johnson will remain PM until the next election. But even compared to countries that have implemented weaker measures, slower than we have, or have had their healthcare systems overwhelmed, or struggled with testing - we've suffered much worse. And the reason why is, at this point, unknown.

One argument is we have a less healthy population, either due to lifestyle factors or due to having relatively mild previous flu seasons. Another is our dense, poor housing and service economy. Another is travel and weather. Will be interesting to see what falls out over the analyses over the next few years, and if anything is done to act on the problems (I doubt..).

The factor that these preparedness plans can't account for who is in charge at the time the disaster hits. We might have technically had the best plans, best scientists, best civil service, best procedures - and then the person in charge refused to listen to them. Like Trump and the CDC. Maybe people will vote for competence over bluster next time around? (I doubt..)

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

#283

Post by neilsense »

DanBC wrote: post #101
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.

> Developed country with great logistics. Please don't under-estimate our ability to fuck this up, probably by giving the distribution contracts to a crony.

Does it tiring being so depressing?

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

#284

Post by School-Cotton »

fsh wrote: post #168
School-Cotton wrote: post #93

Earlier quoted context omitted.

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.

Good to know!

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

#285

Post by disgruntledphd2 »

swarnie_ wrote: post #193
apsec112 wrote: post #107

Earlier quoted context omitted.

I'm sure the UK is in the top twenty countries in the world for logistics infrastructure. It's easy to read news stories about your country messing things up, and quietly not read foreign-language media about poorer countries messing things up a lot more by comparison, and get a biased perspective.

OP appears to have got lost on the way to /r/unitedkingdom where similar comments are generated by angry bots all day, every day. Some perspective would be nice. When you tell your buyers to go grab every last bit of PPE they can and cut them a blank cheque to do it of course you're not going to get the best price, especially when every other country in the world is doing the same things. Do you focus on the 10s of m…

I mean, even their own watchdogs say that there were problems:

>In the months following the emergence of the COVID-19 pandemic in March 2020 in the UK, government awarded around £18 billion of contracts using emergency procurement regulations to buy goods, services and works to support its response to the pandemic. Government was having to work at pace, with no experience of using emergency procurement on such a scale before and was developing its approach at the same time as procuring large quantities of goods and services quickly, frequently from suppliers it had not previously worked with, in a highly competitive international market. This procurement activity secured unprecedented volumes of essential supplies necessary to protect front-line workers. Our separate report on the supply of PPE looks in detail at the extent to which demand for that equipment was met and the value-for-money achieved.

While government had the necessary legal framework in place to award contracts directly, it had to balance the need to procure large volumes of goods and services quickly, with the increased commercial and propriety risks associated with emergency procurement. We looked in detail at a sample of contracts selected on a risk basis. Although we found sufficient documentation for a number of procurements in our sample, we also found specific examples where there is insufficient documentation on key decisions, or how risks such as perceived or actual conflicts of interest have been identified or managed. In addition, a number of contracts were awarded retrospectively, or have not been published in a timely manner. This has diminished public transparency, and the lack of adequate documentation means we cannot give assurance that government has adequately mitigated the increased risks arising from emergency procurement or applied appropriate commercial practices in all cases. While we recognise that these were exceptional circumstances, there are standards that the public sector will always need to apply if it is to maintain public trust.

From: https://www.nao.org.uk/report/government-procurement-during-...

And remember everyone, when reading reports like this one should replace any soft seeming rebukes with phrases such as "these muppets had no idea what they were doing" and "this looks incredibly corrupt, but if we say that this report will never be released".

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

#286

Post by rienbdj »

kmlx wrote: post #246
samdamsamma wrote: post #186

Earlier quoted context omitted.

Actually the UK government is an absolute wreck.

it really depends. they're pushing for more cycling, more climate measures, more taxes on IT giants etc and these are Conservatives, the opposite of left-leaning. on the other hand, their Covid response was the same as Spain, Italy, France etc i.e. pretty bad. but they also approved the vaccine really quick, and we're getting that next week. so overall, a meh, like most other countries where I lived. as a point of re…

The climate measures are completely inadequate and cycling spending has been cut by 15%

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

#287

Post by tonyedgecombe »

pmoriarty wrote: post #268
usrusr wrote: post #216

Earlier quoted context omitted.

Fully expect the same. Basically, if you are less than 65 years old and not working in one of the early access professions, forget all concerns about vaccine safety. Buckle up to face the virus natively in that third wave that will sweep through unmitigated once the high mortality groups are vaccinated.

There may be places you won't be allowed to go and things you won't be allowed to do (like work, maybe) unless you show proof of having been vaccinated. There's a good chance that situation will create a black market both for vaccines (real and fake) and forged proof of vaccination.

There may be places you won't be allowed to go and things you won't be allowed to do (like work, maybe) unless you show proof of having been vaccinated.

The UK government has ruled out having a vacination passport (for good reason in my opinion).

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

#288

Post by disgruntledphd2 »

jfoster wrote: post #234
gr2zr4 wrote: post #75

This could be the fastes approval in the whole drugs' history considering that The assessment of a marketing authorisation application for a new medicine takes up to 210 ‘active’ days. This active evaluation time is the time spent by EMA experts to evaluate the evidence provided by the applicant in support of a marketing authorisation application. This time is interrupted by one or two ‘clock-stops’ during which the…

Do drug approvals even have much history? My impression was that the concept of drugs needing to be approved has been around for less than 100 years, but I guess it will vary from country to country.

It's been around (for clinical trials and whatnot) since the late 50's in the US I believe.

I think it's been mandatory since thalidomide.

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

#289

Post by usrusr »

pmoriarty wrote: post #268
usrusr wrote: post #216

Earlier quoted context omitted.

Fully expect the same. Basically, if you are less than 65 years old and not working in one of the early access professions, forget all concerns about vaccine safety. Buckle up to face the virus natively in that third wave that will sweep through unmitigated once the high mortality groups are vaccinated.

There may be places you won't be allowed to go and things you won't be allowed to do (like work, maybe) unless you show proof of having been vaccinated. There's a good chance that situation will create a black market both for vaccines (real and fake) and forged proof of vaccination.

You are painting a scenario that could theoretically become an issue if vaccination somehow got stuck at some point close to or far beyond the 50% mark for some reason. E.g. to deliberately exclude some part of the population, or in some "the vaccine is actually a carrier for something else" movie plot. But if the limits of vaccination are just the confines of ramp-up and particularly if priority is given to the elderly, it's just a phantom fear. Not allowed to go to work unless you are older than 75? Right...

At first glance forgery seems like a very real threat considering how hard it is to tell vaccine from sodium chloride (entire testing procedures are based on this), but the same difficulty is also working against a black market: why pay if the seller can't give event the slightest indication that it's not a fake and the fake has no intrinsic value at all? You'd have to fake the distribution structures and not the product and an elaborate fake structure isn't something that suddenly pops up from some dark market investment, it could only evolve from simpler black market schemes. But those won't happen, at least not in time (except maybe in places with a truly corrupt regular distribution system, where it would start with "redistributed" real vaccine and then slowly shift over to fakes)

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

#290

Post by _opc6 »

swores wrote: post #276
Wintamute wrote: post #241

Earlier quoted context omitted.

What you're missing is that amongst a certain class of Brit, and across much of the West, relentless and savage cultural self-criticism has become the norm, and a currency used for in-group signalling. Even when people in the UK should be celebrating, as literally the first country in the world to develop an approved C19 vaccine in record breaking time, and enjoy the privilege of a free health system that can roll it…

> Even when people in the UK should be celebrating, as literally the first country in the world to develop an approved C19 vaccine in record breaking time The UK has one of the first (Oxford/AstraZenica), but this news about the first approved is not a vaccine developed in the UK. But I'm still happy to celebrate the Turkish couple's German company that's owned by Pfizer, as I will be when Oxford hopefully release mo…

It's strange how we immediately take pride in stuff we had nothing to do with just because we identify in some way with the developers/creators.
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