COVID-19: Vaccine and testing procedures Megathread Part 3 - Read OP

Monster249 wrote: »

I can't tell if you're trolling? The HSE are operated by the government. It literally has everything to do with the government.

The HSE and department of health are virtually entirely separate. Watch any of the press briefings and see if you can hear the CMO answering questions for the HSE.

NeuralNetwork wrote: »

Well, it would depend on whether the testing is actually 'a shambles' or whether you are just getting the one or two outlying cases that got delayed and are being shouted about online.

If there's a general issue with tests taking days, it's a problem. If it's a small % of tests that are delayed e.g. you could have a system error or something that caused a delay or a machine down or anything like that behind the scenes that caused a processing delay.

The only way you could assess the quality of the system is to see the general stats for test turnover time.

Which of course they don't release because it would bring necessary criticism.

titan18

RavenBea17b wrote: »

I thought Novartis where to be producing the Pfizer BioNtech vaccine in Switzerland - hadn't they made a contract to help increase the production of Pfizer due supply issues and to ramp up production.
I may be wrong on this, but I haven't spotted any separate new vaccine that is being developed by them in EU. Again I may well be mistaken.

Think I'm confusing them with Novavax. That was the one I think they never ordered but has discussions.

ACitizenErased wrote: »

Do you really think that Stephen Donnelly has any say in testing

I can't tell if you're trolling? The HSE are operated by the government. It literally has everything to do with the government.

Well, it would depend on whether the testing is actually 'a shambles' or whether you are just getting the one or two outlying cases that got delayed and are being shouted about online.

If there's a general issue with tests taking days, it's a problem. If it's a small % of tests that are delayed e.g. you could have a system error or something that caused a delay or a machine down or anything like that behind the scenes that caused a processing delay.

The only way you could assess the quality of the system is to see the general stats for test turnover time.

Monster249 wrote: »

Explain how it has nothing to do with the government? Are the HSE a privatized business?

Do you really think that Stephen Donnelly has any say in testing

is_that_so

Stark wrote: »

Is Sanofi definitely "failed"? I thought they were still hoping for something late-2021/early-2022 but were focusing their manufacturing efforts on Pfizer in the meantime.

Failure seems to mean about Q2 or by Q3 at the latest but yeah, it's a big failure alright!
https://www.fiercepharma.com/pharma/after-pfizer-deal-sanofi-offers-a-hand-to-johnson-johnson-for-covid-19-vaccine-production

ACitizenErased wrote: »

that has literally got nothing to do with the government

Explain how it has nothing to do with the government? Are the HSE a privatized business?

Dressoutlet

Monster249 wrote: »

The testing is a shambles. I've an elderly relative waiting 2 days for a result, they have had a f**king year to streamline it and make it more efficient.

We continue to do our job and the government repeatedly fail.

It is really great news. There is some caution in certain circumstances of course but it is clear the vaccines are the silver bullet, once enough people Get them there will be no precautions, no more than measles/meningitis etc precautions that we have.

Stark wrote: »

Is Sanofi definitely "failed"? I thought they were still hoping for something late-2021/early-2022 but were focusing their manufacturing efforts on Pfizer in the meantime.

They're still working on a second candidate product. They had two pipelines, the second was higher tech than the first.

is_that_so

Monster249 wrote: »

The testing is a shambles. I've an elderly relative waiting 2 days for a result, they have had a f**king year to streamline it and make it more efficient.

We continue to do our job and the government repeatedly fail.

Why are strangers on the internet your first port of call? Has it not occurred to someone in your family to contact the HSE about that?

Monster249 wrote: »

The testing is a shambles. I've an elderly relative waiting 2 days for a result, they have had a f**king year to streamline it and make it more efficient.

We continue to do our job and the government repeatedly fail.

I don't get how that's taking 2 days - they're under far less pressure at the moment given the case numbers and referral for testing numbers having gone down.

We'd two encounters with them in my extended family though since the start and the results were next day and followed up by texts.

Stark

Is Sanofi definitely "failed"? I thought they were still hoping for something late-2021/early-2022 but were focusing their manufacturing efforts on Pfizer in the meantime.

Monster249 wrote: »

The testing is a shambles. I've an elderly relative waiting 2 days for a result, they have had a f**king year to streamline it and make it more efficient.

We continue to do our job and the government repeatedly fail.

that has literally got nothing to do with the government

is_that_so

odyssey06 wrote: »

At least they have given us something to chew on, worth bearing in mind in criticism of them - unlike the top 3 vaccine manufacturers Sanofi, Merck and GSK whose candidates all failed.

Those first two will work on Pfizer and J&J respectively, with Sanofi looking to do both and GSK have a whole lot of things going on.

https://www.gsk.com/en-gb/media/resource-centre/our-contribution-to-the-fight-against-2019-ncov/

The testing is a shambles. I've an elderly relative waiting 2 days for a result, they have had a f**king year to streamline it and make it more efficient.

We continue to do our job and the government repeatedly fail.

odyssey06

Dressoutlet wrote: »

The CDC say no you don't have to isolate or be tested if you are fully vaccinated and become a close contact.

I see that now, new advice.

Fully vaccinated people with no COVID-like symptoms do not need to quarantine or be tested following an exposure to someone with suspected or confirmed COVID-19, as their risk of infection is low.
Any fully vaccinated person who experiences symptoms consistent with COVID-19 should isolate themselves from others, be clinically evaluated for COVID-19, and tested for SARS-CoV-2 if indicated.

https://www.cdc.gov/coronavirus/2019-ncov/vaccines/fully-vaccinated-guidance.html#anchor_1615135598178

Dressoutlet

jackryan34 wrote: »

Can anyone answer this?

Can't see it on HSE site

The CDC say no you don't have to isolate or be tested if you are fully vaccinated and become a close contact.

RavenBea17b wrote: »

I thought Novartis where to be producing the Pfizer BioNtech vaccine in Switzerland - hadn't they made a contract to help increase the production of Pfizer due supply issues and to ramp up production.
I may be wrong on this, but I haven't spotted any separate new vaccine that is being developed by them in EU. Again I may well be mistaken.

BioNTech purchased a Novartis facility in Marburg in Germany, quite close to their HQ and are adapting it to produce this.

Sanofi, which is one of the largest vaccine makers in the world, have opted to help Pfizer and BioNTech with production capacity, more so filling capacity, which is actually HIGHLY specialised.

A lot of people commenting on here seem to not comprehend what's involved in what sounds like an easy task - fill and finishing. It's actually an extremely complex process involving very expensive technology to vials. Brewing up the vaccine is complex, but the production of it is only about 1/4 of the steps to getting it to a patient.

There are also something like two companies who make the machines to fill those and the lead time to order them is something like two years normally. It's incredibly specialist stuff when you're dealing with any injectable product.

It's the kind of process that very few companies are trusted to do and that you just cannot get even a tiny bit wrong or you can literally kill people. So, it's not like they can just spin up a new plant based on stuff they bought a few months ago.

I would suspect that what's actually happening is they've large quantities of other drugs through fill and finish and stockpiled and them and are now running vaccines on the same lines etc. Those machines aren't just hanging around doing nothing waiting for a pandemic.

You also have issues around things like access to glass and other materials for vials, syringes and all sorts of very simple stuff in normal times but when you get into the detail of them they're extremely complicated and all about quality assurance and a very narrow supply chain of a handful of very trusted manufacturers.

The fact that this stuff is moving at the speed it's going at, even with these glitches and hiccups is quite remarkable.

The commentary and anger is understandable, but I would say if you're working in the industry, it must be extremely frustrating to see people lashing out at companies that are probably pulling out all the stops and working flat out to get this stuff safely delivered.

You're talking about a 5+ year timeline being condensed to basically weeks and months.

In the case of the mRNA vaccines nobody's ever made them at scale before and AstraZeneca and Moderna have had to build a supply chain in both cases from scratch more or less.

The outcome of this is not going to be perfect. Stuff will glitch and I think as long as best efforts are being made, there's not much more anyone can do.

The EU programme was definitely somewhat underestimated in scope at the start though, which is pretty obviously down to lack of experience. Europe doesn't have any kind of central purchase system for drugs and medicines, nor does it have agencies like FEMA or anything like that as healthcare was always a closely guarded national competency.

seamus

brickster69 wrote: »

Sputnik seeks apology from EMA

https://www.cityam.com/sputnik-v-makers-demand-apology-from-eu-after-comparing-vaccine-to-russian-roulette/

The whole Sputnik thing is pure politiking by the Russians.

They are absolutely dying for the EU to prove that it is biased against the use of Sputnik so that they can claim an anti-Russia bias in Europe.

It all started with Russia's claim that the EMA had ignored their request for approval, when it turned out that they hadn't submitted one at all.

I'm not 100% sure what the game is here. It might be an attempt to sow discord amongst eastern EU nations with large Russian heritages.

The EMA can't refuse to accept an application to approve Sputnik, but they don't have to give it a special pass.

In reality the comment is exactly the same thing that the EMA said about the UK's fast-track approval of Pfizer in December. The Russians have just decided to leap on this because they love to claim bias against them.

Dressoutlet

Irish Stones wrote: »

They never said the vaccine stops transmission.

The CDC say you don't have to isolate or be tested if you're fully vaccinated and become a close contact.
If you don't have to isolate or even be tested then it's obviously because you are not transmitting it.
You are well aware of the data by now.

RavenBea17b

eoinbn wrote: »

It depends on what they mean by the balance. In the first week of April do we expect our normal delivery + 125k from Q1 or just our normal delivery + the required amount to bring it up to 125k? It is likely the latter.

The 40m from AZ was in Q1 was never going to happen. When they said 31m, and not 30m, you can be sure they were already stressed to make the 31m. It seemed they tried to move 9m doses from early Q2 into Q1 but haven't managed it.

So for April, based on what the companies are telling us I would expect

Pfizer/BioNtech 350k-400k
J&J 50k-75k
Moderna 100k
AZ 150k-350k

So between 650k-925k. I would expect it to be in the mid to lower range. About 750k. That isn't too bad for a month with 4 delivers. We should see a pretty decent month in May with the Marburg plant supplying doses for the full month and ramping up production further. Also should have a full month of J&J delivers.

I see a few people saying that if Sanofi/GSK vaccine hadn't been delayed then we would be in a good place now. That vaccine hadn't even started P3 trial. It wasn't due until June. We would be in exactly the same situation even if it had worked. Apparently it did work on 18-49 year olds but not on older adults. Makes one wonder should they have continued with it if it was effective on 18-49. However that was likely just putting a positive spin on the failure.

I don't necessarily disagree with your comment about Sanofi, BUT, the EU had such a huge order c300m doses, the results were known timewise fairly early on in the procurement/trail timeline, due earlier trial peer reviews etc. What I struggle to understand, is why not adapt doses for others and or look to other s to evaluate/place provisional suppliers working on potentials. Valneva Novavax etc earlier ? The failure to review in a timely manner, get some orders in sooner to others has put pressure on the supply chain. Again my opinion.

Gile_na_gile

Wolf359f wrote: »

And they made the EU aware before it's even approved and not a week before their first delivery was due, like some other company!

A second EU official, also involved in talks with vaccine makers, said the bloc was trying to boost industrial capacity to bottle more shots in the EU, as part of plans to smooth out J&J deliveries.

At least there are efforts underway from Eurogov to fix our supply lines now, so it should pay off in Q2 and beyond.