COVID-19: Vaccine/antidote and testing procedures Megathread [Mod Warning - Post #1]

CIARAN_BOYLE

manofwisdom wrote: »

When do you reckon it will rollout in Ireland. A matter of wait and see with England first or ploughing ahead regardless?

European medical agency says it will make a decision whether to approve before 29 December.

Gael23

ACitizenErased wrote: »

Massive news from the UK today. The beginning of the end - happy Wednesday.

While we await an action plan to be then signed off by a dozen managers in the HSE before we even think about vaccinating anyone

mean gene

ACitizenErased wrote: »

I would say first week in January

any link to this exclusive

drunkmonkey

Deleted User wrote: »

It has been mentioned many times, and ignored many times. What people need to understand is in the absence of such a scheme we would either have had an incredibly expensive vaccine or a very slow vaccine development.

The indemnity doesn't effect the speed of the vaccine development as it's already here unless you're saying it wouldn't have been developed as quick if manufacturers had to guarantee it.
It could still turn out to be a very expensive vaccine as we are not being told the cost estimate of the indemnity it's a secret apparently.

Government are sending a massage that they will stand over someone else's product to inspire confidence in the public, I think it has the opposite effect it's the indemnity pharma companies have been given is worrying some people.

brisan

marno21 wrote: »

If we have 1 million of the most vulnerable vaccinated this becomes a completely different kettle of fish. The hospitalisation rate will be well under 1% and by March we will hopefully be able deploy the Oxford vaccine which won’t have the scarcity issue.

I hope they are getting ready for a mass vaccination of less at risk groups at the end of Q1, early Q2 with Oxford and maybe J&J which will have bigger supply. We’ll have this killed by the middle/end of Q2 then.

All dependent on the HSE not messing up the rollout which they will
Even McSharry on the tonight show said we have to get this right ,he knows if there is a way to screw this up the HSE will find it and he is worried for FFs future

drunkmonkey

drunkmonkey wrote: »

The indemnity doesn't effect the speed of the vaccine development as it's already here unless you're saying it wouldn't have been developed as quick if manufacturers had to guarantee it.
It could still turn out to be a very expensive vaccine as we are not being told the cost estimate of the indemnity it's a secret apparently.

Government are sending a massage that they will stand over someone else's product to inspire confidence in the public, I think it has the opposite effect it's the indemnity pharma companies have been given is worrying some people.

Its standard.

Dempo1

ACitizenErased wrote: »

Massive news from the UK today. The beginning of the end - happy Wednesday.

I'm all for the vaccine but am a little perturbed at the UK"s seemingly rushed decision on this and the UKs appalling handling of the Pandemic to date makes me even more concerned.

I don't fully understand the process regarding approval but am I incorrect in assuming not all data has infact been released? The FDA have yet to approve or the European medicines agency (albeit that may be down to boards meeting). I guess I've two concerns.

A. What Data have the UK agency recieved that seemingly no one else has

B. I'm genuinely concerned that this appears a rushed, first past the post decision.

I'm not questioning the abilities of the UK agency that has approved this, just wondering what I'm missing here.

ixoy

CIARAN_BOYLE wrote: »

2. Reductions in hospitalisations and deaths (while this should follow from #1 it doesn't necessarily and no trial has a large enough sample group to say one way or the other)

Moderna are claiming 100% reduction in severe Covid-19, including older age groups, which should certainly reduce hospitalisation / deaths.

brisan

Deleted User wrote: »

For Pfizer and Moderna, it might need special centres/teams to get it done. Astra Zeneca can be done via pharmacies and GPs, like the flu jab.

Croke Park ,The Aviva ,The RDS ,IKC exhibition centre ,3 Arena ,numerous other big venues around the country
The will and the ability to do has to be there though
Arm to co-ordinate and provide personnel and medical staff to do vaccinations
Drive in ,arm out the window get jabbed and drive out .
All paperwork done beforehand
It can be done for testing ,why not for vaccinations

CruelSummer

[Deleted User] wrote: »

It has been mentioned many times, and ignored many times. What people need to understand is in the absence of such a scheme we would either have had an incredibly expensive vaccine or a very slow vaccine development. It also does not absolve manufacturers from adhering to standard safety protocols or deliberately covering up or hiding potential issues

I still don’t think this cost should fall to the Irish taxpayer. It should fall to an EU body set up for this purpose. Our public finances are far too vulnerable at the moment.

brisan

Hmmzis wrote: »

Even with the full/full AZ/Oxford one you should be grand at 14 days after your 2nd dose. Just stay away from nursing homes if infection prevalence is high in the community.

Plus stay away from hospitals
Nursing homes and hospitals are the two setting where you are most likely to catch covid

Sheep2020

ixoy wrote: »

Moderna are claiming 100% reduction in severe Covid-19, including older age groups, which should certainly reduce hospitalisation / deaths.

As long as you dont get Covid before 40 days or straight away?

Bit confused on that

You have to get the 2 injections and 14 days after your body is 100% at its best

What happens if you encounter Covid a few days after 1st injection

Lower than 90% efficacy then?

Miccoli

Hopefully the beginning of the end now. Anyone know the reasons as to why the EU is so slow to approve compared to UK?

ixoy

CruelSummer wrote: »

I still don’t think this cost should fall to the Irish taxpayer. It should fall to an EU body set up for this purpose. Our public finances are far too vulnerable at the moment.

We're an net contributor to the EU now, so we'd be paying for it even then - it'd just be masked a bit more. Possibly also down a bit to the legislative differences in other countries.

Anyway, every EU country has vulnerable pubic finances right now.

Russman

Dempo1 wrote: »

I'm all for the vaccine but am a little perturbed at the UK"s seemingly rushed decision on this and the UKs appalling handling of the Pandemic to date makes me even more concerned.

I don't fully understand the process regarding approval but am I incorrect in assuming not all data has infact been released? The FDA have yet to approve or the European medicines agency (albeit that may be down to boards meeting). I guess I've two concerns.

A. What Data have the UK agency recieved that seemingly no one else has

B. I'm genuinely concerned that this appears a rushed, first past the post decision.

I'm not questioning the abilities of the UK agency that has approved this, just wondering what I'm missing here.

I think some people were saying that they (the people commenting) hadn't seen the data. I'd guess everything the companies have has been submitted to the regulators, who are the ones that really matter rather than joe public or professor XYZ on TV. That's from my very limited understanding of it anyway.

There's possibly an element of the UK wanting to "one up" Europe alright, but sure, let them at it.

JMNolan

Dempo1 wrote: »

I'm not questioning the abilities of the UK agency that has approved this, just wondering what I'm missing here.

You're missing a lot of data that the independent Medicines and Healthcare products Regulatory Agency have. Not sure why then you think it's rushed if you are missing all the data they have.

stephenjmcd

MHRA holding a briefing at 10am, the last one a few weeks ago was very informative. Would expect this one to be the same.

hmmm

All the main regulators have been shadowing the big trials e.g. EMA have been reviewing the data from Pfizer formally since October (https://www.ema.europa.eu/en/news/ema-starts-second-rolling-review-covid-19-vaccine). It's going to take a bit of time to review the formal submissions they have received which are going to be hefty data dumps from the drugs companies and the independent drug trial boards, but its very unlikely there are any show-stoppers in the data submissions which no-one has spotted until now. It all still has to be read and reviewed, and I'm assuming the EMA is a bit slower just because multiple countries are involved. There's nothing stopping the Irish regulator doing what the UK has done and decide to approve for themselves earlier.

These approvals are also not approval for wide-scale use. These approvals will be limited to certain high-risk groups where the regulators are happy that the risk from Covid exceeds any concern about the vaccine. If you're working in an ICU now with Covid patients, I'm sure most would like to get some protection as you are putting yourself in danger every day.

Wider approval for people who are not in high-risk groups will be a bit away yet.

CIARAN_BOYLE

ixoy wrote: »

Moderna are claiming 100% reduction in severe Covid-19, including older age groups, which should certainly reduce hospitalisation / deaths.

Its certainly positive but the numbers are tiny.

11 with symptoms got the vaccine.

I hope it reduces severe symptoms. They would need a lot more cases to say for sure. If we randomly took 11 people with symptoms would we find one with severe symptoms?

I dont know. Would we be 95% confident of finding one person if we took a group of 11 people with symptoms.

Definitely not.

Its promising but it could be chance.

timsey tiger

mean gene wrote: »

any link to this exclusive

Citizen said, "I would say ..." In english this means that he is giving his opinion.

BrianD3

Massive news indeed from the UK. There are surely major political implications from this given the media reports that the EMA will meet re: Pfizer "by the" 29th December. Usually that would mean "on the 29th and no earlier" but given what the British have done things may be different

If this vaccine isn't approved by EMA (well) before the 29th, Brexit will have been justified in the eyes of many and there could be lot of anger among EU citizens. Pressure from the Germans who seem to be at an advanced stage of preparation for rollout. If approval happens well before the 29th where does that leave us and our "taskforce"

OTOH if the EMA meeting is brought forward there will be accusations of rushing the approval and reacting to what the British have done.

hmmm

BrianD3 wrote: »

OTOH if the EMA meeting is brought forward there will be accusations of rushing the approval and reacting to what the British have done.

My back of the envelope calc is that there is about 4-5,000 Covid deaths a day in Europe at the moment, say 30,000 a week. If you're a regulator right now every single day matters when you are reviewing a potential vaccine. I expect them to take as long as they need and only as long as they need.

drunkmonkey

Deleted User wrote: »

Its standard.

It's not standard, it's the new normal for these vaccines, it's certainly not the standard before now.

A wait and see approach would be prudent, we'll know in a couple of months when millions have had it. If the UK are two months ahead of us what harm it's not like normal will be coming straight back for anyone that gets it right now.

ixoy

BrianD3 wrote: »

OTOH if the EMA meeting is brought forward there will be accusations of rushing the approval and reacting to what the British have done.

They're damned if they do and damned if they don't. For some people it'll always be rushed and others not rushed out fast enough. Some will want detailed assurance as to why it's approved (even if they wouldn't necessarily understand the science and process of it), others will put full faith in the manufacturers.

The only real issue is, once EMA approved it, how fast your own country can push it out. Which is where many of us have little faith in the HSE.

drunkmonkey

drunkmonkey wrote: »

It's not standard, it's the new normal for these vaccines, it's certainly not the standard before now.

It has been the standard since the 80s.

drunkmonkey

Hardyn wrote: »

It has been the standard since the 80s.

We indemnify manufacturers with new drugs? How much has the swine flu vaccine cost the state, we've got this wrong before.

Gael23

Fianna Fáil will be remembered as the party that screwed up if they let the HSE get this wrong so there should be massive political pressure and input for them to do it right

Turtwig

We'll know pretty quickly now if it doesn't actually work once they start vaccinating vulnerable groups.

drunkmonkey

drunkmonkey wrote: »

We indemnify manufacturers with new drugs? How much has the swine flu vaccine cost the state, we've got this wrong before.

If the swine flu vaccine had gone fully through the courts over a number of years with the manufacturers fighting it all the way, they would have been exonerated as the rates of adverse events was no higher than would have been expected had they just had the swine flu. What the indemnity does is bypass the requirement for years of litigation as every small illness occurring post vaccine become a potential expensive case irrespective of whether it was casued by the vaccine. This saves money in the long run as the state was run redress schems that address the specific cases caused by the vaccine, rather the the cost being factored into the initial price.

I dont know why there is a want in some quarters to find issues where none exist

stephenjmcd

drunkmonkey wrote: »

It's not standard, it's the new normal for these vaccines, it's certainly not the standard before now.

A wait and see approach would be prudent, we'll know in a couple of months when millions have had it. If the UK are two months ahead of us what harm it's not like normal will be coming straight back for anyone that gets it right now.

Indemnity agreements always have been part of vaccine contracts. Its standard for years, do a bit of research.

You want an affordable vaccine you provide indemity to a certain level.