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

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.

Mitch Connor

Turtwig wrote: »

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

i worry that we won't know quickly enough for some, and in the absence of improvements a certain type of person will jump on the lack of info as proof the vaccines are a con.

If the first dose was given on Jan 1st, I believe there needs to be a couple of weeks til the second dose, and then there is a time lag to when the vaccine is considered effective. So you are looking at Feb, maybe, before you would even begin to see an impact of the vaccine. But I fear you will have people screaming in mid-January if the numbers are dramatically improving and using it as 'proof' of them being right in their anti-vax views.

Turtwig

ixoy wrote: »

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.

Our public health immunisation programs so far have been pretty good. Don't see why this one should be a catastrophe. It'll be a challenge. Biggest way any country can fck this up is by too much political and administrative interference. Let the people who've handled these programmes in the past, mistakes included, do what they have the most relevant experience in doing.

Sweet.Science

Mitch Connor wrote: »

i worry that we won't know quickly enough for some, and in the absence of improvements a certain type of person will jump on the lack of info as proof the vaccines are a con.

If the first dose was given on Jan 1st, I believe there needs to be a couple of weeks til the second dose, and then there is a time lag to when the vaccine is considered effective. So you are looking at Feb, maybe, before you would even begin to see an impact of the vaccine. But I fear you will have people screaming in mid-January if the numbers are dramatically improving and using it as 'proof' of them being right in their anti-vax views.

I would predict Covid wont be reported as it now. Daily cases deaths etc

UK have 800k doses next week and up to 10m by end of year, 1.4m NHS staff could all have first dose by Christmas if those numbers hold up.

stephenjmcd

stephenjmcd wrote: »

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.

Without such agreements we'd probably have no vaccines at all.

lbj666

Copy and Paste from the Guardian

European countries were on Tuesday given a clear timeframe for the start of their vaccination programmes after the EU’s medicines regulator said it would decide by 29 December whether to grant emergency approval for the first Covid-19 jabs, AFP reports.

France plans to prioritise the most fragile and exposed groups in early 2021, followed by a second campaign for the rest of the population between April and June, the president Emmanuel Macron announced.

Germany has already said it is hoping to launch its immunisation drive in the first quarter of 2021 and is preparing vaccination centres across the country.

The European Medicines Agency (EMA) said it would hold an extraordinary meeting on 29 December “at the latest” to consider emergency approval for a vaccine developed by Germany’s BioNTech and US giant Pfizer.

Hopes that shots could be ready for use by the end of this year received a boost when US firm Moderna said it was filing Monday for emergency authorisation of its vaccine in the United States and Europe.

The EMA said it would hold a separate meeting to assess that request by 12 January at the latest.

Large-scale trial data released last month showed that both vaccines were safe and around 95 percent effective against Covid-19.

European Commission spokesman Stefan de Keersmaecker told reporters that once the EMA gave regulatory permission, formal authorisation from Brussels would follow “very quickly”, probably “in a matter of days”.

drunkmonkey

stephenjmcd wrote: »

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

People want a safe vaccine the manufacturer will stand over. Asking for a state guarantee against possible litigation doesn't inspire confidence.

If we had a poll and asked will you pay €20 for a vaccine with a state guarantee or €200 for a vaccine with a manufacturer guarantee I'm not convinced the majority will choose the cheap shot.

AdamD

drunkmonkey wrote: »

People want a safe vaccine the manufacturer will stand over. Asking for a state guarantee against possible litigation doesn't inspire confidence.

If we had a poll and asked will you pay €20 for a vaccine with a state guarantee or €200 for a vaccine with a manufacturer guarantee I'm not convinced the majority will choose the cheap shot.

I don't even know where to begin with this. Whoever's guaranteeing the vaccine doesn't change what's being put into your arm, you realise that right?

stephenjmcd

drunkmonkey wrote: »

People want a safe vaccine the manufacturer will stand over. Asking for a state guarantee against possible litigation doesn't inspire confidence.

If we had a poll and asked will you pay €20 for a vaccine with a state guarantee or €200 for a vaccine with a manufacturer guarantee I'm not convinced the majority will choose the cheap shot.

Fair play pick out one line of the reply and single that out for your reply. You've really no argument here so I'm not sure what's so difficult to understand.

Providing indemnity doesn't infer that its not safe.

Of course the manufacturer stands over it, so you understand how business works ?? EU: We want a supply agreement at say €20 a dose. Manufacturer: Its €50 per dose. Middle ground reached say €30 per dose in return you cover x amount of legal costs in the unlikely event they occur. Deal, everyone gets what they want and doesn't change what's going into your arm.

This is nothing new for contracts for any vaccines. You really are taking this completely out of context. I'd bet with high certainty that any vaccine you've ever taken has had indemity included in its supply contract to a certain level.

Sweet.Science

People are going to be so miserable when these vaccines take affect and things return to normal

boetstark

ixoy wrote: »

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.

No faith whatsoever. They don't even know where vaccination will be administered. Most other countries have work commenced. Jersey channel Islands will have Fort Regent ready by next week for vaccinating the island population.
We have local politicians here in limerick discussing how best to decorate the city for a bloody hurley match. Getting priorities right.....

stephenjmcd

UK briefing on now, informative as usual. Would be great to see something similar here down the line.

Once again running through the development process

stephenjmcd

UK approval is for all adults aged 16 and over.

JDD

I do think that the UK decision to approve Pfizer vaccine for mass rollout will put some pressure on the EMA to come to a decision sooner than 29 December. How could it not? No matter what you do here, it's a lose lose situation for the EMA and the EU.

If they call their EGM for say, 18 December, and approve the vaccine, people will say that the EU regulators cut corners on their review in order to not look bad in comparison to the UK. If they wait until 29 December, and then EU countries only start rolling out the vaccine in early January, some clever folk will work out how many health care workers and vulnerable died in EU as opposed to the UK in the 3/4 weeks between the two approvals. The UK will certainly market that as a massive benefit of Brexit for British people.

The only way the EMA come out of this smelling of roses is if, in fact, they find issues with the Pfizer vaccine and don't approve it by year end. The critics will then round on the UK and start asking questions about their approval. But that scenario is so so so unlikely.

It seems that the UK regulator and the EMA weren't communicating that closely. If they were, and the EMA knew that the UK approval would be this early in December, they could have been more vague on their dates for decision and given themselves a little flexibility.

That being said, I do hope the EMA close their ears and carry out their review in the way that they had planned to do. Ultimately it will lead to increased trust in their review and won't feed into the "rushed" vaccine narrative. I mean, there is people that will believe this vaccine is rushed no matter whether the EMA come out with their decision tomorrow or on 29 December, but you don't want to be adding any more fuel to the fire.

stephenjmcd

JDD wrote: »

I do think that the UK decision to approve Pfizer vaccine for mass rollout will put some pressure on the EMA to come to a decision sooner than 29 December. How could it not? No matter what you do here, it's a lose lose situation for the EMA and the EU.

If they call their EGM for say, 18 December, and approve the vaccine, people will say that the EU regulators cut corners on their review in order to not look bad in comparison to the UK. If they wait until 29 December, and then EU countries only start rolling out the vaccine in early January, some clever folk will work out how many health care workers and vulnerable died in EU as opposed to the UK in the 3/4 weeks between the two approvals. The UK will certainly market that as a massive benefit of Brexit for British people.

The only way the EMA come out of this smelling of roses is if, in fact, they find issues with the Pfizer vaccine and don't approve it by year end. The critics will then round on the UK and start asking questions about their approval. But that scenario is so so so unlikely.

It seems that the UK regulator and the EMA weren't communicating that closely. If they were, and the EMA knew that the UK approval would be this early in December, they could have been more vague on their dates for decision and given themselves a little flexibility.

That being said, I do hope the EMA close their ears and carry out their review in the way that they had planned to do. Ultimately it will lead to increased trust in their review and won't feed into the "rushed" vaccine narrative. I mean, there is people that will believe this vaccine is rushed no matter whether the EMA come out with their decision tomorrow or on 29 December, but you don't want to be adding any more fuel to the fire.

Bottom line for EMA with regards to timeline is Pfizer only applied this week. It takes time now to go over the full submission now.

stephenjmcd

UK prioritisation list for rollout

funnydoggy

They're starting rollout next week. Great news.

The HSE must be mortified.

stephenjmcd

funnydoggy wrote: »

The HSE must be mortified.

Why would they be ?

funnydoggy

stephenjmcd wrote: »

Why would they be ?

Not being serious, just messing around

ixoy

I can imagine the HSE cogging from the NHS's list and applying a colour scheme to it so they won't appear to be copying their neighbour's homework.

stephenjmcd

funnydoggy wrote: »

Not being serious, just messing around

Ah no worries. Hard to tell given the way some people seem to be now complaining that we're too slow despite EMA only getting the submission this week.

Light at the end of the tunnel either way.

funnydoggy

stephenjmcd wrote: »

Ah no worries. Hard to tell given the way some people seem to be now complaining that we're too slow despite EMA only getting the submission this week.

Light at the end of the tunnel either way.

Roll on handshakes and hugs

lbj666

JDD wrote: »

I do think that the UK decision to approve Pfizer vaccine for mass rollout will put some pressure on the EMA to come to a decision sooner than 29 December. How could it not? No matter what you do here, it's a lose lose situation for the EMA and the EU.

If they call their EGM for say, 18 December, and approve the vaccine, people will say that the EU regulators cut corners on their review in order to not look bad in comparison to the UK. If they wait until 29 December, and then EU countries only start rolling out the vaccine in early January, some clever folk will work out how many health care workers and vulnerable died in EU as opposed to the UK in the 3/4 weeks between the two approvals. The UK will certainly market that as a massive benefit of Brexit for British people.

The only way the EMA come out of this smelling of roses is if, in fact, they find issues with the Pfizer vaccine and don't approve it by year end. The critics will then round on the UK and start asking questions about their approval. But that scenario is so so so unlikely.

It seems that the UK regulator and the EMA weren't communicating that closely. If they were, and the EMA knew that the UK approval would be this early in December, they could have been more vague on their dates for decision and given themselves a little flexibility.

That being said, I do hope the EMA close their ears and carry out their review in the way that they had planned to do. Ultimately it will lead to increased trust in their review and won't feed into the "rushed" vaccine narrative. I mean, there is people that will believe this vaccine is rushed no matter whether the EMA come out with their decision tomorrow or on 29 December, but you don't want to be adding any more fuel to the fire.

You got to hope that the EU and EMA are above any such petulant politicizing of the timelines but will do what they need to do properly but in an urgent manner. Let the UK have their little win, its one thing to have it approved, its another to have it rolled out fast as they are saying. Wouldnt be surprised if they have the cameras out next week with film a few nurses getting their jabs, just to say they have started, but then actual not see it fully ramp up until a few weeks later.

As for the 3/4 week difference and its impact on deaths in UK vs anywhere, its not that easy to demonstrate given that UK have consistently had one of the higher incidence rates in europe and different countries in europe differ quiet. Who knows what tides these rollouts will have to row again when incidence level rise after xmas.

The Germans as an example seem very ready to go full steam ahead in January and it wouldnt surprise me if they passed the UK not long after.

seamie78

the 29th is the latest date, could be much sooner. id expect approval middle of the month possibly in line with the taskforces plan

Gael23

That list is not very clear. Do people with serious health conditions but who are not terribly ill fall into point 6?

funnydoggy

December flies by. We'll be knee deep in vaccine soon.

brisan

Gael23 wrote: »

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

The HSE mandarins were in power before this Gov were elected and they will still be in position after this Gov has gone
The HSE has a long record of failure and I can see nothing but problems with the roll out of this vaccination plan

brisan

lbj666 wrote: »

Copy and Paste from the Guardian

European countries were on Tuesday given a clear timeframe for the start of their vaccination programmes after the EU’s medicines regulator said it would decide by 29 December whether to grant emergency approval for the first Covid-19 jabs, AFP reports.

France plans to prioritise the most fragile and exposed groups in early 2021, followed by a second campaign for the rest of the population between April and June, the president Emmanuel Macron announced.

Germany has already said it is hoping to launch its immunisation drive in the first quarter of 2021 and is preparing vaccination centres across the country.

The European Medicines Agency (EMA) said it would hold an extraordinary meeting on 29 December “at the latest” to consider emergency approval for a vaccine developed by Germany’s BioNTech and US giant Pfizer.

Hopes that shots could be ready for use by the end of this year received a boost when US firm Moderna said it was filing Monday for emergency authorisation of its vaccine in the United States and Europe.

The EMA said it would hold a separate meeting to assess that request by 12 January at the latest.

Large-scale trial data released last month showed that both vaccines were safe and around 95 percent effective against Covid-19.

European Commission spokesman Stefan de Keersmaecker told reporters that once the EMA gave regulatory permission, formal authorisation from Brussels would follow “very quickly”, probably “in a matter of days”.

Meanwhile we are having meetings

ixoy

ixoy wrote: »

I can imagine the HSE cogging from the NHS's list and applying a colour scheme to it so they won't appear to be copying their neighbour's homework.

One thing I would say the UK have been telling trusts and hospitals to "get ready" for months now. HSE don't appear to have done that yet. 50 UK hospitals have the freezers needed, they have rejigged some of the Nightingale locations. Not saying it's going to be perfectly smooth, but the groundwork is visible. If the HSE are doing stuff in the background, great, but it'd be nice to see the work a little.

Gael23

brisan wrote: »

The HSE mandarins were in power before this Gov were elected and they will still be in position after this Gov has gone
The HSE has a long record of failure and I can see nothing but problems with the roll out of this vaccination plan

Your right but it’s the government that will get the bashing if it goes wrong so it’s up to them to intervene at the highest level to get it right

brisan

Deleted User wrote: »

One thing I would say the UK have been telling trusts and hospitals to "get ready" for months now. HSE don't appear to have done that yet. 50 UK hospitals have the freezers needed, they have rejigged some of the Nightingale locations. Not saying it's going to be perfectly smooth, but the groundwork is visible. If the HSE are doing stuff in the background, great, but it'd be nice to see the work a little.

They are having meetings, what more do you want
You would hardly expect them to have contracts with Croke Park ,The Aviva ,The IKC , The 3 arena and other big venues around the country in place would you .
Did you expect them to be in touch with the army and Civil defence for logistics and manpower at this early stage
They have only known about the possibility of vaccines for a few months at this stage ,give them time and paperwork
Although to be fair they have an agreement with the IKC on the National show centre until July 2021

wadacrack

Vaccination beginning in Northern Ire next week.

https://twitter.com/derryjournal/status/1334089038085693440

brisan

Gael23 wrote: »

Your right but it’s the government that will get the bashing if it goes wrong so it’s up to them to intervene at the highest level to get it right

Do you honestly think the HSE takes a blind bit of notice of the Government of the day
They know there will be another Government in a couple of years
I personally knew the head man in Beaumont hospital (knew him since age 11 ) ,some of the stories he told were incredulous about ineffiency and waste

opinionated3

Alok Sharma almost trying to paint this as a victory for Brexit and that Britain leads the way for exiting the pandemic. Deposit the fact that the vaccine is developed by a German company. Hancock saying it's because of Brexit that they were able to accelerate distribution. My god.

drunkmonkey

stephenjmcd wrote: »

UK prioritisation list for rollout

Do we know what percentage of the population that will cover?

MrMusician18

Mark1916 wrote: »

https://t.co/X6S4ED2XWN

Covid-19 vaccine from Pfizer/BioNTech has been approved by Britain's Medicines and Healthcare products Regulatory Agency (MHRA) and is expected to be made available from next week

What I'm a bit confused by is that the FDA are not the first or of the blocks here.

You would expect that the largest, most well resourced regulators would be first. This definitely smells political.

brisan

brisan wrote: »

Do you honestly think the HSE takes a blind bit of notice of the Government of the day
They know there will be another Government in a couple of years
I personally knew the head man in Beaumont hospital (knew him since age 11 ) ,some of the stories he told were incredulous about ineffiency and waste

The stories themselves were incredulous? How did the stories relay their incredulity?

Also, the head man in Beaumont is kind of responsible for the waste, so maybe it should have been you who were incredulous at him basically telling stories decrying waste in the system, when he was the individual responsible

timsey tiger

drunkmonkey wrote: »

People want a safe vaccine the manufacturer will stand over. Asking for a state guarantee against possible litigation doesn't inspire confidence.

If we had a poll and asked will you pay €20 for a vaccine with a state guarantee or €200 for a vaccine with a manufacturer guarantee I'm not convinced the majority will choose the cheap shot.

Manifacturer, wouldn't be standing over it anyway, some insurance company would. They are happy with the risk all they do is load on the premiums, which is then passed on to the public aka. the government.

So instead of indemnifying the risk very likely to be free, we'd just end up fueling massive profits to the insurance sector at the cost to the state.

So well done giving €180 to an insurance company for something that costs €20.

drunkmonkey

drunkmonkey wrote: »

Do we know what percentage of the population that will cover?

In total it's 28 million over 50 in the UK.

The first 2 groups, care homes, health staff and everyone over 80 is 6 million, with expected uptake and supply no reason that can't be done by end January.

It's about another 14m over 60 including high and moderate risk under 65. That uses up all their Pfizer doses.

Micky 32

stephenjmcd wrote: »

Light at the end of the tunnel either way.

Aye, to think we had the experts on here with the “ There won’t be a vaccine” a few weeks back