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

ACitizenErased

Bild are reporting that the German Health Ministry and Merkel have told the EMA to hurry up basically

brisan

Deleted User wrote: »

No, but I'm guessing the hope with this would be it might be one to use on young people and possibly eventually achieve eradication of the virus. These vaccine types tend to give long term protection for other viruses.

Given it's only just starting out I don't think it will play any part in ending the pandemic but might be a useful tool long term.

If successful it would certainly be a gamechanger for vaccinating children and mass vaccinations in poorer countries

Mitch Connor

brisan wrote: »

And once the vaccine is approved (something they have no control over )they will roll it out within 48 hrs
MM saying we will roll out the week ,yes the week after approval
God forbid someone in the HSE should have to cut short their Christmas holidays

If it is approved on the 23rd, I can't see their being massive appetite to start vaccines on the 25th. or the Saturday 26, Sunday 27th. Monday 28th seems reasonable, imo. Which would be the week after.

ACitizenErased

BILD article for those who can read German https://www.bild.de/politik/2020/politik/exklusiv-impfstoff-zulassung-noch-am-23-dezember-74471126.bild.html

Marhay70

ACitizenErased wrote: »

Here's the report, citing Bild (German newspaper)
https://medicalxpress.com/news/2020-12-germany-eu-vaccine.html

Well that's not exactly to say that it will be approved on 23rd.
I'd love to know what exactly the EMA need to know that's different from the US or Singapore or Canada. Early on I was inclined to think , " well they're being thorough" but now I'm thinking "get the finger out"

brisan

Dickie10 wrote: »

why on earth do they come out with things like that? like i have this knawing feeling that the medical people have this fantasy world they would like society to be like. What would a medics social life be like n this fantasy world? what would people do for fun?

Read the Lancet while playing with their concernometers

Deenie78

I'm as hesitant as the next person is about how the HSE are going to manage this, however I think its a bit of a waste of energy and headspace to get frustrated and annoyed about the potential disaster this is going to be. As I understand it there was a few unknowns about these vaccines until recently so for example putting a plan in place for the elderly and vulnerable first, throwing lots of resources at that and then discovering it wasn't suitable for them could have been a waste of time.

Also, there isn't an actual vaccine available yet, so we're complaining about being behind when we're not actually in a position to start yet.

Don't get me wrong, I agree they should have had some sort of plan before now (and perhaps they did) but maybe we wait to see what the actual plan is today, then see when the vaccines become available and if at that point we are lagging behind or making a mess of it then by all means it should be open season on the HSE, etc.
(Just to mention I am desperate for this vaccine to become available, I have a really vulnerable Dad who would like to get back to seeing his kids and grandkids while he still can)

brisan

leahyl wrote: »

I honestly think they are just being cautious so that when most people are vaccinated by late April they can say “we are ahead of schedule”! Hopefully...! :-P

Have you lived in Ireland long or ever had reason to interact with the HSE

ixoy

ACitizenErased wrote: »

BILD article for those who can read German https://www.bild.de/politik/2020/politik/exklusiv-impfstoff-zulassung-noch-am-23-dezember-74471126.bild.html

Google Translate tells me that it needs the Irish Emer Cooke, head of the EMA, to get this across the line.

schmoo2k

leahyl wrote: »

Like, I’m curious, was this always the way it was going to be, that we will still need restrictions even after most people are vaccinated because if so, what is the point of the vaccine??! This is what I just don’t understand! It’s like some medical professionals want it to keep going; depressing stuff

The earliest we will see restrictions lifting will be once the high risk folks have had their vaccines and hospital numbers have dropped. Could be as soon as early Feb...

is_that_so

CIARAN_BOYLE wrote: »

No date in that quote.

He could mean christmas 2021 there for all you know.

It's a good call at this point not to put dates on it and it's the political message that is absolutely key as NPHET will just say it like it is in that blunt approach of theirs.

is_that_so

schmoo2k wrote: »

The earliest we will see restrictions lifting will be once the high risk folks have had their vaccines and hospital numbers have dropped. Could be as soon as early Feb...

Not if, as claimed, we will have limited supplies of vaccines for a few months. March or April are probably more realistic.

brisan

seamus wrote: »

Early Summer would be considerably ahead of schedule. Most western countries aren't expecting effective 100% coverage before the end of 2021.

What you might have heard is that the main priority groups will be done by early Summer.

There are two things going on here;

- "The vaccine is not the end of Covid" means that the start of vaccinations does not mean the end of restrictions. We will still be working with level 3-5 restrictions for 8-16 weeks after vaccinations start. They're trying to get it into peoples' heads that vaccine approval doesn't mean binning the masks and having granny over for a party.

- "We will still have restrictions until <some far off date>" is sand-bagging for the most part. We can make educated guesses at where we will be as the year progresses, but politicians are wary of over-promising. If you tell people you expect to be near the end of restrictions in May, then you'll be crucified if something unexpected happens and you still have restrictions in August. Instead, tell people it could be July and they'll be glad when it's May.
I would hope so. When you go into a hospital it is dead simple and no effort at all to sanitise your hands as you move through it.
There's no reason we can't do the same in every building on an ongoing basis. Why wouldn't you?

Have you any links to back up the piece in bold ??

ACitizenErased

ixoy wrote: »

Google Translate tells me that it needs the Irish Emer Cooke, head of the EMA, to get this across the line.

I'm shocked that an Irish person's taking their time

brisan

Irish Stones wrote: »

Italy is planning to make the vaccine mandatory, so it won't matter whether people bother or not. If other European countries follow the example, there will be no big issue.

Not questioning the statement ,but is that actually legal
Posters on here saying it not legally possible

is_that_so

Deenie78 wrote: »

I'm as hesitant as the next person is about how the HSE are going to manage this, however I think its a bit of a waste of energy and headspace to get frustrated and annoyed about the potential disaster this is going to be. As I understand it there was a few unknowns about these vaccines until recently so for example putting a plan in place for the elderly and vulnerable first, throwing lots of resources at that and then discovering it wasn't suitable for them could have been a waste of time.

Also, there isn't an actual vaccine available yet, so we're complaining about being behind when we're not actually in a position to start yet.

Don't get me wrong, I agree they should have had some sort of plan before now (and perhaps they did) but maybe we wait to see what the actual plan is today, then see when the vaccines become available and if at that point we are lagging behind or making a mess of it then by all means it should be open season on the HSE, etc.
(Just to mention I am desperate for this vaccine to become available, I have a really vulnerable Dad who would like to get back to seeing his kids and grandkids while he still can)

They organise flu' vaccines perfectly well every year, this year over 1m of them. It won't be a challenge until we get to the much larger numbers of general population. That's likely to be around summertime.

Marhay70

ixoy wrote: »

Google Translate tells me that it needs the Irish Emer Cooke, head of the EMA, to get this across the line.

That would suggest it's an admin decision rather than a clinical decision, again not an ideal situation.
My vision of the EMA approval would be a panel of top doctors and scientists assessing the findings and passing judgement on the findings.

is_that_so

brisan wrote: »

Not questioning the statement ,but is that actually legal
Posters on here saying it not legally possible

They already do it.

Vaccines against the following diseases are mandatory for Italian schoolchildren: polio, diphtheria, tetanus, hepatitis B, haemophilus influenzae B, measles, mumps, rubella, whooping cough, and chickenpox.

brisan

Mitch Connor wrote: »

If it is approved on the 23rd, I can't see their being massive appetite to start vaccines on the 25th. or the Saturday 26, Sunday 27th. Monday 28th seems reasonable, imo. Which would be the week after.

Do you honestly think elderly vulnerable people in care homes who have had no visitors for months ,or HCW who are at work would have an issue getting vaccinated on Christmas day

CIARAN_BOYLE

is_that_so wrote: »

It's a good call at this point not to put dates on it and it's the political message that is absolutely key as NPHET will just say it like it is in that blunt approach of theirs.

I'm reading the NPHET line

The vaccine wont get us back to normal until the majority of the country has been vaccinated

although I admit the italicised section is something I am adding in myself.

braychelsea

Marhay70 wrote: »

Well that's not exactly to say that it will be approved on 23rd.
I'd love to know what exactly the EMA need to know that's different from the US or Singapore or Canada. Early on I was inclined to think , " well they're being thorough" but now I'm thinking "get the finger out"

https://www.reuters.com/article/idUSKBN28P174

Irish Stones

brisan wrote: »

Not questioning the statement ,but is that actually legal
Posters on here saying it not legally possible

As far as I knew, it might be not legal, but plans are these.
Yesterday our Health Minister said that unless a good number of people is going to take the vaccine voluntarily, they will need to make it compulsory.
The last stats say that at least 30-35% of population isn't going to take the vaccine, another 15% is unsure, then there are those who already had the covid who, apparently, might be the last to take it, and those who might be exempt because of health conditions.
Only 50-60% of health workers is willing to take the vaccine, according to a very recent survey.

Mitch Connor

Marhay70 wrote: »

Well that's not exactly to say that it will be approved on 23rd.
I'd love to know what exactly the EMA need to know that's different from the US or Singapore or Canada. Early on I was inclined to think , " well they're being thorough" but now I'm thinking "get the finger out"

UK approved for Emergency Authorization.
US approved for Emergency Authorization.

I don't know about Canada or Singapore.

I would assume EMA don't approve for Emergency Authorization as that would be a country specific decison rathen than a Euro-Zone wide decision.

Ireland could approve for Emergency Authorization just as the UK did, but have decided (rightly/wrongly) to wait for EMA approval.

Marhay70

is_that_so wrote: »

They organise flu' vaccines perfectly well every year, this year over 1m of them. It won't be a challenge until we get to the much larger numbers of general population. That's likely to be around summertime.

Flu vaccine doesn't pose the same logistical problems as the Pfizer vaccine.

The HSE has presided over a multitude of cock ups since its inception, I can fully understand why people would question their ability to deal with this.

Mitch Connor

brisan wrote: »

Do you honestly think elderly vulnerable people in care homes who have had no visitors for months ,or HCW who are at work would have an issue getting vaccinated on Christmas day

I don't know. I just don't think it particularly likely.

And if they did, I reckon you'd have a co-hort of people saying it is a disgrace that they are rushing the vaccine out for Christmas day PR reasons.

brisan

is_that_so wrote: »

They already do it.

Vaccines against the following diseases are mandatory for Italian schoolchildren: polio, diphtheria, tetanus, hepatitis B, haemophilus influenzae B, measles, mumps, rubella, whooping cough, and chickenpox.

So there is no international law or Geneva ruling to stop any country in Europe (Ireland included ) from making the Covid vaccine mandatory unless on medical grounds ?
Would that be correct ?

schmoo2k

is_that_so wrote: »

Not if, as claimed, we will have limited supplies of vaccines for a few months. March or April are probably more realistic.

I was assuming the limited numbers would cover the high risk folks? Once they are vaccinated the hospital admissions and ICU numbers will be reduced significantly.

is_that_so

Marhay70 wrote: »

Well that's not exactly to say that it will be approved on 23rd.
I'd love to know what exactly the EMA need to know that's different from the US or Singapore or Canada. Early on I was inclined to think , " well they're being thorough" but now I'm thinking "get the finger out"

Their latest date for a decision was always Dec 29. Not sure why you're fussing so much about this. The EU plan is for a January start anyway on vaccinations.

is_that_so

schmoo2k wrote: »

I was assuming the limited numbers would cover the high risk folks? Once they are vaccinated the hospital admissions and ICU numbers will be reduced significantly.

I'd say so, Groups 1-4 the targets I reckon.

Marhay70

Mitch Connor wrote: »

UK approved for Emergency Authorization.
US approved for Emergency Authorization.

I don't know about Canada or Singapore.

I would assume EMA don't approve for Emergency Authorization as that would be a country specific decison rathen than a Euro-Zone wide decision.

Ireland could approve for Emergency Authorization just as the UK did, but have decided (rightly/wrongly) to wait for EMA approval.

What's to stop the EMA from approving for Emergency Authorisation for the EU and the individual countries deciding whether or not to approve for their own country? Makes more logical sense to me.

brisan

Mitch Connor wrote: »

I don't know. I just don't think it particularly likely.

And if they did, I reckon you'd have a co-hort of people saying it is a disgrace that they are rushing the vaccine out for Christmas day PR reasons.

Surely it would be health reasons and not PR reasons
Do you not think other European countries will be vaccinating on Christmas day if the Vaccine is approved before then ??

is_that_so

brisan wrote: »

So there is no international law or Geneva ruling to stop any country in Europe (Ireland included ) from making the Covid vaccine mandatory unless on medical grounds ?
Would that be correct ?

That I don't know but I've seen posters say that. Here's the ECtHR view on it.

The ECtHR has reiterated in its established case-law that the notion of ‘necessity in a democratic society’ implies a pressing social need to which the interference at stake corresponds and, in particular, that this interference is proportionate to the legitimate aim pursued

Link
https://voelkerrechtsblog.org/articles/do-compulsory-vaccinations-against-covid-19-violate-human-rights/

The Italian law makes a lot of sense in the face of big falloffs in children being vaccinated. France have something similar.

Here's a commentary on the Italian law.

https://www.eurosurveillance.org/content/10.2807/1560-7917.ES.2019.24.26.1900371

schmoo2k

CIARAN_BOYLE wrote: »

I'm reading the NPHET line

The vaccine wont get us back to normal until the majority of the country has been vaccinated

although I admit the italicised section is something I am adding in myself.

Restrictions and normality are two different things!

schmoo2k

brisan wrote: »

So there is no international law or Geneva ruling to stop any country in Europe (Ireland included ) from making the Covid vaccine mandatory unless on medical grounds ?
Would that be correct ?

What some places do is require vaccinations before children can attend school - folks still have the option to not vaccinate and home school.

hmmm

Marhay70 wrote: »

What's to stop the EMA from approving for Emergency Authorisation for the EU and the individual countries deciding whether or not to approve for their own country? Makes more logical sense to me.

From what I've read that's the plan. The EMA will sign off on it, but each individual country has their own regulator who will also need to sign off (hopefully that's just a formality). Then the EU is talking about everyone starting vaccinations on the same day - I presume that's to avoid claims of favoritism or attempts to cut corners.

brisan

is_that_so wrote: »

That I don't know but I've seen posters say that. The Italian law makes a lot of sense in the face of big falloffs in children being vaccinated. France have something similar.

Here's a commentary on the Italian law.

https://www.eurosurveillance.org/content/10.2807/1560-7917.ES.2019.24.26.1900371

Its an interesting option to have if take up is low
I can see a large group of anti vaxxers taking this all the way to the European courts
It would be good if the European courts gave a ruling on this early in the year

Marhay70

hmmm wrote: »

From what I've read that's the plan. The EMA will sign off on it, but each individual country has their own regulator who will also need to sign off (hopefully that's just a formality). Then the EU is talking about everyone starting vaccinations on the same day - I presume that's to avoid claims of favoritism or attempts to cut corners.

Yep that makes more sense to me, I was replying to someone who understood the opposite to be the case.
It makes it even harder to understand the delay in signing off though, given that equally competent authorities have done so with the same information.

Mitch Connor

Marhay70 wrote: »

What's to stop the EMA from approving for Emergency Authorisation for the EU and the individual countries deciding whether or not to approve for their own country? Makes more logical sense to me.

I don't know. But IMO it doesn't make sense that way around.

Let the countries decide emergency level (As the UK did, within the Euro framework), let EMA approve for general usage at a euro-level. That makes sense to me as a process but I've its not like I've delved into the processes.

ZX7R

Irish Stones wrote: »

Italy is planning to make the vaccine mandatory, so it won't matter whether people bother or not. If other European countries follow the example, there will be no big issue.

Italian government have back tracked on making the vaccination mandatory.
After there helth ministry carried out a survey trough SG.
A higher uptake of the vaccination will acoure if its vaccination is voluntary

CIARAN_BOYLE

Marhay70 wrote: »

What's to stop the EMA from approving for Emergency Authorisation for the EU and the individual countries deciding whether or not to approve for their own country? Makes more logical sense to me.

Pfizer didn't apply for emergency authorisation from the ema.

The UK got a cut back data packet when Pfizer applied to them. The UK also have to approve each batch separately because of this.

They applied for conditional market approval in the eu which is a higher standard with more information required.

Mitch Connor

Mitch Connor wrote: »

I don't know. But IMO it doesn't make sense that way around.

Let the countries decide emergency level (As the UK did, within the Euro framework), let EMA approve for general usage at a euro-level. That makes sense to me as a process but I've its not like I've delved into the processes.

The Irish regulator isn't well resourced enough to put in the work needed for an approval, like a lot of national regulators they do good work and contribute to the work of the EMA, but on their own don't have the expertise.

The UK regulator has 1200 staff (compared with the EMA's 900), have a lot of staff that used to be with the EMA before they moved to Holland and have been getting prepared to work off their own bat before Brexit.

Irish Stones

is_that_so wrote: »

Here's a commentary on the Italian law.

https://www.eurosurveillance.org/content/10.2807/1560-7917.ES.2019.24.26.1900371

There's little mistake in that article, nothing that diminishes the validity of the content, but just to be precise, the number of regions in Italy is 20, not 21.

Irish Stones

ZX7R wrote: »

Italian government have back tracked on making the vaccination mandatory.
After there helth ministry carried out a survey trough SG.
A higher uptake of the vaccination will acoure if its vaccination is voluntary

The statement from the health minister is from yesterday, he said "if a sufficient number of voluntary vaccinations isn't reached, we're thinking of making it mandatory"
This statement had been spoken out before, and then back tracked, and stated again. So, it is possible that they will do what they are saying.

The other statement a few days ago was that it should be mandatory for health workers.

ACitizenErased

FDA says no specific safety concerned for Moderna vaccine.
Looks like they’ll approve that one soon.

Be fairly bad if the US have 2 approved vaccines and the entire EU none tbh

AdamD

ACitizenErased wrote: »

FDA says no specific safety concerned for Moderna vaccine.
Looks like they’ll approve that one soon.

Be fairly bad if the US have 2 approved vaccines and the entire EU none tbh

Currently the UK are week 2 into rolling out the vaccine and we're still tendering (?) for the IT system we're going to use. Not great. Also they've mentioned the 29th as the date so many times our lot don't look like they'd be ready if it was pushed forward a week, despite the EU always stating it was 29th at the latest.

Obviously wait and see how we actually do it before giving out but it certainly looks like it could go wrong. The IT system etc. could have been done months ago, and I don't think that's an exagerration.

brisan

AdamD wrote: »

Currently the UK are week 2 into rolling out the vaccine and we're still tendering (?) for the IT system we're going to use. Not great. Also they've mentioned the 29th as the date so many times our lot don't look like they'd be ready if it was pushed forward a week, despite the EU always stating it was 29th at the latest.

Obviously wait and see how we actually do it before giving out but it certainly looks like it could go wrong. The IT system etc. could have been done months ago, and I don't think that's an exagerration.

The HSE knew for months that their IT systems were not fit for purpose
However to give them their due it seems as though it was only late last month that they realized a vaccination program would need to be rolled out and for that rollout they would need a plan

eigrod

EMA meeting brought forward to 21st Dec

https://twitter.com/ema_news/status/1338837357034868736?s=21

https://twitter.com/vonderleyen/status/1338836944088948738?s=21

ACitizenErased

eigrod wrote: »

EMA meeting brought forward to 21st Dec

https://twitter.com/ema_news/status/1338837357034868736?s=21

https://twitter.com/vonderleyen/status/1338836944088948738?s=21

Brilliant!!!!

cgc5483

hmmm wrote: »

From what I've read that's the plan. The EMA will sign off on it, but each individual country has their own regulator who will also need to sign off (hopefully that's just a formality). Then the EU is talking about everyone starting vaccinations on the same day - I presume that's to avoid claims of favoritism or attempts to cut corners.

The EMA issue an opinion which is then signed off by the European Commission who issue the authorisation. There is no additional sign off by the regulators in each country.

brisan

eigrod wrote: »

EMA meeting brought forward to 21st Dec

https://twitter.com/ema_news/status/1338837357034868736?s=21

https://twitter.com/vonderleyen/status/1338836944088948738?s=21

Are the British not Europeans any more ?
I sincerely hope that the HSE are ready to roll, if the EMA authorize use on the 21st or will Paul from HR be travelling home for Christmas and he has the keys to the vaccine boxes