Delays in rolling out vaccine

The Seerum (sic) Institute in India is producing AZ vaccines globally (supplying eg Australia) and seems less affected by supply issues than the newer AZ facilities in Europe.

The EMA are looking at authorising it as a facility which can export covid vaccines to EU.

I don't know if such a deal would be ok to pursue by Ireland independently with the Seerum (sic) institute or would need to come under the auspices of the EU programme - as the EU already have a contract with AZ.

If Michael Martin is talking to the head of AZ that's the kind of conversation to have, not about the supply from the EU facilities which the EU are already hammering them about.
 
odyssey06 said:
The Seerum (sic) Institute in India is producing AZ vaccines globally (supplying eg Australia) and seems less affected by supply issues than the newer AZ facilities in Europe.

The EMA are looking at authorising it as a facility which can export covid vaccines to EU.

I don't know if such a deal would be ok to pursue by Ireland independently with the Seerum (sic) institute or would need to come under the auspices of the EU programme - as the EU already have a contract with AZ.

If Michael Martin is talking to the head of AZ that's the kind of conversation to have, not about the supply from the EU facilities which the EU are already hammering them about.
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I thought I read that EU members can't do any deals with manufacturers if the EU has already entered into a contract with them.
This is how Hungary were able to deal with Russia and China directly.

Seerum (language filter)are a 3rd party but ultimately its the AZ vaccine.
My tuppence.
 
Paul O Mahoney said:
I thought I read that EU members can't do any deals with manufacturers if the EU has already entered into a contract with them.
This is how Hungary were able to deal with Russia and China directly.

************************** are a 3rd party but ultimately its the AZ vaccine.
My tuppence
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You're probably right, I was hoping there might be some wiggle room as the Seerum institute is an independent production plant not an AZ facility (if I understand the setup correctly) and could enter into its own contracts. As in the contract would be with the Seerum institute not AZ.
 
odyssey06 said:
You're probably right, I was hoping there might be some wiggle room as the Seerum institute is an independent production plant not an AZ facility (if I understand the setup correctly) and could enter into its own contracts. As in the contract would be with the Seerum institute not AZ.
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I actually thought the same until I read why Hungary were allowed to source elsewhere.
Next question is why were AZ vaccines being shipped from Italy to Australia?

India is the world's biggest vaccine producer.
 
Now a new angle the Americans have 10s of millions of AZ vaccine which they have in storage because they have not authorized it yet and are not likely to soon as they are doing more trials. Michael Martin is to be asked to get onto Joe Biden about releasing some of these to Ireland. What sort of deal did the Americans do with AZ (and this was the Trump administration remember) . Did they also get preferential treatment in comparison to the EU . Looks like even the Trump administration got the vaccine rollout right .
 
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joe sod said:
Now a new angle the Americans have 10s of millions of AZ vaccine which they have in storage because they have not authorized it yet and are not likely to soon as they are doing more trials. Michael Martin is to be asked to get onto Joe Biden about releasing some of these to Ireland. What sort of deal did the Americans do with AZ (and this was the Trump administration remember) .
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Where are you reading that about the US AZ vaccines (other than here)?
 
Paul O Mahoney said:
No mention of Brazilian variant the 55% relates to SA variant
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You're quite right.I misread it.My apologies.
Fwiw,I think we're all following developments in real time anxious for instant updates.
But the reality is when a new variant is discovered it takes time,quite a lot of time,for clinical trials and data to be gathered and analysed.
The deadly Kent variant was only really known about since around Christmas when the initial Covid vaccination programme was just beginning to get underway so to have positive data within a couple of months is remarkable.
And even I'm guilty sometimes of forgetting that to have so many viable vaccines across the world within a year of the first recorded case of Covid is a truly wonderful achievement.
The most positive news is that the vaccines we have appear to be repsonding well to each new strain that comes along.
 
johnwilliams said:
is the problem with az vaccine a problem with getting ingredients from a 3rd party?
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I read something to the effect that it takes a while to fine tune the production of the mRNA vaccines at the AZ facilities.
Lot of teething problems. It seems like a complex production process with lots that can go wrong.
But could be wrong on that.
 
odyssey06 said:
Where are you reading that about the US AZ vaccines (other than here)?
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It was on the news bulletins, 9 o clock news tonight aswell . I think the EU have got some information about AZ vaccines the US have which I think Joe Biden has been keeping quite. Actually I think this is a very good angle that the EU can exploit because can he really stay on that ground morally when they have all these vaccines that they are not actually using? If he says No then everything he said in his inauguration speech was just crap and then also why are they not using them ?
If nothing else it is a golden opportunity to take some of the heat off the european vaccine rollout and put some pressure on Joe Biden and their vaccine "selfishness"
 
odyssey06 said:
I read something to the effect that it takes a while to fine tune the production of the mRNA vaccines at the AZ facilities.
Lot of teething problems. It seems like a complex production process with lots that can go wrong.
But could be wrong on that.
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Further to this. One of the main AZ facilities named in the EU contract and based in Netherlands has not been authorized by EMA yet. It ìs producing vaccines - these may be going to UK. The article appears to suggest AZ have been slow in providing all necessary info to EMA.

EU’s AstraZeneca vaccine problems linked to mystery factory delay

Dutch facility listed in EU contract is yet to deliver a single dose to the bloc
www.ft.com www.ft.com
 
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odyssey06 said:
Further to this. One of the main AZ facilities named in the EU contract and based in Netherlands has not been authorized by EMA yet. It ìs producing vaccines - these may be going to UK. The article appears to suggest AZ have been slow in providing all necessary info to EMA.

EU’s AstraZeneca vaccine problems linked to mystery factory delay

Dutch facility listed in EU contract is yet to deliver a single dose to the bloc
www.ft.com www.ft.com
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Bizarre, it says that the plant was contracted by AZ to produce up to December. What happened after that?

If it was cleared to produce up to December surely it was validated by the EU , I mean the UK wouldn't have had jurisdiction to validate it.

If its producing without licence from the EU what quality assurance regime are they operating under?

This is weird
 
Paul O Mahoney said:
Bizarre, it says that the plant was contracted by AZ to produce up to December. What happened after that?

If it was cleared to produce up to December surely it was validated by the EU , I mean the UK wouldn't have had jurisdiction to validate it.

If its producing without licence from the EU what quality assurance regime are they operating under?

This is weird
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I think the UK authorities have approved the facility and so can accept exports from it.
The UK has approved Seerum Institute in India to receive exports of AZ from it. The EMA only seem to be starting this process now.

EMA approval hasn't been forthcoming for the Dutch facility - whether that's because they are slower at processing the paperwork, or require more paperwork than UK, or AZ are slowplaying their compliance so they can export the vaccines without breaching EU contract.
 
BioNTech Forms New Manufacturing Alliance, WSJ reports here (paywall).

- New alliance of 13 companies, including Novartis AG , Merck KGaA and Sanofi SA, in an effort to meet—and perhaps exceed—an ambitious target of making two billion doses of vaccine this year.
- Pfizer struggling to meet production targets so new alliance designed to jolt production of the vaccine and speed up vaccinations in Europe and elsewhere.
- BioNTech is also increasing its own production. Its German factory, expected to come on line in April, should produce 750 million doses a year.
 
odyssey06 said:
I think the UK authorities have approved the facility and so can accept exports from it.
The UK has approved Seerum Institute in India to receive exports of AZ from it. The EMA only seem to be starting this process now.

EMA approval hasn't been forthcoming for the Dutch facility - whether that's because they are slower at processing the paperwork, or require more paperwork than UK, or AZ are slowplaying their compliance so they can export the vaccines without breaching EU contract.
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But I thought the country/regulatory body of the location also had to validate the plant.
For example the Indian regulator would also have to be satisfied with what was being done.

I remember herself having US/ European and Irish regulators in her place each with their own requirements.
I've little doubt that the production up to December would have been authorised by the EMA, but what happened in January?

I'll ask her to read the story and see what her take is, I'm no expert but at a basic level this makes no sense.
 
odyssey06 said:
BioNTech Forms New Manufacturing Alliance, WSJ reports here (paywall).

- New alliance of 13 companies, including Novartis AG , Merck KGaA and Sanofi SA, in an effort to meet—and perhaps exceed—an ambitious target of making two billion doses of vaccine this year.
- Pfizer struggling to meet production targets so new alliance designed to jolt production of the vaccine and speed up vaccinations in Europe and elsewhere.
- BioNTech is also increasing its own production. Its German factory, expected to come on line in April, should produce 750 million doses a year.
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It's getting tight.
 
odyssey06 said:
I think the UK authorities have approved the facility and so can accept exports from it.
The UK has approved Seerum Institute in India to receive exports of AZ from it. The EMA only seem to be starting this process now.

EMA approval hasn't been forthcoming for the Dutch facility - whether that's because they are slower at processing the paperwork, or require more paperwork than UK, or AZ are slowplaying their compliance so they can export the vaccines without breaching EU contract.
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She said that the plant is probably authorised by the Dutch regulator but needs to be authorised to "export " to the EU by the EMA. The plant is also able to produce for inventory.

This would explain why vaccines were being shipped from Italy to Australia the Australians much have authorised both plants?

There was another story on RTE that said if we are to get the vaccines AZ say we are going to get at the end of March the plant must be authorised by 25th of March.

Reading that would infer there is stock on hand, but the EMA hasn't got the finger out and authorised the exports / or AZ hasn't supplied the necessary information to the EMA.

Either way it needs to get sorted.
 
EasilyAmused said:
AstraZeneca vaccinations suspended in Ireland and elsewhere.

More blood clotting issues.
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Well supply suddenly becomes moot.

It'll be interesting how the UK respond to this , if they respond.

This will have huge ramifications if the link can be established.
 
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Well it seems all a bit convenient to suspend AZ after AZ announce that they will fall short of delivery targets and crucially just before a potentially very awkward conversation between Michael Martin and Joe Biden where he was expected to ask about all those millions of vaccines in storage in the US. I wonder were Nphet leaned on an being the ultra cautious organisation they are it was very easy for them to suspend this vaccine. That way they can blame AZ for the very slow vaccine roll out. The timing of the whole thing is a bit suspect as Nphet could have suspended it on Friday but chose not to , I wonder if Michael Martin had succeeded in getting more vaccines from AZ Friday evening in his talk with the AZ boss would Nphet then have come and suspended the vaccine today, I very much doubt it ?
Crucially though this was done before the talk with Joe Biden, by raising this sensitive issue it would have put Joe Biden in the "vaccine nationalism" and "America First" camp that he is now very much in but does not want really publicised especially by Ireland
 
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