A nice gig for the Irish arm of EY to spend four years producing a report stating there are lessons to be learned and recommending an annual audit to be conducted by EY on an ongoing basis.
Nah thats too soft, they will be reemed when the FDA/EMA/British health board do the regulatory audits. Every piece of paperwork on this will now be pulled. A public boo boo like this is a massive red flag for them
From the Financial Times
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
AstraZeneca’s struggle to ramp up vaccine supplies to the EU is partly because of the failure of one of the company’s key European manufacturing sites to deliver any doses to the bloc six months after the supply contract was agreed. The Dutch factory, run by subcontractor Halix, is yet to receive EU regulatory approval to supply the region even though it was named in the deal signed between AstraZeneca and the European Commission in August. EU officials said AstraZeneca was yet to provide sufficient data. The company said approval of the site remained “on track”. The mystery of the Dutch factory underlines the growing questions over both AstraZeneca’s management of its EU contract and the bloc’s oversight. AstraZeneca has fallen far behind its planned vaccine deliveries to the EU, which has had a major effect on vaccination rollout.
The EU had administered 10.4 vaccine doses per 100 residents by Friday, compared with 29.7 in the US and 36.5 in the UK, according to data gathered by the Financial Times. Both the US and UK did deals with AstraZeneca earlier than the European Commission. EU officials said this week that AstraZeneca would fall roughly 10m doses short of its target to deliver 40m doses by the end of March. That goal was already well below the original supply schedule of at least 100m shots by the end of the month. Thierry Breton, EU industry commissioner, said on Thursday that he did not believe AstraZeneca had made “best efforts” to meet its commitments — a reference to language in the August supply contract. Concern is now growing that the British-Swedish company might also fail to deliver the 180m doses it had initially promised the EU for the second quarter of the year, half of which are due to come from outside the bloc.
The US has so far refused to allow exports of any of the company’s US-based production, EU officials say. Supplying the EU from other countries in AstraZeneca’s worldwide production network could also be difficult. The Halix factory is one of two facilities — along with the Belgian plant at Seneffe — named as main sources of so-called vaccine drug substance in AstraZeneca’s contract with the commission. Pascal Soriot, the company’s chief executive, explained in an interview with European newspapers in January that the vaccine drug substance is produced in Belgium and the Netherlands and then finished and packaged into vials at plants in Germany and Italy.
The Seneffe plant has struggled with lower-than-expected yields, while the Halix plant in the Netherlands’ Leiden Bio Science Park has produced vaccines but is still not authorised to supply them in the EU. Last week Breton visited the Halix facility — which should produce at least 5m doses a month — as part of a tour of European vaccine manufacturing sites. Discussions over regulatory approval for the plant from the European Medicines Agency to supply the EU market were ongoing, the officials said.
Asked about the Halix situation, the commission said on Friday that the EMA was ready to fast-track authorisation of new production facilities once it received an application and the necessary information from AstraZeneca. “It is, however, the responsibility of the company to request plants to be covered by a marketing authorisation and to submit all necessary data to that effect,” it said. “The commission encourages the company to do so.” A spokesman for AstraZeneca said: “The approval of the site with the EMA remains on track with our original plans and we can confirm that it forms part of our delivery plans.” Halix did not respond to requests for comment.
EU diplomats have grown increasingly agitated over how many vaccine doses Halix has actually manufactured in the meantime and what AstraZeneca is doing with the product. Officials are counting on stockpiled vaccine to be released for use in the EU once the factory is authorised. In January, the bloc introduced new discretionary controls on vaccine exports to 31 high- and middle-income countries, which Italy has already used to prevent a shipment to Australia.
Brussels has clashed previously with both AstraZeneca and London over vaccine exports. EU officials have claimed the company has shipped vaccines produced in the EU to the UK. AstraZeneca has so far not sent doses in the other direction, even though two UK drug substance plants are referenced in the EU’s supply contract as potential sources of vaccine. The Halix situation also raises the question of whether the European Commission and EU member states paid sufficient attention to tracking whether the plant was on schedule to deliver.
Halix did not issue a press release announcing it had been contracted to produce vaccines until December, more than three months after it was named in the AstraZeneca contract with the commission. “If it is the case that this facility is not producing for the EU then it is truly baffling,” said one EU diplomat. “It would mean that three of the four plants listed in the original EU contract are not providing doses to the EU."
Surely the EU can check whether it exported vaccines from that factory or not.
5m vaccines a month is not that impressive a yield is it?
115 doses a minute based on a 30 day months running 24/7. Savage yield tbf
Only 60m in a 12 month period.
Think AZ’s contract is for 3-400m so that plant will only yield 20% of the contract order in the stated time period.
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The plan was that plants from outside the EU would supplying additional doses in Q2, but that is also looking dodgy.
@glasagusban two articles on the journal today. One on other EU countries calling out certain countries have behind the door deals for vaccines and the other on chump going to joe obiden to help out the olde country, a request from mickeys good buddy billy. But its all nonsense
Five EU states seek summit on ‘unfair’ vaccine handouts https://jrnl.ie/5380541
Unlimited use of Shannon airport for the next decade in return for 5,000,000 vaccines.
A fair deal.
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They can use the Skellig’s for extraordinary rendition once they’ve closed Guantanamo
If CJH, Albert Reynolds or Bertie were Taoiseach we’d have vaccines. Be it by skullduggery or whatever they’d get them.
The current ‘leaders’ haven’t a fucking clue. Bluff, no substance and depending on advisors!
Martin is fucking useless. Varadkar and Ryan are worse and Donnelly hasn’t a notion.
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My man challenging the yield and he not having a fucking bulls notion
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CJH would have charmed the relevant people no doubt
“My cousin Vladimir Haughey and I reached an agreement today”
It’s a savage yield. Absolutely savage
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They drove out all the cute hoors and look what we have now. People need to be forgiving of a bit of ould mild corruption from visionary strongmen like CJH.
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Bertie would have sorted the supply and probably even administered the vaccines himself.
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CJH would probably have bought a few crates of vaccines at his own expense for his people
5 million /30 days/24 hours/60 minutes =115 units per minute. Based on running at 80% they probably have a capacity of 150 units per minutes. I am going to assume they have one production line validation to produce this in this plant, with the view to possibly increasing over time but they clearly don’t have the MA to sell product from this facility to the market. A validation woth all resources throw at it will take 12 weeks alone.
What part of the civil service deals with high volume manufacturering? Or validation to see medical to the European market? Or cultivation of the vaccine in large quantities especially on a new product?
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So, with the original target being 90 million by the end of march, AZ are now saying their ability to deliver 30 million vaccines hinges on the approval of a factory in the Netherlands. So they might be able to reach one third of their target. Hopefully.
There’s something very off about all of this