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Discovery of 29M AstraZeneca vaccine doses in Italy raises EU hackles

Mitz

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Company says 29m shots are awaiting quality approval before distribution to bloc and Covax

The fate of 29m AstraZeneca vaccine doses in Italy sparked finger pointing and recriminations on Wednesday as the EU warned that the company was far short of meeting its latest supply target.

The European Commission called on AstraZeneca to explain the origin and intended destination of a stockpile identified by Italian authorities at the Anagni finishing plant, while some EU officials asked if the active ingredients in the doses had come from a Dutch facility as yet unlicensed to supply to the bloc.

AstraZeneca said it was “incorrect” to describe it as a stockpile, adding that the doses were waiting for “quality control” processes to be completed before being released.

Approximately 13m of the doses were destined for the international Covax scheme that distributes mainly to poor and middle-income countries. Those doses were made with vaccine drug substance manufactured outside the EU, the company said.

The remaining 16m jabs were due to be dispatched to EU countries, with almost 10m doses earmarked for delivery during the last week of March, and the rest in April, it added. “The process of manufacturing vaccines is very complex and time-consuming. In particular, vaccine doses must wait for quality control clearance after the filling of vials is completed.”

The mistrust over the vaccine doses at the factory near Rome highlights the near-complete breakdown in relations between the EU and AstraZeneca, whose low-priced jab was supposed to be a cornerstone of the bloc’s troubled immunisation drive.

“Europe doesn’t want to be a useful idiot in all this,” said an official from France, which has been at the forefront of a push for tougher vaccine export controls floated by the commission.

Valdis Dombrovskis, EU trade commissioner, said on Wednesday AstraZeneca was far short of delivering even a quarter of the maximum 120m doses originally targeted by the end of March in the company’s contract with the commission last year.

“They are promising to be able to deliver 30m doses but they are not even close to this figure as of today,” he told reporters.

AstraZeneca says it has made “best efforts”, as required by the contract, to meet the EU delivery schedule, adding that the timetable has been hit by low product yields at a plant in Belgium.

Italian authorities identified the 29m doses after the commission ordered an inspection of the plant on Saturday, the Italian government said.

Some EU officials suspect that some of the vaccine drug substance used to make the doses could have originated from a much-scrutinised plant in the Netherlands contracted to make the active ingredients for AstraZeneca. The Halix plant has been unable to deliver to the EU because it does not have authorisation from the European Medicines Agency. The company has insisted the approval process is “on track”, but commission and EU member state officials have asked why it hasn’t been completed already.

In its statement, AstraZeneca did not clarify the source of the drug substance in the 16m EU-bound doses at Anagni.

The supply from the Halix factory is at the centre of a row between the EU and UK, which both want part of the production from the plant. The European bloc has refused, underlining that no vaccines have ever been shipped from AstraZeneca’s UK plants to help alleviate shortfalls in the rest of Europe.

EU member states, whose Covid-19 vaccination programmes have been outpaced by those of the UK and the US, are particularly worried about a public backlash because European factories have exported millions of doses to foreign markets.

https://www.ft.com/content/48b28b7e-9161-47a4-9c37-cf89fea2bc12
 
what a mess...

"EU member states, whose Covid-19 vaccination programmes have been outpaced by those of the UK and the US, are particularly worried about a public backlash"

That's at the heart of all this I'm sure.
 
I was reading this earlier, farcical:

"An AstraZeneca plant has come under investigation by the Italian police at the request of Brussels in a sign of the breakdown in relations between the Anglo-Swedish vaccine supplier and the EU.

Officers were sent into the facility in the town Anagni, east of Rome, on Saturday evening after the European commission contacted the Italian government with concerns.

AstraZeneca has been accused by the commission of overselling its ability to deliver doses and reneging on its contract with the EU after delivering less than a quarter of the 120m doses it had promised this quarter. The EU’s executive branch believes that the company has unfairly prioritised its contract with the UK government.

Following a report in the Italian media that a stockpile of 29m doses had been discovered destined for the UK, a statement was issued by AstraZeneca dismissing the claim as as “inaccurate”.

AstraZeneca said no exports were currently planned outside of the EU other than to developing countries via the Covax facility, and it was incorrect to describe the batches in the factory – run by the US-based company Catalent to provide vial filling and packaging – as a “stockpile”.

“There are 13m doses of vaccine waiting for quality control release to be dispatched to Covax as part of our commitment to supply millions of doses to low-income countries, the vaccine was made outside the EU and brought to the Anagni plant to be filled into vials,” the company said.

It added that a further 16m doses were waiting for quality control release before being dispatched to Europe. “Close to 10m doses will be delivered to EU countries during the last week of March, [and] the balance in April as the doses are approved for release after quality control.”

A statement from the office of the Italian prime minister, Mario Draghi, confirmed that the Anagni plant had been inspected at the commission’s request and that batches found were destined for Belgium.

La Stampa had reported on Wednesday that the doses – almost twice the amount the EU has so far received from AstraZeneca – were found “hidden” in the factory following a search by Italian police on Saturday at the request of the European commission, and that they were probably destined for the UK.

Draghi caused controversy this month after blocking 250,000 AstraZeneca vaccine doses from being exported from the Anagni plant to Australia in response to the company failing to meet its EU delivery targets.

It is at least the second time that the commission has asked national authorities to investigate AstraZeneca production facilities. In January, Belgian officials were asked to probe a plant in Seneffe, south of Brussels. EU officials were suspicious of claims by the company that the plant had suffered low yield. It has long been suspected that doses had instead been shipped on a large scale to the UK, a suspicion for which no evidence has so far emerged."

https://www.theguardian.com/world/2...-29m-vaccine-doses-in-italy-were-bound-for-uk
 
All in all it's making me feel quite negative towards the EU.
 
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