When military police entered an Italian factory at the EU's request over the weekend, they not only discovered 29 million COVID vaccine doses — they triggered ripples of anxiety around the world as countries feared being deprived of vital shots.
It was a sign of how low trust between the European authorities and drugmaker AstraZeneca had fallen when Italian carabinieri, the country's military police, inspected a vaccine filling plant over the weekend. It was also a remarkable demonstration of the fever pitch the scramble for vaccine supplies has created — and just how far the situation has moved from talks of global cooperation.
The doses, an Italian official explained, were ready for shipment to Belgium.
The plant is owned by Catalent, a company that helps drugmakers with the jab's fill-and-finish, and AstraZeneca sent doses there to be made ready for distribution. A spokesman for Catalent said that “at any one time there will be a balance of vaccine drug substance ready for filling, packaging, inspection and quality release, and packaged vials awaiting shipment to AstraZeneca’s distribution facilities.”
The Italian police “found the company’s records to be in order” and “their visit was not related to any manufacturing or quality issues,” he added.
According to an EU official, the visit was set in motion by Internal Market Commissioner Thierry Breton after he noticed that the numbers for the doses weren’t adding up.
Contacted by the Commission, Italian Prime Minister Mario Draghi then requested his health ministry to carry out an inspection, which took place Saturday and Sunday, according to the Italian official.
Asked whether Rome would trigger the EU export mechanism to block export of the newly-found doses, the Italian official declined to comment.
An EU official said the active ingredient for a large portion of the doses probably comes from AstraZeneca’s Halix plant in the Netherlands. However, the European Medicines Agency still needs to approve that factory before its vaccines can be distributed within the bloc.
The relationship between the drugmaker and the Commission has soured since the company reneged on its initial delivery schedule, cutting the expected first-quarter deliveries from 80-100 million to only 30 million. To date, EU countries have received at least 17 million doses from AstraZeneca, according to the vaccine tracker of the European Centre for Disease Prevention and Control.
Now, EU officials aren’t trusting the drug company to give honest accounts of its vaccine stock and where it is going.
“Between what's certainly produced in Europe and what's possibly delivered to Europe, there's a delta,” the EU official explained. “We don't know where it goes."
Another senior EU official commented that any decision to stockpile vaccines would be indefensible, “given the pandemic situation.”
“I think all companies that we have contracted with are responsible companies that are looking at a long-term European market, and I assume that they will act very responsibly with all their decisions,” the senior official said.
For its part, AstraZeneca said there's a reasonable explanation for the doses and denied accusations of stockpiling. Of the stash at the Catalent plant, 13 million doses are intended for the COVAX vaccine pool for developing countries. The rest are destined for Europe, awaiting quality control sign-off, the company said.
"It is incorrect to describe this as a stockpile," a company spokesperson said in a written statement. "The process of manufacturing vaccines is very complex and time consuming."
But such words haven't been enough to lessen suspicions.
"Everything that AstraZeneca says, it must be fact-based," the first EU official said. "For now, it is only word-based."
The official floated one explanation: It’s possible AstraZeneca was counting on current vaccine export controls to lapse so that it could move the shots abroad, perhaps to the U.K.
But the U.K. hadn't expected any deliveries from this Italian plant, a British official said.
Non-EU diplomats, who were also not British, said they fear the confrontation between the Commission and the company has spilled into an all-out freezing effect on supply chains.
Beyond securing Oxford/AstraZeneca vaccine doses, companies are getting concerned about the impact that the EU’s planned export restrictions could have on raw materials, which criss-cross in and out of the bloc.
In particular, these non-EU diplomats said, there's a shock wave effect: The EU’s steps have created nervousness among manufacturers about supplies and are triggering plans to stockpile raw materials around the world — thereby delaying the completion of finished doses, which could, in turn, derail vaccine rollout programs.
For now, other countries also expect to receive vaccine doses from Italy or other EU member states in the coming weeks. They expect these to be delivered in tranches, often towards the end of a quarter in order to meet agreed deadlines. But these countries are now concerned that the EU’s steps will delay their delivery elsewhere.
These steps didn’t amount to hidden stockpiles, one diplomat said, but rather in many cases, normal preparations for a shipment.
The EU’s moves on Wednesday to widen export controls have further aggravated concerns over snarled supply chains. The Commission is proposing new rules that would allow the EU to cut vaccine exports for six weeks to places like the U.K. and U.S. — countries that are either receiving EU-made vaccines but not sending other shots back, or that have vaccinated more of their population than the EU.
EU leaders will take up the issue at a virtual summit Thursday and Friday.
"It’s putting doses in a holding pen," commented one diplomat who is neither from the EU nor the U.K. "It also looks to put raw materials in a holding pen. It risks putting our deadlines off. Ultimately, the longer it goes on, the more it will stop vaccines from being made."
https://news.google.com/__i/rss/rd/articles/CBMiYWh0dHBzOi8vd3d3LnBvbGl0aWNvLmV1L2FydGljbGUvZXUtc2VuZHMtaXRhbGlhbi1wb2xpY2UtdG8tZmluZC1hc3RyYXplbmVjYS1jb3JvbmF2aXJ1cy12YWNjaW5lcy_SAWVodHRwczovL3d3dy5wb2xpdGljby5ldS9hcnRpY2xlL2V1LXNlbmRzLWl0YWxpYW4tcG9saWNlLXRvLWZpbmQtYXN0cmF6ZW5lY2EtY29yb25hdmlydXMtdmFjY2luZXMvYW1wLw?oc=5
2021-03-24 16:39:53Z
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