It was a sign of the lack of trust between the European authorities and the drug maker AstraZeneca when the Italian riflemen, the country’s military police, inspected a vaccine filling plant over the weekend. It was also a remarkable demonstration of the fever that the vaccine scramble has created – and how far the situation has moved away from discussions of global cooperation.
The doses, an Italian official explained, were ready to be shipped to Belgium.
The factory is owned by Catalent, a company that helps drugmakers with the filling and finishing of the jab, and AstraZeneca has sent doses there to be ready for distribution. A spokesperson for Catalent said that “at all times there will be a balance of vaccine drug substance ready for filling, packaging, inspection and quality, and packaged vials awaiting shipment to. AstraZeneca’s distribution facilities. ”
The Italian police “judged that the company files were in order” and “their visit was not related to any manufacturing or quality problem”, he added.
According to an EU official, the visit was launched by Internal Market Commissioner Thierry Breton after noting that the dose figures did not add up.
Contacted by the Commission, Italian Prime Minister Mario Draghi then asked his Ministry of Health to carry out an inspection, which took place on Saturday and Sunday, according to the Italian official.
Asked whether Rome would trigger the EU’s export mechanism to block the export of the newly discovered doses, the Italian official declined to comment.
An EU official said the active ingredient for a large part of the doses likely came from AstraZeneca’s Halix plant in the Netherlands. However, the European Medicines Agency has yet to approve the plant before its vaccines can be distributed within the bloc.
The relationship between the drugmaker and the Commission has deteriorated since the company reneged on its original delivery schedule, reducing expected first quarter deliveries from $ 80 million to $ 100 million to just $ 30 million. To date, EU countries have received at least 17 million doses of AstraZeneca, according to the vaccine tracker from the European Center for Disease Prevention and Control.
Now EU officials do not trust the pharmaceutical company to give honest accounts of its vaccine stock and where it is going.
“Between what is certainly produced in Europe and what can be delivered in Europe, there is a delta,” explained the EU official. “We don’t know where this is going.”
Another senior EU official said any decision to stockpile vaccines would be indefensible, “given the pandemic situation”.
“I think all the companies we have contracted with are responsible companies that see a European market for the long term, and I guess they will act very responsibly in all of their decisions,” the senior official said.
For its part, AstraZeneca said there was a reasonable explanation for the doses and denied the storage charges. From the Catalent plant reserve, 13 million doses are destined for the COVAX vaccine pool for developing countries. The rest are destined for Europe, pending quality control approval, the company said.
“It is incorrect to describe this as a stock,” a company spokesperson said in a written statement. “The vaccine manufacturing process is very complex and time consuming. ”
But such words were not enough to allay suspicion.
“Everything AstraZeneca says must be based on facts,” said the EU’s chief official. “For now, it’s just words. ”
The official blurted out an explanation: It is possible that AstraZeneca was relying on the expiration of current vaccine export controls in order to be able to move the vaccines overseas, possibly to the UK.
But the UK was not expecting any deliveries from the Italian factory, a UK official said.
Non-EU diplomats, who were also not British, said they feared the confrontation between the Commission and the company could turn into a total freezing effect on supply chains.
Beyond securing doses of the Oxford / AstraZeneca vaccine, companies are concerned about the impact that planned EU export restrictions could have on raw materials, which ply in and out. outside the block.
In particular, these non-EU diplomats said, there is a shockwave effect: the EU measures have created nervousness among manufacturers over supplies and trigger plans to stockpile raw materials in the market. world – thus delaying the completion of finished doses, which could, in turn, derail vaccine deployment programs.
For now, other countries are also expecting to receive vaccine doses from Italy or other EU member states in the coming weeks. They expect these to be delivered in installments, often towards the end of a quarter in order to meet agreed deadlines. But these countries are now worried that EU measures will delay their delivery elsewhere.
These steps were not hidden stocks, one diplomat said, but rather, in many cases, normal preparations for an expedition.
Steps taken by the EU on Wednesday to expand export controls further heightened concerns about harassed supply chains. The Commission is proposing new rules that would allow the EU to cut its vaccine exports for six weeks to countries like the UK and the US – countries that receive EU-made vaccines but do not ship no other vaccines, or who have vaccinated more of their population than the EU.
EU leaders will address the issue at a virtual summit on Thursday and Friday.
“He puts doses in a pen,” commented a diplomat who is neither from the EU nor from the United Kingdom. “He’s also looking to put raw materials in a pen. This may delay our deadlines. In the end, the longer it lasts, the more it will prevent the manufacture of vaccines. ”