BRUSSELS – A stockpile of 29 million doses of AstraZeneca’s Covid-19 vaccine that were found in a facility in Italy became the new flashpoint on Wednesday in the conflict between the pharmaceutical and the European Union as the bloc was preparing to reveal strict exports, the restrictions were mainly aimed at preventing drug manufacturers from sending doses abroad.
Italian authorities found the vaccines on a site visit, European Union officials said, at a factory near Rome that was contracted to fill and finish the Covid-19 vaccine vials for AstraZeneca.
Italian authorities went to the scene after receiving an alert from the European Commission, which found a discrepancy between what the company said it was producing at the European Union’s facilities and what the facilities themselves were reporting.
The presence of so many doses raised suspicions that the drugmaker was trying to find a way to export them to Britain or elsewhere, something that the bloc required AstraZeneca to stop doing until the company fulfilled its delivery promises.
The European Union should receive more than 100 million doses of vaccines from AstraZeneca in the first quarter of this year, but received only 16.6 million. The scarcity of supply has helped to make vaccination efforts in the 27 member countries unfeasible and has contributed to embarrassingly low inoculation rates on the continent.
What most irritated the European Union is that AstraZeneca has consistently fulfilled its contract with Britain, while letting the bloc suffer the impact of its production failures, which diminish supplies. AstraZeneca has denied violating its contract with the EU. The bloc took the first step last week to litigate the issue by activating a friendly dispute mechanism with AstraZeneca, but there is no indication that either party intends to take the issue to court.
The bloc tried to force AstraZeneca to deliver more doses by introducing an export authorization system on February 1, but only one shipment from AstraZeneca, a small batch bound for Australia, has been blocked since it came into force.
On Wednesday, the European Union presented a stricter export control plan aimed at cracking down on exports, as the bloc fears that AstraZeneca’s deliveries will also disappoint in the second quarter, as the bloc faces a third wave of infections and prolonged blocks.
EU officials said there was no evidence that the stock in Italy, first reported by the Italian daily La Stampa, went to Britain. They said the company, when faced with doses, said 16 million doses were destined for the EU market and 13 million for countries under the Covax initiative, which aims to take doses to poorer countries. These latter exports would be exempt from EU controls, as they are considered to be of a humanitarian nature.
AstraZeneca did not immediately respond to a request for comment.
The officials said they asked AstraZeneca for additional information on where the active ingredient in the vaccine bottles found in Italy had been manufactured – an issue that aims to force the company to provide more information about its supply chain and production capacity.
For AstraZeneca, the dispute over Italian doses was the latest in a series of communication errors with health officials on both sides of the Atlantic, which damaged the company’s relationship with various governments.
Some American employees learned of an obstacle in the company’s clinical trials last year through the media. The company’s testing in the United States was halted for nearly seven weeks last fall, in part because AstraZeneca was slow to provide American regulators with evidence that the vaccine had not caused neurological disease. (The researchers later concluded that the symptoms were unrelated to the vaccine.)
But analysts believe that some of AstraZeneca’s manufacturing difficulties are also a reflection of the company’s ambitious global distribution plans. The intention was to make up to three billion doses this year, in part by contracting its manufacture to factories around the world. Other vaccine manufacturers, on the other hand, have only a few facilities.
This global network of factories, analysts said, had the potential to create complications in the company’s supply chain, although it is also part of what made the vaccine so critical to the global vaccination effort.
Benjamin Mueller contributed reporting from London.