Cache of 29 Million AstraZeneca doses in Italy raises EU suspicions

A stockpile of 29 million doses of AstraZeneca’s COVID-19 vaccine that were found languishing in a facility in Italy became the new flash point on Wednesday in the conflict between the pharmaceutical company and the European Union, as the bloc prepared to unveil stringent export restrictions primarily meant to stop drugmakers from sending doses abroad.

Italian authorities found the vaccines in a site visit, European Union officials said, at a factory near Rome that is contracted to fill and finish COVID-19 vaccine vials for AstraZeneca.

Italian authorities went to the site after receiving an alert from the European Commission, which found a discrepancy between what the company said it was producing in European Union facilities, and what the facilities themselves were reporting.

The presence of so many doses raised suspicions that the pharmaceutical company was trying to find a way to export them to Britain or elsewhere, something the bloc has demanded that AstraZeneca stop doing until the company fulfills its promises for deliveries.

The European Union was meant to receive more than 100 million vaccine doses from AstraZeneca in the first quarter of this year, but has received only 16.6 million. The supply shortage has helped to derail vaccination efforts across the 27 member countries and contributed to embarrassingly slow inoculation rates on the continent.

What has most irked the European Union is that AstraZeneca has been consistently delivering on its contract with Britain while letting the bloc take the brunt of its production failures that have diminished supplies. AstraZeneca has denied it has violated its EU contract. The bloc took the first step last week to litigate the issue by activating an amicable dispute mechanism with AstraZeneca, but there is no indication either party intends to take it to court.

The bloc tried to force AstraZeneca to deliver more doses by introducing a system of export authorizations on Feb. 1, but only one AstraZeneca shipment, a small batch headed to Australia, has been blocked since that came into force.

On Wednesday, the European Union introduced a stricter export-control plan that aims to crack down on exports, as the bloc fears AstraZeneca deliveries will also disappoint in the second quarter as the bloc confronts a third wave of infections and extended lockdowns.

EU officials said there was no evidence that the stockpile in Italy, first reported by the Italian daily La Stampa, was bound for Britain. They said the company, when confronted about the doses, said that 16 million doses were bound for the EU market and 13 million to countries under the Covax initiative that aims to get doses to poorer nations. Those latter exports would be exempt from EU controls, as they are deemed to be of humanitarian nature.

AstraZeneca did not immediately respond to a request for comment.

The officials said they had asked AstraZeneca for additional information about where the active ingredient in the vaccine vials found in Italy had been manufactured — a question aimed at forcing the company to provide more information about its supply chain and production capacity.

For AstraZeneca, the dispute over the Italian doses was the latest in a series of communications blunders with health officials on both sides of the Atlantic that have soured the company’s relationship with several governments.

Some American officials learned about a snag in the company’s clinical trials last year from the news media. The company’s U.S. trial was paused for nearly seven weeks last fall, in part because AstraZeneca was slow to provide U.S. regulators with evidence that the vaccine had not caused a neurological illness. (Investigators later concluded the symptoms were not linked 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. It had intended to make as many as three billion doses this year, in part by contracting its manufacturing to plants all over the world. Other vaccine makers, by contrast, are relying on only a few facilities.

That global network of factories, analysts said, had the potential to create complications in the company’s supply chain, though it is also part of what has made the vaccine so critical to the global vaccination effort.