Italy has blocked the export of 250,000 doses of the Oxford/AstraZeneca vaccine to Australia in a major escalation of a row with the Anglo-Swedish company.
In the first such intervention under the EU’s controversial export authorisation scheme, the Italian government ordered that the doses remain in the bloc with the backing of the European commission.
The move will alarm those concerned that the EU is moving towards a protectionist approach to vaccine supply. The commission had repeatedly and publicly insisted that it did not intend to impose a ban.
The EU has been engaged in high-profile row with AstraZeneca after the company informed officials of a shortfall in deliveries this quarter due to a production problem in one of its EU sites.
A mechanism under which vaccine suppliers would need to gain authorisation for exports out of the EU was drawn up amid concerns that doses made within the bloc were being delivered to the UK.
The commission had insisted for weeks that the mechanism was primarily about transparency. But Ursula von der Leyen, the commission president, had privately assured the 27 EU heads of state and government at a summit last week that exports would be prevented in cases where suppliers were not fulfilling their contractual obligations.
AstraZeneca has production sites in Belgium, the Netherlands, Germany and Italy. Australia has purchased 53m doses from the company, which are due to be rolled out this month. The vaccine has the advantage of being able to be kept in normal refrigerated conditions rather than in freezers.
AstraZeneca had made deliveries to Italy last week that were about 10-15% lighter than expected. But the company had insisted it would respect its commitment to supply the country with 4.2m doses in the first quarter of the year.
The Italian government, under its new prime minister, Mario Draghi, formerly president of the European Central Bank, had nevertheless notified the commission at the end of the week of its intentions and received Brussels’ backing. He had voiced his concerns that the EU was not being stricter on exports during the leaders’ summit.
The EU has approved about 150 requests for the export of vaccines since it established its authorisation mechanism, with only Italy so far having rejected such a request.
The export authorisation mechanism has been criticised for adding an extra layer of bureaucracy to the production and distribution of vaccines.
Franz-Werner Haas, the chief executive of the German pharmaceutical company CureVac, with whom the commission has a contract for 225m doses of its as yet unapproved vaccine, highlighted last week the unintended consequences of the policy.
“This has been hitting us somehow because we couldn’t get clinical trial material to Latin America,” Haas told MEPs during a committee hearing. “We did then get immediate support from the commission as well as the German authorities. [But] for rather a small company, 600 people, certainly this adds an extra layer … We lost a week to ship the material which was necessary and is necessary to run the clinical trial.”
AstraZeneca was due to provide 120m doses of its vaccine to the EU in the first quarter of this year but was only able to commit to 40m due to yield issues at its site in Belgium.
The commission had been furious that the company then refused to redirect doses made in its two UK plants in Staffordshire and Oxford to the EU.
Under its agreement with Oxford university, which devised the vaccine, the company was bound to use doses made in those sites in the UK first, before satisfying its other orders.
One EU diplomat said: “Italy has sent a crystal clear message to AstraZeneca: Contracts are to be honoured. AstraZeneca’s vaccine delivery to the EU will fall short by more than 60 million doses in the first quarter of 2021 alone putting at risk the lives of 30 million EU citizens.
“Being in this situation, not making up for it, not even offering excuses to the people they have led down and then asking for an export authorisation is a very brazen move. Italy rightly stopped it.”
The EU has a total order of 400m doses with AstraZeneca. Germany, France and Belgium are among EU countries that have in recent days changed their guidance on the vaccine to recommend it for all age groups.
On becoming prime minister last month, Draghi announced a target to administer 56m vaccine doses by June. The country has vaccinated 4.6 million people so far.