European officials claim to have found millions of doses of the AstraZeneca-Oxford vaccine in Italy during a snap inspection. A new twist in the bloc's efforts to ban exports of the drug to the UK.
Brussels directed an Italian government inspection of the Anagni factory, south-east of Rome, where AstraZeneca vaccines are bottled. The raid uncovered 29 million doses that the authorities had not previously recorded.
The stockpile represents a significant find when the manufacturer is under fire for delivering only 30 million shots of the vaccine to the EU in the current quarter.
A spike in Covid-19 infections in Germany, Italy and elsewhere has put Europe's political class under intensify pressure to bring the pandemic under control. Angela Merkel was forced to U-turn yesterday on plans for a five day shut down over the Easter break at the start of April. She apologised as she explained the drastic closure plan could not be implemented at short notice.
"This mistake is mine alone," Mrs Merkel said. "The whole process has caused additional uncertainty, for which I ask all citizens to forgive me."
La Stampa newspaper said that the vaccine batches were manufactured by Halix, the Dutch plant at the centre of European efforts to redirect doses away from Britain, where more than 30 million people have had a first injection.
The Halix factory has not yet been approved in the EU, as AstraZeneca did not submit sufficient data to the EU drugs regulator.
Vaccines produced there cannot be used in the EU until that approval is received.
AstraZeneca said some of the doses had been earmarked to be shipped under the Covax vaccine sharing initiative, while the remainder was waiting quality control before distribution.
"There are 13 million doses of vaccine waiting for quality control release to be dispatched to Covax as part of our commitment to supply millions of doses to low income countries, the vaccine was made outside the EU and brought to the Agnani plant to be filled into vials", a statement from the company said.
"There are another 16 million doses waiting for quality control release to be dispatched to Europe. Close to 10 million doses will be delivered to EU countries during the last week of March, the balance in April as the doses are approved for release after quality control.
"It is incorrect to describe this as a stockpile. The process of manufacturing vaccines is very complex and time consuming. In particular, vaccine doses must wait for quality control clearance after the filling of vials is completed.”
European Commissioner Thierry Breton, who leads the vaccine task force, is conducting an audit of vaccines produced by the Anglo-Swedish company in the EU. He accused AstraZeneca of evading its contracts to the EU.
Sandra Gallina, another EU official, told the European parliament on Tuesday that no AstraZeneca shipments had left the EU since a delivery to Australia was blocked in early March.
The bloc’s closest neighbours, including countries in the Balkans and those that have special EU trading relationships, such as Norway and Switzerland, will need authorisation to import coronavirus vaccines made in the bloc, under a proposal to be unveiled on Wednesday.
The plan, which will be made public in Brussels about noon, seeks to strengthen the EU's existing export rules by insisting that nations receiving doses from the bloc also send vaccines back.
It will also consider a country's vaccination rate and pandemic situation when deciding on whether to authorise shipments.
The mechanism will not be automatic but will be used on a case-by-case basis, officials familiar with the proposal said.
The new export rules came to light as the health outlook dramatically deteriorated in Europe, with many of the biggest countries, including Germany and France, announcing new lockdowns.
When EU leaders meet on Thursday to discuss the proposal, some are expected to say the “situation remains serious” and that “restrictions, including non-essential travel, must therefore be upheld”.
Neighbouring countries will be included in the new directive because of the increased risk of third parties using their special trade privileges to help circumvent the tighter export criteria.