It follows an inspection of the Catalent factory in Anagni this weekend by the Italian authorities at the request of the European Commission.
An official in the French presidency said this week that the destination of these doses “still needs to be clarified,” and noted that if the injections were intended for export, they could be blocked.
The factory is in charge of the bottling of AstraZeneca vaccines produced in the Halix factory in the Netherlands.
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According to some reports, 29 million doses were “hidden” at the Anagni plant, which was originally intended for the United Kingdom.
Italian newspaper La Stampa had claimed the doses likely came from the Halix factory, but the Dutch factory has yet to be approved for vaccine production by the European Medicines Agency.
The Anglo-Swedish company responded by denying that it was a stock and clarified that 13 million of the 29 million jabs are ready to go to the countries of the COVAX program after being checked for quality control.
The initiative supported by the World Health Organization is providing the AstraZeneca vaccine to many developing countries at cost.
AstraZeneca added that an additional 16 million doses were destined for European countries, also after “the release of quality control”.
Development comes as the European Commission asks tighter controls on coronavirus vaccine exports in Britain and other areas with much higher vaccination rates.
Commission President Ursula von der Leyen said “open roads should run both ways”, adding: “The EU has an excellent portfolio of different vaccines and we got more than enough doses for the entire population. But we need to make sure in a timely manner and in sufficient quantity. vaccine deliveries to EU citizens. Every day counts. ”
The proposals recommend more transparency and reciprocity, but fall short of including a ban on exports to the UK.
AstraZeneca has been at the heart of a cross-Channel feud after Ms von der Leyen threatened to halt vaccine exports under pressure over the bloc’s slow deployment.
In a statement Wednesday, a spokesperson for AstraZeneca said: “We wish to clarify some inaccurate statements regarding vaccine doses at the Anagni plant.
“There are currently no exports planned other than to COVAX countries. There are 13 million doses of vaccine awaiting release from quality control to be shipped to COVAX as part of our commitment to deliver millions of doses to low-income countries.
“The vaccine was manufactured outside the EU and brought to the Anagni factory for vialing. The EU fully supports the supply of low and middle income countries through the COVAX facility.
“There are an additional 16 million doses awaiting release from quality control to be shipped to Europe. Almost 10 million doses will be delivered to EU countries in the last week of March, the rest in April, as the doses are approved for release after quality control. ”
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The spokesperson added: “It is incorrect to describe this as a stock. The vaccine manufacturing process is very complex and time consuming. In particular, vaccine doses must await approval from quality control after filling the vials. ”
An Italian official had confirmed that the inspection had taken place, in which the 29 million doses were found, and said the injections were to be sent to Belgium.
Earlier this month, reports said AstraZeneca expects to have delivered 30 million doses to the EU by the end of March – 10 million less than it had promised on last month and only a third of its contractual obligation.
A person familiar with the situation said there had been difficulties with international supply chains, according to Reuters.
Industry leaders have warned of manufacturing issues as countries attempt to protect their own supplies of vaccines, ingredients and equipment to manufacture, bottle and transport them.