After inspection, AstraZeneca says 29 million Covid-19 doses in Italy are for EU, poorer countries

(Reuters) - AstraZeneca said on Wednesday that some 29 million doses of Covid-19 vaccines found in an inspection at a plant in Italy were destined for the EU and for donations to poorer countries via the COVAX scheme co-led by the World Health Organization.

At the request of the European Commission, Italian security forces inspected a Catalent factory in Anagni, near Rome, at the weekend and found the store of vaccine doses, according to Italian newspaper La Stampa.

Italy's Prime Minister Mario Draghi later confirmed the report of the inspection and said some of the batches of doses were seized while two batches were sent to Belgium. A batch can contain a million doses.

A flurry of reactions to the report reflected the level of mistrust in the EU towards the Anglo-Swedish firm, which slashed its supply target to the EU by the end of June to 100 million from 300 million envisaged in its contract with the 27-nation bloc. The 29 million doses found would be enough to vaccinate 14.5 million people.

"A stock of almost 30 million doses has been identified near Rome during an inspection we put in place. It has now been seized," French government spokesman Gabriel Attal told reporters after a cabinet meeting. "The EU won't be the fall guy of vaccinations."

Another French official said it was under consideration whether some batches could be blocked.

EU lawmaker Peter Liese, from the same party as German Chancellor Angela Merkel, said the report left him speechless, and he urged AstraZeneca to clarify the situation.

Later on Wednesday, AstraZeneca said that most of the doses in the Catalent plant were for the EU, and the rest were for poorer countries supplied by the COVAX scheme co-led by the World Health Organization.

"There are no exports currently planned other than to COVAX countries. There are 13 million doses of vaccine waiting for quality control release to be dispatched to COVAX," the company said.

The remaining 16 million will be shipped to Europe this month and in April, it said.

Mario Gargiulo, Regional Biologics President for Europe at Catalent, told Reuters that having 29 million doses in the Anagni factory was in line with normal procedure and that the company often had more there.

After AstraZeneca's comments, Draghi told the Italian Parliament that EU Commission President Ursula von der Leyen had told him on Saturday there were some batches stored at the Catalent factory that needed to be checked as they were missing from EU deliveries.

He said he ordered an inspection which identified "batches in excess".

"Some batches have been seized today, and two have been sent to Belgium," he said, adding that he did not know their final destination.

The European Commission declined to comment on the doses at the Anagni factory.

Earlier on Wednesday, UNICEF said on behalf of the COVAX vaccine-sharing facility that the projected deliveries of vaccines to all countries, including Vietnam, had to be delayed due to production delays.

HALIX

An EU official said some of the doses at the Catalent plant might come from a vaccine factory in the Netherlands run by AstraZeneca's subcontractor Halix.

The Anagni plant is in charge of bottling AstraZeneca vaccines produced at the Halix factory and also at a plant in Belgium run by subcontractor Thermo Fisher Scientific.

AstraZeneca said that the factory also bottles doses received from outside the EU and to be shipped to COVAX countries.

Both vaccine-making factories in Belgium and the Netherlands are listed in the contract AstraZeneca signed with the EU in August as suppliers to the EU.

However, the Halix factory has not yet been approved in the EU, as AstraZeneca did not submit sufficient data to the EU drugs regulator. It has also not been approved in Britain.

Vaccines produced there cannot be used in the EU until that approval is received, which AstraZeneca and EU officials said they expected in the coming days.

It is unclear why AstraZeneca did not seek earlier approval for the factory. The Anglo-Swedish drugmaker declined to comment on that point.

Halix is also listed as a supplier for Britain, which is urging the EU to allow the shipment of doses produced there. Britain has so far exported no AstraZeneca vaccines to the EU, despite two UK plants being listed in the EU contract as suppliers for the bloc.

Halix said it started producing vaccines for the EU in December and has a capacity to produce about 5 million doses per month. The company declined to comment on how many vaccines it had already produced or on their destination.

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