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Exclusive: EU told to expect no AstraZeneca vaccines from U.S. in near future – sources

(C) Reuters. FILE PHOTO: AstraZeneca coronavirus vaccination in Copenhagen

By Francesco Guarascio and John Chalmers

BRUSSELS (Reuters) – Washington has told the European Union that it should not expect to receive AstraZeneca (NASDAQ:AZN) COVID-19 vaccines manufactured in the United States any time soon, two EU sources said on Thursday, in a new blow to the bloc’s supplies.

The U.S. message could complicate vaccination plans in the 27-nation bloc, which has been grappling since January with delays in deliveries from vaccine makers.

“The U.S. told us there was no way it would ship AstraZeneca vaccines to the EU,” said a senior official directly involved in EU-U.S. talks.

AstraZeneca told the EU earlier this year it would cut its supplies in the second quarter by at least half to less than 90 million doses, EU sources told Reuters, after a bigger reduction in the first three months of the year.

Later, however, AstraZeneca offered to partly plug the gap with vaccines produced outside Europe, including in the United States.

A senior EU diplomat said that the European Commission told member states’ diplomats at a meeting in Brussels on Wednesday that the bloc should not expect any exports from the United States “at this point in time”.

“Basically the situation is such that any exports are tricky, but there is a willingness to talk,” the diplomat said.

AstraZeneca declined to comment and the White House had no immediate comment

It is not known what is behind the possible move on exports. It is unclear whether AstraZeneca is producing much vaccine in the U.S. or if the U.S. would apply a restrictive measure on trade. AstraZeneca’s vaccine has not yet been approved for use in the United States.

The move comes after Austria stopped using a batch of AstraZeneca shots while investigating a death from coagulation disorders and an illness from a pulmonary embolism.

Asked about vaccine talks with the United States, European Commission spokesman Eric Mamer said on Thursday: “Whatever the legal situation in the United States, we want to work on the ground with the United States to keep the supply chains open.”

“We’re not going to give a blow-by-blow account of the discussions that are taking place with our American partners.”

But the EU’s executive did not reply to specific questions about a possible move on exports from the United States.

The U.S. stance could jeopardise AstraZeneca’s attempts to bring deliveries closer to its contractual obligation with the EU of 180 million doses in the second quarter.

U.S. President Joe Biden said on Wednesday the U.S. government will first give Americans COVID-19 vaccines, but any surplus would be shared with the world.

AstraZeneca’s COVID-19 vaccines are produced in the United States in a plant near Baltimore run by Catalent (NYSE:CTLT), which is listed in the EU supply contract with AstraZeneca as a “back-up supply site” and has been authorised by the EU drugs regulator as a manufacturer of vaccine ingredients.

The head of the European Commission, Ursula von der Leyen, had a call with Biden last week, which was followed this week by a meeting between EU industry commissioner Thierry Breton and White House COVID-19 response coordinator, Jeffrey Zients.

In both talks, vaccines were discussed, according to EU statements issued afterwards.

Talks with the U.S. on vaccines were continuing, with new calls expected this week, one EU official said.

INDIA

AstraZeneca had also told the EU it could provide extra doses to the EU from India, where its vaccines are manufactured by the Serum Institute.

The EU drugs regulators are currently reviewing Serum’s manufacturing site, Reuters exclusively reported earlier in March.

But another EU official said on Thursday the auditing process was “complicated” because both the site and the substances used for vaccine production had to be authorised.

The U.S. is also part of the production network for Johnson & Johnson (NYSE:JNJ) vaccines due to be used in the EU, because under the EU-J&J contract shots made in the Netherlands would need to be bottled in the U.S.

The sources made no reference to potential U.S. hurdles on the shipment to the EU of J&J vaccines, but several European diplomats said they were concerned about J&J production.

Reuters exclusively reported on Tuesday that J&J told the EU it was facing supply issues that may complicate plans to deliver 55 million doses of its COVID-19 vaccine to the bloc in the second quarter of the year.

J&J plans to begin supplying the EU in April. Its vaccine was recommended earlier on Thursday by Europe’s drugs regulator for use in the EU.

In a separate development, health authorities in Denmark, Norway and Iceland said they had suspended the use of AstraZeneca’s vaccine shots after reports of the formation of blood clots in some who have been vaccinated.[L1N2L91Q3]

AstraZeneca on Thursday told Reuters in a written statement the safety of its vaccine had been extensively studied in human trials and peer-reviewed data had confirmed the vaccine was generally well tolerated.

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