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Washington has told the European Union it should not expect to receive US-made AstraZeneca vaccines any time soon, two EU Reuters sources said on Thursday in a new strike on supplies to the 27 member states. Bulgaria is among them, and according to a source in the agency, the authorities in Sofia knew about the new situation on Wednesday. Curiously, the AstraZeneca vaccine has not even been approved in the United States.
The announcement from the United States could further complicate vaccination plans in the EU, which has struggled since January with delayed and reduced supplies by vaccine manufacturers against COVID-19.
AstraZeneca informed the EU earlier this year that it would cut supplies in the second quarter by at least half of what was agreed – to less than 90 million doses, EU sources told Reuters after an even bigger drop in the first three However, AstraZeneca later offered to partially fill the shortage with vaccines produced outside Europe, including the United States.
“The United States has told us that there is no way to send AstraZeneca vaccines to the EU,” said a senior official directly involved in the EU-US talks.
A senior EU diplomat said the European Commission had informed member states’ diplomats at a meeting in Brussels on Wednesday that the bloc should not expect any exports from the United States “at this time”. “In general, the situation is such that every export is complicated, but there is a willingness to talk,” the diplomat said. AstraZeneca declined to comment to Reuters.
White House spokeswoman Jen Psaki told reporters that the US government had stated clearly and publicly that it would focus first on providing vaccination to Americans, but recalled that direct purchases still depend on the actions of individual countries and companies. “Our first focus is to ensure that Americans are vaccinated,” she said. “Of course, any country can buy vaccines directly from these manufacturers.”
It is not known what is behind the possible manifestation. It is also unclear whether AstraZeneca produces many vaccines in the United States or whether the United States will impose trade restrictions. The AstraZeneca vaccine is not yet approved for use in the United States.
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Negotiations with the United States
Asked about vaccine talks with the US, European Commission spokesman Eric Mamer said on Thursday: “Whatever the legal situation in the US, we want to work on the ground with the US to keep supply chains open. (…) We will not provide detailed information on the discussions that are taking place with our American partners. “
The European Commission has not answered specific questions about possible US actions affecting exports. Washington’s position could jeopardize AstraZeneca’s attempts to increase supplies to its contractual obligation with the EU by 180 million doses in the second quarter.
US President Joe Biden said on Wednesday that the US government would give Americans vaccines first, but any surplus would be shared with the world.
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AstraZeneca’s COVID-19 vaccines are produced in the United States at a plant near Baltimore run by Catalent. This site is listed in the EU supply contract with AstraZeneca as a “back-up point” and is authorized by the EU drug regulator as a manufacturer of vaccine ingredients.
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Last week, European Commission President Ursula von der Leyen spoke with Biden last week. This was followed by a meeting between European Industry Commissioner Thierry Breton and Jeffrey Zienz, White House coordinator for the COVID-19 response. Vaccines were discussed in both talks, EU statements said afterward. Negotiations with the United States on vaccines continue, with new talks expected this week, an EU official said.
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- Plan B – factories in India
- AstraZeneca had also told the EU that it could provide additional doses from India, where vaccines are produced by the Serum Institute. EU regulators are currently inspecting the Serum production site, Reuters reported earlier in March. But another EU official said on Thursday that the audit process was “complicated” as the location and substances used to make vaccines had to be approved.
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It is also part of Janssen’s production in the United States
The United States is also part of the Janssen vaccine production network (Johnson & Johnson’s pharmaceutical division), which is to be used in the EU. According to the agreement between the EU and J&J, doses produced in the Netherlands must be sent to the United States, bottled there and returned to Europe. Sources did not mention potential obstacles in the United States to the supply of J&J vaccines to the EU, but several European diplomats said they were also concerned about J&J production.
Reuters exclusively reported on Tuesday that J&J had told the EU it was facing supply problems that could complicate plans to deliver 55 million doses to the union in the second quarter of the year.
J&J plans to start shipping to the EU in April. Her vaccine was recommended earlier Thursday by the European Medicines Regulatory Authority for use in the EU. Shortly afterwards, the European Commission authorized the product to be placed on the single market.
AstraZeneca vaccine break in several countries
All this coincides with a decision by Denmark, Norway and Iceland to temporarily stop using AstraZeneca vaccines following reports of blood clots in people who have been vaccinated. Health authorities in these countries do not say that there is a direct link between vaccination and this problem. Other countries – Romania joined them shortly before midnight – have frozen the use of a specific consignment of the vaccine, which is being tested by the EMA. Large countries such as France, Germany and Spain said they saw no reason to impose any restrictions.
On Thursday, AstraZeneca sent a written statement to Reuters that the safety of its vaccine had been thoroughly studied in human testing, and reviewed data confirmed that the vaccine was generally well tolerated.
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