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Washington has told the European Union that it should not expect to receive US-made AstraZeneca vaccines anytime soon, two Reuters sources from the EU said on Thursday in a further attack on supplies to the 27 member states. Bulgaria is among them, and according to an agency source, the Sofia authorities learned of the new situation on Wednesday. Interestingly, the AstraZeneca vaccine has not even been approved in the United States.
The US announcement could further complicate vaccination plans in the EU, which has struggled since January with delayed and reduced supplies from COVID-19 vaccine manufacturers.
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, to less than 90 million doses, EU sources told Reuters after an even bigger drop in supplies. However, AstraZeneca later offered to partially fill the shortage with vaccines produced outside of Europe, including the United States.
“The United States has told us that there is no way to ship AstraZeneca vaccines to the EU,” said a senior official directly involved in the EU-US talks. USA
A senior EU diplomat said the European Commission had informed member state diplomats at a meeting in Brussels on Wednesday that the bloc should not expect any US exports “at this time.” “In general, the situation is such that any export is complicated, but there is a will to dialogue,” said the diplomat. AstraZeneca declined to comment with Reuters.
White House spokeswoman Jen Psaki told reporters that the US government had clearly and publicly stated that it would focus first on providing vaccinations to Americans, but recalled that direct purchases are still dependent on the actions of individual countries and companies. “Our first goal is to make sure that Americans are vaccinated,” he said. “Of course, any country can buy vaccines directly from these manufacturers.”
It is not known what is behind the possible demonstration. 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
When asked about the vaccine talks with the US, European Commission spokesman Eric Mamer said Thursday: “Whatever the legal situation in the US, we want to work on the ground with the US. To keep supply chains open … to provide detailed information on ongoing discussions with our US 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 to the EU by 180 million doses in the second quarter.
US President Joe Biden said Wednesday that the US government would give Americans the vaccines first, but that 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 Catalent-run facility near Baltimore. This site is listed in the EU supply contract with AstraZeneca as a “point of endorsement” and is licensed by the EU Medicines Regulator as a manufacturer of vaccine ingredients.
Last week, the president of the European Commission, Ursula von der Leyen, spoke with Biden last week. This was followed by a meeting between European Industry Commissioner Thierry Breton and Jeffrey Zienz, the White House coordinator for the COVID-19 response. Vaccines were discussed in both conversations, EU statements later said. Negotiations with the United States on vaccines continue and further talks are 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 the Serum Institute produces the vaccines. EU regulators are currently inspecting the Serum production site, Reuters reported in early March. But another EU official said Thursday that the audit process was “complicated” as the location and substances used to make the 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 Janssen’s (Johnson & Johnson pharmaceutical division) vaccine production network, which will be used in the EU. According to the agreement between the EU and J&J, the doses produced in the Netherlands must be annealed in the United States, bottled there and returned to Europe. The sources did not mention potential obstacles in the United States for supplying J&J vaccines to the EU, but several European diplomats said they were also concerned about J&J production.
Reuters reported exclusively 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. Its vaccine was recommended on Thursday by the European Medicines Regulatory Authority for use in the EU. Shortly after, the European Commission authorized the marketing of the product in the single market.
AstraZeneca vaccine breaks in several countries
All of this coincides with the 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 – froze the use of a specific shipment of the vaccine, which is being tested by the EMA. Large countries like France, Germany and Spain said they saw no reason to impose restrictions.
On Thursday, AstraZeneca sent a written statement to Reuters that the safety of its vaccine had been thoroughly studied in human trials, and the data reviewed confirmed that the vaccine was generally well tolerated.
