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Furious at AstraZeneca, the EU plans export controls for COVID vaccines made on its home turf

January 26, 2021, 3:06 PM UTC

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AstraZeneca’s week is going from bad to worse—though you wouldn’t be able to tell by looking at its share price.

The drugmaker’s argument with the European Union, over its failure to deliver contractually-agreed amounts of its COVID-19 vaccine this quarter, has intensified to the point where the EU suspects AstraZeneca of selling those missing doses to countries outside the bloc.

As a result, the EU is now planning to institute export controls on vaccines made there, to ensure it knows what is going where.

Meanwhile, reports in German media have suggested that the U.K.-based firm’s vaccine is barely effective in older people. It appears these reports were incorrect, but the implication—that the AstraZeneca jab is a waste of time for the elderly people that have been the first to receive it—is doing the rounds on social media nonetheless. Either way, the reports have caused a minor diplomatic crisis, with AstraZeneca at its center.

At the time of writing, AstraZeneca’s shares had risen 3.2% on Tuesday.

EU fury

AstraZeneca’s COVID-19 vaccine is still awaiting approval by the European Medicines Agency (EMA), whose opinion should appear later this week, but the EU has already ordered up to 400 million doses of the stuff.

Around 80 million of those doses were supposed to be delivered in the first quarter of this year, but on Friday AstraZeneca informed EU leaders that it would only deliver 31 million doses during this period. EU officials reportedly said the company was blaming production problems at a Belgian plant.

Coming as it did on the heels of a Pfizer/BioNTech supply reduction—due to the need to re-tool a Belgian factory so as to increase its output—AstraZeneca’s announcement put a big hole in the EU’s short-term vaccination plans. Figures such as the embattled Italian Prime Minister Giuseppe Conte started talking about lawsuits.

That heads of state are threatening a drugmaker with legal action for a drug that hasn’t yet been approved speaks volumes to the frayed relations.

So Monday saw a lot of discussion between AstraZeneca, the European Commission and national officials. The meetings, in which Reuters reports the company offered to increase its February deliveries, did not go well.

“Discussions with @AstraZeneca today resulted in dissatisfaction with the lack of clarity and insufficient explanations,” tweeted Health Commissioner Stella Kyriakides on Monday evening.

The Commission is now proposing an “export transparency mechanism” to govern shipments of EU-made vaccines heading outside the bloc as it has done at times throughout the pandemic to guarantee that vital medical supplies don’t run out. The implication is clear: it does not trust AstraZeneca, and suspects it might have to send EU-earmarked vaccines elsewhere.

“The European Union wants to know exactly which doses have been produced by AstraZeneca and where exactly so far and if or to whom they have been delivered,” Kyriakides said in a statement.

“In the future, all companies producing vaccines against COVID-19 in the EU will have to provide early notification whenever they want to export vaccines to third countries,” she said. “Humanitarian deliveries are of course not affected by this. The European Union will take any action required to protect its citizens and rights.”

Commission President Ursula von der Leyen repeated the call for the new measures on Tuesday, in her speech to the virtual-this-year World Economic Forum.

“The EU and others helped with money to build research capacities and production facilities. Europe invested billions to help develop the world‘s first COVID-19 vaccines. To create a truly global common good. And now, the companies must deliver,” said von der Leyen. “They must honor their obligations. This is why we will set up a vaccine export transparency mechanism. Europe is determined to contribute. But it also means business.”

The EU has already used export controls in the context of this pandemic—between March and May last year, it required export authorization from manufacturers of personal protection equipment, or PPE.

However, it is too soon to say how similar the Commission’s incoming controls would map to those instituted last year. Spokesman Stefan de Keersmaecker told Fortune Tuesday that the Commission would set out its complete proposal by the end of this week.

Some in the U.K. fear the worst, particularly as their supplies of the crucial Pfizer/BioNTech vaccine are made in Belgium.

“If the EU were to take action unilaterally that restricted supplies of vaccine bought legally and fairly by the U.K., it would poison economic relations for a generation,” former health secretary Jeremy Hunt told the Telegraph. “At such a critical moment, the world needs vaccine nationalism like a hole in the head.”

Efficacy row

And then there’s the row over the AstraZeneca vaccine’s efficacy among older people.

This all started with reports in the German newspapers Handelsblatt and Bild, which quoted unnamed German government sources as saying AstraZeneca’s trial data showed only 8% or 10% efficacy among those aged over 65. The reports suggested the EMA would therefore not recommend the vaccine’s use among the elderly.

AstraZeneca was quick to hit back, describing the reports as “completely incorrect” and pointing to the decision by British regulators to give the doses to elderly people.

“In November, we published data in The Lancet demonstrating that older adults showed strong immune responses to the vaccine, with 100% of older adults generating spike-specific antibodies after the second dose,” the firm added.

The University of Oxford, which is AstraZeneca’s partner in this venture, also chimed in to say trials had shown “similar immune responses in younger and older adults.”

On Tuesday, the German government itself also hit back at the reports.

“At first glance, it seems that two things have been confused in the reports: About 8% of the subjects in the AstraZeneca efficacy trial were between 56 and 69 years of age, and only 3%-4% were over 70 years of age,” the health ministry said in an emailed statement. “However, this does not imply an efficacy of only 8% in the elderly.”

The ministry also noted it is not news that AstraZeneca’s first vaccine trials had included relatively few older people—a fact that means there is relatively little data for this age group, so far.

“There needs to be much more detail of any study of vaccine effectiveness before offering comment,” said Stephen Evans, professor of pharmacoepidemiology at the London School of Hygiene & Tropical Medicine, in a Tuesday statement. “The authors of The Lancet paper say additional data will become available and it will be best to rely on those data.”

Again, some in the recently-Brexited U.K. see a reason to gripe about their continental counterparts. Government sources reportedly told Politico’s London Playbook that the German government’s briefing of journalists about the great British vaccine hope were of the sort you might “expect…from the Russians” and that “after this, support for Brexit will be at about 90%.”

All eyes will now be on the EMA’s decision about the AstraZeneca vaccine, which should arrive Friday.