Amid vaccines row, EU adopts regulation to control export of COVID-19 jabs

The European Commission has adopted a regulation to control the export of coronavirus vaccines manufactured in the EU, amid a row with vaccine manufacturer AstraZeneca, and warnings of a brewing vaccine war with the UK.

Announcing the measures, EU trade commissioner Valdis Dombrovskis insisted the export checks weren’t being targeted at a specific country, and there was a long list of countries exempted from the measures.

The row with the pharmaceutical company centres on AstraZeneca’s announcement that it would not be able to deliver as many doses to the EU as initially agreed, due to manufacturing issues – with doses made in the UK set to remain there as per its own agreement with the company.

In a press conference on Friday afternoon, AstraZeneca’s chief executive Pascal Soriot avoided referring to the row with the European Commission directly, but said “glitches and delays” in the manufacturing process were unavoidable.

But he suggested the firm could bring in supplies from elsewhere in the world to fill any shortfall in Europe.

It came after Dombrovskis spoke of a “race against the clock” to deliver vaccines.

“To do this we need to ensure all advance purchase agreements for vaccines made by the EU are honoured. We paid these companies to increase production and now we expect them to do their work,” he said.

The measures will be in place until the end of March he added, and countries exempt include EFTA countries, Switzerland, the EU’s eastern and southern neighbourhood, the Balkans, and the more than 90 countries in the COVAX scheme. Dombrovskis said this was so the EU could “fully honour our humanitarian aid commitments”.

Earlier on Friday, the EU published its coronavirus vaccine contract with AstraZeneca, as the fight over delays to vaccine deliveries continued to escalate.

It came after European Commission President Ursula von der Leyen weighed in on the dispute, telling a German radio station on Friday that there is “no plausible explanation” for its delay in supplying its vaccine to the EU.

The European Medicines Agency on Friday said it recommended conditional marketing authorisation for the AstraZeneca jab after clinical trials showed it was “safe and effective at preventing COVID-19 in people from 18 years of age.”

It will be the third cleared for use in the EU, after the BioNTech-Pfizer and Moderna vaccines.

The European Commission has been locked in a dispute with the British-Swedish pharmaceutical company since it said it would deliver far smaller than expected supplies to EU member nations.

The European Union is looking at legal ways to guarantee the delivery of all the COVID-19 vaccine doses it bought from AstraZeneca and other drugmakers.

‘These are binding orders’, says von der Leyen

The Commission President increased the pressure on AstraZeneca in her interview, reiterating the EU’s view that the contract is unambiguous and its rejection of the company’s reasons for cutting planned supplies by at least 60%.

“There is no plausible explanation. We want to be clear about that now,” von der Leyen told Deutschlandfunk radio.

“There are binding orders and the contract is crystal clear,” she said.

Von der Leyen dismissed the claims by AstraZeneca — which has blamed “glitches” in production — that under its contract with the EU it was only obliged to make “best efforts” to deliver supplies.

“(The phrase) ‘best efforts’ meant as long as it was not clear whether they (AstraZeneca) can develop a vaccine. We have now passed that time. The vaccine is here.”

She added that the Commission wanted to make the contract public. Later, the Commission did just that.

“We want to publish it today,” she said. “This is business sensitive data, that’s clear. But basically: we want to create transparency on these issues that I have just touched on. We know exactly what is in the contract, which is why it is important to us that it is now made public.”

What are the key points in the contract?

The 41-page contract that has been published by the EU is heavily redacted, with details relating to costs, funding, and delivery schedule blacked out.

One key dispute appears to be over the phrase “best reasonable efforts”, which appears more than 15 times.

The contract states that AstraZeneca should use its “best reasonable efforts” to manufacture initial European doses “within the EU for distribution” and deliver them following the marketing authorisation.

“On best effort, the CEO of AstraZeneca was right,” says Gustav Oertzen, a lecturer at Leuphana University in Germany.

“This is all about ‘best reasonable effort’. No clear commitments for delivery, no recognisable penalties, unless in the redacted part. No idea what von der Leyen means by ‘crystal clear commitments’ based on this contract.”

“The argument of AstraZeneca that a problem in the European manufacturing reduces the European (and not the UK) supply is more solid than I thought before,” Oertzen added.

“Maybe a case for lawyers, but together with the ‘best effort’ clauses AstraZeneca seems to have a good case.”

Professor Alberto Alemanno, an EU Law Professor at HEC Paris, told Euronews publication of redacted contracts “would have limited the level of speculation before it snowballed into one of the lowest points for Union’s popular perception,” although he says this wouldn’t have provided answers to all the questions that have arisen.

“More broadly, the current spat between the European Union and Big Pharma unveils an uncomfortable truth. To entrust the discovery, manufacturing and distribution of a vaccine to the private sector through conventional contract law was a suboptimal choice. Under such an approach, industry’s incentives are inherently misaligned to policymakers’ expectations,” he says.

“The EU could have largely avoided this mess with a proactive transparency.”

EU to ‘explore all options’

In a sign of the level of EU mistrust in AstraZeneca, on Thursday Belgian authorities inspected a factory in Belgium that is part of AstraZeneca’s vaccine production chain. It followed a crisis meeting the previous evening between EU officials and the company which failed to resolve the issue.

In a reply to a letter he received from four European government leaders, EU Council President Charles Michel said the EU “should explore all options and make use of all legal means and enforcement measures at our disposal,” if negotiations with drug companies don’t yield satisfaction.

AstraZeneca said last week that it planned to cut initial deliveries in the EU from the scheduled 80 million doses for the first quarter of the year to 31 million doses. The company cited reduced yields from its manufacturing plants in Europe, but the EU suspects doses produced in Europe have been directed elsewhere.

Michel said use of the EU treaties would allow the EU and member states to take “appropriate urgent measures, to ensure effective vaccine production and supply for our population”.

The European Commission also plans to new rules strengthening the control of vaccine exports to ensure the doses it bought are delivered to the bloc’s residents.

The dispute highlights the tension over vaccine supplies as Europe struggles to roll out inoculation programmes against the coronavirus.

AstraZeneca and UK refute German claims

The UK and AstraZeneca hit back on Thursday at the draft recommendation in Germany to restrict use of the vaccine only to people aged 18-64 for now. The country’s vaccination advisory committee cited what it said was insufficient data to judge its effectiveness for older people.

“Our own authorities have made it very clear that they think the Oxford AstraZeneca vaccine is very good and efficacious,” said British Prime Minister Boris Johnson. “The evidence that they’ve seen, that they’ve supplied, is that they think that it is effective across all age groups and provides a good immune response across all age groups.”

“The latest analyses of clinical trial data for the AstraZeneca/Oxford COVID-19 vaccine support efficacy in the over 65 years age group. We await a regulatory decision on the vaccine by the EMA in the coming days,” an AstraZeneca spokesperson said.

Germany’s health minister has stressed that a final decision will not be made until after Friday’s EMA meeting.

Read the original article in EURONEWS