Brussels warns AstraZeneca will miss already reduced targets

Europe’s vaccination campaign took another blow when Brussels warned that AstraZeneca supplies threatened to run out in the first quarter and hopes faded that the United States would deliver more blows.

Thierry Breton, Internal Market Commissioner, said he did not see AstraZeneca’s “best efforts” to meet its EU delivery targets. He urged the company’s board to put pressure on officials to increase production.

Separately, the European Commission told diplomats in a private meeting that efforts to get more AstraZeneca doses of the United States were unlikely to succeed in the short term.

The drugmaker is struggling to ramp up production in the EU after cutting back on delivery commitments. The company had initially offered to ship at least 100 million doses of the Oxford / AstraZeneca vaccine to the EU by the end of March, but in January it angered the bloc by revealing it would be fine in this side.

Managing Director Pascal Soriot later agreed to a revised target of 40 million doses in the first quarter, but the commission now believes the company is on track to miss even that sharply reduced target.

“I see efforts, but not ‘best efforts’ – it is not yet good enough for AstraZeneca to meet its obligations in the first quarter,” Breton said in a statement to the Financial Times on Thursday evening. “It is about time. for AstraZeneca’s board of directors to exercise its fiduciary responsibility and do what it takes now to fulfill AZ’s commitments. ”

The company has been plagued by production problems, including lower than expected yields in the bioreaction that produces the raw vaccine. To date, its deliveries to EU countries amount to just 11.75 million, according to data from the Union’s European Center for Disease Prevention and Control consulted on March 11.

AstraZeneca declined to comment on Breton’s statement.

In another blow to Europe’s vaccination effort, Denmark, Norway and Iceland suspended use of the AstraZeneca vaccine as a “precaution” after a Danish woman died with blood clots after inoculation.

At least five other European countries have discontinued the use of a specific batch of vaccine this week, after reports of blood clots sparked a safety investigation by the European drug watchdog. At the same time, Italy’s medicines regulator said on Thursday it had stopped use of another batch, ABV2856, after two deaths.

“Right now we need all the vaccines we can get,” said Soren Brostrom, head of the Danish health authority. “Therefore, withholding one of the vaccines is not an easy decision.”

Authorities in Denmark, Austria and Europe said it was not yet possible to determine whether there was a link between the blood clots and the vaccine. The Swedish Medicines Agency told local media it did not believe there was “enough evidence” to suspend the vaccine.

The Italian regulator stressed that no causal link had been identified between the vaccine and the deaths, adding that it was working with the European Medicines Agency to probe the lot.

Despite the suspensions, the EMA said on Thursday that the benefits of the vaccine still outweighed the risks and that the vaccine could continue to be given while the incidents were investigated.

The UK Medicines and Health Products Regulatory Agency said it was keeping the issue under review. With over 11 million doses of the AstraZeneca vaccine administered in the UK, “reports of blood clots received so far are no greater than the number that would have occurred naturally in the vaccinated population,” he said. .

AstraZeneca, whose shares fell 2.5% on Thursday in London, said patient safety was its “top priority”.

“Regulators have clear and strict efficacy and safety standards for the approval of any new drug, and that includes,” its vaccine, the company said.

“The safety of the vaccine has been extensively studied in Phase 3 clinical trials and the peer-reviewed data confirms that the vaccine was generally well tolerated,” he said.

No deaths have been attributed directly to a Covid-19 vaccination.

Elsewhere in Europe, Spain has postponed expanding the use of the jab to people over 55 pending further guidance from the EMA. France and Germany said no further action was needed.

Additional reporting by Michael Peel in Brussels, Sarah Neville in London, Dan Dombey in Madrid, Leila Abboud and Victor Mallet in Paris and Guy Chazan in Berlin

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