Brussels warns that AstraZeneca will miss already reduced targets

Europe’s vaccination push was dealt another severe blow when Brussels warned supplies from AstraZeneca threatened to fall short in the first quarter and hopes faded that the US would provide extra jabs.

Thierry Breton, the internal market commissioner, said he was not seeing “best efforts” from AstraZeneca to meet its EU delivery targets. He urged the company’s board to press managers to increase production.

Separately, the European Commission told diplomats in a private meeting that efforts to secure extra AstraZeneca doses from the US were not likely to succeed in the short term.

The drugmaker is struggling to increase production in the EU after cutting its delivery commitments. The company originally offered to ship at least 100m doses of the Oxford/AstraZeneca vaccine to the EU by the end of March, but in January it angered the bloc by disclosing it would fall well short. 

Chief executive Pascal Soriot has subsequently agreed to a revised target of 40m doses in the first quarter, but the commission now believes the company is on track to miss even this heavily reduced target. 

The safety of the vaccine has been extensively studied in phase 3 clinical trials and peer-reviewed data confirms the vaccine has been generally well-tolerated

“I see efforts, but not ‘best efforts’ — that’s not good enough yet for AstraZeneca to meet its Q1 obligations,” Breton said in a statement to the Financial Times on Thursday night. “It’s time for AstraZeneca’s board to exercise its fiduciary responsibility and now do what it takes to fulfil AZ’s commitments.”

The company has been plagued by production problems, notably lower than hoped for yields in the bioreaction that produce the raw vaccine. Its deliveries to EU countries to date amount to just 11.75m, according to data from the bloc’s European Centre for Disease Prevention and Control accessed on March 11.

AstraZeneca declined to comment on Breton’s statement.

In a separate blow to Europe’s vaccination effort, Denmark, Norway and Iceland suspended use of the AstraZeneca vaccine in a “precautionary” move after a Danish woman died with blood clots following inoculation.

At least five other European countries have halted the use of a specific batch of the vaccine this week, after reports of blood clots sparked a safety probe from the European drugs watchdog. Meanwhile, Italy’s drug regulator on Thursday said it had halted the 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, pausing one of the vaccines is not an easy decision.”

Danish, Austrian and EU authorities said it could not yet be concluded whether there was a link between the blood clots and the vaccine. Sweden’s medical products agency told local media it did not think there was “sufficient evidence” to suspend the vaccine.

Italy’s 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 batch.

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

The UK’s Medicines and Healthcare products Regulatory Agency said it was keeping the issue under review. With more than 11m doses of the AstraZeneca vaccine administered in the UK, the “reports of blood clots received so far are not greater than the number that would have occurred naturally in the vaccinated population”, it said.

AstraZeneca, whose shares fell 2.5 per cent on Thursday in London, said patient safety was its “highest priority”.

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

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

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

Elsewhere in Europe, Spain postponed broadening use of the jab on those over the age of 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