AstraZeneca vaccine: EU regulators recommend approval of Covid-19 injection

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The much-anticipated decision by the European Medicines Agency came after several EU countries warned they were running out of vaccine doses and as coronavirus deaths were piling up across the continent.

Over the past week, the EU and AstraZeneca have been embroiled in a bitter dispute over vaccine delivery. A week ago, the British-Swedish pharmaceutical giant said it wouldn’t be able to deliver as many doses as the European Union expected – turning the bloc’s vaccination plans upside down.

The European Commission – which has ordered 400 million AstraZeneca doses on behalf of EU member states and is poised to roll the first over the block – said the delay was unacceptable and that the drug maker must find a way to increase supply.

The EMA’s approval came a day after the German Vaccine Commission said it would not recommend the AstraZeneca vaccine to people aged 65 or older, citing insufficient data. The move made distribution plans in Europe’s largest economy even more complicated.

In response, an AstraZeneca spokesperson said the latest analyzes of clinical trial data “support efficacy in the age group over 65 years old.”

German officials say AstraZeneca vaccine should not be given to people over 65, citing lack of data
The dispute between Europe and AstraZeneca is set against a difficult background. EU countries, including Germany, were already short on vaccines, even before the AstraZeneca vaccine was approved on Friday. US drug company Pfizer had previously delayed deliveries of the vaccine it developed with BioNTech in the EU while a manufacturing facility was being upgraded.

In Spain, the Madrid regional government stopped administering the first doses of the vaccine on Wednesday for the next two weeks to ensure there are enough second doses for those who have already received their first injections.

Concerns about expected shortages of the Moderna and Pfizer / BioNTech vaccines mean some French regions, including Paris, will suspend or cancel appointments for first injections, the French Ministry of Health said in a press statement on Thursday.

The death toll from Covid-19 is on the rise, and the slow rollout of shots through the bloc threatens a very fragile economic recovery from the pandemic. This week, only 2 in 100 people in the EU got injections, compared to 7 in 100 people in the US and 11 in 100 in the UK, according to figures from Our World in Data.
Earlier this week, AstraZeneca’s CEO, Pascal Soriot, told La Repubblica of Italy that at least three million doses would be shipped to Europe once the vaccine was approved, with the goal of delivering a total of 17 million doses by the end of February .
Europe has a vaccine shortage. So why is it fighting AstraZeneca?

As the dispute unfolded on Friday, the European Commission published on its website the edited contract it signed with AstraZeneca to purchase its vaccine for all EU member states.

The EU had asked AstraZeneca to publish the contract, signed on August 27, following the company’s announcement of delays. The details of the vaccine delivery schedule have been removed from the published document.

The UK, whose regulator approved the Oxford / AstraZeneca vaccine on December 30, has been administering doses to people over 65 for nearly a month.
In its report, the UK regulator MHRA said there was “limited information available on efficacy in participants aged 65 or older, although nothing indicates a lack of protection”.

CNN’s Schams Elwazer, Nadine Schmidt, Claudia Otto and Chris Liakos contributed to this report.

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