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European regulator approves AstraZeneca vaccine for people over 18

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The European Medicines Agency (EMA) recommended on Friday granting marketing authorization for AstraZeneca’s vaccine against Covid-19 for people aged 18 and over. This is the third vaccine against Covid-19 for which the EMA has recommended authorization.

The European regulator for vaccines and antibiotics, the European Medicines Agency (EMA), on Friday, January 29, authorized the anti-Covid vaccine produced by AstraZeneca and Oxford for people over 18 years old.

This is the third vaccine against Covid-19 for which the EMA has recommended authorization, after the Pfizer / BioNTech and Moderna vaccines.

However, the European Union (EU) is in dispute with the British laboratory, guilty according to it of not respecting the terms of the contract concluded with Brussels.

The EU thus published, on Friday, the contract signed with AstraZeneca for its anti-Covid vaccine, with the stated aim of increasing pressure on the laboratory, called on to respect its commitments, while it reported significant delays of production.

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Brussels demanded from the Swedish-British group the publication of the contract signed in August on the pre-order of 400 million doses, after the announcement of a three-quarter reduction in the first quarter of deliveries promised to the EU.

The forty-page contract, posted online by the Commission, is stripped of many passages deemed “confidential” or relating to “business secrecy” – which include the price, the terms of payment and the exact schedule for deliveries.

“A classic legal objective”

The agreement ensures that AstraZeneca will do “its best” to increase its production capacities, while recalling that compliance with the contract constitutes for it “a legal, valid and binding obligation”.

The company “pledged to make all reasonable efforts to build capacity to produce 300 million doses of the vaccine, without profit or loss,” the text said, citing the option. for the EU to order 100 million additional doses.

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The CEO of AstraZeneca had suggested, in an interview with several media, that his group did not have a formal commitment in terms of deliveries because of the formula “do your best”.

“It seems to say that this is a subjective notion: it is not legally true (…) ‘Best reasonable effort’ is a classic legal objective, usually used in this type of agreement when you buy. something that does not yet exist, ”a Commission official explained on condition of anonymity.

If factors (authorization of the vaccine for example) do not depend on the company, “the rise in production capacities is entirely in the hands of the group,” he said.

UK-made production debate

AstraZeneca has argued a “drop in performance” at a European manufacturing site to explain its delays in deliveries to the EU. An explanation deemed “unsatisfactory” by the Commission, which called for an inspection of the Belgian industrial site concerned, managed by a subcontractor of the group.

According to the EU executive, the contract provides that production would take place in four factories, two in the EU and two in the UK – indications hidden in the text released on Friday – and yield cuts in Belgium should therefore be compensated elsewhere.

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In an interview with certain media, the CEO of AstraZeneca, the French Pascal Soriot, had however assured to have to reserve to the British the production of the factories in the United Kingdom.

An argument strongly contested by Brussels: the use of British factories to supply the EU “is not an option, it is a contractual obligation”, insisted the European official. “We are somewhat embarrassed by the fact that several factories are obviously supposed to supply us with the vaccines ordered, and yet we only receive doses from one of them,” he criticized.

With AFP

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