Covid-19: EU drugs regulator approves AstraZeneca vaccine

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The EU’s drugs regulator has approved the use of the Oxford-AstraZeneca Covid vaccine for all adults.

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Photo: Verwendung weltweit/ AFP

The European Medicines Agency (EMA) said the AstraZeneca vaccine was about 60 percent effective in the trials on which it based its decision.

The move comes amid a dispute over whether AstraZeneca is breaking its vaccine delivery commitments to the EU.

The European Commission has published its contract with the Anglo-Swedish drug-maker, hoping to show a breach.

The bloc agreed to buy up to 400 million doses of the Astra-Zeneca vaccine last year.

In a press conference later on Friday, the drug giant’s chief executive Pascal Soriot said that while “of course there will be glitches” in manufacturing, the important thing was that the world had developed several vaccines within a year.

Soriot said AstraZeneca had millions of doses ready to ship to the EU, and was working 24/7 to increase capacity.

What is the supply row about?

Last week AstraZeneca said vaccine supplies would be reduced because of problems in one of its EU factories.

The shortfall is expected to be about 60 percent in the first quarter of 2021. The EU has also received fewer than expected doses of the two other vaccines it has approved – from Pfizer-BioNTech and Moderna.

The EU has said AstraZeneca must honour its commitments and deliver the jabs it ordered by diverting doses manufactured in the UK. The company said its contract for UK supplies prevented this.

But an EU source familiar with the matter told the BBC that AstraZeneca’s UK facilities were legally obliged to do so, saying: “This is not an option, it is a contractual obligation.”

The UK plants are not back-up facilities; they are part of the main network, the source added.

The company’s chief executive, Soriot, said earlier this week that the contract obliged AstraZeneca to make its “best effort” to meet EU demand, without compelling it to stick to a specific timetable – an assertion disputed by the EU.

“There are binding orders and the contract is crystal clear,” European Commission chief Ursula von der Leyen said in an interview with German radio on Friday morning.

“‘Best effort’ was valid while it was still unclear whether they could develop a vaccine. That time is behind us. The vaccine is there.

“AstraZeneca has also explicitly assured us in this contract that no other obligations would prevent the contract from being fulfilled,” she said.

What is the EU doing about shortages?

The European Commission said on Friday it had agreed a plan to introduce export controls on coronavirus vaccines. This means individual member states will decide whether to allow the export of vaccines produced in the territory. It will be in place until the end of March.

EU Health Commissioner Stella Kyriakides told a news conference the controls were being introduced to ensure all EU citizens had access to vaccines, and to make sure all parties played by the rules.

“This approach is built on trust, transparency and responsibility,” she said.

“Commitments need to be kept, and agreements are binding. Advance purchase agreements need to be respected.

“Today, we have developed a system which will allow us to know whether vaccines are being exported from the EU. This increased transparency will also come with a responsibility for the EU to authorise, with our members states, these vaccine exports.”

The World Health Organization’s Mariangela Simao, assistant director for access to medicines and health products, described the export ban as a worrying trend.

How effective is the AstraZeneca vaccine?

Germany’s vaccine commission has said it cannot recommend the use of the jab in people aged over 65, citing a lack of data on how it affected this age group.

Individual EU countries are free to decide who vaccines should be given to, once they have been approved.

However, the UK has been using the AstraZeneca vaccine in its mass immunisation programme for weeks now, and public health officials say it is safe and provides “high levels of protection”.

Research has shown it is highly effective. No-one who received the Oxford vaccine in trials was hospitalised or became seriously ill due to Covid.

The vaccine is given via two injections to the arm, the second between 4 and 12 weeks after the first.

Confirming it had approved the AstraZeneca vaccine, the European Medicines Agency (EMA) said that most participants in the test studies were between 18 and 55 years old. It said that while there were not yet enough results to show how the vaccine will work in older people, “protection is expected, given that an immune response is seen in this age group and based on experience with other vaccines.”

AstraZeneca has said a US study will shortly provide additional data on the vaccine’s efficacy in older adults.

– BBC

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