AstraZeneca Covid Vaccine Approved for EU Market

The use of the Oxford-AstraZeneca Covid-19 vaccine for people aged over 18 has been approved by the European Medicines Agency (EMA).

The EU’s drugs regulator said the AstraZeneca vaccine was about 60% effective in the trials on which it based its decision.

The move comes amid a dispute over whether Anglo-Swedish drug-maker is breaking its vaccine delivery commitments to the EU.

The European Commission has published its contract with Astra-Zeneca, hoping to show a breach.

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% 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.

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The EU has said AstraZeneca must honor its commitments and deliver the doses it ordered by diverting doses manufactured in the UK. However, the company said its contract for UK supplies prevents this.

European Commission chief Ursula von der Leyen told German radio on January 29 that the EU contract signed in August contained “binding orders”, and called for an explanation.

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

A European Commissioner said it was being introduced to enhance transparency and to ensure that all EU citizens had access to vaccines.

Germany’s vaccine commission said this week that it could not recommend the use of AstraZeneca vaccine in people aged over 65, citing a lack of data on how it affected this age group.

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

Confirming it had approved the vaccine, the 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.”

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