Supply issues remain as EMA to make decision on AstraZeneca vaccine

A member of staff holding a dose of the Oxford/Astrazeneca coronavirus in the UK. File picture

The European Medicines Agency (EMA) is due to announce a decision on whether to approve the AstraZeneca/Oxford University vaccine today.

The vaccine would be the third jab approved for use in the EU, after the BioNTech/Pfizer and Moderna vaccines.

It is expected that the EMA will approve the vaccine, however, there is frustration surrounding the supply of the vaccine within the EU.

The AstraZeneca jab has been hailed as a “game-changer” by the Taoiseach and the Health Minister, but there are fears Ireland’s supply of the vaccine could be halved.

European authorities are under pressure after a sluggish start to the EU’s vaccination campaign in its first month, and the AstraZeneca serum would add much-needed extra supplies.

AstraZeneca said last week that it planned to cut initial deliveries in the EU from the scheduled 80 million doses scheduled to 31 million doses because of reduced yields from its manufacturing plants in Europe.

The company cited reduced yields from its manufacturing plants in Europe, but the EU suspects doses produced in Europe have been directed elsewhere.

In a reply to a letter he received from four European government leaders, European Council president Charles Michel said the EU “should explore all options and make use of all legal means and enforcement measures at our disposal”, if negotiations with drug companies do not yield satisfaction.

Adding to the uncertainty, a draft recommendation from a German expert committee called for offering the Oxford/AstraZeneca vaccine only to people under the age of 65 for now.

The draft recommendation adds a question mark over how widely it might be used — though the country’s health minister stressed that a final decision will not be made until after Friday’s EMA meeting.

Germany’s vaccination advisory committee, an independent panel advising the government, called for using AstraZeneca’s vaccine for the 18-64 age group on the basis of currently available information.

It said that “there currently is not sufficient data to assess the vaccination effectiveness from 65 years”.

AstraZeneca said after Thursday’s release of the German draft that “the latest analyses of clinical trial data for the AstraZeneca/Oxford Covid-19 vaccine support efficacy in the over 65 years age group”.

It added that it awaits EMA’s decision.

Earlier this week, Health Minister Stephen Donnelley rowed back on a commitment to have the entire country vaccinated by September by claiming he never made such a promise.

Mr Donnelly said his recent announcement on the rollout of vaccines "wasn't a promise" as it was "heavily caveated" based on the schedule of advanced purchase.