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European regulator seeking extra data on AstraZeneca vaccine

Regulator says it expects more clinical trial results in January

The European Medicines Agency has requested more data from pharmaceutical company AstraZeneca regarding the safety and efficacy of its Covid-19 vaccine, which has been approved for emergency use in some countries but has not yet received EU approval.

“So far, some evidence has been assessed on safety and efficacy coming from a pooled analysis of interim clinical data from four ongoing clinical trials in the UK, Brazil and South Africa,” the EMA said on 30 December. The agency said that in addition to requesting extra data it expected further data from clinical trials to be made available in January.

The EMA has been carrying out a rolling review of the AstraZeneca vaccine, developed with the University of Oxford, since October 2020. It is considering whether to recommend a longer-term authorisation than the emergency authorisations that have been issued by regulators in countries including the UK. 

‘High EU standards’

So far, the EU has approved only the Covid-19 vaccine developed by BioNTech and Pfizer, while the UK and United States have approved two vaccines. Critics have hit out at the duration of the EU evaluation process and slow pace of individual countries’ rollout of the EU’s one approved vaccine, as countries including Israel and the UK have made much faster progress on vaccination.

But the EMA said its process “ensures that Covid-19 vaccines meet the same high EU standards as for all vaccines and medicines”.

Its announcement came a day after European Commission president Ursula von der Leyen announced that the EU had ordered an additional 100 million doses of the vaccine developed by BioNTech and Pfizer, bringing the total order to 300 million doses.