EU regulator says not enough data on AstraZeneca vaccine as UK begins rollout

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As the United Kingdom begins rolling out the Oxford-AstraZeneca Covid-19 vaccine on Monday, the European Medicines Agency (EMA) has said it still lacks sufficient data in order to approve it.

In a statement, the EMA, which advises the European Commission on whether medicines can be authorised for marketing, said it was currently assessing data on the vaccine as part of a rolling review.

It said additional scientific information was needed on issues "related to quality, safety and efficacy of the support the rigour required for a conditional marketing authorisation".

"The available data must indicate that the medicine’s benefits outweigh its risks," it said.

UK rollout

The United Kingdom on Monday began its rollout of the vaccine developed by AstraZeneca and the University of Oxford with 530,000 doses.

It is considered a game-changer by many experts because it does not require ultra-cold temperatures for storage like the vaccines from Pfizer-BioNTech and Moderna.

The EMA pointed out that the UK medicines regulator "granted a temporary authorisation of supply of the vaccine in the emergency use setting, which is distinct from a marketing authorisation".

"EMA, its European experts and the European Commission are working towards conditional marketing authorisation of Covid-19 vaccines, with all the safeguards, controls and obligations that this imposes," it stated.

On 21 December, the EMA recommended granting a conditional marketing authorisation to the Pfizer-BioNTech vaccine for the EU. It is expected to announce approve a similar recommendation same with the Moderna jab on Wednesday.