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 vaccine...to support the rigour required for a conditional marketing authorisation".
"The available data must indicate that the medicine’s benefits outweigh its risks," it said.
BREAKING NEWS: The Government has accepted @MHRAgovuk recommendation for authorisation of @OxfordVacGroup/@AstraZeneca's #COVID19 vaccine for use in the UK.— Department of Health and Social Care (@DHSCgovuk) December 30, 2020
✅ clinical trials
✅ data analysis
✅ MHRA authorisation
Read full statement:https://t.co/Q7axT6mXWN pic.twitter.com/Bw2PARzlBp
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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.
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