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THE HAGUE: AstraZeneca and Oxford University have applied for authorisation for their coronavirus vaccine in the European Union with a decision possible by January 29, The European Medicines Agency said on Tuesday.
The jab would be the third available for the 27-nation EU after the Pfizer-BioNTech and Moderna drugs, as the bloc struggles to speed up the rollout.
“EMA has received an application for conditional marketing authorisation for a COVID-19 vaccine developed by AstraZeneca and Oxford University,” the Amsterdam-based regulator said in a statement.
The EMA said its assessment would “proceed under an accelerated timeline”.
“An opinion on the marketing authorisation could be issued by 29 January… provided that the data submitted on the quality, safety and efficacy of the vaccine are sufficiently robust and complete,” it said.
The EU and the EMA have been under pressure to speed up the approval of new vaccines against the virus, which has claimed the lives of more than 620,000 people across the continent.
The jab would be the third available for the 27-nation EU after the Pfizer-BioNTech and Moderna drugs, as the bloc struggles to speed up the rollout.
“EMA has received an application for conditional marketing authorisation for a COVID-19 vaccine developed by AstraZeneca and Oxford University,” the Amsterdam-based regulator said in a statement.
The EMA said its assessment would “proceed under an accelerated timeline”.
“An opinion on the marketing authorisation could be issued by 29 January… provided that the data submitted on the quality, safety and efficacy of the vaccine are sufficiently robust and complete,” it said.
The EU and the EMA have been under pressure to speed up the approval of new vaccines against the virus, which has claimed the lives of more than 620,000 people across the continent.
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