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EMA announces the date of Moderna’s vaccine review

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December 21, 2020
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EMA announces the date of Moderna’s vaccine review
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The European Medicines Agency (EMA), the block’s drug watchdog, said Thursday it had brought the deadline for assessing a regulatory application for Moderna’s coronavirus vaccine up by almost a week to January 6.

“Taking into account the progress made, the committee has scheduled an extraordinary meeting on January 6, 2021 to finalize its assessment if possible. The meeting, scheduled for January 12, 2021, will be maintained if necessary, “EMA said in a statement on Thursday.

The Amsterdam-based European Medicines Agency (EMA) was originally supposed to make a decision on the US Moderna vaccine on January 12th. However, the regulator announced that Moderna had pre-filed the last outstanding packet of data required to evaluate the application.

“We were able to revise the timelines for the COVID-19 vaccine evaluation due to the incredible efforts of everyone involved in these evaluations: the chairs of the scientific committees, the rapporteurs and their evaluation teams, the scientific experts from all EU member states and my staff at EMA “Said Emer Cooke, EMA Executive Director.

The European Medicines Agency has been under increasing pressure from member states to proceed with approval of a coronavirus vaccine before Christmas. EMA earlier in the week Approved The vaccine candidate approval assessment meeting, developed by US drug maker Pfizer and its German partner BioNTech, would also be postponed a week before December 29 instead of December 29.



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