European medicines regulator brings forward Moderna's vaccine review date - Reuters UK - 1 minute read
FILE PHOTO: Vials with a sticker reading, "COVID-19 / Coronavirus vaccine / Injection only" and a medical syringe are seen in front of a displayed Moderna logo in this illustration taken October 31, 2020. REUTERS/Dado Ruvic/Illustration
(Reuters) - Europe’s medicines regulator on Thursday set up an exceptional meeting for Jan. 6 to assess a marketing authorisation application for Moderna’s COVID-19 vaccine.
The European Medicines Agency (EMA) had earlier planned to meet on Jan. 12 to review the application.
“Today, ahead of schedule, (Moderna) has submitted the last outstanding data package needed for the assessment of the application. This contains information that is specific to the manufacturing of the vaccine for the EU market,” the EMA said.
The regulator had said on Tuesday that an expert panel would convene on Dec. 21 to evaluate the vaccine made by U.S. company Pfizer and German partner BioNTech. It had previously said the meeting could be as late as Dec 29.
Source: Reuters
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(Reuters) - Europe’s medicines regulator on Thursday set up an exceptional meeting for Jan. 6 to assess a marketing authorisation application for Moderna’s COVID-19 vaccine.
The European Medicines Agency (EMA) had earlier planned to meet on Jan. 12 to review the application.
“Today, ahead of schedule, (Moderna) has submitted the last outstanding data package needed for the assessment of the application. This contains information that is specific to the manufacturing of the vaccine for the EU market,” the EMA said.
The regulator had said on Tuesday that an expert panel would convene on Dec. 21 to evaluate the vaccine made by U.S. company Pfizer and German partner BioNTech. It had previously said the meeting could be as late as Dec 29.
Source: Reuters
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