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Monday, January 4, 2021

EU drugs agency still undecided on Moderna COVID vaccine

 The European Medicines Agency (EMA) has not been able to reach a decision on the approval of Moderna’s COVID-19 vaccine on Monday, the Dutch national medicines authority said.

The EMA’s human medicines committee (CHMP) had called an unscheduled meeting Monday afternoon to discuss Moderna’s vaccine, two days ahead of its originally planned meeting on Wednesday.

The Dutch medicines regulator CBG said approval could still follow at the meeting on Jan 6.

It said it was not clear why a decision was not reached on Monday.

“This is how it goes, of course we had hoped for more, but we knew it could be impossible to answer all questions in detail in one meeting”, CBG chairman Ton de Boer told reporters.

“I hope there will be a decision on Wednesday. But I don’t know.”

The agency has set a Jan. 12 deadline for whether to recommend Moderna’s vaccine. It recommended a COVID-19 vaccine from Pfizer and its German partner BioNTech on Dec. 21.

https://www.reuters.com/article/us-health-coronavirus-vaccine-moderna/eu-drugs-agency-still-undecided-on-moderna-covid-vaccine-dutch-regulator-idUSKBN2991I6

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