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No EMA decision on Moderna’s Covid-19 vaccine yet

Credit: Belga

The European Medicines Agency (EMA) was unable to decide on an authorisation for the Covid-19 vaccine from US company Moderna on Monday.

The news was first announced by the Dutch MEB (Medicines Evaluation Board), and later confirmed by the EMA itself.

The Agency was expected to announce a decision on Monday evening, following news that the committee was meeting two days earlier than initially agreed.

“This indicates that a careful process is taking place to reach a decision,” MEB President Ton de Boer said during a press conference.

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The MEB is the Dutch medicines agency that is part of the EMA network, as is the Belgian FAMHP (Federal Agency for Medicines and Health Products).

The green light for the Moderna vaccine will be given by a specialised committee of the EMA, in which all European Member States will be represented.

“It now looks like a decision will be reached on 6 January,” said de Boer, who spoke of “great time pressure.”

Several European countries submitted further questions on the vaccine over the weekend. As they have not all been answered, the meeting has not yet been able to make a decision.

Moderna was among the first companies to submit an application for conditional marketing authorisation to EMA, along with Pfizer / BioNTech, whose vaccine was recommended for approval on 21 December 2020, and approved by the European Commission on the same day.

Maïthé Chini
The Brussels Times