Monday, 04 January 2021
A decision on whether Moderna’s coronavirus vaccine could be recommended for approval in Europe could come as early as Monday evening.
The European Medicines Agency (EMA) was initially expected to decide whether or not to issue a recommendation for approval for the Moderna vaccine on Wednesday, but the agency’s committee responsible for medicines for human use is meeting two days earlier.
The committee will look into the safety and efficacy of the Moderna vaccine. If they do not reach a conclusion yet, the agency will continue its review on Wednesday.
Moderna was among the first companies to submit an application for a 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.
The United Kingdom started its rollout of the AstraZeneca / Oxford coronavirus vaccine on Monday, but it is unlikely the EU will approve that vaccine in January, as EMA has yet to receive an application for approval.
So far, only the vaccine developed by Pfizer and BioNTech has been approved for use in the EU. The Commission has ordered a total 300 million doses of the vaccine so far.
The Brussels Times