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European Medicines Agency market authorisation meeting for Moderna vaccine brought forward to 6 January

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Over the last few weeks, EMA has made good progress on the assessment of the marketing authorisation application for Moderna’s mRNA-1273 COVID-19 vaccine. A continuous dialogue with the company has ensured that questions that arose during the evaluation were swiftly followed up and addressed by the company.

Today (17 December) ahead of schedule, the company 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.

Taking due account of the progress made, the Committee has scheduled an extraordinary meeting on 6 January 2021 to conclude its assessment, if possible. The meeting planned for 12 January 2021 will be maintained if needed. 

“We have been able to revise the timetables for the evaluation of the COVID-19 vaccines due to the incredible efforts of everybody involved in these assessments: the chairs of the scientific committees, the rapporteurs and their assessment teams, scientific experts in all EU Member States and my staff at EMA,” said Emer Cooke, EMA Executive Director, who also stressed that these timetables, as for any medicine, are set provisionally. “We have constantly revised our planning to further streamline all the procedural aspects that need to be in place for a robust scientific assessment that leads to a marketing authorisation in all EU countries. The number of infections is increasing across Europe and we are aware of the huge responsibility we have to get a vaccine to the market as quickly as is feasible, whilst maintaining the robustness of our scientific review.”

The rate of progress of the further evaluation will depend on the robustness of the data as well as the availability of additional information from the company to respond to questions raised during the evaluation. The EMA need convincing evidence that the benefits of the vaccine are greater than any potential risks.

Once market authorisation is given the European Commission will be able to fast track its decision-making process with a view to granting a marketing authorisation valid in all EU and EEA Member States within days.

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