Coronavirus

Corona vaccine: EMA declares on December 11th. all the process of approval

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Chancellor Angela Merkel (CDU) and EU Commission chief Ursula von der Leyen made high hopes for a quick approval of a corona vaccine. Merkel expects a corona vaccine to be approved in Europe as early as December or “very soon after the turn of the year”, as she said on Thursday evening after video consultations with EU heads of state and government.

Von der Leyen said that the vaccines from Biontec and Pfizer as well as Moderna could get conditional marketing approval in the second half of December – if everything goes on without any problems. The Mainz company Biontech and its US partner Pfizer announced on Wednesday that the effectiveness of their vaccine was 95 percent – and thus even higher than previously known. The US company Moderna had recently calculated an effectiveness of 94.5 percent for its preparation.

The European Medicines Agency (EMA) itself has announced that it will organize a virtual meeting, accessible to all interested parties, on December 11th to explain the processes for the development, evaluation, approval and safety monitoring of Covid-19 vaccines in the EU.

It will also give the public and stakeholders the opportunity to speak up and share their needs, expectations and concerns, which will be taken into account by the EMA and the European Network for Medicines Regulation in the decision-making process.

Three vaccines are in the “rolling” approval process

The EMA is currently undergoing approval processes for three potential corona vaccines: the vaccine from Oxford University and AstraZeneca, the active ingredient called BNT162b2 from Biontech and Pfizer, and the candidate mRNA-1273 from Moderna on November 16.

Approval takes place in a so-called “rolling review” – a “rolling”, i.e. continuous evaluation of the data – introduced for particularly urgent approval procedures. In this way, parts of the application regarding the quality, safety and effectiveness of the vaccine can be submitted and assessed before the complete application is submitted. Until there is enough data for a formal application for approval.

The task of the EMA is to coordinate medicines and vaccines in Europe in a centralized process. Approval for all EU member states is then carried out by the European Commission.

with dpa

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