The European Medicines Agency Ema has started the rapid test procedure for the vaccine from the Tübingen manufacturer Curevac.
The Ema announced on Friday.
The decision is based on the preliminary results of laboratory tests and clinical studies. According to the authority, this makes it clear that the vaccine stimulates the production of antibodies against the coronavirus.
Ema evaluates the data according to the so-called rolling review procedure.
The data and results are continuously checked, even if the studies have not yet been completed and no application for approval in the EU has yet been submitted.
The procedure is faster than conventional tests, as the authority’s employees can work in advance and already have a knowledge advantage when the actual application for approval is submitted. According to Ema, the procedure is just as careful as with the conventional method.
EU Health Commissioner Stella Kyriakides welcomed the news from Friday. This will speed up the approval of another vaccine, she wrote on Twitter.
How long the exam will take is still unclear. A vaccine from the pharmaceutical company Johnson & Johnson, for example, has been in the Ema rolling review process since the beginning of December, without an application for approval having been submitted so far. This step is only possible once there is extensive evidence of the effectiveness and safety of a vaccine. Only then does an Ema expert group issue a recommendation for approval.
Second mRNA vaccine from Germany
The vaccine from Curevac is the second mRNA vaccine to be developed in Germany after the product from Biontech. Curevac recently signed a cooperation agreement with the pharmaceutical giant Bayer.
Like the Biontech product, the vaccine contains the instructions for a coronavirus protein with which the pathogen penetrates body cells and thus infects them. This protein alone cannot cause any damage. However, the body recognizes it as an intruder and puts defenses into position.
The se can also stop the real virus.
The mRNA vaccines from Biontech and Moderna have proven to be very effective in the studies that are crucial for approval.
The re is therefore justified hope that the Curevac product will also be effective. However, this can only be assessed with certainty when the results of a large-scale study in which around 35,000 people in Europe and Latin America are taking part. Curevac expects results in the first quarter, i.e. by the end of March at the latest.
The se are crucial for approval.
Should the vaccine be as effective as the other mRNA vaccines, it would have a significant advantage. In contrast to Biontech, the Curevac vaccine does not have to be stored so cool, according to the manufacturer. Accordingly, it lasts for three months even at five degrees. Germany has secured up to 74 million cans.
So far, three vaccines against corona have been approved in the EU and are already being used.
The se are vaccines from the Mainz-based pharmaceutical company Biontech and its US partner Pfizer, the US company Moderna and the British-Swedish group AstraZeneca and the University of Oxford. In addition to the procedure for the Johnson & Johnson vaccine, a rolling approval process for a drug from the US manufacturer Novavax is currently in progress.