01 October 2020
15:28
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The European Medicines Watchdog starts the accelerated evaluation of the potential Covid-19 vaccine that the British AstraZeneca and the University of Oxford are developing.
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Such a procedure, the first in Europe for a Covid-19 vaccine, allows the EMA as regulator to evaluate all data while clinical tests are still ongoing, with the advantage that it can estimate more quickly whether the vaccine is in the right direction. applies.
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Still waiting for a lot of data
The EMA emphasizes that it has only just started to analyze the data from the laboratory studies of the vaccine, and therefore not yet with the clinical data. The watchdog points out that no conclusions can yet be drawn about the safety and effectiveness of the candidate vaccine, because a lot of data still has to be provided.
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For example, large-scale clinical studies with thousands of people are still ongoing worldwide and the results will become available in the coming weeks and months. EMA indicates that the ‘rolling review’ will continue until there is enough evidence to support a formal market authorization application.
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The European Commission previously negotiated a collective purchase deal for 300 million doses of the British AstraZeneca-Oxford vaccine, which is distributed among Member States according to population size. Of that our country buys 7.5 million doses On.
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