The accelerated assessment (‘rolling review’) of the corona vaccine of Valneva has started. This is reported by the CHMP, the assessment committee of the European medicine agency EMA. The MEB Medicines Authority is a member of this committee on behalf of the Netherlands.
From judgement was started on the basis of preliminary results from laboratory studies and first studies in adults. From this data, it seems that this vaccine causes the body to make antibodies against the coronavirus.
How does this vaccine work?
Valneva’s vaccine VLA2001 is a so-called inactivated virus vaccine. It contains inactivated (“dead”) virus particles. These have been edited in such a way that they can no longer make someone sick. This vaccine also contains two excipients (‘adjuvants’) that enhance the body’s immune response to this virus.
If you get this shot, your body learns to make antibodies against the coronavirus. Will you really come into contact with the coronavirus later? Then you may not get sick or become less sick as a result. We also know this technique from other vaccines, such as the flu shot.
Accelerated procedure
In a rolling review, manufacturers submit information about the vaccine on an ongoing basis, even before all studies have been completed. As soon as data is available, the EMA will assess that information. The committee is looking at whether the benefits of the vaccine outweigh the drawbacks. Is there enough data available? Then the manufacturer can submit an application for market authorisation. It is not yet possible to predict how long that will take.
There are now four vaccines in Europe with (conditional) market approval. Valneva is the fifth corona vaccine that the committee is now reviewing.
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