The start of the rolling review means that the committee has started evaluating the first batch of data on the vaccines, which come from laboratory studies (non-clinical data). This does not mean that a conclusion can be reached yet on the vaccines’ safety and effectiveness, as much of the evidence is still to be submitted to the committee.

A rolling review is one of the regulatory tools that EMA uses to speed up the assessment of a promising medicine or vaccine during a public health emergency. Normally, all data on a medicine’s effectiveness, safety and quality and all required documents must be submitted at the start of the evaluation in a formal application for marketing authorisation. In the case of a rolling review, the CHMP reviews data as they become available from ongoing studies, before deciding that sufficient data are available and that a formal application should be submitted by the company. More information.