Coronavirus: EMA starts first rolling reviews of COVID-19 vaccines
October 8, 2020
EMA’s human medicines committee (CHMP), in which the FAMHP takes part, has started the first ‘rolling reviews’ of COVID-19 vaccines. The review concerns the vaccine developed by AstraZeneca and the University of Oxford and the vaccine developed by BioNTech and Pfizer.
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.