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.
The CHMP’s decision to start the rolling review of the vaccines is based on preliminary results from non-clinical and early clinical studies suggesting that the vaccines trigger the production of antibodies and T cells (cells of the immune system, the body’s natural defences) that target the virus.
Large-scale clinical trials involving several thousands of people are ongoing, and results will become available over the coming weeks and months. These results will provide information on how effective the vaccines are in protecting people against COVID-19 and will be assessed in later rolling review cycles. All the available data on the safety of the vaccine emerging from these studies, as well as data on its quality (such as its ingredients and the way it is produced), will also be reviewed.
The rolling review will continue until enough evidence is available to support a formal marketing authorisation application.
EMA will complete its assessment according to its usual standards for quality, safety and effectiveness. While the overall review timeline cannot be forecast yet, the process should be shorter than a regular evaluation due to the time gained during the rolling review. The rolling review process has been used previously in the assessment of the COVID-19 medicine, Veklury (remdesivir).