The European Medicines Agency (EMA) has started the first ‘rolling review’ of a COVID-19 vaccine, which is being developed by AstraZeneca in collaboration with the University of Oxford.
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 EMA’s Committee for Medicinal Products for Human Use (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 rolling review speeds up the regulatory process for a promising medicine or vaccine during a public health emergency.
The CHMP’s decision to start the rolling review of the vaccine is based on preliminary results from non-clinical and early clinical studies suggesting that the vaccine triggers the production of antibodies and T cells.
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 efficacy. 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.
