EMA’s human medicines committee (CHMP) has started the first ‘rolling review’ by evaluating the first batch of nonclinical data of the COVID-19 vaccine developed by AstraZeneca in collaboration with the University of Oxford.
The vaccine is made up of an adenovirus that has been modified to contain the gene for making the SARS-CoV-2 spike protein.
A rolling review is one of the regulatory tools that the agency 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 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 that target the virus.
Results from large-scale clinical trials 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, will also be reviewed.
The rolling review will continue until enough evidence is available to support a formal marketing authorisation application. The rolling review process has been used previously in the assessment of the COVID-19 medicine, remdesivir.