Rolling review of AstraZeneca's COVID-19 vaccine started by EMA unit

The European Medicines Agency’s human medicines committee (CHMP) has started the first ‘rolling review’ of a COVID-19 vaccine, AZD1222, which is being developed by AstraZeneca (LSE: AZN) in collaboration with the University of Oxford.

The start of the rolling review means that the committee has started evaluating the first batch of data on the vaccine, which come from laboratory studies (non-clinical data). This does not mean that a conclusion can be reached yet on the vaccine’s 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 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.