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EMA begins rolling review of AZ’s COVID-19 vaccine candidate

Agency has started evaluating data from non-clinical laboratory studies

The Europe Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has begun its first ‘rolling review’ of AstraZeneca/Oxford University’s COVID-19 vaccine candidate.

According the EMA, the ‘rolling review’ has already started, with the agency already evaluating the first batch of data on the vaccine from non-clinical laboratory studies.

This type of review allows the EMA to accelerate the assessment of a promising medicine or treatment within the context of a public health emergency.

In a ‘rolling review’, as opposed to the traditional method of having access to all data on a medicine’s safety, efficacy and quality prior to submission, the CHMP instead reviews data as and when it becomes available from ongoing studies.

The EMA said that it has started to review the vaccine based on preliminary results from non-clinical and early clinical studies of AZ’s AZD1222 candidate, which suggested that the vaccine triggers the production of antibodies and T cells.

Although large-scale trials involving thousands of participants are currently ongoing, studies of AZ’s vaccine are still on hold in the US after a participant in the UK-based trial experienced a serious adverse event.

“AstraZeneca continues to work with the Food and Drug Administration (FDA) to facilitate review of the information needed to make a decision regarding resumption of the US trial,” AZ said in a statement.

“The safety of trial participants is of paramount importance and we are committed to upholding the highest standards of conduct in clinical trials,” the company added.

Despite the likely delays in the US, the EMA is set to review the data from other large-scale studies over the coming weeks and months.

The agency added that while it cannot definitively say how long the review will take, it expects the process to be shorter than a regular evaluation due to the process of the ‘rolling review’.

“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,” the EMA added.

Article by
Lucy Parsons

2nd October 2020

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