NewsWorldEMA has began a rolling review of new COVID-19 vaccine manufactured by...

EMA has began a rolling review of new COVID-19 vaccine manufactured by Valneva

The European Medicine Agency (EMA) announced that its human medicines committee (CHMP) has started a rolling review of VLA2001, a COVID-19 vaccine being developed by French company Valneva.

The CHMP’s decision to start the rolling review is based on preliminary results from laboratory studies (non-clinical data) and early clinical studies in adults.

These studies suggest that the vaccine triggers the production of antibodies that target SARS-CoV-2, the virus that causes COVID-19, and may help protect against the disease.

EMA will evaluate data as they become available to decide if the benefits outweigh the risks. The rolling review will continue until enough evidence is available for a formal marketing authorisation application.

EMA notes in its announcement that the CHMP will assess the compliance of VLA2001 with the usual EU standards for effectiveness, safety and quality.

While EMA cannot predict the overall time lines, it should take less time than normal to evaluate an eventual application because of the work done during the rolling review.

The European Medicines Agency will communicate further when the marketing authorisation application for the vaccine has been submitted.

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