COVID19: EMA reviews new Valneva vaccine

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The European Medicines Agency (EMA) announced its human medicines committee (CHMP) started a rolling review of VLA2001, a COVID-19 vaccine 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 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.

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

It will communicate further when the marketing authorisation application for the vaccine has been submitted.

The vaccine contains inactivated (killed) SARS-CoV-2 that cannot cause the disease.

VLA2001 also contains two ‘adjuvants’, substances to help strengthen the immune response to the vaccine.

When a person is given the vaccine, their immune system identifies the inactivated virus as foreign and makes antibodies against it.

If, later, the vaccinated person comes into contact with SARS-CoV-2, the immune system will recognise the virus and be ready to defend against it.