EMA’s human medicines committee (CHMP) has started a rolling review of VLA2001, a COVID-19 vaccine being developed by 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 will assess the compliance of VLA2001 with the usual EU standards for effectiveness, safety and quality. 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.
EMA will communicate further when the marketing authorisation application for the vaccine has been submitted.

How is the vaccine expected to work?

VLA2001 is expected to prepare the body to defend itself against infection with SARS-CoV-2, the virus that causes COVID-19. 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.