Europe – EMA accepts Valneva’s marketing authorisation application for COVID-19 vaccine

The European Medicines Agency (EMA) has accepted Valneva’s marketing authorisation application (MAA) for its COVID-19 vaccine candidate, VLA2001.

The COVID-19 vaccine candidate can now move from the initial rolling review process to the formal review process, which is overseen by the Committee for Human Medicinal Products (CHMP).

Valneva’s vaccine candidate is currently the only whole virus, inactivated, adjuvanted candidate for COVID-19 in clinical trials in Europe.

The vaccine is intended for active immunisation of vulnerable populations to prevent carriage and symptomatic infection with COVID-19 during the pandemic. It is also hoped that it will be used for routine vaccination and as means of addressing new variants…