Europe – EMA ends rolling review of CVnCoV COVID-19 vaccine following withdrawal by CureVac AG

EMA has ended the rolling review of CVnCoV, CureVac AG’s COVID-19 vaccine, after the company informed the Agency that it was withdrawing from the process.

Since February 2021, EMA’s human medicines committee (CHMP) has been reviewing data on CVnCoV as part of a rolling review, whereby the company submits data as they become available in order to speed up the evaluation of an eventual marketing authorisation application.

At the time of the company’s withdrawal, EMA had received non-clinical (laboratory) data, data from ongoing clinical studies, data on the quality and manufacturing process of the vaccine and the risk management plan (RMP)…