Europe – EMA starts rolling review of COVID-19 vaccine Vidprevtyn

EMA’s human medicines committee (CHMP) has started a rolling review of Vidprevtyn, a COVID-19 vaccine developed by Sanofi Pasteur.

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, which 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 Vidprevtyn 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…