EMA initiates rolling review of Valneva’s COVID-19 vaccine (VLA2001)

The European Medicines Agency (EMA)’s human medicines committee (CHMP) has begun a rolling review of VLA2001, a COVID-19 vaccine being developed by Valneva, a French specialty vaccine company focused on the development and commercialisation of prophylactic vaccines for infectious diseases.

The CHMP’s decision to start the rolling review is based on preliminary results from laboratory studies and early clinical studies in adults which suggest that the vaccine triggers the production of antibodies that target SARS-CoV-2 and may help protect against the disease.

EMA stated that it 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.

According to EMA, VLA2001 is expected to prepare the body to defend itself against infection with SARS-CoV-2. The vaccine contains inactivated SARS-CoV-2 that cannot cause the disease. VLA2001 also contains two adjuvants to help strengthen the immune response to the vaccine.

On the 23 November 2021, Valneva signed an Advance Purchase Agreement (APA) with the European Commission (EC) to supply up to 60 million doses of VLA2001 over two years following the EC’s approval on 10 November.

EMA will assess the compliance of VLA2001 with the usual EU standards for effectiveness, safety and quality. EMA also claimed that, while EMA cannot predict the overall timelines, it should take less time than normal to evaluate an eventual application due to the work done during the rolling review. EMA will communicate further when the marketing authorisation application for the vaccine has been submitted.