EMA initiates rolling review of CureVac’s CVnCoV COVID-19 vaccine
The rolling review will assess CVnCoV’s efficacy and immunogenicity data as it becomes available, speeding the decision process for an eventual marketing authorisation application.
The European Medicines Agency (EMA)’s Committee for Human Medicinal Products (CHMP) has started a rolling review of CureVac AG’s COVID-19 vaccines, CVnCoV.
The review was initiated because preliminary laboratory studies and early clinical trial results suggest the vaccine triggers the production of antibodies and immune cells that target SARS-CoV-2, the virus that causes COVID‑19.
The review will sequentially review data as it becomes available, starting with the preclinical and early phase evidence currently submitted. In contrast to a traditional marketing authorisation application, in which all data on a medicine’s or vaccine’s effectiveness, safety and quality and all required documents must be ready at the start of the evaluation.
Ongoing trials are continuing to evaluate the vaccine’s safety, immunogenicity and effectiveness against COVID-19. EMA will evaluate data from these and other clinical trials as they become available.
The rolling review will continue until the CHMP decides that sufficient data is available for a formal marketing authorisation application. As a result of the work undertaken in the rolling review, it should take less time than normal to evaluate such an application.
EMA will assess the vaccine’s compliance with the usual standards for effectiveness, safety and pharmaceutical quality within the rolling review process.
CVnCoV is an mRNA vaccine which encodes the SARS-CoV-2 Spike (S) protein. The mRNA sequence is formulated in minute lipid particles to prevent it from being broken down too quickly.
When a person receives the vaccine, some of their cells will use the mRNA molecules to temporarily produce the S protein. This activates the person’s immune system, priming it to respond more quickly to a subsequent SARS-CoV-2 infection.
The mRNA from the vaccine does not persist in the body, it is broken down shortly after vaccination.