EMA’s Committee for Medicinal Products for Human Use (CHMP) has started a rolling review of the COVID 19 vaccine being developed by CureVac.
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. These studies suggest that the vaccine triggers the production of antibodies and immune cells that target SARS-CoV-2, the virus that causes COVID 19.
The company is currently conducting trials in people to assess its safety, immunogenicity (how well the vaccine triggers a response against the virus) and its effectiveness against COVID-19. EMA will evaluate data from these and other clinical trials as they become available. The rolling review will continue until enough evidence is available for a formal marketing authorisation application.
EMA will assess the vaccine’s compliance with the usual standards for effectiveness, safety and pharmaceutical 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.
How is the vaccine expected to work?
The CureVac vaccine is expected to prepare the body to defend itself against a COVID-19 infection. The SARS-CoV-2 virus uses proteins on its outer surface, called spike proteins, to enter the body’s cells and cause COVID-19. Curevac’s candidate vaccine contains a molecule called messenger RNA (mRNA) which has instructions for making the spike protein. The mRNA is contained in tiny particles of fats (lipids) that prevent it from being broken down too quickly.
When a person is given the vaccine, some of their cells will read the mRNA instructions and temporarily produce the spike protein. The person’s immune system will then recognise this protein as foreign and produce antibodies and activate T cells (white blood cells) against it.
If later on, the person comes into contact with SARS-CoV-2 virus, their immune system will recognise the protein and be ready to defend the body against the virus.
The mRNA from the vaccine does not stay in the body but is broken down shortly after vaccination.