Great news from EMA! The human medicines committee (CHMP) has started a “rolling review” of data on a new vaccine for COVID-19, mRNA-1273, which is being developed by Moderna Biotech Spain, S.L..
Preliminary results from non-clinical and clinical studies in adults suggest that the vaccine triggers the production of antibodies and T cells that target the virus. EMA will assess the vaccine’s compliance to the usual standards for effectiveness, safety and quality.
In particular, the Committee has started evaluating the first batch of data on the vaccine, which come from pre-clinical studies.
Three main large-scale clinical trials (NCT04283461, NCT04405076, NCT04470427) involving several thousands of people are ongoing, and results are expected shortly. Preliminary data from these trials are available here.
If you wish to discover more about clinical studies exploring new treatments for COVID-19 visit our COVID-19 page!
The rolling review will continue until enough evidence is available to support a formal marketing authorisation.
Discover more about the EMA rolling review procedure by reading our tips and follow us to keep you up to date on the latest advancements of the research on COVID-19!