On Nov. 16, 2020, Moderna announced that the European Medicines Agency (EMA) human medicines committee (CHMP) had started a rolling review of mRNA-1273, the Company’s vaccine candidate against COVID-19.

The CHMP’s decision to start the rolling review of mRNA-1273 was based on preliminary results from non-clinical studies and early clinical studies in adults which suggest that the vaccine triggers the production of antibodies and T cells (cells of the immune system, the body’s natural defences) that target the virus.

The Committee had started evaluating the first batch of data on the vaccine, which come from laboratory studies (non-clinical data). Large-scale clinical trials involving several thousands of people are ongoing, and results are expected shortly. These results provided information on how effective the vaccine was in protecting people against COVID-19 and was assessed once submitted to the agency. All the available data on the safety of the vaccine as well as its pharmaceutical quality (such as its ingredients, the way it is produced, stability and storage conditions) were also reviewed as they become available.