EMA Starts Rolling Review Of Moderna COVID-19 Vaccine

European Medicines agency releases a statementsaying that it has begun a 'rolling review' on a potential COVID-19 vaccine from Moderna.

• "EMA's human medicines committee has started a 'rolling review' of data on a vaccine for COVID-19 known as mRNA-1273, which is being developed by Moderna Biotech Spain, S.L. The CHMP's decision to start the rolling review of mRNA-1273 is 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 has 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 will provide information on how effective the vaccine is in protecting people against COVID-19 and will be 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) will also be reviewed as they become available."
• Wires reporting Moderna as saying that the candidate vaccine is now expected to remain stable at standard refrigerator temperatures of 2 to 8 degrees Celsius (36 to 46 degrees Fahrenheit) for 30 days, up from previous estimate of 7 days.