The European Medicines Agency (EMA) has started a rolling review of Moderna's mRNA-1273 COVID-19 vaccine, after the company reported interim data from the clinical trial.
Preliminary results from non-clinical studies and early clinical studies in adults suggest the vaccine triggers the production of antibodies and T cells.
The primary endpoint of the clinical study was based on the analysis of confirmed COVID-19 cases, adjudicated starting two weeks following the second dose of the mRNA-1273 vaccine. There were 95 confirmed case of COVID-19, of which 90 were observed in the placebo group versus five in the vaccine group.
The phase 3 study met statistical criteria, with vaccine efficacy of 94.5 per cent. The 95 COVID-19 cases included 15 older adults (ages 65+) and 20 participants identifying as being from diverse communities.
A secondary endpoint was severity of COVID-19. Eleven severe cases (as defined in the study protocol) were reported in this first interim analysis. All 11 cases occurred in the placebo group, and none in the mRNA-1273 vaccinated group.
The safety analysis showed that the majority of adverse events were mild or moderate in severity, and the preliminary analysis suggests a broadly consistent safety and efficacy profile across all evaluated subgroups.