relax: "Today's results represent an important step forward in the development of mRNA-based influenza vaccines to address the substantial burden of disease caused by influenza. We are encouraged by the safety and tolerability profile, and by the strong immunogenicity results against Influenza A viruses which cause the overwhelming majority of flu-related disease in older adults. We now look forward to the efficacy results from the ongoing pivotal Phase 3 efficacy study being conducted in parallel," said Stephen Hoge, M.D., Moderna's President. "While we did not achieve non-inferiority for the Influenza B strains which are more frequent in younger populations, we have already updated the vaccine that we believe could improve immune responses against Influenza B and will seek to quickly confirm those improvements in an upcoming clinical study thanks to the agility of our mRNA platform."
Moderna said it has already updated mRNA-1010 in a way it believes will improve immune responses against Influenza B and will test those changes.
The first per protocol interim analysis of efficacy is now expected to be reviewed by an independent Data and Safety Monitoring Board (DSMB) before the end of the first quarter. Based on these results the DSMB will notify the Company whether the primary efficacy endpoint has been met or whether the study should continue accruing further cases towards the final analysis.
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