- Moderna Inc's MRNA first vaccine candidate against influenza is mRNA-1010, which is being developed in adults.
- The independent Data and Safety Monitoring Board (DSMB) has completed the first interim efficacy analysis for the second Phase 3 trial (P302) conducted in the Northern Hemisphere to evaluate the safety and non-inferior efficacy compared to a licensed flu vaccine.
- The DSMB said mRNA-1010 did not meet the statistical threshold necessary to declare early success.
- The safety board recommended that the trial continues with efficacy follow-up towards the next analysis.
- The DSMB did not identify any safety concerns. Blinded follow-up for safety and efficacy is ongoing in this trial.
- In February, Moderna announced interim results from another Phase 3 trial (P301) of mRNA-1010 in adults.
- Non-inferiority was not met for seroconversion rates and geometric mean titer ratios for the influenza B/Victoria- and B/Yamagata-lineage strains. Meanwhile, mRNA-1010 showed an acceptable safety and tolerability profile.
- The company has developed an update to mRNA-1010 that is expected to have improved immunogenicity against influenza B strains and announced plans to initiate a confirmatory Phase 3 trial this month.
- Moderna's combination vaccine candidates cover respiratory viruses. Phase 1 combination studies with Covid+Flu (mRNA-1073), Flu+RSV (mRNA-1045), and Covid+Flu+RSV (mRNA-1230) have completed enrollment.
- An investigational new drug application for a next-generation Covid+Flu vaccine candidate (mRNA-1083) has been submitted.
- Moderna plans to have combination vaccines available by 2025. It expects six major vaccine product launches in the next few years.
- The company estimates respiratory product sales in 2027 of around $8 billion-$15 billion, with an operating profit of $4 billion-$9 billion.
- Moderna estimates the annual global endemic COVID-19 booster market to be approximately $15 billion. The company has COVID vaccine sales of approximately $5 billion currently contracted for 2023 delivery.
- The company plans R&D spending of $6 billion-$8 billion over the next few years.
- Price Action: MRNA shares are down 3.98% at $153.77 during the premarket session on the last check Tuesday.
- Moderna covid-19 vaccine photo via Wikimedia Commons
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