Moderna Inc's (NASDAQ: 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
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