Moderna Inc. announced positive interim results from a Phase 1/2 trial of its combination vaccine against COVID-19 and flu on Wednesday, and said it would start a Phase 3 trial for adults aged 50 and above. The trial sought to evaluate the safety and immunogenicity of mRNA-1083 compared to a standard dose influenza vaccine, Fluarix, in adults 50-64 years of age, and against an enhanced influenza vaccine, Fluzone HD, in adults 65-79 years of age. For both age groups, mRNA-1083 was compared against the company’s Spikevax COVID booster. The company expects to launch the Phase 3 trial in 2023 and is aiming for approval in 2025. Moderna has previously said it expects respiratory product sales of $8 billion to $15 billion in 2027, producing operating profit of $4 billion to $9 billion. The stock MRNA was up 0.6% premarket but has fallen 43% in the year to date, while the S&P 500 SPX has gained 10%. More to come.
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