Moderna sees combo flu/COVID vaccine available as early as 2025

Shares of Moderna are up $6.65, or 6%, to $111.89 after the company earlier announced business and clinical updates across its franchises and introduced several new development programs at the company’s annual R&D Day. Moderna stated: “On September 11, 2023, the U.S. Food and Drug Administration approved the supplemental Biologics License Application for Spikevax for ages 12 years and above. Emergency Use Authorization for the Moderna COVID-19 Vaccine was also received for individuals 6 months through 11 years of age. Moderna’s updated COVID-19 vaccine contains spike proteins for the XBB.1.5 sublineage of SARS-CoV-2 to help prevent COVID-19 in individuals 6 months of age and older. Clinical trial data confirm mRNA-1273.815 showed a strong immune response in humans against BA.2.86, EG.5 and FL.1.5.1 variants. With the U.S. FDA’s decision, Moderna has begun shipping doses to vaccination sites across the U.S., with updated vaccines expected to be available in the coming days. In addition, the company’s next-generation, refrigerator-stable COVID-19 vaccine, mRNA-1283, demonstrated encouraging results in multiple clinical studies and has now completed enrollment of its Phase 3 trial… Moderna’s development strategy for combination vaccines can provide substantial public health benefits. The company’s combination vaccine candidates address respiratory viruses associated with the largest disease burden in the category and are designed for higher compliance, increased uptake, consumer convenience and benefits to healthcare systems. Enrollment is now complete in the following combination trials: Flu/COVID-19 (mRNA-1073: mRNA-1010 + mRNA-1273) Phase 1/2; Flu/RSV (mRNA-1045: mRNA-1010 + mRNA-1345) Phase 1; Flu/COVID-19/ RSV (mRNA-1230: mRNA-1010 + mRNA-1273 +mRNA-1345) Phase 1; Flu/COVID-19 (mRNA-1083: mRNA-1010 + mRNA-1283) Phase 1/2. The company intends to have a combination vaccine available as early as 2025 and expects to regularly update combinations with improved next-generation vaccine candidates as appropriate. The Company further expects to provide an investor update in Q4 of this year.”