Biotech Values

[DewDiligence]

MRNA’s flu/COVID combination vaccine meets phase-3 endpoints, showing non-inferior immune responses compared to SNY’s standalone Fluzone HD [high dose]/Fluarix and MRNA’s standalone Spikevax:

https://investors.modernatx.com/news/news-details/2024/Moderna-Announces-Positive-Phase-3-Data-for-Combination-Vaccine-Against-Influenza-and-COVID-19-/default.aspx

The ongoing Phase 3 clinical trial (https://clinicaltrials.gov/study/NCT06097273?id=NCT06097273 ) is a randomized, observer-blind, active control study evaluating the safety, reactogenicity and immunogenicity of mRNA-1083 in two independent age group cohorts of approximately 4,000 adults each.

One cohort, consisting of adults 65 years and older, compared mRNA-1083 to co-administered Fluzone HD, an enhanced influenza vaccine, and Spikevax, Moderna's currently licensed COVID-19 vaccine.

The other cohort of adults 50 to 64 years of age compared mRNA-1083 to co-administered, Fluarix, a standard dose influenza vaccine, and Spikevax.

The immune responses from a single dose of mRNA-1083 were found to be non-inferior versus the co-administered, routinely recommended, licensed comparators.

Note that the COVID component of mRNA-1083 (the code name for MRNA’s combination flu/COVID vaccine) is mRNA-1283, not the currently marketed Spikevax. I do not know the difference between mRNA-1283 and Spikevax, but MRNA refers to mRNA-1283 as its “next generation” COVID vaccine.

The flu portion of MRNA’s combination vaccine is mRNA-1010, for which mixed phase-3 results were reported in Feb 2023 (#msg-171230922).