News Brief
Moderna has voluntarily withdrawn the pending Biologics License Application (BLA) for its combination flu-COVID vaccine candidate mRNA-1083, for adults aged 50 years and older, according to the company.
Moderna says the withdrawal was done “in consultation with the US Food and Drug Administration.”
In June 2024, Moderna announced positive Phase 3 trial results for mRNA-1083, reporting the combo flu-COVID vaccine elicited statistically significantly higher immune responses against three influenza strains (H1N1, H3N2, and B/Victoria) and the SARS-CoV-2 variant Omicron XBB.1.5 in both age cohorts (50-64 years and 65 years and older) compared to the licensed flu and COVID-19 vaccines.
The company said it plans to resubmit the BLA later this year, after vaccine efficacy data from the ongoing Phase 3 trial of its investigational seasonal influenza vaccine, mRNA-1010, are available (data expected this summer).
