21 May 2025 - Moderna today announced that in consultation with the US FDA, the Company has voluntarily withdrawn the pending biologics license application for mRNA-1083, its flu/COVID combination vaccine candidate for adults aged 50 years and older.
The Company plans to resubmit the biologics license application later this year, after vaccine efficacy data from the on-going Phase 3 trial of its investigational seasonal influenza vaccine, mRNA-1010, are available.