Also known as: mResvia, mRESVIA
mRESVIA is Moderna's mRNA-based respiratory syncytial virus vaccine approved to prevent RSV-associated lower respiratory tract disease in older adults and in adults aged 18-59 at increased risk. FDA documentation includes approval letters in 2025 reflecting expanded indications and updates.
GSK's RSV vaccine Arexvy received expanded FDA approval to cover all high-risk adults, adding approximately 21 million Americans under 50 to the eligible population and matching competitor approvals from Pfizer and Moderna.
Moderna announced UK authorization for its updated Spikevax vaccine targeting the LP.8.1 variant and European Commission marketing authorization for mNEXSPIKE, its third vaccine approved in the EU.
Moderna's seasonal influenza vaccine candidate mRNA-1010 receives FDA acceptance after initial refusal, with a PDUFA date set for August 5, 2026. The revised application proposes full approval for adults 50-64 and accelerated approval for those 65 and older.
Moderna partners with Recordati on propionic acidemia therapy for up to $160 million, while FDA Commissioner defends mRNA vaccine support following funding cuts and regulatory challenges.
Moderna received European Commission marketing authorization for its COVID-19 vaccine mNEXSPIKE for individuals aged 12 and older. The FDA also reversed its decision and agreed to review the company's seasonal flu vaccine application.
Moderna faces a pivotal transition from pandemic-era revenues to a diversified mRNA portfolio, with recent regulatory setbacks offset by strong RSV vaccine performance and upcoming Phase 3 oncology readouts.
The European Commission has granted marketing authorization for Moderna's mNEXSPIKE (mRNA-1283) COVID-19 vaccine for individuals aged 12 years and older across all 27 EU member states plus Iceland, Liechtenstein and Norway.
