Also known as: Fluarix
The European Medicines Agency's Committee for Medicinal Products for Human Use has adopted a positive opinion recommending marketing authorization for Moderna's mCOMBRIAX, the world's first combination Covid-19 and influenza vaccine, for individuals 50 years 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.
The FDA has reversed its earlier refusal and will now review Moderna's mRNA-based flu vaccine application, with a decision expected by August 5. The company modified its regulatory approach to address concerns about older adults.
The FDA has agreed to review Moderna's mRNA influenza vaccine application after initially rejecting it, following modifications by the company. A decision is expected by August 5, 2026.
The FDA agreed to review Moderna's mRNA-based flu vaccine after initially refusing, accepting a split regulatory approach with traditional approval for ages 50-64 and accelerated approval for 65 and older. Decision date set for August 5, 2026.
The FDA reversed its refusal to review Moderna's mRNA flu vaccine application after the company amended its submission. The agency will now consider full approval for adults 50-64 and accelerated approval for those 65 and older, with a decision expected by August 5, 2026.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07259252 |
Influenza Vaccination After Acute Coronary Syndrome |
RECRUITING | NA |
| NCT07071701 |
A Clinical Trial to Observe the Safety of 23-Valent Pneumococcal Polysaccharide Vaccine in Target Population |
COMPLETED | |
| NCT06864143 |
A Study to Investigate the Immunogenicity, Reactogenicity, and Safety of mRNA-1083 (Influenza and COVID-19) Vaccine in Adults ≥18 to <65 Years of Age |
COMPLETED | PHASE2 |
| NCT06738082 |
Influenza Vaccine Elicited Immune Response in Immunocompromised Patients |
COMPLETED | |
| NCT06716567 |
Maternal Determinants of Immunity to Influenza |
COMPLETED | PHASE4 |
| NCT06355232 |
Covid-19 and Influenza Oral Vaccine Study |
RECRUITING | PHASE1 |
| NCT06336317 |
Effect of infLuenza vaccInation After Myocardial INfArction on Cardiac inflammaTory responsE |
RECRUITING | PHASE4 |
| NCT06279871 |
Immunogenicity and Safety Study of Self-amplifying mRNA COVID-19 Vaccine Administered With Influenza Vaccines in Adults |
COMPLETED | PHASE3 |
| NCT06141655 |
HD vs SD Quadrivalent Influenza Vaccine in Adults Aged 65 to 79 Years in Galicia |
COMPLETED | PHASE4 |
| NCT06097273 |
A Study of mRNA-1083 (SARS-CoV-2 and Influenza) Vaccine in Healthy Adult Participants, ≥50 Years of Age |
COMPLETED | PHASE3 |
