Also known as: seasonal flu
Seasonal influenza is an acute viral respiratory infection that circulates globally each year. Most cases are self-limited, but severe illness and deaths occur, especially in high-risk groups.
FDA's advisory committee voted 9-0 that Moderna's mRNA flu vaccine mFlusiva benefits outweigh risks for adults 50-64 and 65+, clearing a key hurdle before an Aug. 5, 2026 decision. The FDA initially declined to review the BLA before reversing course.
The FDA has refused to file Moderna's flu vaccine candidate mRNA-1010. The company will push forward outside the U.S. and pause its combination flu vaccine, while expressing disappointment over the decision's regulatory implications.
Moderna shares fell 11% on Friday, eyeing their worst week since August 2025 after a June surge. An FDA panel voted 9-0 for its mRNA-1010 flu vaccine, with a decision due by August 5.
Merck will acquire Terns Pharmaceuticals for $6.7 billion to bolster its cancer pipeline ahead of Keytruda's 2028 patent expiration. The deal gives Merck access to TERN-701, an oral tyrosine kinase inhibitor for chronic myeloid leukemia. Merck projects over $70 billion in commercial opportunities from its pipeline by the mid-2030s.
Cidara Therapeutics is approaching a critical interim analysis of its Phase 3 ANCHOR trial for CD388, an influenza prophylactic candidate. The results will determine whether the company proceeds with its planned Biologics License Application.
Moderna's mRNA-1010 seasonal influenza vaccine enters FDA review following a revised approach that splits approval pathways by age group, with a decision expected by August 2026.
The FDA reversed an earlier refusal and agreed to review Moderna's seasonal flu vaccine application after the company revised its approach based on age groups, setting a decision date of August 5, 2026.
The FDA agreed to review Moderna's mRNA-1010 seasonal flu vaccine after initially refusing to file the application, setting a decision date of August 5, 2026. If approved, it would be the first mRNA-based seasonal influenza vaccine on the market.
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 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.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT06863142 |
Evaluating the Dose, Safety, Tolerability, and Immunogenicity of Mosaic Hexavalent Influenza Vaccine VRCFLUMOS0116-00-VP (FluMos-v2) With and Without ALFQ Adjuvant in Healthy Adults |
RECRUITING | PHASE1 |
| NCT06602024 |
A Study of mRNA-1010 Compared With a Licensed Influenza Vaccine in Adults ≥50 Years of Age |
COMPLETED | PHASE3 |
| NCT06049927 |
A Phase III Clinical Trial of Quadrivalent Influenza Vaccine in Healthy Subjects Aged 6 to 35 Months |
COMPLETED | PHASE3 |
| NCT05827978 |
Study of mRNA-1010 Seasonal Influenza Vaccine in Adults |
COMPLETED | PHASE3 |
| NCT05827068 |
A Study of mRNA-1011.1, mRNA-1011.2, and mRNA-1012.1 Candidate Seasonal Influenza Vaccines in Healthy Adults |
COMPLETED | PHASE1/PHASE2 |
| NCT05566639 |
A Study of mRNA-1010 Seasonal Influenza Vaccine in Adults 50 Years Old and Older |
COMPLETED | PHASE3 |
| NCT05512494 |
Lot-to-lot Consistency of Quadrivalent Influenza Vaccine (Split Virion), Inactivated |
COMPLETED | PHASE4 |
| NCT05431725 |
Immunogenicity and Safety Study of Influenza Vaccine (Split Virion), Inactivated, Quadrivalent |
COMPLETED | PHASE3 |
| NCT05415462 |
A Study of mRNA-1010 Seasonal Influenza Vaccine in Adults |
COMPLETED | PHASE3 |
| NCT05397223 |
A Study of Modified mRNA Vaccines in Healthy Adults |
COMPLETED | PHASE1 |
