Influenza is a viral respiratory disease that occurs in seasonal epidemics and can also cause pandemics. WHO reports that seasonal influenza infects up to about one billion people each year, with millions of severe cases and substantial mortality.
A 19-month-old girl with influenza A (H1N1)-associated acute necrotizing encephalitis made a complete neurological recovery despite a severity score of 6. Multimodal immunomodulatory therapy including IVIG, corticosteroids, anakinra, and plasma exchange led to rapid decline in blood cytokine levels. The case underscores early recognition and targeted treatment in young children.
The FDA approved Moderna's mFlusiva, the first mRNA-based flu vaccine, for adults 50 and older. Full approval covers ages 50-64; accelerated approval covers 65+. Moderna expects availability later this year, pending CDC recommendation.
Merck & Co. is bolstering its oncology pipeline with acquisitions like Terns Pharmaceuticals and Cidara Therapeutics, while Keytruda remains the key growth driver. It expects Keytruda peak sales of $35 billion by 2028 and aims to launch 20 new drugs by 2030.
FDA approved Moderna's mFLUSIVA, the first mRNA-based flu vaccine for adults 50+. It was 27% more effective than standard flu shots in a large trial. The approval came after earlier FDA pushback.
Moderna posted Q2 2026 revenue of $145 million and a GAAP net loss of $0.8 billion, while improving its 2026 spending outlook. Its norovirus candidate missed Phase 3 interim criteria, and mFLUSIVA faces an August 5 PDUFA decision.
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.
The European Medicines Agency is enforcing clinical trial transparency and has launched a new vaccine information initiative, while a coalition of health professionals warns of suboptimal vaccination coverage across Europe. An analysis also shows that only a portion of EMA-approved medicines are available to NHS patients in England after additional assessments.
The FDA has agreed to review Moderna's mRNA flu vaccine after initially rejecting it, with a decision expected by August 2026. The reversal occurs amid a contraction in the vaccine sector, with funding drops and layoffs under the Trump administration.
NHMRC Tracker newsletters cover the new Research Translation Strategy 2026–2030, a revised generative AI policy, RRR Capacity Building grants, and consultations on drinking water and clinical guidelines.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07779408 |
Study to Assess Safety and Immunogenicity of an Egg-based H5N8 Influenza Vaccine at Multiple Dose Levels Adjuvanted With Matrix-M in Healthy Participants 18 Years of Age and Above. |
NOT_YET_RECRUITING | PHASE1/PHASE2 |
| NCT07739446 |
Effect of Surgical Masks in Preventing Acute Respiratory Infections |
ENROLLING_BY_INVITATION | NA |
| NCT07737106 |
Phase I/II Clinical Trial of Influenza Vaccine (Split Virion), Inactivated (High Dose) |
COMPLETED | PHASE1 |
| NCT07703514 |
Safety and Immunogenicity of Chimeric Hemagglutinin mRNA Vaccine Candidates |
NOT_YET_RECRUITING | PHASE1 |
| NCT07678619 |
Smart Analysis and Decision-Making for Emerging Infectious Diseases |
ENROLLING_BY_INVITATION | NA |
| NCT07651761 |
Patient-Centered Practical Vaccine Talk For Busy Clinicians |
ENROLLING_BY_INVITATION | NA |
| NCT07645534 |
Safety and Pharmacokinetics of Ingavirin Forte, Capsules, 90 mg + 20 mg (Valenta Pharm JSC, Russia) Compared With Ingavirin, Capsules, 90 mg, Under Fasting and Fed Conditions. |
RECRUITING | PHASE1 |
| NCT07610967 |
Light-based Immunomodulation for Guarding Against Human Respiratory Tract Infections |
NOT_YET_RECRUITING | NA |
| NCT07599449 |
Virological Surveillance of Acute Respiratory Infection in Primary Health Care in Metropolitan France |
RECRUITING | |
| NCT07545564 |
A Study on Mucosal Specific IgA Immunokinetics After Administration of Nasal Spray Live Attenuated Influenza Vaccine |
ENROLLING_BY_INVITATION | PHASE4 |
