mFLUSIVA (influenza vaccine, mRNA) / Moderna - LARVOL DELTA

mFLUSIVA - an mRNA-based influenza vaccine. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Infectious Disease • Influenza • Novel Coronavirus Disease • Respiratory Diseases

mRNA-1010 and the Future of Seasonal Influenza Prevention: Towards Next-Generation Respiratory Vaccination. (PubMed, Vaccines (Basel)) - "At the same time, challenges related to manufacturing scalability, cost, cold-chain requirements, and global accessibility remain important considerations for widespread implementation. This perspective examines whether mRNA-1010 represents an incremental advance in influenza vaccination or a potential transformative milestone in respiratory immunization, while considering the continuing roles of alternative vaccine platforms in achieving optimal effectiveness, safety, and equitable global access."

Journal • Infectious Disease • Influenza • Novel Coronavirus Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

In older adults, mRNA-1010 vs. a licensed standard-dose influenza vaccine reduced influenza A- or B-related ILI at a median 181 d. (PubMed, Ann Intern Med) - "GIM/FP/GP: [Formula: see text] Infectious Disease: [Formula: see text] Public Health: [Formula: see text]."

Journal • Infectious Disease • Influenza • Respiratory Diseases

Indirect comparison of mRNA-1010 versus enhanced influenza vaccines in adults aged 65 years and older during the 2024-2025 US influenza season. (PubMed, J Med Econ) - "Consistency of findings across sensitivity analyses support the robustness of these results. Newer influenza vaccine modalities, including mRNA-based vaccines provide an additional comparable option to existing EVs to help further reduce severe influenza disease burden among older adults ≥65 years for whom enhanced vaccines are recommended."

Clinical • Journal • Infectious Disease • Influenza • Respiratory Diseases

U.S. FDA approves first mRNA flu shot from Moderna (cnbc) - "The shot, mFlusiva, was given a traditional approval for adults aged 50 to 64, ​and an accelerated approval for ​those 65 years and ​older. Moderna has agreed to run an additional study and submit more data in adults 65 and older to confirm the vaccine’s benefit in that age group....The approval was based on data from a late-stage trial involving more than 40,000 adults aged 50 and older, which showed the shot was 26.6% more effective than a licensed standard-dose flu vaccine."

FDA approval • Influenza

Optimized seasonal influenza mRNA vaccine compositions demonstrate safety and enhanced immunogenicity in a phase 2 study. (PubMed, Hum Vaccin Immunother) - P2 | "All mRNA-1010 vaccine compositions were well tolerated, with no safety concerns identified; all compositions induced HA-specific humoral and cellular immune responses against all influenza strains evaluated, with the optimized compositions exhibiting higher immune responses against influenza B strains compared with the original mRNA-1010 composition. These results, together with findings from other mRNA-1010 clinical studies, support continued evaluation of mRNA-1010 for enhanced protection against seasonal influenza.Clinical Trials Registration: Clinicaltrials.gov: NCT05868382."

Journal • P2 data • Infectious Disease • Influenza • Respiratory Diseases

Efficacy and Safety of an mRNA Seasonal Influenza Vaccine in Adults. (PubMed, N Engl J Med) - P3 | "In this trial, mRNA-1010 was superior to standard-dose licensed vaccines for prevention of RT-PCR-confirmed, protocol-defined influenza-like illness in adults 50 years of age or older. Solicited adverse reactions were more frequent with mRNA-1010. (Funded by Blackstone Life Sciences and Moderna; Fluent ClinicalTrials.gov number, NCT06602024.)."

Clinical • Journal • Fatigue • Infectious Disease • Influenza • Musculoskeletal Pain • Pain • Respiratory Diseases

mRNA-CRID-001: A Study of Modified mRNA Vaccines in Healthy Adults (clinicaltrials.gov) - P1 | N=308 | Completed | Sponsor: ModernaTX, Inc. | Active, not recruiting ➔ Completed

Trial completion • Cytomegalovirus Infection • Infectious Disease • Influenza • Novel Coronavirus Disease • Respiratory Diseases

Moderna Announces the U.S. Food and Drug Administration will Initiate the Review of Its Investigational Seasonal Influenza Vaccine Submission (ACCESS Newswire) - "To advance the review, Moderna proposed a regulatory pathway based on age, seeking full approval for adults 50 to 64 years of age and accelerated approval for adults 65 and older, along with a post-marketing requirement to conduct an additional study in older adults...Following submission of the amended application, the FDA has accepted the biologics license application (BLA) for review and assigned a Prescription Drug User Fee Act (PDUFA) goal date of August 5, 2026. Pending review and FDA approval, mRNA-1010 would be available for U.S. adults 50 years of age and older, including adults 65 and older, for the 2026/2027 flu season."

FDA event • FDA filing • Launch US • Influenza

mRNA-1010 has now been accepted for review in the United States, Europe, Canada and Australia with further submissions planned in 2026. Moderna expects the first potential approvals for mRNA-1010 in 2026, subject to various ongoing regulatory reviews. (ACCESS Newswire)

Approval • Filing • Influenza

Phase 1/2 randomized, observer-blind clinical trial of a first-generation, mRNA-based vaccine against seasonal influenza and COVID-19 in healthy adults. (PubMed, Hum Vaccin Immunother) - P1/2 | "Systems serology analysis indicated that mRNA-1073 induced robust, balanced antibody responses with comparable immune profiles to mRNA-1010 + mRNA-1273. mRNA-1073 had an acceptable safety profile and elicited durable immune responses against all vaccine-matched influenza and SARS-CoV-2 strains, supporting ongoing evaluations of mRNA-based multicomponent vaccines that simultaneously protect against seasonal influenza and COVID-19 in a single dose.Registration: ClinicalTrials.gov identifier: NCT05375838 (https://clinicaltrials.gov/study/NCT05375838)."

Clinical • Journal • P1/2 data • Infectious Disease • Influenza • Novel Coronavirus Disease • Respiratory Diseases

An mRNA influenza vaccine induces immunity comparable to an adjuvanted vaccine in a randomized trial. (PubMed, NPJ Vaccines) - P1 | "mRNA-1010 and FLUAD generated strong HA-specific CD4+ T-cell responses; a trend toward higher CD8+ T-cell responses was observed in mRNA-1010 recipients compared with FLUAD recipients for two of the four strains. These findings support the potential of the mRNA platform for seasonal influenza vaccination."

Journal • Infectious Disease • Influenza • Respiratory Diseases • CD4 • CD8

Moderna Announces Global Regulatory Submissions for Its Investigational Seasonal Influenza Vaccine (Yahoo Finance) - "The Company has filed for marketing authorization with the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), Health Canada, and the Therapeutic Goods Administration (TGA) in Australia....The regulatory applications are based on positive data from multiple Phase 3 studies."

Filing • Influenza

mRNA-1010 influenza vaccine elicits distinct and enhanced humoral immunity compared to adjuvanted inactivated vaccines. (PubMed, NPJ Vaccines) - P1 | "However, mRNA-1010 generated stronger Fc-receptor engaging antibodies, faster and completed functional humoral maturation, broader HA-specific binding antibodies, enhanced NK cell activating antibodies to two of the vaccine antigens, and higher HA-specific neutrophil activating antibodies across all vaccine HA antigens. Findings suggest that mRNA vaccination may elicit distinct Fab and Fc responses that may improve viral control and clearance."

Journal • Infectious Disease • Influenza • Respiratory Diseases

A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1010 in Healthy Adults (clinicaltrials.gov) - P2 | N=172 | Completed | Sponsor: ModernaTX, Inc. | Recruiting ➔ Completed | N=325 ➔ 172

Enrollment change • Trial completion • Infectious Disease • Influenza • Respiratory Diseases

mRNA-1010, an mRNA-Based Influenza Vaccine, is Safe and Efficacious in Adults Aged ≥50 Years, Including Individuals at High Risk for Severe Disease (ESWI 2025) - No abstract available

Clinical • Late-breaking abstract • Infectious Disease • Influenza

A Study of mRNA-1010 Compared With a Licensed Influenza Vaccine in Adults ≥50 Years of Age (clinicaltrials.gov) - P3 | N=40817 | Completed | Sponsor: ModernaTX, Inc. | Active, not recruiting ➔ Completed | Trial completion date: Jun 2026 ➔ Aug 2025 | Trial primary completion date: Jun 2026 ➔ Aug 2025

Trial completion • Trial completion date • Trial primary completion date • Infectious Disease • Influenza • Respiratory Diseases

Immunogenicity and safety of mRNA-based seasonal influenza vaccines encoding hemagglutinin and neuraminidase. (PubMed, Nat Commun) - P1/2 | "In this phase 1/2 trial (NCT05333289), healthy adults 18-75 years were randomly assigned to receive different doses of mRNA-1020 or mRNA-1030 (encoding HA and NA at different ratios), mRNA-1010 (encoding HA), or a licensed active comparator (recombinant HA). There were no vaccine-related serious adverse events nor significant associated safety concerns through 181 days. mRNA-1020 and mRNA-1030 elicited high HA-specific immune responses and induced NA-specific immune responses with no additional reactogenicity at equivalent dose levels beyond an mRNA-based, HA-only-containing vaccine."

Clinical • Journal • Fatigue • Infectious Disease • Influenza • Pain • Respiratory Diseases

A Study of mRNA-1010 Compared With a Licensed Influenza Vaccine in Adults ≥50 Years of Age (clinicaltrials.gov) - P3 | N=56000 | Active, not recruiting | Sponsor: ModernaTX, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease • Influenza • Respiratory Diseases

Shared clinical and immunologic features of mRNA vaccines: preliminary results from a comparative clinical study. (PubMed, Front Immunol) - P1 | "This ongoing, open-label, phase 1 trial randomized healthy adults (18-75 years) to receive a single dose of mRNA-1273.222 (bivalent COVID-19), mRNA-1345 (RSV), mRNA-1010 (influenza), and FLUAD (active influenza comparator) or 2 or 3 doses of mRNA-1647 (CMV). This suggests that the observed reactogenicity of mRNA vaccines may be related to shared features of the mRNA platform (LNP platform). ClinicalTrials.gov, identifier NCT05397223."

Clinical • Journal • Infectious Disease • Inflammation • Influenza • Novel Coronavirus Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections • CCL4 • CCL8 • CD4 • CD8 • CXCL9 • IFNG • IL1R1 • IL2RA • IL6

A Study of mRNA-1010 Compared With a Licensed Influenza Vaccine in Adults ≥50 Years of Age (clinicaltrials.gov) - P3 | N=56000 | Recruiting | Sponsor: ModernaTX, Inc. | Trial primary completion date: Dec 2025 ➔ Jun 2026

Trial primary completion date • Infectious Disease • Influenza • Respiratory Diseases

An mRNA-based seasonal influenza vaccine in adults: Results of two phase 3 randomized clinical trials and correlate of protection analysis of hemagglutination inhibition titers. (PubMed, Hum Vaccin Immunother) - P3 | "An analysis of HAI titers as a correlate of protection against influenza infection provided support for its use as a surrogate endpoint for mRNA-1010, similar to licensed influenza vaccines. These findings support further optimization and development of mRNA-1010 against seasonal influenza."

Clinical • Journal • P3 data • Infectious Disease • Influenza • Respiratory Diseases

A phase 3 randomized safety and immunogenicity trial of mRNA-1010 seasonal influenza vaccine in adults. (PubMed, Vaccine) - P3 | "These findings support the potential benefit of mRNA-1010 as a seasonal influenza vaccine."

Journal • P3 data • Infectious Disease • Influenza • Respiratory Diseases

A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1010 in Healthy Adults (clinicaltrials.gov) - P2 | N=325 | Recruiting | Sponsor: ModernaTX, Inc. | Active, not recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Influenza • Respiratory Diseases

A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1010 in Healthy Adults (clinicaltrials.gov) - P2 | N=325 | Active, not recruiting | Sponsor: ModernaTX, Inc. | N=98 ➔ 325

Enrollment change • Infectious Disease • Influenza • Respiratory Diseases