Breaking news from moderna signals a major step forward in the fight against respiratory viruses. The company recently announced positive results from a late-stage trial of its experimental mRNA-based flu vaccine. This success not only paves the way for the standalone flu shot but also clears a crucial path for Moderna’s highly anticipated combination vaccine targeting both influenza and COVID-19. For millions of people seeking simplified immunization, these findings represent a significant development.
Groundbreaking Trial Shows Strong Flu Vaccine Performance
Moderna’s experimental mRNA-based flu vaccine, known as mRNA-1010, demonstrated superior performance in a large Phase 3 clinical trial. The company reported on Monday that the shot produced a stronger immune response compared to a currently available standard flu vaccine. This trial involved over 40,000 adults aged 50 and above. Participants were randomly assigned to receive either a single dose of Moderna’s mRNA-1010 or a standard competitor vaccine.
The results revealed compelling efficacy data. Moderna’s shot was 26.6% more effective than the comparator vaccine across the overall study population. This increased effectiveness was particularly pronounced in older adults. Specifically, in adults aged 65 and older, the mRNA-1010 shot showed 27.4% greater efficacy than the standard flu vaccine.
Efficacy Across Key Flu Strains
The trial confirmed that the mRNA-1010 vaccine provided robust protection against the major influenza strains included in the shot. This includes efficacy against the A/H1N1 and A/H3N2 lineages, as well as the B/Victoria lineage. Importantly, Moderna noted that the vaccine’s benefits were consistent across different age groups. Efficacy held steady regardless of whether participants had various risk factors or their prior vaccination status against the flu.
Moderna CEO Stephane Bancel hailed the efficacy results as a “significant milestone.” He emphasized the importance of more effective vaccines, especially following the severity of recent flu seasons. Data from the Centers for Disease Control and Prevention (CDC) shows a concerning trend. Seasonal flu-related hospitalizations and outpatient visits reached a 15-year high during the 2024 to 2025 season. Over 600,000 Americans were hospitalized due to flu-related illness last year alone, according to the CDC. This highlights the urgent public health need for advanced flu protection.
Clearing the Path for a Combination Shot
The positive data from the standalone flu vaccine trial is critical for Moderna’s strategy involving a combined flu and COVID-19 vaccine. The company had previously attempted to gain U.S. Food and Drug Administration (FDA) approval for this combination shot in May. However, that application was voluntarily withdrawn after discussions with the FDA. Regulators at the time requested additional efficacy data specifically for the standalone flu vaccine component before they could proceed with the combination shot review.
With the successful Phase 3 trial now complete, Moderna has the necessary data. Stephen Hoge, Moderna’s head of research and development, confirmed in an interview that the company plans to resubmit the application for the combination vaccine. They also plan to file for approval of the standalone flu shot later this year. Hoge stated that if regulators approve the flu vaccine, the company can then advance the combination shot. Moderna expects approvals for both shots sometime next year, pending the FDA’s reviews.
Simplifying Vaccination for Public Health
Moderna believes a combination jab could significantly simplify vaccination. This streamlining effort is intended to “help the health-care system,” according to Hoge. By offering a single shot for protection against both viruses, the company aims to reduce the workload for doctors and nurses. It could also help slash costs associated with separate vaccination appointments. Crucially, a simpler schedule is expected to improve vaccine uptake among patients.
This is particularly relevant given the ongoing need for protection against both viruses. Public health experts note the substantial morbidity and mortality associated with the co-circulation of influenza and SARS-CoV-2 globally. Co-infected individuals often face worse outcomes. Developing combined vaccines that can be updated frequently to address viral mutations and waning immunity is paramount.
The Race for a Dual-Target Vaccine
Moderna appears to be a front-runner in the competitive landscape for bringing a combination flu and COVID-19 vaccine to market. Rivals like Pfizer and Novavax are also developing similar products. The market for respiratory virus vaccines is vast. While Moderna hasn’t released specific revenue projections for individual products, Hoge indicated that COVID, flu, and respiratory syncytial virus (RSV) each represent multibillion-dollar markets. “We’re obviously hoping that our products allow us to earn our fair share of them,” he added.
External research highlights key differences in the approaches taken by competitors. Pfizer/BioNTech are also developing a dual-target mRNA candidate. Their Phase 1/2 trials showed robust immune responses, but a recent Phase 3 trial update indicated their candidate did not meet non-inferiority criteria for the Influenza B strain compared to licensed vaccines. This challenge for Pfizer contrasts with Moderna’s reported success across the tested flu strains in its Phase 3 trial. Moderna’s approach has also historically involved higher mRNA dosages in its vaccines, potentially leading to stronger immune responses, although sometimes associated with higher reactogenicity. Moderna’s platform is also noted for potentially better temperature stability, a logistical advantage.
Safety Profile and Regulatory Landscape
The safety data for Moderna’s mRNA-1010 vaccine from the recent trial was consistent with previous findings from another Phase 3 study on the shot. Most adverse reactions reported were mild or moderate, similar to licensed comparators. No severe adverse reactions were reported in these Phase 3 trials. While Pfizer/BioNTech’s trials also reported mild to moderate reactions, external sources note that severe allergic reactions (anaphylaxis) have been observed during mass vaccination campaigns for Pfizer’s platform outside of clinical trials. Based on available trial data, Moderna’s candidate seems to present a potentially more favorable safety profile within clinical trial settings.
The current regulatory environment in the U.S. presents some uncertainty for vaccine developers. The administration has made several moves impacting vaccine policy. When asked about this, Stephen Hoge stated that Moderna is engaging closely with the FDA to understand its requirements and ensure they are satisfied. Despite potential challenges, he expressed confidence regarding the flu vaccine pathway: “I believe, as relates to flu, I think we’ve got a pretty clear path.”
Frequently Asked Questions
What did Moderna’s recent flu vaccine trial results show?
Moderna announced that its experimental mRNA flu vaccine, mRNA-1010, showed significantly higher efficacy compared to a standard flu shot in a large Phase 3 trial of over 40,000 older adults. It was 26.6% more effective overall and 27.4% more effective in adults aged 65+. The vaccine also demonstrated strong efficacy against key influenza strains like H1N1, H3N2, and B/Victoria.
How does Moderna’s combination shot development compare to competitors?
Moderna is considered a front-runner in the race for a combination flu and COVID-19 vaccine against rivals like Pfizer/BioNTech. While both use mRNA technology, Moderna’s standalone flu vaccine demonstrated positive Phase 3 efficacy needed for regulatory filing. Pfizer/BioNTech have faced challenges, specifically not meeting non-inferiority criteria for the Influenza B strain in their combination candidate’s Phase 3 trial, according to external reports.
When might Moderna’s flu and combination shots become available?
Following the positive Phase 3 data for the standalone flu vaccine, Moderna plans to resubmit its application for the combination flu and COVID-19 shot. The company also intends to file for approval of the standalone flu shot later this year. Moderna’s head of R&D expects potential regulatory approvals for both vaccines sometime next year, pending the FDA’s review process.
Conclusion: A Promising Future for Moderna
The positive late-stage trial results for Moderna’s mRNA flu vaccine mark a critical turning point for the company. After a challenging year marked by declining COVID-19 vaccine sales and a complex regulatory landscape, this news provides a much-needed bright spot. The strong efficacy data validates Moderna’s mRNA platform for seasonal influenza. More importantly, it directly addresses the regulatory hurdle that previously delayed the company’s combination flu and COVID-19 shot.
With plans to resubmit the combination shot application and file for the standalone flu vaccine this year, Moderna is poised for potential approvals in 2026. The prospect of a single, effective shot protecting against both major respiratory viruses could significantly impact public health by simplifying vaccination schedules, improving uptake, and easing burdens on healthcare systems. As Moderna navigates the final stages of development and regulatory review, the successful flu trial results underscore the potential of mRNA technology to offer enhanced protection against seasonal threats. This development positions Moderna favorably in the competitive market for future respiratory virus vaccines.
