FDA Approves Moderna mRNA Flu Vaccine for Adults Over 50
The US Food and Drug Administration has approved Moderna's mRNA seasonal influenza vaccine, mFlusiva, for adults aged 50 and older. The authorization follows a reversed regulatory stance and a Phase 3 trial involving over 40,000 participants. The vaccine targets four common strains, though trials indicated higher rates of mild to moderate side effects compared to traditional options.
Key points
- Moderna, a major biotechnology and pharmaceutical company, developed the mRNA seasonal flu vaccine known as mFlusiva or mRNA-1010.
- The US Food and Drug Administration approved the vaccine for adults aged 50 and older following an initial refusal to review the application.
- A Phase 3 clinical trial for the vaccine enrolled 40,805 adults across 11 countries to evaluate its safety and efficacy against standard options.
- Trial results indicated that mFlusiva was superior to standard-dose licensed vaccines for preventing influenza-like illness, though participants experienced more frequent solicited adverse events like injection-site pain, fatigue, and muscle pain.
The US Food and Drug Administration (FDA) has officially approved Moderna's mRNA-based seasonal influenza vaccine, mFlusiva, following an initial refusal by the agency to review the application. The pharmaceutical company announced that the immunization is cleared for adults aged 50 and older, marking a significant regulatory milestone for mRNA technology beyond COVID-19.
Approval for individuals aged 50 to 64 was granted after a comprehensive Phase 3 clinical trial that enrolled 40,805 adults across 11 countries. Additionally, the vaccine received accelerated approval for patients aged 65 and older. According to Moderna, researchers concluded during the studies that mRNA-1010 demonstrated superiority over standard-dose licensed vaccines in preventing influenza-like illness within the targeted age demographics.
Despite the positive efficacy findings, the trials also highlighted increased occurrences of solicited adverse events compared to conventional flu shots. Patients reported higher frequencies of mild-to-moderate and transient side effects, including injection-site pain, fatigue, headache, and myalgia. The World Health Organization previously estimated that common flu variants cause up to five million severe cases and as many as 650,000 respiratory deaths annually globally, establishing a substantial public health market for the newly approved immunization.
Sources
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