The US Food and Drug Administration (FDA) has approved Moderna’s mFlusiva, making it the first messenger RNA (mRNA)-based seasonal influenza vaccine authorised in the United States for adults aged 50 and older.
The vaccine received traditional approval for adults aged 50 to 64, while those aged 65 and above were granted accelerated approval, Moderna announced on Wednesday.
The accelerated approval for older adults was based on data showing that mFlusiva produced a strong immune response. Moderna is required to conduct an additional clinical study to confirm the vaccine’s long-term benefits in this age group, with continued approval dependent on those results.
“Influenza remains a major public health challenge, and mFlusiva offers an important new vaccination option for older adults,” Moderna Chief Executive Officer Stéphane Bancel said in a statement.
The FDA’s decision was supported by a late-stage clinical trial involving more than 40,000 participants aged 50 and above.
According to Moderna, the study found that mFlusiva was 26.6% more effective at preventing laboratory-confirmed influenza-like illness than an existing licensed standard-dose influenza vaccine.