The US FDA has approved mRNA-1010 (mflusiva), the first mRNA-based influenza vaccine, for active immunization against influenza A and B in adults aged ≥50 years, with accelerated approval for those ≥65 years based on immune response data. Mechanism of Action mRNA-1010 delivers messenger RNA encoding influenza antigens, enabling host cells to produce these antigens and generate an immune response.
Clinical Evidence Approval is supported by a phase 3, randomized, active-controlled trial (n≈40,000+) in adults ≥50 years, where mRNA-1010 demonstrated superior efficacy vs standard-dose inactivated influenza vaccine, achieving a relative vaccine efficacy of ~26.6% against RT-PCR–confirmed influenza-like illness. Dosage and Administration Route: Intramuscular Dose: Single 0.38 mL injection administered prior to influenza season Contraindications History of severe allergic reaction (e.g.,…
