The FDA has approved the first mRNA flu vaccine from Moderna
- FDA has approved the first mRNA vaccine against influenza
- The mRNA‑1010 vaccine covers three strains: A/H1N1, A/H3N2, B/Victoria
- Intended for adults aged 50 and older
- The composition can be quickly changed according to WHO recommendations
The U.S. Food and Drug Administration (FDA) has officially approved the world's first preventive vaccine against influenza based on mRNA technology. The approval came from Moderna and marks an important step in expanding the arsenal of tools against seasonal respiratory infections.
The vaccine is designated mRNA‑1010 and has the commercial name mFLUSIVA. The preparation contains mRNA encoding the surface hemagglutinins (HA) of the three most common strains of the influenza virus: A/H1N1, A/H3N2, and B/Victoria. For each strain, a dose contains 12.5 µg of mRNA, which provides a sufficient immune response without excessive burden.
mRNA technology and its flexibility
The mRNA technology, successfully used in COVID‑19 vaccines, allows for rapid changes to the antigenic composition of the preparation. This is especially valuable for influenza, where strains change from year to year. According to the recommendations of the World Health Organization (WHO), the composition of the vaccine can be adjusted based on current epidemiological data, which reduces the time for developing and producing new doses.
The mFLUSIVA vaccine is intended for the prevention of influenza in adults aged 50 and older. This age group is traditionally more susceptible to severe disease and has a higher risk of complications, including hospitalization and mortality. The choice of target audience reflects the aim to minimize the severe consequences of seasonal outbreaks.
According to the Centers for Disease Control and Prevention (CDC), influenza causes between 9,000 and 45,000 deaths annually in the United States, as well as hundreds of thousands of hospitalizations. The introduction of the mRNA vaccine may enhance prevention effectiveness, as traditional inactivated vaccines sometimes show limited protection due to strain mismatch.
The regulatory process, which concluded with FDA approval, included an assessment of clinical data on safety and immunogenicity. Phase III trials demonstrated good tolerability of the drug and a significant increase in antibody levels to each of the three strains compared to placebo.
The approval of mRNA‑1010 paves the way for a more flexible strategy in the fight against influenza, allowing the vaccine to be adapted to changing viral landscapes. It is expected that in the coming seasons, Moderna will begin mass production and supply, and other pharmaceutical companies may follow suit, expanding the range of mRNA-based drugs for the prevention of infectious diseases.
Source: N+1
