High-dose seasonal flu vaccine approved

The FDA recently approved a new high-dose vaccine against seasonal influenza subtypes A and B for patients 65 and older.

The vaccine, Fluzone High-Dose (Sanofi Pasteur Inc.), contains a total of 180 micrograms (mcg) of influenza virus hemagglutinin (HA) in each dose, made up of 60 mcg of each of the three influenza virus strains. Other currently licensed vaccines contain a total of 45 mcg of virus hemagglutinin, the FDA announcement said.

In clinical studies, the high-dose vaccine demonstrated an enhanced immune response compared with regular Fluzone in individuals 65 and older, although non-serious adverse events were more frequent. The rate of serious events was comparable. The vaccine was approved under the FDA's accelerated pathway, which requires the manufacturer to conduct further studies to verify that it will decrease seasonal influenza disease after vaccination.