What to know
- Fluzone High-Dose flu vaccine contains four times the antigen as standard dose flu vaccines.
- In the United States, Fluzone High-Dose vaccine is approved for people 65 years and older.
- It is one of three flu vaccines that are preferentially recommended for people 65 years and older.
About Fluzone High-Dose vaccine
Fluzone High-Dose vaccine contains four times the antigen as standard dose flu vaccines. It is manufactured by Sanofi Pasteur Inc. Fluzone High-Dose is a three-component (trivalent) flu vaccine. It is one of three flu vaccines (along with Flublok and Fluad) that are preferentially recommended for people 65 years and older. There is no preferential recommendation for people younger than 65 years.
People who can receive Fluzone High-Dose vaccine
In the United States, Fluzone High-Dose vaccine is approved for people 65 years and older. Fluzone High-Dose is not approved for people younger than 65 years but is recommended as an acceptable option for flu vaccination (along with other age-appropriate inactivated and recombinant flu vaccines) for people 18 through 64 years who have had a solid organ transplant and are taking immunosuppressive medications. People of any age with a history of severe allergic reaction to any flu vaccine or to vaccine components other than eggs should not receive Fluzone High-Dose. Information about vaccine ingredients is located in the manufacturer's package insert.
Differences between Fluzone High-Dose vaccine and Fluzone vaccine
Fluzone High-Dose vaccine contains four times the antigen, the part of the vaccine that helps your body build up protection against influenza viruses, compared to Fluzone (standard-dose) vaccine and other standard-dose inactivated flu vaccines. The higher dose of antigen in the vaccine is intended to give people 65 years and older a better immune response to vaccination, and therefore, better protection against flu.
Data from immunogenicity studies comparing Fluzone High-Dose vaccine to Fluzone vaccine among people 65 years and older indicated that a stronger immune response (i.e., higher antibody levels) occurred after vaccination with Fluzone High-Dose vaccine. A randomized efficacy study published in the New England Journal of Medicine indicated that the trivalent high-dose vaccine was 24% more effective in preventing flu in adults 65 years and older relative to a standard-dose vaccine.
Both Fluzone High-Dose vaccine and Fluzone vaccine are produced by the same manufacturer and are trivalent vaccines. There are a number of other flu vaccines produced by other manufacturers.
Fluzone High-Dose vaccine compared to the adjuvanted flu vaccine (Fluad)
There are currently no randomized studies comparing the efficacy of high-dose and adjuvanted flu vaccines against laboratory-confirmed flu. Observational studies comparing each of these vaccines suggest that each is potentially more effective (with the most data being available for the high-dose vaccine). But, the magnitude of the relative effectiveness varies with the study and season, making it difficult to conclude that one vaccine is consistently more effective than the other across multiple seasons. Most currently available data comes from studies of the trivalent formulations of both of these vaccines.
Safety of Fluzone High-Dose vaccine
Some side effects were reported more frequently after vaccination with trivalent Fluzone High-Dose vaccine than after standard-dose inactivated flu vaccines. The most common side effects experienced during clinical studies were mild and temporary, and included pain, redness at the injection site, headache, muscle aches, and malaise. Most of these were mild in severity.