Fluzone High-Dose Seasonal Influenza Vaccine

This page provides information on the high-dose seasonal flu vaccine, Fluzone High-Dose.

Questions and Answers

What is Fluzone High-Dose vaccine?

Fluzone High-Dose is three-component (trivalent) inactivated flu vaccine, manufactured by Sanofi Pasteur Inc. Fluzone High-Dose is licensed specifically for people 65 years and older. Fluzone High-Dose contains four times the antigen (the part of the vaccine that helps your body build up protection against flu viruses) of standard-dose inactivated influenza vaccines. The higher dose of antigen in the vaccine is intended to give older people a better immune response, and therefore, better protection against flu.

Who can receive Fluzone High-Dose?

In the United States, Fluzone High-Dose is licensed only for persons aged 65 years and older. As with all flu vaccines, Fluzone High-Dose is not recommended for persons with a history of severe allergic reaction to the vaccine or to components other than eggs. Information about vaccine components is located in package inserts from each manufacturer.

What is the difference between Fluzone High-Dose and Fluzone Quadrivalent?

These products are both flu vaccines produced by one manufacturer. There are a number of other flu vaccines produced by other manufacturers.

Fluzone High-Dose and Fluzone Quadrivalent are both injectable influenza vaccines made to protect against the flu viruses most likely to cause illness for that particular flu season. Fluzone High-Dose contains four times the amount of antigen (the part of the vaccine that prompts the body to make antibody) contained in standard-dose inactivated influenza vaccines. The additional antigen is intended to create a stronger immune response (more antibody) in the person getting the vaccine.

Are there benefits of Fluzone High-Dose compared to standard dose seasonal flu vaccines for adults 65 years and older?

Data from clinical trials comparing Fluzone (a trivalent standard dose vaccine) to Fluzone High-Dose (a trivalent high-dose vaccine) among persons aged 65 years or older indicate that a stronger immune response (i.e., higher antibody levels) occurs after vaccination with Fluzone High-Dose. A study published in the New England Journal of Medicine indicated that the high-dose vaccine was 24.2% more effective in preventing flu in adults 65 years of age and older relative to a standard-dose vaccine. The confidence interval for this result was 9.7% to 36.5%. A separate study published in The Lancet Respiratory Medicine reported that Fluzone High-dose was associated with a lower risk of hospital admissions compared with standard-dose Fluzone for people aged 65 years or older, especially those living in long-term care facilities. The study compared hospitalization rates among more than 38,000 residents of 823 nursing homes in 38 states during the 2013-14 flu season.

Does Fluzone High-Dose offer better protection than the adjuvanted flu vaccine?

To date, there have been no randomized studies comparing Fluzone High-Dose with FLUAD (the adjuvanted influenza vaccine).

There are many vaccine options to choose from, but the most important thing is for all people 6 months and older to get a flu vaccine every year. If you have questions about which vaccine is best for you, talk to your doctor or other health care professional.

 How safe is Fluzone High-Dose?

Some adverse events (which are also reported after regular flu vaccines) were reported more frequently after vaccination with Fluzone High-Dose than after standard-dose inactivated influenza vaccines. The most common adverse events experienced during clinical studies were mild and temporary, and included pain, redness at the injection site, headache, muscle aches, and malaise. Most people had minimal or no adverse events after receiving the Fluzone High-Dose.

Does CDC recommend one vaccine above another for people 65 and older?

The CDC and its Advisory Committee on Immunization Practices have not expressed a preference for any flu vaccine indicated for people 65 and older. CDC recommends flu vaccination as the first and most important step in protecting against the flu.

Where can I find more information about Fluzone High-Dose?

More information about Fluzone High-Dose is available on the Food and Drug Administration (FDA) web site.

What other flu vaccines are available for people in this age group?

In addition to Fluzone High-Dose, one other influenza vaccine is licensed specifically for people 65 years and older.  The adjuvanted influenza vaccine contains an adjuvant, an ingredient intended to help improve immune response.  The adjuvanted vaccine was more effective than unadjuvanted standard-dose inactivated vaccine in a single-season observational study conducted among people 65 years and older. People in this age group may also receive standard-dose, unadjuvanted influenza vaccines or the recombinant influenza vaccine.  There is no preferential recommendation made for any flu vaccine formulation for this age group.

Why is there a need for flu vaccines designed specifically for people 65 years of age and older?

CDC studies conducted during previous flu seasons estimate that that between about 70 percent and 85 percent of seasonal flu-related deaths have occurred in people 65 years and older and between 54 percent and 70 percent of seasonal flu-related hospitalizations have occurred among people in that age group. However, older adults with weaker immune systems also may have a lower protective immune response after flu vaccination compared to younger, healthier people. This can result in lower vaccine effectiveness (i.e., a measure of how well the flu vaccine protects against flu illness), in these people. Newer flu vaccines made specifically for people 65 years of age attempt to improve the immune response and protection provided by flu vaccination in this age group.