Fluzone High-Dose Seasonal Influenza Vaccine

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

What is Fluzone High-Dose Quadrivalent vaccine?

Fluzone High-Dose Quadrivalent is the only licensed high-dose inactivated influenza (flu) vaccine; it is manufactured by Sanofi Pasteur Inc. Fluzone High-Dose Quadrivalent is a four-ingredient (quadrivalent) flu vaccine approved for people 65 years and older.

Who can receive Fluzone High-Dose Quadrivalent?

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

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

Fluzone High-Dose Quadrivalent contains four times the antigen, the part of the vaccine that helps your body build up protection against flu viruses, then Fluzone Quadrivalent and other standard-dose inactivated flu vaccines. Both are quadrivalent 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. Both these products are flu vaccines produced by the same manufacturer. There are a number of other flu vaccines produced by other manufacturers.

Are there benefits of Fluzone High-Dose Quadrivalent 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 and 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 Medicineexternal icon indicated that the high-dose vaccine was 24% more effective in preventing flu in adults 65 years and older relative to a standard-dose vaccine. Another study published in The Lancet Respiratory Medicineexternal icon reported that Fluzone High-dose was associated with a lower risk of hospital admissions compared with standard-dose Fluzone in adults 65 years and older, especially those living in long-term care facilities. This study was conducted during the 2013-14 flu season among more than 38,000 resident of 823 nursing homes in 38 states.

For the 2020-21 season, trivalent Fluzone High-Dose will be replaced by Fluzone High-Dose Quadrivalent. Data comparing the effectiveness of Fluzone High-Dose Quadrivalent with standard-dose inactivated vaccines are not yet available.

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

Studies published in the Journal of Infectious Diseases conducted during the 2017-2018external icon and 2018-2019external icon flu seasons among Medicare beneficiaries aged 65 years and older found that Fluzone High-Dose and FLUAD provided greater protection against flu-related hospitalizations than standard-dose, egg based vaccines in both seasons, while Flucelvax provided greater protection during the 2017-2018 season only.

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 Quadrivalent?

Some adverse events were reported more frequently after vaccination with trivalent Fluzone High-Dose than after standard-dose inactivated flu 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. In a study comparing Fluzone High-Dose Quadrivalent with trivalent Fluzone High-Dose, some of these side effects were slightly more common with the quadrivalent vaccine, but most were mild and resolved within a few days.

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

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

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

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

What other flu vaccines are available for people 65 years and older?

In addition to Fluzone High-Dose Quadrivalent, one other influenza vaccine is licensed specifically for people 65 years and older.  The adjuvanted flu vaccines (FLUAD and FLUAD Quadrivalent)external icon contain an adjuvant, an ingredient intended to help improve immune response.

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

People 65 years and older are at the highest risk for flu-related deaths and they have poorer immune responses to flu vaccines than younger people. CDC studies conducted during previous flu seasons estimateexternal icon that people 65 years and older account for 70 to 85 percent of flu-related deaths and 50 to 70 percent of flu-related hospitalizations each flu season. Older adults typically show lower protective immune responses after flu vaccination compared to healthy young people. Lower immune responses may lead to lower vaccine effectiveness (i.e., a measure of how well the flu vaccine protects against flu illness). Given the high risk of severe flu illness and low protective immune response after vaccination among older adults, substantial research and development have produced new flu vaccines intended to provide better immunity in this age group.