Fluzone High-Dose Seasonal Influenza Vaccine

High-dose flu vaccine, brand name Fluzone High-Dose Quadrivalent

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-component (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 people 65 years and older. Fluzone High-Dose Quadrivalent is not recommended for people 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, than Fluzone Quadrivalent 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. Both Fluzone High-Dose and Fluzone Quadrivalent (standard dose) are produced by the same manufacturer and are quadrivalent vaccines. 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 previously available trivalent high-dose vaccine) among people 65 years and older indicated that a stronger immune response (i.e., higher antibody levels) occured 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 people 65 years and older who got Fluzone High-dose had a lower risk of hospital admission compared with people in that age group who got the standard-dose Fluzone, 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 2021-22 season, all Fluzone High-Dose vaccine will be quadrivalent. Data comparing the effectiveness of Fluzone High-Dose Quadrivalent with standard-dose inactivated quadrivalent 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 (a standard dose egg-based vaccine with MF 59 adjuvant approved for people 65 years and older) provided greater protection against flu-related hospitalizations than standard-dose, egg based vaccines in both seasons.

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 side effects were reported more frequently after vaccination with trivalent Fluzone High-Dose 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 people had minimal or no side effects 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 (ACIP) have not expressed a preference for any flu vaccine indicated for people 65 years and older.

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 vaccine,FLUAD Quadrivalent, external icon contains an adjuvant, an ingredient intended to help improve immune response.

One recombinant influenza vaccine, Flublok Quadrivalent (four ingredient), is available during the 2020–2021 influenza season. Flublok Quadrivalent was first licensed by the FDA in the United States for use in adults 18 years and older in 2017.  An earlier trivalent version was licensed in 2013 but was later replaced by the quadrivalent version. A new CDC study showed that flu shots made using recombinant technology produced a better antibody response among health care personnel compared with both cell-based and traditional flu shots.

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

People 65 years and older are at increased risk of developing serious complications from flu compared with young, healthy adults. This is partly because human immune defenses become weaker with increasing age. During most seasons, people 65 years and older account for the majority of flu hospitalizations and deaths. In the United States, between about 70 percent and 85 percent of seasonal flu-related deaths and between 50 percent and 70 percent of seasonal flu-related hospitalizations have occurred among people 65 years and older. The weakened immune system can also mean that older people don’t respond as well to flu vaccination. Given the higher risk of severe flu illness and lower protective immune response after vaccination among older adults, substantial research and development have led to the production of new flu vaccines intended to provide better immunity in this age group.