Fluzone High-Dose Seasonal Influenza Vaccine

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

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

What is Fluzone High-Dose Quadrivalent vaccine?

Fluzone High-Dose Quadrivalent vaccine contains four times the antigen as standard dose flu vaccines. It is manufactured by Sanofi Pasteur Inc. Fluzone High-Dose Quadrivalent is a four-component flu vaccine. It is one of three influenza vaccines (along with Flublok Quadrivalent and Fluad Quadrivalent) that is preferentially recommended for people 65 years and older. This preferential recommendation is new for the 2022-2023 season.

Who can receive Fluzone High-Dose Quadrivalent?

In the United States, Fluzone High-Dose Quadrivalent vaccine is approved only for people 65 years and older. Fluzone High-Dose Quadrivalent is not approved for people younger than 65 years or for people of any age with a history of severe allergic reaction to any influenza vaccine or to vaccine components other than eggs. Information about vaccine ingredients is located in the manufacturer’s package insert.

Are any of the available flu vaccines recommended over others?

Yes, for some people. There are three influenza vaccines that are preferentially recommended for people 65 years and older. These are Fluzone High-Dose Quadrivalent vaccine Flublok Quadrivalent recombinant Influenza vaccinea nd Fluad Quadrivalent adjuvanted influenza vaccine. This recommendation was based on a review of available studies which suggests that, in this age group, these vaccines are potentially more effective than standard dose unadjuvanted influenza vaccines. There is no preferential recommendation for people younger than 65 years.

What if a preferentially recommended flu vaccine is not available?

If none of the three influenza vaccines preferentially recommended for people 65 years and older is available at the time of administration, people in this age group should get any other age-appropriate influenza vaccine instead. 

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 immunogenicity studies 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) occurred after vaccination with Fluzone High-Dose. 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.

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

There are currently no randomized studies comparing the efficacy of high-dose and adjuvanted influenza vaccines against laboratory-confirmed influenza. Observational studies comparing each of these vaccines suggest that each is potentially more effective in preventing influenza-associated hospitalizations (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. Of note, there are not yet studies comparing the efficacy or effectiveness of the currently available quadrivalent formulations of the high-dose and adjuvanted inactivated vaccines with standard-dose unadjuvanted vaccines. Currently available data comes from studies of the trivalent formulations of both of these vaccines.

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 of these were mild in severity. In a study comparing Fluzone High-Dose Quadrivalent with trivalent Fluzone High-Dose, some of these side effect were slightly more common with the quadrivalent vaccine, but most were mild and resolved within a few days.

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

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

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

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

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

All flu vaccines available for the 2022-2023 season (with the exception of the live attenuated influenza vaccine, which is approved for ages 2 through 49 years) can be used for people aged 65 years and older. However, three specific vaccines are preferentially recommended for this age group. In addition to Fluzone High-Dose Quadrivalent, one other flu vaccine is licensed specifically for people 65 years and older. This is Fluad Quadrivalent, which contains an adjuvant, an ingredient intended to help improve immune response. Additionally, there is a recombinant influenza vaccine, Flublok Quadrivalent, which was first licensed by the FDA in the United States for use in adults 18 years and older. Fluzone High-Dose Quadrivalent, Fluad Quadrivalent, and Flublok Quadrivalent are all preferentially recommended for people aged 65 years and older.

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, including Fluzone High-Dose Quadrivalent vaccine, Flublok Quadrivalent recombinant vaccine, and Fluad Quadrivalent vaccine that potentially provide better immunity in this age group.