Fluzone High-Dose Seasonal Influenza Vaccine

This document provides information on the Fluzone High-Dose seasonal influenza vaccine.

Visit What You Should Know for the 2016-2017 Influenza Season for flu and flu vaccine information specific to the 2016-17 flu season.

What is Fluzone High-Dose influenza vaccine?

Fluzone High-Dose is an influenza vaccine, manufactured by Sanofi Pasteur Inc., designed specifically for people 65 years and older.

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

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

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

The intradermal flu vaccine is a shot that is injected into the skin instead of the muscle. The intradermal shot uses a much smaller needle than the regular flu shot, and it requires less antigen to be as effective as the regular flu shot. It may be used in adults 18-64 years of age.

Why is a higher dose vaccine available for adults 65 and older?

Human immune defenses become weaker with age, which places older people at greater risk of severe illness from influenza. Also, ageing decreases the body’s ability to have a good immune response after getting influenza vaccine. A higher dose of antigen in the vaccine is supposed to give older people a better immune response, and therefore, better protection against flu.

Does the higher dose vaccine produce a better immune response in adults 65 years and older?

Data from clinical trials comparing Fluzone to Fluzone High-Dose 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. Whether or not the improved immune response leads to greater protection has been the topic on ongoing research. 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 more immunogenic, high-dose vaccines can reduce the number of hospital admission 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.

Is Fluzone High-Dose safe?

The safety profile of Fluzone High-Dose vaccine is similar to that of regular flu vaccines, although some adverse events (which are also reported after regular flu vaccines) were reported more frequently after vaccination with Fluzone High-Dose. 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 vaccine.

Who can get this vaccine?

Fluzone High-Dose is approved for use in people 65 years of age and older. As with all flu vaccines, Fluzone High-Dose is not recommended for people who have had a severe reaction to the flu vaccine in the past.

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.

How is the Fluzone High-Dose vaccine available?

This vaccine is approved for marketing in 0.5 mL preservative-free, single dose, prefilled syringes.

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.