Flu Vaccine With Adjuvant

This page provides information on FLUAD influenza vaccine.

Questions & Answers:

What is FLUAD?

FLUAD is a standard-dose, three-component (trivalent) inactivated flu vaccine, manufactured by Seqirus that contains an adjuvant. FLUAD is designed specifically for people 65 years and older. It is manufactured using an egg-based process (like most flu vaccines), and is formulated with the adjuvant MF59. An adjuvant is an ingredient added to a vaccine that helps create a stronger immune response to vaccination.

What is MF59?

MF59 is an oil-in-water emulsion of squalene oil. Squalene, a naturally occurring substance found in humans, animals and plants, is highly purified for the vaccine manufacturing process. FLUAD is approved for use among people 65 years and older, who often have a lower protective immune response after flu vaccination compared to younger, healthier people.

Why are adjuvants added to flu vaccines?

An adjuvant is an ingredient of a vaccine that helps promote a better immune response. Adjuvants also can reduce the amount of virus needed for production of a vaccine, which can allow for greater supplies of vaccine to be manufactured.

Is FLUAD approved in other countries, besides the U.S.?

FLUAD was initially approved in Italy in 1997, and at the time of its U.S. approval in November 2015, had been licensed in 38 countries, including Canada and 15 European countries.

 Who can receive FLUAD?

In the United States, FLUAD is licensed only for persons aged 65 years and older. FLUAD 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.

Are there benefits of FLUAD compared to unadjuvanted seasonal flu vaccines for adults 65 years and older?

Studies that have tested FLUAD’s ability to generate an immune response against an influenza virus (immunogenicity) have found that antibody levels were comparable to levels induced by unadjuvanted trivalent seasonal flu vaccines (e.g., Agriflu). However, an observational study conducted in Canada among adults 65 years of age and older during the 2011-2012 flu season found that FLUAD was significantly more effective in preventing laboratory-confirmed influenza compared with an unadjuvanted standard-dose inactivated influenza vaccine.

Does FLUAD offer better protection than the high-dose flu vaccine?

To date, there have been no randomized studies comparing FLUAD with High-Dose flu vaccine (brand name, Fluzone).

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.

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 safe is FLUAD?

Some adverse events (which are also reported after regular flu vaccines) were reported more frequently after vaccination with FLUAD. The most common adverse events experienced during clinical studies were mild to moderate and were temporary, and included pain, redness at the injection site, headache, muscle aches, and malaise.

Where can I find more information about FLUAD?

More information about FLUAD 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 FLUAD, one other influenza vaccine is licensed specifically for people 65 years and older. The high dose vaccine contains four times the amount of antigen as the standard-dose inactivated influenza vaccine, and has been associated with a stronger immune response following vaccination and better effectiveness than the regular dose flu vaccine in older people in a two-season randomized trial. 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.