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FLUAD™ Flu Vaccine With Adjuvant

FLUAD™ Flu Vaccine With Adjuvant

This page provides information on FLUAD™ influenza vaccine.

Summary:

The U.S. Food and Drug Administration (FDA) has licensed a new seasonal influenza (flu) vaccine containing adjuvant for adults 65 years of age and older. An adjuvant is an ingredient added to a vaccine to create a stronger immune response to vaccination. The new flu vaccine, FLUAD™ [PDF - 270 KB], was licensed in November 2015 and will be available during the 2016-2017 flu season. It contains MF59 adjuvant, an oil-in-water emulsion of squalene oil. FLUAD™ is the first adjuvanted seasonal flu vaccine marketed in the United States.

Questions & Answers:

What is FLUAD™?

FLUAD™ is a standard-dose, three-component (trivalent) inactivated flu vaccine that contains an adjuvant. 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?

Adjuvants can be added vaccines to enhance 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.?

Yes, 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.

Is everyone approved to receive FLUAD™?

No, FLUAD™ is only licensed and approved 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 increased benefits of FLUAD™ compared to unadjuvanted seasonal flu vaccines for this age group?

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 Fluzone High-Dose vaccine.

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.

What other flu vaccines are available for people in this age group?

Previously, people 65 years and older had two flu shots available: A regular dose flu vaccine and a flu vaccine designed specifically for people 65 and older with a higher dose. The high dose vaccine contains four times the amount of antigen as the regular flu shot and has been associated with a stronger immune response following vaccination and better effectiveness than the regular dose flu vaccine in older people. Based on new CDC and Advisory Committee on Immunization Practices (ACIP) recommendations, FLUAD™ is now an acceptable alternative to other vaccines licensed for people 65 and older. There is no preferential recommendation made for any flu vaccine formulation for this age group.

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

CDC studies conducted during previous flu seasons estimate that 80 to 90 percent of seasonal flu-related deaths and 50-70 percent of hospitalizations occur among people 65 years of age and older. 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.

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