FDA approves flu vaccine for elderly

The U.S. Food and Drug Administration recently approved the first seasonal influenza vaccine to contain a natural occurring substance known to enhance or direct the immune response of those who are vaccinated.

The new vaccine, Fluad, is a trivalent vaccine, which means it protects against three flu strains (two subtype A and one type B), and has been approved for seasonal flu prevention for the elderly population. It is manufactured using an egg-based process and is formulated with adjuvant, an oil-in-water emulsion of squalene oil that is highly purified for the vaccine manufacturing process.

“Fluad provides another alternative for a safe and effective influenza vaccine in people 65 years of age and older,” said Dr. Karen Midthun, director of the FDA’s Center for Biologics Evaluation and Research, in a news release. “Immunizing individuals in this age group is especially important because they bear the greatest burden of severe influenza disease and account for the majority of influenza-related hospitalizations and deaths.”

In recent years, according to the U.S. Centers for Disease Control and Prevention, it’s estimated that 80 to 90 percent of seasonal flu-related deaths and 50 to 70 percent of hospitalizations have occurred in people 65 years old and older.

The approval of Fluad was based on the results of a multicenter clinical trial of more than 7,000 older adults that showed the vaccine demonstrated a strong immune response to all three vaccine strains without any safety concerns. The most common adverse effects were reported were injection site pain and tenderness, muscle aches, headache and fatigue.

“This new flu vaccine could be good for the pure amount of vaccine being produced as it could mean less of a possibility for shortages in the future,” says Dr. Brian Chudik, an Advocate Medical Group family medicine physician on staff at Advocate Sherman Hospital in Elgin, Ill. “This vaccine has been around for a number of years in other countries.”

Fluad was first approved for use in Italy in 1997 and is currently approved in 38 countries, including Canada and 15 European countries.

The CDC recommends an annual flu shot for everyone over 6 months old, unless they’re allergic to the vaccine. Last year, the majority of people older than 65 received their flu shot, while only 33 percent of adults 18 to 49 years got vaccinated.

“For my patients over 65 years old, I recommend the high-dose flu vaccine in hope that there is a better immune response and therefore better protection when exposed to the virus,” Dr. Chudik says.