First Seasonal Flu Vaccine of Its Kind Gets the FDA Seal of Approval

It’s not too late to get a flu vaccine, and now there’s a new one to consider. The first seasonal flu vaccine containing an adjuvant, Fluad, received accelerated approval from the US Food and Drug Administration (FDA) for adults age 65 and older.

Flu vaccination in the elderly has been a long-standing debate, and while a recent study made a case for why they should get them, researchers have developed a new approach in this highly susceptible group. The Centers for Disease Control and Prevention (CDC) reports that 80% to 90% of fatalities from seasonal influenza occurs in those ages 65 and older. Fluad, a trivalent vaccine, is able to protect against three influenza virus strains, including two subtype A and one type B.

“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,” Karen Midthun, MD, director of the FDA’s Center for Biologics Evaluation and Research said in a news release.

• The MD Magazine Infectious Disease specialty page

Fluad first went on the market in Italy in 1997. Since then, it has been approved in 38 additional countries, including Canada and 15 in Europe. A clinical trial conducted in the United States including 7,082 adults ages 65 and older tested the vaccine for its ability to cause an antibody response as well as safety. It was also tested for safety in another 27,000 elderly participants. Adverse effects were minimal with the most common people headache, fatigue, muscle aches, and pain and tenderness at the injection site.

Fluad generated a response comparable to Agriflu, an FDA-approved unadjuvanted trivalent seasonal influenza vaccine. The new vaccine received accelerated approval regulatory pathway from the FDA, which can be used for products pertaining to serious or life-threatening diseases and shows promising beneficial evidence.

“Fluad provides another alternative for a safe and effective influenza vaccine in people 65 years of age and older,” Midthun confirmed.

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