Fluad is First Flu Vaccine with Adjuvant Approved by FDA

Fluad is First Flu Vaccine with Adjuvant Approved by FDA
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December 1, 2015

The Food and Drug Administration (FDA) has issued an approval for Fluad, the first seasonal influenza vaccine containing an adjuvant. The agency believes this treatment, a trivalent vaccine produced from three influenza virus strains, is an effective preventative tool to combat the disease in elderly patients.

Fluad is formulated with the adjuvant MF59, 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. Adjuvants are incorporated into some vaccine formulations to enhance or direct the immune response of the vaccinated individual.

"Fluad provides another alternative for a safe and effective influenza vaccine in people 65 years of age and older," Karen Midthun, director of the FDA's Center for Biologics Evaluation and Research, said in a written statement. "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."

Safety was also evaluated in approximately 27,000 additional individuals 65 years of age and older. No safety concerns were identified with Fluad. The most common adverse events reported include injection site pain and tenderness, muscle aches, headache and fatigue.

Fluad was approved using the accelerated approval regulatory pathway, which allows the FDA to approve products for serious or life-threatening diseases based on evidence that the product has an effect on an outcome that is reasonably likely to predict clinical benefit. In the case of Fluad, the antibody response to the vaccine provided this evidence. Under the accelerated approval requirements, a confirmatory study is required to verify and describe the clinical benefit of Fluad.

According to the Centers for Disease Control and Prevention (CDC), in recent years, it is estimated that 80 to 90 percent of seasonal influenza-related deaths and 50 to 70 percent of seasonal influenza-related hospitalizations have occurred among people 65 years of age and older.

Fluad was first approved for use in Italy in 1997 and is currently approved in 38 countries, including Canada and 15 European countries. Fluad and Agriflu are manufactured by Novartis Vaccines and Diagnostics Limited.