FDA approves Fluad for seniors

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The Food and Drug Administration has approved Fluad, the first seasonal influenza vaccine containing an adjuvant.

Fluad is approved for preventing the flu in those over age 65. It contains the adjuvant MF59, an oil-in-water emulsion of squalene oil.

Up to 90% of seasonal influenza-related deaths and between 50% and 70% of hospitalizations related to flu are among people over age 65.

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

Fluad was evaluated in a multicenter clinical trial where 7,082 participants received either Fluad or Agriflu. Fluad induced antibody levels that were comparable to the levels induced by Agriflu. There were no safety concerns identified with Fluad.