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FDA Approves First Flu Vaccine Containing an Adjuvant

Adjuvant can enhance or direct the immune response of the vaccinated individual

injections jar

MONDAY, Nov. 30, 2015 (HealthDay News) -- The first seasonal influenza vaccine with an adjuvant has been approved for use in seniors, according to the U.S. Food and Drug Administration.

Fluad is a trivalent vaccine, and contains the adjuvant MF59, which is made with squalene oil, the FDA said in an agency news release.

The vaccine's approval is based on an international clinical trial of 7,082 people, aged 65 and older, who received either Fluad or Agriflu, another trivalent seasonal flu vaccine. Both vaccines triggered comparable immune responses. The study also concluded that Fluad was safe. The most common side effects were injection site pain and tenderness, muscle aches, headache, and fatigue.

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

Fluad -- made by Novartis -- has been used in Italy since 1997 and is currently approved in 38 countries, the FDA said.

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